Supporting 10-Day Letter

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Centers for Disease Control and Prevention

National Center for Health Statistics

3311 Toledo Road

Hyattsville, Maryland 20782

July 25, 2011

Margo Schwab, Ph.D.

Office of Management and Budget

725 17th Street, N.W.

Washington, DC 20503

Dear Dr. Schwab:

The staff of the NCHS Questionnaire Design Research Laboratory (QDRL) (OMB No. 0920-0222, exp. 03/31/2013) plans to conduct research to evaluate the 2012 Asthma Management Supplement for the Division of Health Care Statistics.

We propose to start advertising for volunteer participants as soon as we receive clearance and to start testing as soon as possible after that.

Background Information about Cognitive Testing of Questionnaires

The methodological design of this proposed study is consistent with the design of typical cognitive testing research. As you know, the purpose of cognitive testing is to obtain information about the processes people use to answer survey questions as well as to identify any potential problems in the questions. The analysis will be qualitative.

Proposed project: 2012 Asthma Management Supplement Study

The purpose of the National Ambulatory Medical Care Survey (NAMCS) (OMB No. 0920-0234) Asthma Management Supplement is to collect information about physician clinical decision making about asthma management for patients in ambulatory care settings. The full supplement is scheduled for fielding in 2012. The Asthma Management Survey is sponsored by a collection of federal agencies collaborating on implementing the National Asthma Education and Prevention Program Guidelines for the Diagnosis and Management of Asthma. The goals of the Asthma Management Supplement are to 1) evaluate physician agreement with core elements of the Guidelines, 2) assess self-reported competency in providing Guideline-compliant care, 3) determine which elements doctors report providing, and 4) assess perceived barriers to providing the core elements of asthma management to patient populations. These data will be used to develop interventions to better educate and equip physicians to fully implement the Guidelines. To obtain adequate sample sizes to allow comparisons between specialties and practices and physician characteristics, additional samples of specialists and generalists will be obtained for this NAMCS supplement, and it will also be fielded simultaneously as a National Hospital Ambulatory Medical Care Survey (NHAMCS) supplement.

The 2012 Asthma Management Supplement that we are evaluating appears as Attachment 1. The testing procedure will conform to the cognitive interviewing techniques that have been described in our generic OMB clearance package.

Cognitive interviews will be conducted with generalists (internists, pediatricians and family practitioners) and specialists (allergists, immunologists and pulmonologists). Physicians will be recruited through flyers, word-of-mouth and advance letters. There will be no coercion. Individuals will be told that their participation in the study is entirely voluntary. The flyer is shown in Attachment 2. The invitation letter is shown in Attachment 3.

For the invitational letters, DHCS will provide the QDRL with contact information for physicians who have most recently participated in the NAMCS Supplement and the closest geographically. DHCS will hand carry contact information to the QDRL. Providing contact information within NCHS, for the purpose of inviting a respondent to participate in additional research that is also conducted by NCHS, is consistent with NCHS Confidentiality Rules and any assurance of confidentiality that respondents have been offered. This proposed recruitment method is the same that was proposed for the DHCS NAMCS & NHAMCS study and explained in a letter dated to you September 30, 2010 as well as the DHCS Physician Workflow EMR study and explained in a letter to you dated January 12, 2011.

As many as forty 60-minute cognitive interviews may be conducted. Though our goal is to conduct 60-minute full-length interviews, if during recruitment individuals repeatedly express willingness for a shorter interview, we may conduct shorter interviews in lieu of no interview at all. Individuals participating in the cognitive interview will be paid $100.00 for their participation. Since the recruitment of physicians is necessary for this study to take place and since physicians are extremely busy and overburdened the incentive has been increased over and above our normal $40 incentive to increase participation, reduce the number of cancelations, and maximize time and travel in a particular state/location.

If however, we are unable to recruit enough local physicians for in-person interviews, we will conduct interviews over the phone. In that case, the Informed Consent form and the Respondent Data Collection Sheet will be mailed or faxed to the scheduled respondent and the signed Informed Consent form and completed Respondent Data Collections Sheet returned prior to the scheduled interview either by fax or mail. We have successfully used this procedure when conducting cognitive interviews for other QDRL studies.

Cognitive interviews will be conducted by QDRL staff members in a private room in the physician’s office, hospital facility or mutually agreeable location. With the consent of the participants, the interviews will be recorded on videotape or audiotape. Participants will be informed of taping procedures (including observation if applicable) in the process of reviewing the consent forms, and the equipment will be turned on once it is clear that the procedures are understood and agreed upon.

At the end of the interviews, participants will be paid and provided with copies of all papers they signed.

We propose paying individuals participating in the cognitive interview $100.00 for their participation. Since the recruitment of physicians is necessary for this study to take place and since physicians are extremely busy and overburdened the incentive has been increased over and above our normal $40 incentive to increase participation, reduce the number of cancelations, and maximize time and travel in a particular state/location.

Extreme care will be taken with all tapes and paperwork from the interviews conducted off-site. Tapes and identifying paperwork will be stored in a secured travel case until returned to NCHS, at which point they will be transferred to the usual secured locked storage cabinets.

In total, for this project, the maximum respondent burden will be 40 hours of interviewing in addition to travel time. An updated burden table for this project is shown below:

Projects	Number of Participants	Number of Responses/ Participant	Average hours per response	Response burden
QDRL Interviews
2) NCHS Surveys	40	1	1	40

Attachments (3)

cc:

M. Moien

D. Holcomb

DHHS RCO

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