Evaluation of the Medical Adult Day Care Services Demonstration (CMS-10204)

Evaluation of the Medical Adult Day Care Services Demonstration

REVISEDfinalOMB1.25.08supportingstatement

Evaluation of the Medical Adult Day Care Services Demonstration (CMS-10204)

OMB: 0938-1017

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Supporting Statement

Prepared for the Office of Management and Budget

Under Paperwork Reduction Act

Evaluation of the Medical Adult Day-Care Services Demonstration

Contract Number 500-00-0031/5

Walter Leutz, Ph.D., Project Director

Brandeis University

Tel: 781-736-3934

[email protected]

Susan Radke, M.S.W., Project Officer

Centers for Medicare & Medicaid Services

Tel: (410) 786-4450

[email protected]

December 17, 2007

Table of Contents

page

Background 4

A. Justification

1. Legal and Administrative Justification 5

2. Use of Information 6

3. Collection of Information 6

4. Duplication of Similar Information 6

5. Impacts on Small Businesses 7

6. Less Frequent Data Collection 7

7. Special Circumstances 7

8. Federal Register Notice/Outside Consultation 7

9. Payments/Gifts to Respondents 7

10. Confidentiality 7

11. Sensitive Questions 8

12. Burden Estimate (Hours & Wages) 8

13. Capital Costs 9

14. Annualized Costs to the Federal Government 9

15. Program Changes 9

16. Publication and Tabulation Dates 9

17. Expiration Date for OMB Approval of Information Collection 9

18. Exceptions to “Certification for Paperwork Reduction

Act Submissions” Statement 9

B. Collections of Information Employing Statistical Methods

1. Respondent Universe and Sampling Methods 9

2. Procedures for the Collection of Information 10

3. Methods to Maximize Response Rates and

Deal with Issues of Non-response 10

4. Tests of Procedures or Methods to be Undertaken 10

5. Statistical Contact 10

Appendices

Appendix A: Description of Satisfaction Survey

from Design Report 13

Appendix B: Legal Basis 16

Appendix C: Evaluation Research Questions Specified

by RTOP No. CMS-05-031/ERD 19

Appendix D: Satisfaction Survey Instruments 22

Appendix E: CMS Privacy Board Letter 39

Appendix F: Verbal Informed Consent Scripts 41

Appendix G: Brandeis University IRB Approval Notification 43

Background

This request seeks Office of Management and Budget’s (OMB) approval of collection of telephone survey data from Medicare beneficiaries (not to exceed 15 minutes in length). These interviews are to be completed during Phase II of the Evaluation of the Medical Adult Day-Care Services Demonstration (Contract Number 500-00-0038/5). The survey was developed based on collection of data from face-to-face interviews with beneficiaries from Phase I of the Demonstration evaluation, which was approved by OMB based on a submission dated July 7, 2006.

The Centers for Medicare & Medicaid Services (CMS), through its Office of Research, Development and Information (ORDI), is conducting an evaluation of the Demonstration of Medical Adult Day Services in five home health agencies in the states of Wisconsin, Texas, Pennsylvania, New York and Florida. The demonstration agencies are affiliated through ownership or contractual agreement with one or more adult day care facilities.

Section 703 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (Pub. L. 108–173) authorizes a three-year demonstration to conduct an evaluation of the clinical and cost-effectiveness of providing medical adult day-care services as a substitute for a portion of home health services that would otherwise be provided in the beneficiary’s home. The evaluation will conduct “an analysis of the patient outcomes and costs of furnishing care to the Medicare beneficiaries participating in the project as compared to such outcomes and costs to beneficiaries receiving only home health services for the same health conditions.” Delivering home health services in the adult day-care setting represents an expansion of coverage under the home health benefit under Medicare. The Demonstration requires the assurance of budget neutrality regardless of whether services are delivered in the home or in the adult day-care facility.

Through a competitive process, five Medicare certified home health agencies were selected by CMS to participate in the demonstration. These five demonstration sites are Aurora Visiting Nurse Association (Milwaukee, Wisconsin), Doctor’s Care Home Health (McAllen, Texas), Landmark Home Health Care Services (Allison Park, Pennsylvania), Metropolitan Jewish Health System (Brooklyn, New York) and Neighborly Care Network (St. Petersburg, Florida).

The Demonstration aims to evaluate both the costs and the benefits of delivering home health services in the adult day-care setting. The evaluation will examine the achievements as well as the difficulties inherent in demonstration implementation, and will include the following components:

Phase I (October 2005 through December 2007)

Case studies to assess the implementation of the Demonstration;
Interviews with small samples of beneficiaries who receive services at participating home health agencies;
Descriptive analyses of beneficiary characteristics, and services provided by the Demonstration sites to enrolled beneficiaries and non-participants, using information on beneficiaries collected by demonstration sites at the start of each home health episode;

Phase II (December 2007 through September 2009)

Selection of control patients matched to beneficiaries participating in the Demonstration, using demographic and medical diagnosis characteristics;
Analysis of the use and cost of home health services among beneficiaries receiving services at the Demonstration sites and matched comparison patients;
Telephone interviews with a large sample of beneficiaries who receive services at the participating home health agencies to assess patient experience with the Demonstration (180 interviews at each of the 5 sites, for a total of 900 interviews; see Appendix A for an excerpt from the Design Report); and
Synthesis of learning from the case studies and descriptive and statistical analyses to assess the possible implementation effects of the Demonstration, including potential areas for improvement.

Phase I data collection is now complete, including the collection of and reporting of beneficiary enrollment data collection by the demonstration sites and beneficiary face-to-face interviews during site visits to Demonstration agencies, as part of the development of case studies as specified by the RTOP. These data were used to develop a survey instrument for Phase II, which has been pre-tested and approved by the Brandeis University Institutional Review Board (IRB).

This request to OMB seeks approval to conduct telephone interviews with beneficiaries - item 6 above.

A. Justification

1. Legal and Administrative Justification

The legal justification for conducting the Demonstration is provided by Section 703 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (Pub. L. 108–173), which authorizes a three-year demonstration “to permit a home health agency, directly or under arrangements with a medical adult day-care facility, to provide medical adult day-care services as a substitute for a portion of home health services that would otherwise be provided in the beneficiary’s home.” [see Appendix B for Legal Basis].

The administrative justification is provided by CMS’s Request for Task Order Proposal (RTOP) No. CMS-05-031/ERD entitled, “Evaluation of the Medical Adult Day Services Demonstration.” This RTOP requires that a case study be conducted at each demonstration site, including “interviews with key informants (HHA administrators, providers, patients, caregivers, advocacy groups, etc.).” The RTOP specifically authorized the inclusion of surveys among the data collection activities, designed to provide “sound and scientifically valid answers” to a number of research questions in the following areas [see Appendix C for Evaluation Research Questions Specified by RTOP No. CMS-05-031/ERD].

Operational issues
Characteristics of participants and non-participants
Impact on use of services
Impact on quality and outcomes
Satisfaction
Market impacts
Cost impacts
Provider impacts
Overall impact and next steps

2. Use of Information

The users of the information will be the Brandeis University team that is evaluating the Demonstration and CMS.

Satisfaction Surveys: Based on learning from the beneficiary interviews conducted in Phase I, Brandeis has developed and pre-tested a satisfaction survey to be administered to up to 900 beneficiaries in Phase II. The satisfaction survey has been designed to assess the domains and degrees of satisfaction with home health care among beneficiaries who participated in and refused to participate in the Demonstration. It also will also collect information about the types and extent of out-of-pocket costs related to home care and adult day services. These data will be used by the evaluator to assess differences in satisfaction and out-of-pocket costs among the Demonstration sites, between participants and refusers, and according to other beneficiary characteristics assessed in the survey.

3. Collection of Information

The general approach to collecting data through the survey was described in the evaluation Design Report to CMS (Appendix A). Based on the beneficiary interviews conducted in Phase I, the survey domains have been refined, specific questions have been developed, and survey instruments have been pretested, revised, and approved by the Brandeis IRB (see Section 10 below for IRB approval and Section B.4. Tests of Procedures or Methods to be Undertaken for pre-test information).

The Satisfaction Survey is attached to this submission (Appendix D). There are four versions - one for participants who agreed to attend Adult Day Care, and one for beneficiaries who declined to attend Day Care. Each of these has both a version for completion with beneficiaries and a version for completion with proxies. The instruments collect basic demographic, health, and functional status information, as well as help needed, help received, and costs payment sources for help. Next, the survey asks about what home health services were received, where they were received, and whether they were satisfactory. Similar questions are asked (of participants only) about use of and satisfaction with adult day services, including transportation, which was a special issue with many of the beneficiaries interviewed. The survey ends with questions about age, race/ethnicity, and Medicaid status.

4. Duplication of Similar Information

The Demonstration, the enrollment data collection, and the interviews being conducted as part of its evaluation do not duplicate any prior efforts by CMS or other organizations.

5. Impacts on Small Businesses

Not applicable. This data collection does not have a significant economic impact on a substantial number of small businesses or other small entities.

6. Less Frequent Data Collection

The survey will be ongoing during the last 10 months or so of the Demonstration. Beneficiaries who begin home health episodes at participating home health agencies who are offered the option to participate in the Demonstration will be telephoned by a staff member from Brandeis University to see if they are willing to be surveyed.

The survey will be administered only once to beneficiaries and is the only means by which CMS and the evaluation team will obtain information from beneficiaries during Phase II. RTOP No. CMS-05-031/ERD (Appendix C) specifies that the evaluation should determine:

"How did the level of satisfaction of demonstration participants and their caregivers compare with that of beneficiaries with same health conditions who received all of their home health services at home?" and

"How did out-of-pocket costs for demonstration participants compare to those of beneficiaries with same health conditions who received all of their home health services at home, including out-of-pocket costs for Medicare-covered services, MADC services, transportation and other related costs?"

The evaluator and Project Officer determined that a satisfaction survey was the only reasonable means to obtain this information. Further, it was decided that a telephone survey was the best way to achieve a high response rate.

7. Special Circumstances

There are no special circumstances as specified in General Instructions for Supporting Statement for Paperwork Reduction Act Submissions, Specific Instruction A.7.

8. Federal Register Notice/Outside Consultation

A 60-day Federal Register notice was published on February 8, 2008.

There has been no prior publication of the enrollment or site visit data collection in the Federal Register. Inquiries to CMS and the Visiting Nurse Association of Boston did not reveal any similar data from the users of home health and medical adult day services. Similarly, search of the home health and medical adult day literature has not revealed any reports of prior surveys.

9. Payments/Gifts to Respondents

Not applicable. No payment or incentive is to be offered to interview or survey respondents.

10. Confidentiality

All Freedom of Information Act (FOIA) and the Federal Privacy Act requirements will be fully met. As approved by OMB in the Phase I submission, the Demonstration sites will provide enrollment and contact data to Brandeis to support selection of the sample for the telephone survey of beneficiaries. Enrollment data and contact information are being transmitted for Brandeis’ use via secure file transfer. The plan for identification and solicitation of Medicare beneficiaries to participate, and protection of beneficiaries’ privacy, was approved by the CMS Privacy Board for the Phase I package to OMB.

The process for contacting potential respondents to the telephone survey will be the same as the approved Phase I process for contacting beneficiaries for the face-to-face interviews. That is, a letter from the CMS Privacy Officer will be sent to potential respondents (Appendix E). This letter explains the purpose of the study and invites participation. It emphasizes the voluntary nature of the study, and the right of the beneficiary to refuse to participate with no consequences to their Medicare benefits. Brandeis will follow up this letter with a phone call to beneficiaries to invite them to participate in the survey. During this call, Brandeis will review a scripted verbal informed consent with beneficiaries to review the purpose of the study, and its voluntary and confidential nature [see Appendix F for Verbal Informed Consent Scripts]. At this time, Brandeis will assure beneficiaries that any information they provide during the interview will remain confidential. If beneficiaries provide informed consent, the survey will be administered.

The proposal for protection of beneficiaries' privacy, the introductory letter, the verbal informed consent script and the survey instruments have been approved by the Committee for Protection of Human Subjects of Brandeis University [see Appendix G for Brandeis University IRB Approval Notification].

The privacy of sampled beneficiaries and respondents will be strictly maintained and the confidentiality of the information obtained will be closely guarded. All information revealed during the surveys will be confidential. No identifying information will be released, and names, addresses and other identifying information will be removed from the final dataset. Results of analysis will be reported only in aggregate, with no identifying information provided. Raw data and data files will physically reside in locked offices at the Schneider Institute in the Heller School for Social Policy and Management at Brandeis University, with password protection for computers, hard drives, folders and individual files. Any backup data sets stored on external media will remain in locked office space at the Schneider Institute. The Project Director and Brandeis University have responsibility for assuring confidentiality of the data. All data files will be destroyed or returned to CMS at the end of the evaluation.

11. Sensitive Questions

There will be no sensitive information collected during the surveys of beneficiaries. There are no sensitive questions contained in the survey protocol. As a further step, respondents are told that they are free not to answer any question that they find troubling, or for any other reason.

12. Burden Estimate (Hours & Wages)

We estimate that the survey data collection will add very little burden to individual beneficiaries. We estimate that, on average, each interview will take 10 minutes to complete, including the informed consent process. Burden-hours for beneficiary surveys are estimated at 150 hours (900 beneficiaries interviewed for an average of 10 minutes per interview). Using $10.40 per hour as the average salary for seniors (based on figures used by CMS for burden estimation in a 2003 OMB submission of Medicare enrollees being conducted by Brandeis University), we estimate the total wage burden to equal $1,560.

13. Capital Costs

There are no capital costs.

14. Annualized Costs to the Federal Government

The cost to the federal government of conducting the data collection is specified in the contract with Brandeis to be $141,385 for 1,485 person-hours. Twenty percent of these costs and hours are associated with Task 4d, “Collection of data from Demonstration Sites”, and 80% are associated with Task 7d "Satisfaction Survey" in Brandeis' final budget for RFP No. CMS-05-031/ERD.

15. Program Changes

The information collection request is for a satisfaction survey based on a collection of data from Phase I face to face interviews with beneficiaries who participate in the demonstration and beneficiaries who refused to participate in the demonstration. Therefore, this is a revision to the PRA Information Collection request # 10204 under contract number 500-00-0038/5 OMB approval number 0938-1017. The burden hours for the satisfaction survey that is enclosed in this package is reduced because the survey is a short 10 minute survey that will be conducted over the telephone. This survey is not updating a previous collection and will include a larger sample size due to increase in participation in the demonstration. Further, a redlined version of the previous collection that was approved by OMB is not included in this package since these are two different types of information collection instruments.

16. Publication and Tabulation Dates

Neither CMS nor Brandeis, as the evaluator, plans to publish collected data in a form that will, in any way, permit identification of individual beneficiaries. Analysis of aggregate results will assist CMS in deciding policy regarding expansion of coverage for medical adult day services under the home health benefit for Medicare beneficiaries. Selected aggregate data may be used in professional publications.

Timeline for the Interviews Data Collection and Report to Congress
Task Description	Date
Phase I Site visits and interviews	August 2007 – October 2007
Final Case Study to CMS	January 2008
Phase II Satisfaction Survey	April 2008-Januray 2009
Final Report to CMS	June 2009
Final Summation for Report to Congress	September 2009

17. Expiration Date for OMB Approval of Information Collection

CMS plans to display the expiration date.

18. Exceptions to “Certification for Paperwork Reduction Act Submissions” Statement

Not applicable. There are no exceptions to the certification statement.

B. Collections of Information Employing Statistical Methods

1. Respondent Universe and Sampling Methods

At each of the five Demonstration sites, the survey will be administered to up to 100 participants and 80 non-participant eligibles who were offered but refused participation (up to 900 total sample). Given the current enrollment pace of the sites, and the time remaining in the Demonstration, we will need to attempt to survey all participants to achieve the sample size required. Since most beneficiaries offered the option to participate turn down the invitation at most sites, we may sample decliners if the number of decliners is sufficiently large. Selection criteria for the beneficiary sample include: 1) use of adult day care services in the two weeks prior to joining the Demonstration or declining to join, and 2) gender.

2. Procedures for the Collection of Information

The general approach to collecting data through the survey was described in the evaluation Design Report to CMS (Appendix A).

3. Methods to Maximize Response Rates and Deal with Issues of Non-response

Issues of non-response to the survey are minimized by CMS’ provision of accurate contact information for respondents. In addition, the introductory letter from the CMS Privacy Board will be useful in encouraging participation. During the phone calls for the case study interviews, it was found that most respondents remembered the letter. Also, stating that we were from a university and that we were working for Medicare to help improve the Medicare program helped to overcome skepticism.

Based on prior experience conducting telephone surveys of elders who were associated with service programs, we expect a positive response rate of 75% among the beneficiaries we invite to participate. We will continue to invite participation until the total sample of 90 beneficiaries per Demonstration site is achieved.

4. Tests of Procedures or Methods to be Undertaken

The surveys were pre-tested on small samples of participants (4) and decliners (4), which led to modifications in the versions tested. The final versions consist of 24 questions for participants and 14 questions for decliners. None of the questions appeared sensitive to respondents. The time to administer the test version for participants and their proxies ranged from 7 to 15 minutes. The time to administer the test version for decliners and their proxies ranged from 4 to 6 minutes. We expect the final version of the participant survey to be at least a minute shorter since we removed two multi-item scaled questions in favor of short, open-ended questions.

We will use appropriate multivariate techniques to analyze the factors associated with satisfaction and out-of-pocket costs, as well as differences in satisfaction and costs between participants and decliners. Independent variables will include those found in Table 1 data (site, gender, prior use of adult day care) and those from the survey itself (demographics, living situation, needs, helpers, race/ethnicity, age, and Medicaid status).

5. Statistical Contact

Grant Ritter, PhD

Senior Scientist

Brandeis University

Schneider Institute for Health Policy

South Street, Waltham, MA 02454

e-mail address - [email protected]

telephone number (781) 736-3872.

Appendix A

Satisfaction Survey Description from Design Report

(Task 3d)

Task 3d Section of Final Design Report

Evaluation of the Medical Adult Day-Care Services Demonstration

Final Design Report

Contract Number 500-00-0031/5

Susan Radke, M.S.W., Project Officer

Walter Leutz, Ph.D., Project Director

Brandeis University

Waltham, MA

May 25, 2006

Satisfaction Survey (Task 3d - Phase I and 7d - Phase II) Sections of Final Design Report

Satisfaction Survey (Task 3d)

The satisfaction survey will be designed to assess the domains and degrees of satisfaction with home health care among participants and refusers. It will also collect information about the types and extent of out-of-pocket costs related to home care and adult day services. The survey will be developed based on staff and beneficiary/family member interviews in the Phase 1 site visits.

In regard to satisfaction, the interviews will focus on identifying and understanding areas and types of beneficiary satisfaction related to various aspects of the demonstration. The interviews will probe for satisfaction with care coordinators, service providers, settings, socialization, costs, value for the money, choice, quality, and other issues that arise in the interviews. Because we will have interviewed staff at each site concerning their perceptions of beneficiary satisfaction and dissatisfaction, we will conduct the beneficiary interviews with a longer list of items to probe, including some items that will be specific to the operations of each site. The interviews will allow beneficiaries to communicate their specific experiences and feelings about their participation in the demonstration and will help us develop a satisfaction survey that addresses a range of beneficiary experiences.

In regard to out-of-pocket expenses, the interviews will probe for costs related to travel, MADC fees, assistance from Medicaid and other sources, and uncovered home care services. Since these will be qualitative, open-ended interviews designed to elicit and probe for respondent experiences that cannot entirely be anticipated, we expect that respondents will report other items as well. Synthesis of the interview responses related to beneficiary spending will inform the choice of cost categories to be included in the satisfaction survey.

Because the content of the satisfaction questions will be synthesized from the interviews, it is not now possible to propose what they will cover. We have used qualitative background interviews to develop questions for quantitative follow-up surveys for similar populations (Leutz, Capitman et al. 2001; Leutz and Capitman forthcoming). The satisfaction survey will be designed to be administered by telephone. It will have approximately 15 items in yes/no and scale formats and take about 10 minutes. Depending on the interview findings about expenses, the questions in this area may be either yes/no regarding categories or open-ended. The survey will be pre-tested, revised, and administered in Phase 2.

Satisfaction survey (Task 7d)

In Month 20 (approximately), we will pre-test the satisfaction survey developed in Phase 1. We will request a small sample of 20 participants and refusers from one of the sites, from which we will interview 8-10, until we are satisfied that beneficiaries understand the questions and that the time to respond is within expected parameters. Revisions will be made accordingly.

The revised survey, along with administration procedures and documents, will be submitted in a draft OMB package to the PO (Month 22). Upon receiving feedback from CMS, a proposal will be submitted to the Brandeis IRB. After IRB approval (Month 23), a final OMB package will be prepared and delivered, with projected approval 6 months later (Month 30). We will implement the survey for 10 months (Months 30-39). This implementation schedule will miss the first year or so of experience, but there should still be adequate samples available, and waiting will allow a test of the more mature demonstration intervention.

Given the decision not to use the beneficiary expenditure logging system proposed in the original design, we have re-budgeted resources and doubled the sample for the surveys. This yields samples of 100 participants and 80 non-participant eligibles who were offered but refused participation at each of the five sites (900 total sample). Achieving these levels will be possible only if sites enroll this many participants in the approximately 10 months of project time available for the survey (see timeline in Figure 2). As detailed in Task 3d, we expect this to be a 10-minute, 15-item survey with scales and yes/no type questions.

We will identify the sample from the lists of new enrollees obtained from the demonstration sites each month. Upon receiving the list, we anticipate that we will send the each participant and refuser a modified and approved version of the Privacy Board Letter in Appendix B, describing the survey and the consent process. One week after sending the letters we will begin telephoning the beneficiaries, first describing the survey and their freedom to decline without penalty, then obtaining consent, and then administering the survey to those who consent. To facilitate the selection and participation of the study sample, we will ask the SC to add a description of the survey process in the initial packet and procedures for enrollment in the demonstration. Beneficiaries who refused participation in the demonstration will not receive this description, and they will not have the experience of being in the demonstration. Therefore, we anticipate that it will take extra time to explain the demonstration and evaluation to these beneficiaries.

Appendix B

Legal Basis

H.R.1

Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Enrolled as Agreed to or Passed by Both House and Senate)

SEC. 703. DEMONSTRATION PROJECT FOR MEDICAL ADULT DAY-CARE SERVICES.

(a) ESTABLISHMENT- Subject to the succeeding provisions of this section, the Secretary shall establish a demonstration project (in this section referred to as the `demonstration project') under which the Secretary shall, as part of a plan of an episode of care for home health services established for a medicare beneficiary, permit a home health agency, directly or under arrangements with a medical adult day-care facility, to provide medical adult day-care services as a substitute for a portion of home health services that would otherwise be provided in the beneficiary's home.

(b) PAYMENT-

(1) IN GENERAL- Subject to paragraph, the amount of payment for an episode of care for home health services, a portion of which consists of substitute medical adult day-care services, under the demonstration project shall be made at a rate equal to 95 percent of the amount that would otherwise apply for such home health services under section 1895 of the Social Security Act (42 U.S.C. 1395fff). In no case may a home health agency, or a medical adult day-care facility under arrangements with a home health agency, separately charge a beneficiary for medical adult day-care services furnished under the plan of care.

(2) ADJUSTMENT IN CASE OF OVERUTILIZATION OF SUBSTITUTE ADULT DAY-CARE SERVICES TO ENSURE BUDGET NEUTRALITY- The Secretary shall monitor the expenditures under the demonstration project and under title XVIII of the Social Security Act for home health services. If the Secretary estimates that the total expenditures under the demonstration project and under such title XVIII for home health services for a period determined by the Secretary exceed expenditures that would have been made under such title XVIII for home health services for such period if the demonstration project had not been conducted, the Secretary shall adjust the rate of payment to medical adult day-care facilities under paragraph (1) in order to eliminate such excess.

(c) DEMONSTRATION PROJECT SITES- The demonstration project established under this section shall be conducted in not more than 5 sites in States selected by the Secretary that license or certify providers of services that furnish medical adult day-care services.

(d) DURATION- The Secretary shall conduct the demonstration project for a period of 3 years.

(e) VOLUNTARY PARTICIPATION- Participation of medicare beneficiaries in the demonstration project shall be voluntary. The total number of such beneficiaries that may participate in the project at any given time may not exceed 15,000.

(f) PREFERENCE IN SELECTING AGENCIES- In selecting home health agencies to participate under the demonstration project, the Secretary shall give preference to those agencies that are currently licensed or certified through common ownership and control to furnish medical adult day-care services.

(g) WAIVER AUTHORITY- The Secretary may waive such requirements of title XVIII of the Social Security Act as may be necessary for the purposes of carrying out the demonstration project, other than waiving the requirement that an individual be homebound in order to be eligible for benefits for home health services.

(h) EVALUATION AND REPORT- The Secretary shall conduct an evaluation of the clinical and cost-effectiveness of the demonstration project. Not later than 6 months after the completion of the project, the Secretary shall submit to Congress a report on the evaluation, and shall include in the report the following:

(1) An analysis of the patient outcomes and costs of furnishing care to the medicare beneficiaries participating in the project as compared to such outcomes and costs to beneficiaries receiving only home health services for the same health conditions.

(2) Such recommendations regarding the extension, expansion, or termination of the project as the Secretary determines appropriate.

(i) DEFINITIONS- In this section:

(1) HOME HEALTH AGENCY- The term `home health agency' has the meaning given such term in section 1861(o) of the Social Security Act (42 U.S.C. 1395x(o)).

(2) MEDICAL ADULT DAY-CARE FACILITY- The term `medical adult day-care facility' means a facility that--

(A) has been licensed or certified by a State to furnish medical adult day-care services in the State for a continuous 2-year period;

(B) is engaged in providing skilled nursing services and other therapeutic services directly or under arrangement with a home health agency;

(C) is licensed and certified by the State in which it operates or meets such standards established by the Secretary to assure quality of care and such other requirements as the Secretary finds necessary in the interest of the health and safety of individuals who are furnished services in the facility; and

(D) provides medical adult day-care services.

(3) MEDICAL ADULT DAY-CARE SERVICES- The term `medical adult day-care services' means--

(A) home health service items and services described in paragraphs (1) through (7) of section 1861(m) furnished in a medical adult day-care facility;

(B) a program of supervised activities furnished in a group setting in the facility that--

(i) meet such criteria as the Secretary determines appropriate; and

(ii) is designed to promote physical and mental health of the individuals; and

(4) MEDICARE BENEFICIARY- The term `medicare beneficiary' means an individual entitled to benefits under part A of this title, enrolled under part B of this title, or both.

Appendix C

Evaluation Research Questions Specified by RTOP No. CMS-05-031/ERD

Operational Issues

How did participating home health agencies determine which of their Medicare clients would be offered an opportunity to participate in the demonstration, and receive a portion of their home health services at a MADC facility? What criteria were used by HHAs to make these determinations? How did these HHA policies affect the selection of beneficiaries into the demonstration?
What was the impact of the demonstration on HHA patient intake practices, care planning, care delivery and discharge planning?
How did HHAs determine which services would be provided in MADC facilities and which would be provided in beneficiaries’ homes?
How did HHAs ensure coordination among their own staff providers and contracted providers, including MADC providers?

Characteristics of Participants and Non-Participants

How many beneficiaries participated in the demonstration, and elected to receive a portion of their home health care in a MADC facility? How many clients of participating HHAs were not offered participation in the demonstration? How many clients of participating HHAs were offered participation in the demonstration but declined?
What percentage of participating beneficiaries withdrew from the demonstration during their episode of care, and reverted to receiving all of their home health care at home? Why did beneficiaries withdraw from the demonstration?
How did beneficiaries who participated in the demonstration differ from those that were not offered the demonstration (including those for whom the demonstration was determined to be medically contraindicated, and those who were excluded for other reasons), in terms of their medical conditions, need for rehabilitative services, availability of family or other social supports or other important factors? How did beneficiaries who participated differ from those who were offered participation but declined?
What motivated beneficiaries and their caregivers to participate in the demonstration? For those who declined participation, what were their motives for declining?
How did participating HHAs compare to other HHAs in terms of their size, organizational structure, or the composition of their Medicare home health patient populations?
Did the demonstration result in a change in the patient mix for the participating HHAs?

Impact on Use of Services

What was the impact of participation in the demonstration on the amount and types of home health services provided beneficiaries under their plans of care?
How did participation in the demonstration affect the setting in which Medicare beneficiaries received home health services? What kinds of services were demonstration participants most likely to receive in a MADC facility rather than in their homes?
What was the impact of participation in the demonstration on beneficiaries’ use of Medicare services other than home health?
What percentage of demonstration participants were MADC clients prior to joining the demonstration? How many began using MADC in order to participate?
Did the demonstration result in an increase in the numbers of patients enrolled with participating MADC facilities? Did this increase result from an influx of Medicare beneficiaries who were users of the Medicare home health benefit?
For dual eligibles, what was the impact of participation in the demonstration on their use of Medicaid services? Was there any evidence that Medicare beneficiaries were becoming Medicaid eligible in order obtain funding for MADC services, so that they could participate in the demonstration?

Impact on Quality and Outcomes

How did the quality of care for demonstration participants differ from what was received by beneficiaries with the same health conditions who received all of their home health services at home?
How did the health and functional status outcomes of demonstration participants compare with the outcomes for beneficiaries with same health conditions who received all of their home health services at home?

Satisfaction

How did the level of satisfaction of demonstration participants and their caregivers compare with that of beneficiaries with same health conditions who received all of their home health services at home?
How was the demonstration viewed by beneficiaries, home health and MADC providers (professional and administrative staff), patient advocacy groups, physicians, discharge planners and other key constituencies?

Market Impacts

Has the existence of the demonstration affected the level or frequency of use of Medicare home health services by beneficiaries within participating home health agencies’ market areas?
How has the existence of the demonstration project affected the availability and use of MADC services in the participating providers’ market areas?

Cost Impacts

How did the costs for Medicare covered services (both home health care services and other services) for demonstration participants compare with costs for beneficiaries with same health conditions who received all of their home health services at home?
How did out-of-pocket costs for demonstration participants compare to those of beneficiaries with same health conditions who received all of their home health services at home, including out-of-pocket costs for Medicare-covered services, MADC services, transportation and other related costs?
What was the overall impact of the demonstration on federal Medicare expenditures, and federal and State Medicaid expenditures?

Provider Impacts

How did participation in the demonstration affect participating HHAs’ financial performance? What was the marginal effect of the demonstration on HHAs’ profit or loss for the episodes involved?
How did participation in the demonstration affect participating MADC facilities’ financial performance?

Overall Impact and Next Steps

Can the findings from this evaluation be used to predict the likely outcome (in terms of cost to Medicare, cost to beneficiaries, costs to States, impact on the home health care or MADC markets) of allowing home health services to be provided in MADC settings as a permanent feature of the Medicare program?
Can any changes to the demonstration be suggested that would improve its operation or outcomes, or that would improve its suitability for adoption as a permanent feature of the Medicare program?

Appendix D

Satisfaction Survey Instruments

PARTICIPANTS

Start with introduction/consent. If yes, continue.

Before I ask you about the home health and day care programs, I have some questions about you

Please tell me who you live with? (check all that apply)

____ No one - lives alone

____ Spouse

____ Son/daughter

____ Other relative

____ Other non-relative

In thinking about how well you get around inside the house, would you say you can (start reading list at top and stop when respondent chooses)

____ Walk independently

____ Walk with a cane or walker

____ Get around in a wheelchair

____ Need to stay in bed all the time

Do you need help with any of the following activities?
1. Bathing __Y __N
2. Dressing __Y __N
3. Using the toilet __Y __N
4. Shopping __Y __N ___ Does not shop
5. Figuring out what medications to take when and remembering to take them __Y __N

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-1017. The time required to complete this information collection is estimated to average

10 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.

If help is needed on Q 3: Is there someone who helps you with these things? (check all that apply)

____ Spouse/partner

____ Son/Daughter/Son-in-law or daughter-in-law

____ Other relative

____ Friend

____ Paid helper

____ No one

(If "paid helper" is checked in #4): Do you pay for the helper or does a government program pay?

___ Program pays

___ I pay or family pays

- If self or family: How much do you pay a week?

$____ Don't know ____

Now let me ask you about the home health services you receive from (Metropolitan, Landmark, Aurora, Doctors Care, Neighborly)

Are you still receiving services or is the episode over?

_____Still receiving

_____Episode over

Please indicate if you have you received any of the following services from (Metropolitan, Landmark, Aurora, Doctors Care, Neighborly) and if so, whether you received them at home or in a day center?

HH Service	Received Service (Y/N)	In Home (check)	In MADC (check)
Nursing
Physical Therapy
Occupational Therapy
Speech Therapy
Home Health Aide

Please tell me if (Metropolitan, Landmark, Aurora, Doctors Care, Neighborly) provided any training or education to your primary caregiver to help them care for you? ____Y ____ N

(If receiving home health AT HOME in #6): Please tell me whether you agree with the following statements about the home health services you receive(d) at home? Would you say yes or no?

	Yes	No
The nurses give good care
The therapists give good care
I get good information about conditions and treatments.
They showed up when they said they would

(If receiving home health IN THE DAY CENTER in #6): Please tell me whether you agree with the following statements about the home health services you receive(d) at home? Would you say yes or no?

	Yes	No
The nurses give good care
The therapists give good care
I get good information about conditions and treatments.
They showed up when they said they would

Now let me ask you about the adult day services you receive

How often do you go (did you go) to the adult day center? (___ days a week)

What things does s/he like most about going to the day care center?

_______________________________________________________

What things does she like least?

______________________________________________________

How satisfied are you with your overall experiences in the adult day center? Would you say.....

____Very satisfied

____Somewhat satisfied

____Dissatisfied

Are you paying for any of the days attend the adult day center? __Y __N
1. If yes, how many days? _______
2. How much does it cost per day? _____

How do you get to the adult day center and back home? (check all that are mentioned)

____ Family or friends

____ Bus/van from program

____ Other ____________

How well do these transportation arrangements work for you? Would you say.....

____ very well

____ OK

____ not work very well

Do you have any costs for transportation to the day center? __Yes __No
1. If yes, how much per one-way trip? $ ______

I have a few more questions about the demonstration in general

Would you like to keep going to day care? ___ Y ___ N

If yes: Would you be willing to pay to go?

___ Yes

___ Yes, I already pay

___ No

___ No - a public program pays

In your own words, can you tell me how the demonstration been good for you?

Again in your own words, how could this demonstration program be improved?

I just have just a few more questions about you.

Please tell me how old you are? ____

Do you receive Medicaid assistance? ___Y ___ N

How would you describe your race and ethnicity? (Check all mentioned)

___ Caucasian or White

___ African American or black

___ Hispanic

___ Other

That's the end of my questions. Thanks so much for your help. Do you have any questions for me?

PARTICIPANT PROXY

Start with introduction/consent. If yes, continue.

Before I ask you about the home health and day care programs, I have some questions about you

A. Please tell me your relationship to (name of participant): ____________________

B. Are you his/her primary caregiver? __ Yes __ No

First we have some questions about your (wife/husband/father/mother,etc)

Can you tell me whom s/he lives with? (check all that apply)

____ No one - lives alone

____ Spouse

____ Son/daughter

____ Other relative

____ Other non-relative

In thinking about how s/he gets around inside the house, would you say s/he can (start reading list at top and stop when respondent chooses)

____ Walks independently

____ Walks with a cane or walker

____ Gets around in a wheelchair

____ Needs to stay in bed all the time

Does s/he need help with any of the following activities?

Bathing __Yes __No
Dressing __Yes __No
Using the toilet __Yes __No
Shopping __Yes __No ___ Does not shop
Figuring out what medications to take when and remembering to take them __Yes __no

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-1017. The time required to complete this information collection is estimated to average

If help is needed on Q 3: Is there someone who helps him/her with these things? (check all that apply)

____ Spouse/partner

____ Son/Daughter/Son-in-law or daughter-in-law

____ Other relative

____ Friend

____ Paid helper

____ No one

(If "paid helper" is checked in #4): Do you pay for the helper or does a government program pay?

___ Program pays

___ I pay or family pays

- If self or family: How much do you pay a week?

$____ Don't know ____

Now let me ask you about the home health services s/he receives from (Metropolitan, Landmark, Aurora, Doctors Care, Neighborly)

Is s/he still receiving services or is the episode over?

_____Still receiving

_____Episode over

Please indicate if you have s/he received any of the following services from (Metropolitan, Landmark, Aurora, Doctors Care, Neighborly) and if so, whether s/he received them at home or in a day center?

HH Service	Received Service (Y/N)	In Home (check)	In MADC (check)
Nursing
Physical Therapy
Occupational Therapy
Speech Therapy
Home Health Aide

Please tell me if (Metropolitan, Landmark, Aurora, Doctors Care, Neighborly) provided any training or education to you (as primary caregiver to help them care for him/her? ____Y ____ N

(If receiving home health AT HOME in #6): Please tell me whether you agree with the following statements about the home health services s/he receive(d) at home? Would you say yes or no?

	Yes	No
The nurses give good care
The therapists give good care
I get good information about conditions and treatments.
They showed up when they said they would

(If receiving home health IN THE DAY CENTER in #6): Please tell me whether you agree with the following statements about the home health services s/he receive(d) at the day center? Would you say yes or no?

	Yes	No
The nurses give good care
The therapists give good care
I get good information about conditions and treatments.
They showed up when they said they would

Now let me ask you about the adult day services you receive

How often does s/he go (did s/he go) to the adult day center? (___ days a week)

What things does s/he like most about going to the day care center?

_______________________________________________________

What things does she like least?

______________________________________________________

How satisfied is s/he with her/his overall experiences in the adult day center? Would you say.....

____Very satisfied

____Somewhat satisfied

____Dissatisfied

Are you paying for any of the days attend the adult day center? __Y __N

If yes, how many days? _______

How much does it cost per day? _____

How do you get to the adult day center and back home? (check all that are mentioned)

____ Family or friends

____ Bus/van from program

____ Other ____________

How well do these transportation arrangements work for him/her? Would you say.....

____ very well

____ OK

____ not work very well

Do you have any costs for transportation to the day center? __Yes __No

If yes, how much per one-way trip? $ ______

I have a few more questions about the demonstration in general

Would you like to keep going to day care? ___ Y ___ N

If yes: Would you be willing to pay to go?

___ Yes

___ Yes, I already pay

___ No

___ No - a public program pays

In your own words, can you tell me how the demonstration been good for you?

Again in your own words, how could this demonstration program be improved?

I just have just a few more questions about him/her.

Please tell me how old s/he is? ____

Does s/he receive Medicaid assistance? ___Y ___ N

How would you describe his/her race and ethnicity? (Check all mentioned)

___ Caucasian or White

___ African American or black

___ Hispanic

___ Other

That's the end of my questions. Thanks so much for your help. Do you have any questions for me?

DECLINER SURVEY

Start with introduction/consent. If yes, continue.

Before I ask you about the home health and day care programs, I have some questions about you

Please tell me who you live with? (check all that apply)

____ No one - lives alone

____ Spouse

____ Son/daughter

____ Other relative

____ Other non-relative

In thinking about how well you get around inside the house, would you say you can (start reading list at top and stop when respondent chooses)

____ Walk independently

____ Walk with a cane or walker

____ Get around in a wheelchair

____ Need to stay in bed all the time

Do you need help with any of the following activities?

Bathing __Y __N

Dressing __Y __N

Using toilet __Y __N

Shopping __Y __N ___ Does not go shopping

Figuring out what medications to take when and remembering to take them __Y __N

If help is needed on Q 3: Is there someone who helps you with these things? (check all that apply)

____ Spouse/partner

____ Son/Daughter/Son-in-law or daughter-in-law

____ Other relative

____ Friend

____ Paid helper

____ No one

(If "paid helper" is checked in #4): Do you pay for the helper or does a government program pay?

____ Program pays

____ I pay or family pays

- If self or family: How much do you pay a week?

$____ Don't know ____

Now let me ask you about the home health services you receive from (Metropolitan, Landmark, Aurora, Doctors Care, Neighborly)

Are you still receiving services or is the episode over?

___Still receiving

___Episode over

Please indicate if you have you received any of the following services from (Metropolitan, Landmark, Aurora, Doctors Care, Neighborly)?

___ Nursing

___ Physical Therapy

___ Occupational Therapy

___ Speech Therapy

___ Home Health Aide

Please tell me if (Metropolitan, Landmark, Aurora, Doctors Care, Neighborly) provided any training or education to your primary caregiver to help them care for you? ____Y ____ N

Please tell me whether you agree with the following statements about the home health services s/he receive(d) at home? Would you say yes or no?

	Yes	No
The nurses give good care
The therapists give good care
I get good information about conditions and treatments.
They showed up when they said they would

When (Metropolitan, Landmark, Aurora, Doctors Care, Neighborly) first talked to you about home health, did they offer you the chance to get the services in an adult day care program or senior center program?

__ Yes (skip to #11)
__ No (ask question d)
__ Don't remember (ask question d)

If No or don't remember, interviewer explains the following: “An adult day program is not a nursing home. It's a program where you go in the morning to a center with other elders for social activities, games, meals, and then come back home in the afternoon.”

Have you heard of this kind of program before? __Yes __No
Would like to go to this kind of program? __Yes __No

Why didn't you go to the adult day program? ____________________________

________________________________________________________________

I just have just a few more questions about you.

Please tell me how old you are? ____

Do you receive Medicaid assistance? ___Y ___ N

How would you describe your race and ethnicity? (Check all mentioned)

___ Caucasian or White

___ African American or black

___ Hispanic

___ Other

That's the end of my questions. Thanks so much for your help. Do you have any questions for me?

DECLINER PROXY

Start with introduction/consent. If yes, continue.

Before I ask you about the home health and day care programs, I have some questions about you

A. Please tell me your relationship to (name of decliner): ____________________

B. Are you his/her primary caregiver? __ Yes __ No

Before I ask you about the home health and day care programs, I have some questions about (name of decliner)

Please tell me who s/he lives with? (check all that apply)

____ No one - lives alone

____ Spouse

____ Son/daughter

____ Other relative

____ Other non-relative

In thinking about how well s/he gets around inside the house, would you say s/he can (start reading list at top and stop when respondent chooses)

____ Walk independently

____ Walk with a cane or walker

____ Get around in a wheelchair

____ Need to stay in bed all the time

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-1017. The time required to complete this information collection is estimated to average

Does s/he need help with any of the following activities?

Bathing __Y __N

Dressing __Y __N

Using toilet __Y __N

Shopping __Y __N___ Does not go shopping

Figuring out what medications to take when and remembering to take them __Y __N

If help is needed on Q 3: Is there someone who helps her/him with these things? (check all that apply)

____ Spouse/partner

____ Son/Daughter/Son-in-law or daughter-in-law

____ Other relative

____ Friend

____ Paid helper

____ No one

(If "paid helper" is checked in #4): Do you pay for the helper or does a government program pay?

___ Program pays

___ I pay or family pays

- If self or family: How much do you pay a week?

$____ Don't know ____

Now let me ask you about the home health services s/he receives from (Metropolitan, Landmark, Aurora, Doctors Care, Neighborly)

Is s/he still receiving services or is the episode over?

_____Still receiving

_____Episode over

Please indicate if s/he has received any of the following services from (Metropolitan, Landmark, Aurora, Doctors Care, Neighborly)?

___ Nursing

___ Physical Therapy

___ Occupational Therapy

___ Speech Therapy

___ Home Health Aide

Please tell me if (Metropolitan, Landmark, Aurora, Doctors Care, Neighborly) provided any training or education to you (or another primary caregiver) to help you care for him/her? ____Y ____ N

Please tell me whether you agree with the following statements about the home health services s/he receive(d) at home? Would you say yes or no?

	Yes	No
The nurses give good care
The therapists give good care
I get good information about conditions and treatments.
They showed up when they said they would

When (Metropolitan, Landmark, Aurora, Doctors Care, Neighborly) first talked to you about home health, do you remember if they offered the chance for him/her to get the services in an adult day care program or senior center program?

__ Yes (skip to #11)
__ No (ask question d)
__ Don't remember (ask question d)

If No or don't remember, interviewer explains the following: “An adult day program is not a nursing home. It's a program where you go in the morning to a center with other elders for social activities, games, meals, and then come back home in the afternoon.”

Have you heard of this kind of program before? __Yes __No
Would s/he like to go to this kind of program? __Yes __No

Why didn't s/he go to the adult day program? ____________________________

________________________________________________________________

I just have just a few more questions about (your wife/husband/mother/father).

Please tell me how old s/he is? ____

Does s/he receive Medicaid assistance? ___Y ___ N

How would you describe her/his race and ethnicity? (Check all mentioned)

___ Caucasian or White

___ African American or black

___ Hispanic

___ Other

That's the end of my questions. Thanks so much for your help. Do you have any questions for me?

Appendix E

CMS Privacy Board Letter

Decliners

CMS Letterhead

<Name>

<City, State, Zip Code>

Dear Medicare Beneficiary:

The Centers for Medicare & Medicare Services (CMS) administers the Medicare program. CMS is sponsoring the Medical Adult Day-Care Services Demonstration, a program designed to see whether Medicare beneficiaries are willing to receive some of their home health services at a medical adult day care center. CMS has chosen Brandeis University to conduct an evaluation of this demonstration.

Your name was selected at random from a list of beneficiaries who were offered an opportunity to participate in this demonstration at Metropolitan Jewish Health Services, but declined. In a few days, you will be contacted by a representative of Brandeis University to ask you if you are willing to participate in a telephone survey. If you agree, a staff person from Brandeis University will ask you questions about your health, your decision not to participate in the demonstration and your experiences with home health care. The interview should take about 10 minutes of your time.

You do not have to participate in this study. Your decisions to participate or not participate will have no effect on your Medicare benefits. All information you and the other participants provide is protected by the Privacy Act.

If you have questions about this letter, please contact 1-800-MEDICARE (1-800-633-4227). This toll-free helpline is available 24 hours a day, seven days a week to answer your questions. You can speak to a Customer Service Representative in English or Spanish. TTY users should call 1-877-486-2048.

If you have any questions about the study, please feel free to call Dr. Walter Leutz at Brandeis University at this number: 781-736-3934. Thank you for your cooperation.

Sincerely,

Walter Stone

CMS Privacy Officer

Participants

CMS Letterhead

<Name>

<City, State, Zip Code>

Dear Medicare Beneficiary:

Your name was selected at random from a list of beneficiaries who are participating in this demonstration at <name of home health agency>, and who receive some of their home health care at a medical adult day care facility. In a few days, you will be contacted by a representative of Brandeis University to ask you if you are willing to participate in a telephone survey. If you agree, a staff person from Brandeis University will ask you questions about your health, your experiences with the demonstration and your home health care. The survey should take 10 minutes of your time.

If you have any questions about the study, please feel free to call Dr. Walter Leutz at Brandeis University at this number: 781-736-3934. Thank you for your cooperation.

Sincerely,

Walter Stone

CMS Privacy Officer

Appendix F: Verbal Informed Consent Scripts

Participants

My name is __________, and I work for Brandeis University in Massachusetts. We are working for the Medicare program to conduct an evaluation of the Medical Adult Day Services Demonstration, and I am calling to speak with (benefiary name)....

If answerer is same gender as beneficiary: Is this Mr./Mrs. _______?
If answerer is opposite gender: Is this his wife or daughter? .... her husband or son?
(Establish if we should be interviewing the beneficiary him/herself or if the answerer will serve as a proxy.)

We understand that you are (he/she is, etc.) currently participating (or recently participated) in the Demonstration through (insert name of home health agency), and that you have received some of your home health services at (insert name of MADS if known). We are interested to learn how the Demonstration works and whether beneficiaries who are participating in the Demonstration like it. We would like to invite you to participate in a telephone survey about your satisfaction with the care you have received. It will take about 10 minutes and it is completely confidential. It is also voluntary - You don't have to do this. Your Medicare and your services will not be affected if you say no.

Do you have any questions about this?

Would you like to do the survey?

If yes, proceed to the participant or participant proxy survey.
If no, thank them for their time and end the call.

Decliners

If answerer is same gender as beneficiary: Is this Mr./Mrs. _______?
If answerer is opposite gender: Is this his wife or daughter? .... her husband or son?
(Establish if we should be interviewing the beneficiary him/herself or if the answerer will serve as a proxy.)

We understand that you were (he/she was, etc.) offered an opportunity to participate in the Demonstration at (insert name of home health agency) but declined to participate. We would like to invite you to participate in a telephone survey about your satisfaction with the care you have received, and also about why you declined to attend adult day services. It will take about 10 minutes and it is completely confidential. It is also voluntary - You don't have to do this. Your Medicare and your services will not be affected if you say no.

Do you have any questions about this?

Would you like to do the survey?

- If yes, proceed the decliner or decliner proxy survey.

- If no, thank them for their time and end the call.

Appendix G

Brandeis University IRB Approval Notification

(via email)

From: "Institutional Review Board, Brandeis University" <[email protected]>

Date: November 5, 2007 4:42:22 PM EST

To: Walter Leutz <[email protected]>

Subject: 06135 Leutz - Mod #1

To: Walter Leutz, Associate Professor

Heller School for Social Policy & Management

Fr: Christopher Tompkins, Chair

Brandeis Committee for Protection of Human Subjects

Re: Protocol #06135: Evaluation of the Medical Adult Day Services

Demonstration (Modification #1)

The Brandeis Committee for Protection of Human Subjects, operating under

Federalwide Assurance #FWA00004408, has reviewed and approved a

modification to the above-referenced protocol. This action approves the

following:

- Addition of phone-administered satisfaction survey.

Please note that this action does not affect your protocol expiration

date of October 10, 2008. If your research, including data analysis,

will continue beyond the approval expiration date, please submit a human

subjects progress report and continuing review request in time to

receive a new approval date that falls on or before that date.

If your work will not continue beyond that date, you must still complete

and submit this form as a progress report, indicating the date by which

your project will terminate.

If you wish to request further modifications to your approved protocol,

please complete a Modification Request Form and submit it to the BCPHS

for review.

File Type	application/msword
File Title	Supporting Statement
Author	stason
Last Modified By	CMS_DU
File Modified	2008-04-25
File Created	2008-01-25