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Using EPC Reports to Promote Changes in Research, Practice and Policy: A Perspective from Two NGOs (Text Version)

Slide Presentation from the AHRQ 2008 Annual Conference

On September 10, 2008, Margo Michaels, M.P.H., made this presentation at the 2008 Annual Conference. Select to access the PowerPoint® presentation (930 KB).

Slide 1

Using Evidence-based Practice Centers (EPCs) Reports to Promote Changes in Research, Practice and Policy: A Perspective from Two Non-governmental Organizations (NGOs)

Panel on Use and Implementation of Effective Health Care (EHC) and EPC Research Products
September 10, 2008

Margo Michaels, MPH
Executive Director, ENACCT
Co PI, Communities as Partners in Cancer Clinical Trials, R13-HS016471

Slide 2

ENACCT (Education Network to Advance Cancer Clinical Trials)

The only national organization solely devoted to community-centered approaches to cancer clinical trials education.
Dedicated to finding evidence-based approaches that work to change attitudes, behaviors and ultimately, accrual.

Slide 3

Community-Campus Partnerships for Health (CCPH) 1997-2007: Transforming Communities and Higher Education

About us...

The only national organization devoted solely to promoting health through partnerships between communities and higher educational institutions, including community-based participatory research.
Conducts research & evaluation, provides training & technical assistance, convenes stakeholders, disseminates info.

Slide 4

Community Based Participatory Research (CBPR)

"Scientific inquiry ...in which community members, persons affected by condition or issue under study and other key stakeholders... (are) full participants in each phase of the work—conception, design, conduct, analysis, interpretation, conclusions and communication of results."

Definition of CBPR. Federal Interagency Working Group on CBPR. Retrieved 2007 from National Institute of Environmental Health Sciences Web site: http://www.niehs.nih.gov/translat/IWG/iwghome.htm.

Slide 5

Evidence Report #99

Utilization of CBPR can improve research quality, enhance intervention quality, improve outcomes, and enhance research recruitment efforts.

To the right of the text is a screen shot of the first page of the evidence report.

Slide 6

Community-Based Participatory Research (continued)

Community-Based Participatory Research (from AHRQ evidence report on CBPR):

Screen shot of a timeline showing the steps involved in CBPR.

Helps identify key issues:
- Leads to Increased motivation to participate:
  - Followed by Health Concerns Identified (Issues).
Helps with study design, budget, proposal submission:
- Leads to Increased accountability and "buy-in":
  - Followed by Study Designed and Funding Sought.
Gives guidance re recruitment and retention:
- Leads to Enhanced recruitment and retention:
  - Followed by Participants recruited and retention systems implemented.
Helps with measures development and testing:
- Leads to Increased reliability and validity:
  - Followed by Measurement instruments designed and data collected.
Helps guide intervention development:
- Leads to Greater relevance and likelihood for success:
  - Followed by intervention designed and implemented (Intervention):

Traditional Research Approach

Issues selected from Epid data:
- Lead to Health Concerns Identified.
Design science and feasibility
Budget: research expenses:
- Lead to Study Designed and Funding Sought
Recruitment and Retention based on science and "best guesses":
- Lead to Participants recruited and retention systems implemented.
Measures adopted or adapted from other studies psychometric testing:
- Lead to Measurement instruments designed and data collected.
Intervention designed by researchers based on literature and theory:
- Leads to Intervention designed and implemented.
Researchers report findings from analysis and publish in peer review journals:
- Leads to Data analyzed and interpreted; Translation of findings.

Slide 7

Evidence Report #122

Uncertainty about effective approaches for cancer clinical trials recruitment.
Need further investigation of effective communication and trust-building strategies.
CBPR should be explored as a way to address persistent barriers.

Slide 8

Awareness Barriers/Promoters:
- Attitudes/Beliefs.
- Self-Efficacy.
- Organizational Environment.
- Health Literacy.
Opportunity Barriers/Promoters:
- Provider Knowledge.
- Provider Attitudes/Beliefs.
- Eligibility/Exclusions by Design.
- Access.
- Medical Insurance.
- Advanced Disease.
- Co-morbidity.
- Organizational Environment.
Acceptance/Refusal Barriers/Promoters:
- Perceived Harms/Benefits.
- Trust in Sponsor/Investigator.
- Self-efficacy.
- Altruism.
- Religious Beliefs.
- Personal Experience.
- No Cost Treatment.
- Financial Incentives.
- Timing.

These factors affect Awareness, Opportunity, Acceptance/Refusal.

Slide 9

Use of the EPCs by our Respective Organizations: ENACCT

Training:
- Community Leaders Community Health Care Providers Training of Trainers Program: "What do you see as the greatest barrier to CCTs in your community?"
Rationale for Grants.
Training Model.

Slide 10

ENACCT's 3-pronged training program

Many barriers relate to lack of knowledge and underlying attitudes and beliefs among patients, communities, primary care providers, oncology teams.
In order to increase CCT participation, it is critical to enhance the knowledge, attitude, and skills of each of these groups.

Slide 11

Use of the EPCs by our Respective Organizations: CCPH

Evidence Report on CBPR:

2004: Disseminated report through CCPH Web site, listservs & newsletter (4000+ audience).
2004: Sponsored first teleconference on the report, featuring authors as speakers (300 attendees).
2005-2007: Incorporated findings into CBPR institutes at American Public Health Association (APHA) and CCPH conferences (500 attendees).
2005-2008: Incorporated review guidelines into merit review for Healthier Wisconsin Partnership Program.
2006: Incorporated findings into evidence-based curriculum, www.cbprcurriculum.info (2000+ hits).

Slide 12

Use of the EPCs by ENACCT & CCPH together:

Rationale for Conference Grant Application to AHRQ:

National Institutes of Health (NIH), National Cancer Institute (NCI), Institute of Medicine (IOM) and the literature have called for the inclusion of public representatives in research design and implementation to address low accrual and improve research outcomes.
How can we leverage the findings of these two evidence reports into action recommendations that will lead to changes in design and implementation of Phase III treatment clinical trials?

Slide 13

Communities as Partners in Cancer Clinical Trials

A national strategic planning effort with core funding from the Agency for Healthcare Research and Quality and the National Cancer Institute (NCI).
Additional core financial support from:
- The Lance Armstrong Foundation.
- American Society of Clinical Oncology.
- Genentech.
- GlaxoSmithKline.

Slide 14

Project Purpose

To bring together a diverse group of stakeholders to explore ways to improve Phase III cancer treatment trials, utilizing the principles & approaches of CBPR.
To develop a national strategic plan for research, practice & policy for incorporating CBPR principles & approaches into Phase III cancer clinical trials.

Slide 15

5 steps, 3 years

Laying the Foundation for CBPR in Cancer Clinical Trials (3/07-8/07).
Convening 1st of Two Invitational Meetings (9/2007).
Developing Preliminary Draft Recs (11/07-2/08).
Vetting and Refining Initial Draft Recs (3/08-8/08).
Disseminating and Implementing Plan (9/08-9/09).

Slide 16

Report Release 9/30/08

1st report to detail how the cancer clinical trial process would involve communities affected by cancer—from trial design to implementation to dissemination of results—with a strong focus on community engagement and CBPR.

Slide 17

Seven Areas of Recommendation

Ensuring a Meaningful Role for Community Representatives/Patient Advocates in Trial Design.
Ensuring Community Perspectives in the Institutional Review Board (IRB) Review Process.
Improving the Informed Consent Process.
Ensuring Community Perspectives in Protocol Development, Trial Design and Implementation.
Improving Trial Participant Recruitment, Accrual and Retention.
Enhancing Local Community Support for Cancer Research.
Enhancing Community Interpretation, Dissemination and Implementation of Trial Outcomes.

Slide 18

Next Steps: Dissemination and Implementation

Sponsors: NCI and the pharmaceutical industry.
Those designing and implementing: The national Cooperative Groups, industry, and local clinical research sites.
Oversight and quality improvement agencies: Food and Drug Administration (FDA), Office for Human Research Protection (OHRP), AHRQ, and local Institutional Review Boards.
Accreditation organizations: Association for the Accreditation of Human Research Protection Programs and the American College of Surgeons' Commission on Cancer.

Slide 19

Thank You!

ENACCT: Education Network to Advance Clinical Cancer Trials.
Community-Campus Partnerships for Health—Transforming Communities & Higher Education, 1997-2007.

www.enacct.org
www.ccph.net

Current as of February 2009

Internet Citation:

Using EPC Reports to Promote Changes in Research, Practice and Policy: A Perspective from Two NGOs. Slide Presentation from the AHRQ 2008 Annual Conference (Text Version). February 2009. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/about/annualmtg08/091008slides/Michaels.htm