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Promoting Patient Engagement in Clinical Preventive ServicesSupporting-Statement-A.docx

Prevention Communication Formative Research

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OMB: 0990-0281

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Promoting Patient Engagement in Clinical Preventive Services: Evaluating the Use of healthfinder




ODPHP Generic Information Collection Request

OMB No. 0990-0281



Supporting Statement — Section A



Submitted February 2 2018








Submitted to:

Sherrette Funn

Office of the Chief Information Officer

U.S. Department of Health and Human Services


Submitted by:

Linda M. Harris, PhD

Director, Division of Health Communication and eHealth

Office of Disease Prevention and Health Promotion

U.S. Department of Health and Human Services

Section A — Justification



  1. Circumstances Making the Collection of Information Necessary


Clinical preventive services (CPS) can provide many benefits to individual patients and are fundamental to early disease detection, effective primary care intervention, and improving health outcomes. In addition, the increased use of CPS could contribute to billions in health care savings and avert the loss of millions of life years annually.1 Yet it is often difficult for patients to understand and obtain CPS2 — this underscores the need for personalized, plain language guidance on when and how to get preventive services.


In line with the health literate care model, the Office of Disease Prevention and Health Promotion (ODPHP) is interested in assessing how its myhealthfinder tool3 and healthfinder content4 could be used in primary care settings to facilitate productive patient-provider conversations and ultimately increase uptake of preventive services. ODPHP is continuing its efforts to better understand how its myhealthfinder tool and healthfinder content could be used to increase the use of CPS.


  1. Purpose and Use of the Information Collection


To support these efforts and better understand how myhealthfinder might increase the use of CPS, ODPHP wants to evaluate the use and any impact of a “prescription for myhealthfinder” on how patients and clinicians prepare for a clinical encounter or the encounter itself. Specifically, ODPHP proposes conducting surveys with patients, following clinical visits, as well as brief interviews with clinicians.

Patient Surveys

ODPHP is seeking approval to conduct 800, 8-minute surveys with patients who received a “prescription for myhealthfinder.” Surveys are the most efficient way to collect information on patient attitudes and experiences related to the use of myhealthfinder, clinician-patient communication, and use of CPS.


In these surveys, ODPHP seeks insight into the following research questions:

  • To what extent did patients use healthfinder?

  • What were patient understandings of recommended clinical preventive services?

  • What were patient experiences of the clinical encounter?


All patient participation is strictly voluntary.


Clinician Interviews

ODPHP also seeks approval to conduct 20, 30-minute debriefing interviews with clinicians. These brief interviews with clinicians are an efficient way to collect in-depth feedback on their experiences and preferences, as well as their perceptions of patient experiences.


Through these interviews, ODPHP seeks insight into the following research questions:

  • How did the use of healthfinder impact clinician-patient conversations around CPS?

  • What impact did the use of healthfinder have on clinic workflow?

  • How did the use of healthfinder impact patient perceptions about CPS?


All clinician participation is strictly voluntary.

Information Use

Following the data collection, ODPHP will develop a summary report that details key findings. ODPHP will present findings in aggregate and will not collect or report information that identifies individual participants.


Surveys with patients and interviews with clinicians will both provide ODPHP with critical insights regarding “prescriptions of myhealthfinder” as a tool to help patients and providers prepare for clinical encounters. ODPHP is continuing its efforts to better understand how the myhealthfinder tool and healthfinder content could be used to increase the use of CPS.


  1. Use of Improved Information Technology and Burden Reduction


Participating clinicians will be recruited using purposive sampling to include clinicians in a variety of practice models and working in rural, suburban, and urban settings. In addition to being methodologically sound, this method for sampling reduces participant burden because no screening process will be necessary. To reduce participant burden, all of the clinician interviews will be conducted remotely at times convenient for participating clinicians via telephone or an internet-based platform. ODPHP will use a laptop to take notes to save transcription time. To ensure that key themes and quotations are captured accurately, ODPHP will also use digital recording tools to audiotape all clinician interviews.


Patients will be chosen at random from among patients scheduled for upcoming wellness visits with participating clinicians. The participant burden is lessened because there will be no need for screening. The patient surveys will be conducted in person following patient wellness encounters with their clinicians. To reduce participant burden for patients of a variety of ages and different comfort levels with technology, all patients will complete the brief paper-based surveys while they are still in their clinician’s office.


  1. Efforts to Identify Duplication and Use of Similar Information


To our knowledge, there is no information of a similar nature that has been or is currently being collected. This study builds upon prior research ODPHP conducted to develop the myhealthfinder tool and healthfinder content. ODPHP is continuing its efforts to better understand how the myhealthfinder tool and healthfinder content could be used to increase the use of CPS.


  1. Impact on Small Businesses or Other Small Entities


No small businesses will be impacted or involved in this data collection.


  1. Consequences of Collecting the Information Less Frequently


This request is for one-time data collection. These data have not previously been collected elsewhere.


  1. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5


There are no special circumstances with this information collection package. This request fully complies with the regulation 5 CFR 1320.5 and will be voluntary.


  1. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency


This data collection is being conducted using the Generic Information Collection mechanism through ODPHP — OMB No. 0990-0281.


  1. Explanation of Any Payment or Gift to Respondents


Patients will not be offered an incentive to participate in the 8-minute survey. Likewise, clinicians will not be offered an incentive for participating in the 30-minute debriefing interview.


  1. Assurance of Privacy Provided to Respondents


The Privacy Act does not apply to this data collection. ODPHP is taking a variety of steps to ensure we are protecting the rights of all participants. An Institutional Review Board has reviewed and approved this study, including the patient survey [see Attachment A] and the interview guide for the clinician interviews [see Attachment B].


ODPHP will not collect any personally identifiable information from participants in either the patient surveys or clinician debriefing interviews. All audio recordings of clinician interviews will be destroyed once the interviews are transcribed, and transcripts will be de-identified if clinicians inadvertently provide any identifying information.


The survey and the interview moderator’s guide all include information for participants about measures the researchers will take to keep data private to the extent allowable by law. Before participating, all participants will review the relevant consent language and sign consent forms indicating that they understand their rights and agree to participate. They will be told that they can stop participating at any time without penalty.


  1. Justification for Sensitive Questions


ODPHP does not anticipate that research participants will perceive questions as sensitive in nature. ODPHP will focus on collecting information needed to see how patients and clinicians use the “prescriptions for myhealthfinder” and healthfinder content in primary care settings to prepare for visits and to see if the tool facilitates productive patient-provider conversations. Prior to participating in the research activities, ODPHP will inform participants that they may decline to respond to any questions they would rather not answer.


  1. Estimates of Annualized Burden Hours and Costs


The estimate for burden hours is based on:

  • 8-minute surveys with a total of 800 patients [see Attachment A]

  • 30-minute interviews with a total of 20 clinicians [see Attachment B]


Table A-12: Estimated Annualized Burden Hours and Costs to Participants

Research Instrument

No. of Participants

Average Burden per Response

Total Burden Hours

Hourly Wage Rate

Total Participant Costs

Attachment A: Patient Survey

800

8/60

107

$23.86

$2553.02

Attachment B: Moderator’s Guide for Clinician Interviews

20

30/60

10

$96.54

$965.40

Totals

820


117


$3518.42


The estimates for clinicians for hourly burden are calculated using the mean hourly wage for family and general practitioners ($96.54), with whom patients are scheduling the wellness visits.5 For patients, estimates for hourly burden are calculated using the mean hourly wage for all occupations ($23.86), because ODPHP anticipates patients will come from diverse occupations.


  1. Estimates of Annualized Burden Hours and Costs


ODPHP does not anticipate that clinicians will incur costs as a result of participating in the in-depth interviews. Likewise, we do not anticipate participating patients will incur costs related to completing the survey.


  1. Annualized Cost to the Government


Table A-14: Estimated Annualized Cost to the Federal Government

Expense

Number/ Amount

Cost/Hourly Wage Rate

Average Cost

Researchers

120

$123.64

$14,836.80

Research Support

300

$66.52

$19,956.00

Facility and Coordination Fee

20

$1000.00

$20,000.00

Estimated Total Cost of Data Collection



$54,792.80

The estimated annual cost to the Federal government is $54,792.80.


  1. Explanation for Program Changes or Adjustments


This is new data collection.


  1. Plans for Tabulation and Publication and Project Time Schedule


Patients will complete paper surveys. Contractor staff will enter the survey data into computer files for analysis with statistical software. Contractor staff will analyze the data to look for key themes and findings in relation to the research questions. These findings will be summarized. No names or other personal information will be reported in the summaries.


The qualitative information shared during clinician interviews will be collected via typed notes and audio recording. After each interview is complete, contractor staff will review the written notes within 24 hours. Contractor staff will analyze the data by reviewing the session notes and pulling out the main themes from each set of discussions. These themes will be summarized. No names or other personal information will be reported in the summaries.


Proposed Timeline

Completion Date

Major Tasks/Milestones

October - January 2017

  • Develop study design and materials

  • Submit request for IRB approval

February –

March 2018

  • Submit request for OMB approval under existing generic clearance

  • Plan for data collection – patient surveys and clinician interviews

April - June 2018

  • Collect data – patient surveys

  • Begin analyzing data – patient surveys

July – Sept 2018

  • Collect data – clinician interviews

  • Analyze data – patient surveys

  • Draft summary report with preliminary findings

October – December 2018

  • Analyze data – clinician interviews

  • Draft summary report with full findings


  1. Reason(s) Display of OMB Expiration Data is Inappropriate


We are requesting no exemption.


  1. Exceptions to Certification for Paperwork Reduction Act Submissions


There are no exceptions to the certification. These activities comply with the requirements in 5 CFR 1320.9.


Section A — List of Attachments

[IN SEPARATE FILES]


  • Attachment A: Patient Survey (Research Instrument)

  • Attachment B: Moderator’s Guide for Clinician Interviews (Research Instrument)

1 Maciosek, M. V., Coffield, A. B., Flottemesch, T. J., Edwards, N. M., & Solberg, L. I. (2010). Greater us of preventive services in U.S. health care could save lives at little or no cost. Health Affairs, 29, 1656 -1660.

2 Ogden, L. L, Richards, C. L., & Shenson, D. (2012). Clinical preventive services for older adults: The interface between personal health car and public health services. American Journal of Public Health, 102, 419-425.

5 May 2017 National Occupational Employment and Wage Estimates, United States. Bureau of Labor Statistics. United States Department of Labor. Retrieved at http://www.bls.gov/oes/current/oes_nat.htm.

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