Attachment 1 Research Plan and Burden_10282014

Audience Research on Self-Management Education Phase III

Description of Attachments to the HMTS Expedited Review Form

Attachment 1

Attachment 1a: Research Plan

Attachment 1b: Burden Hours

Attachment 2

Attachment 2: Materials for Testing

Attachment 3

Attachment 3: Moderator’s Guide

Attachment 4

Attachment 4: Eligibility Screener

Attachment 5

Attachment 5: Informed Consent Document

Audience Research on Self-Management Education Phase III

Attachment 1 to the HMTS Expedited Review Form

Contents

Attachment 1a: Research Plan 1

Attachment 1b : Burden Hours and Distribution of Respondents 5

Attachment 1a: Research Plan

Audience Research on Self-Management Education Phase III

October 28, 2014

Background

Self-management education (SME) is the term used for a number of educational interventions that prepare individuals to live the best possible quality of life with their chronic condition(s). SME programs vary in content and delivery, but all aim to build skills that allow participants to better manage their health and improve their quality of life. However, despite mounting evidence demonstrating the effectiveness of SME, participation in these programs remains low. Therefore, as CDC continues to invest in SME interventions as an evidence-based strategy, the agency is exploring the feasibility of creating a broad campaign that markets the concept of SME as a way to manage chronic disease, in addition to promoting individual SME programs.

In the first two phases of the project, Audience Research on Self-Management Education Phase I and II were conducted in Summer/Fall 2013, FHI 360 worked with CDC to conduct formative research to assess the feasibility of the proposed campaign approach. Through a situational analysis, including key informant interviews, and message and concept testing, FHI 360 found that with the right blend of messages and creative executions, and with sufficient exposure, the general concept of SME can be marketed to consumers in a way that engages their interest and encourages action.

The next phase of the feasibility study, scheduled for Fall/Winter 2014, builds on the previous work and will focus on developing a marketing plan and marketing materials to promote SME among people with a chronic condition.

Methodology and Research Design

FHI 360 will conduct focus groups with the key audience to test SME marketing materials that impart information, demonstrate benefits, address barriers, and increase receptiveness to SME. Focus groups are valuable in exploring consumer reactions to materials before additional resources are put into their dissemination.¹

The primary goal of the materials testing is to use target audience feedback to refine SME marketing materials prior to campaign implementation and materials dissemination. The objectives of the research task are to:

1. Test SME marketing materials to assess appeal, motivational impact, acceptability, and comprehension

2. Examine unintended consequences of materials

3. Explore differences in target audiences’ reactions to the materials

4. Assess audiences’ preferred sources and channels

FHI 360 research staff will develop instruments, recruit respondents, conduct the focus groups, analyze the data collected, and summarize key findings in a topline report.

Site Selection

Eight (8) focus groups will be conducted across two U.S. markets: We propose San Antonio, TX (South), and Cincinnati, OH (Midwest). FHI 360 considered the following criteria when selecting the locations for materials testing:

• Geographical distribution

• Diversity of population (race/ethnicity)

• Prevalence of SME programs

• Proportion of population taking medication to manage a chronic condition using Scarborough data

• Market size (secondary/mid-tier media markets) using Nielsen data

Of note, our experience with prior research for health seeking and self-care behavior suggests a gender difference, thus we propose segmenting groups by gender. However, we do not propose segmenting groups by race/ethnicity as the concepts will be designed to appeal across racial/ethnic groups to a national English speaking audience. The groups will consist of individuals with 1 or more chronic conditions:

• Women with 1 or more chronic conditions, which can be helped by SME.

• Men with 1 or more chronic conditions, which can be helped by SME.

• Each group will include participants with a mix of chronic conditions.

The research designs presented in table 1 below:

Table 1: Focus Groups Design – Materials Testing with Persons with Chronic Conditions

Audience Segment	San Antonio, Texas	Cincinnati, Ohio	Total
Women with 1 or more chronic condition	2 Groups (9 participants/group)	2 Groups (9 participants/group)	4 Groups
Men with 1 or more chronic condition	2 Groups (9 participants/group)	2 Groups (9 participants/group)	4 Groups
TOTAL	4 Groups	4 Groups	8 Groups

Recruitment

FHI 360 will contract with a professional recruitment agency to identify, invite, and schedule participants for focus groups. The professional recruitment agency will contact potential participants from their databases and will use the approved screening instrument, developed by FHI 360 in conjunction with CDC, to select participants and recruit them for the focus groups. Ten participants will be recruited for each focus group to ensure that 8 to 10 show up for the groups. FHI 360 will convene the in-person focus groups at a professional research facility in each market. The focus groups will be held at a convenient time of day for working people – e.g., at noon or in the late afternoon and evening.

Recruitment quotas for each of the groups of people will include:

• Age (45-75 yrs)

• Race/Ethnicity (White, Black, and Hispanic [English-Speaking])

• Education (Less than College and College graduate or more)

• Number of conditions that would benefit from SME (1 vs. more than 1)

• Patient Activation Model (Level 1, 2 or 3)

Focus Group Protocol

Each discussion will last no longer than 90 minutes. A professional moderator will conduct the focus groups. The focus groups will use prepared boards with message concepts and graphics/images for review and discussion. Participation will be strictly voluntary and based on informed consent. Prior to participating in discussions, respondents will be asked to read and sign a consent form.

The proceedings will be audio taped and transcribed for the purposes of report writing only. Names and any other personal identifying information will be maintained in a secure manner, and will not appear on notes, audiotapes, transcripts, or in the summary report. Notes, transcripts, and audiotapes will be stored in a locked cabinet at FHI 360, separate from any materials that contain personal identifying information, and will be destroyed two years after completing the research report.

Moderator’s Guide

In conjunction with CDC, FHI 360 will develop and finalize the moderator guide. The guides will be used to ensure that the discussions stay focused. The guides will be organized around the following main topic areas:

• Health information-seeking behaviors;

• Reactions to materials, logo, and draft Web site.

Data Analysis and Report Writing

Once the data collection is complete, FHI 360 research staff will analyze the focus group notes and transcripts using a systematic approach to identify themes across and within segments. FHI 360 will summarize the data in two topline reports. Each report will be 15-20 pages in length. The report will include the following components:

• Overview of the research design

• Summary of key findings and recommendations

  • Including emergent themes specific to participant subgroups (e.g., gender, race/ethnicity, etc.), if any

• Interview guide

• Screening questionnaire

HMTS and IRB Clearance Package

This project does not require IRB review and approval.

Attachment 1b : Burden Hours and Distribution of Respondents

Audience Research on Self-Management Education

October 28, 2014

Burden Hours

Type of Respondents	Form Name	Number of Respondents	Number of Responses per Respondent	Burden per Response (in hr)	Total Burden (in hr)
Individuals with 1 or more chronic conditions	Focus Group Eligibility Screener	80	1	10/60	14
	Moderator’s Guide for Focus Groups	80	1	90/60	120
Total					134

Total Number of Respondents and Distribution by Region

Type of discussion group	Total # of groups (across all 3 regions*)	Total # of respondents that will be recruited for each group	Total # of respondents
Focus Groups with individuals with 1 or more chronic conditions	8 (4 in each region1)	10	80 respondents
1 Regions include: (2) South and (2) Midwest			80 respondents

1 Krueger, R.A. (1994). Focus groups: A practical guide for applied research, (2nd ed.) Thousand Oaks, CA: Sage Publications.