Special Diabetes Program for Indians: Cardiovascular Disease Prevention Group

Planning Meeting 2

Recruitment and Retention Issues and Strategies

January 11, 2005

Jeffrey A. Henderson, M.D., M.P.H.

President and CEO

Black Hills Center for American Indian Health

Black Hills Center for American Indian Health

• Community-based 501 (c)(3) organization

• Founded in 1998

• To conduct activities that will lead to the enhanced wellness of American Indian peoples, communities, and tribes

• Research, Service, Education, and Philanthropy

Black Hills Center for American Indian HealthResearch Portfolio

• Six DHHS/NIH peer-reviewed health research grants totaling $8.8 million

1. Education and Research Towards Health (EARTH Study) – NIH/NCI

2. Native American Research Centers for Health: Lakota Center for Health Research – NIH/NIGMS/IHS

3. Stop Atherosclerosis Among Natives with Diabetes (SANDS Study) – NIH/NHLBI

Black Hills Center for American Indian HealthResearch Portfolio

4. Project Export – NIH/NCMHHD

5. Minority Research Infrastructure for MT/WY Tribes – DHHS/AHRQ

6. Environmental Justice on Cheyenne River – NIH/NIEHS

Black Hills Center for American Indian HealthResearch Portfolio

Grants currently under development:• Health Careers Opportunity Program (HCOP)• The experience of chest pain in a Lakota

community• Knowledge, attitudes, and behaviors about

prostate and colorectal cancer screening among Lakota men

• Ethical, legal, and social implications of genetic testing/studies for environmental pollutants

• Mold, tribal housing, and adverse health effects

Black Hills Center for American Indian HealthResearch Portfolio

• BHCAIH has consented more than 4,000 American Indians into its various studies in the past 18 months

• We expect to recruit another 3,000 in the next 18 months

Some examples…

• A baseline feasibility study for a longitudinal study of risk factors for cancer and other chronic diseases

• Three linked RO-1s: BHCAIH, Alaska Native Tribal Health Consortium (Lanier), and the University of Utah (Slattery)

• Total recruitment goal at baseline ~ 16,000 American Indians/Alaska Natives

Black Hills Center for American Indian HealthThe EARTH Study

Black Hills Center for American Indian HealthThe SANDS Study

• A multicenter, randomized clinical trial to prevent CVD among American Indians with DM through LDL- and SBP-lowering.

• Sioux San is the only site on the Northern Plains. • Two groups with goals of 100/70 (LDL) and 130/115

(SBP), respectively.

Black Hills Center for American Indian HealthThe SANDS Study

• The primary endpoint is carotid intimal-medial thickness and plaque progression. Secondary endpoints include cardiac function measures by echocardiography, lipoproteins, albuminuria, and C-reactive protein.

• American Indians 40 yrs. and older with type 2 DM and without signs of CVD.

• Recruitment began in May 2003 and ended July 2004, with three years of follow-up .

The Good Red Road: Tribal Collaborations in Health Research

The BHCAIH Experience

The Good Red Road: Tribal Collaborations in Health Research

American Indians and Alaska Natives, too, have historical situations that have fostered mistrust

– Thyroid (I131) studies in Alaska in the 1950s

– Barrow alcohol study, 1970s– Coerced sterilization of American Indian/Alaska Native

women, 1970s– Early pre-approval use of Depo-Provera and Norplant, 1980s– Present situation involving Havasupai, 2004

The Good Red Road: Tribal Collaborations in Health Research

American Indian and Alaska Native Tribes are unique in many ways

– Domestic, dependent nations with sovereignty

– Unique types and levels of approval, which vary by tribe, PLUS group consent in most cases

– Very different demographics

– DHHS/PHS/Indian Health Service beneficiaries

The Good Red Road: Tribal Collaborations in Health Research

American Indian and Alaska Native Tribes are unique in many ways

– Frequently lack typical supportive and easily accessible community resources (e.g., colleges and universities, social service agencies, grant-making bodies, etc.)

– Have such pressing needs that often health research, including health promotion, falls far down the list of priorities

The Good Red Road: Tribal Collaborations in Health Research

Recruitment and retention issues and strategies:

1. You’d like to maximize community resources in order to:a. Avoid duplication of effortsb. Encourage wider participation in your projectc. Help participants to be more comfortable with their

participationd. Make it easier for people to participate

Strategies:a. Partner with the local health center (and other interested

parties)b. Hire staff from the community

The Good Red Road: Tribal Collaborations in Health Research

Recruitment and retention issues and strategies:

1. You’d like to maximize community resources for recruitment (con’t)

c. Market the project to physicians and other providers, staff, and patients Consider providing transportation and child care

d. Use a staged recruitment strategy

e. Provide an appropriate incentive

f. Engender a sense of community, belonging, and ownership

The Good Red Road: Tribal Collaborations in Health Research

Recruitment and retention issues and strategies:

2. You’d like to try to ensure that participants are committed to seeing the project through to the end.

a. Use a staged recruitment process consisting of:

– A medical record review

– A personalized letter

– A pre-screening telephone call

– Two screening visits

– Randomization or consenting visit

The Good Red Road: Tribal Collaborations in Health Research

Recruitment and retention issues and strategies:

2. You’d like to try to ensure that participants are committed to seeing the project through to the end.

b. Use a staged incentive system:

– Payment after the 1st screening visit and after randomization or study entry

– Payments to accompany each follow-up visit

c. Build rapport with personal contact

d. Maximize privacy and confidentiality within the limits of your project

CONTACT INFORMATION

Jeff Henderson

President and CEO

Black Hills Center for American Indian Health

701 St. Joseph St., Suite 204

Rapid City, SD 57701

(605) 348-6100

(605) 348-6990 fax

E-mail: jhenderson@bhcaih.org