ThumpThump Pilot Study: Partnering With Communities to Improve Brain and Heart Care

Yale University

Summary

Brain disease and heart disease are the leading causes of death and disability in the US; at least 60% of cases can be attributed to modifiable risk factors such as hypertension, dyslipidemia, and poor-quality diet. Our mission is to deliver high-quality preventive care to whole geopolitically defined communities, reaching every resident. ThumpThump is a novel implementation strategy that 1) uses sociology, marketing, and behavioral science to engage residents and 2) adapts population health methods from high-functioning health systems to geopolitically defined communities. ThumpThump is starting with hypertension in Derby, CT in collaboration with city residents and city leaders. The ThumpThump Pilot Study will estimate the likelihood that a large, definitive trial of ThumpThump can succeed. The pilot study will enroll 150 residents who are at least 40 years of age. Specific aims are: 1) demonstrate ThumpThump can reach residents of Derby, 2) measure and achieve fidelity to standard hypertension care, and 3) measure success in applying our implementation strategy. The pilot is a one-arm trial. Proven population health methods from high-functioning health systems will be used to first classify participants according to hypertension (none, controlled, uncontrolled) and then help those in need get to goal. Home blood pressure cuffs will be given to all participants. Participants with no or controlled hypertension will have blood pressure re-measured at three and six months. Participants with uncontrolled hypertension will be offered two options: 1) to continue care from their personal healthcare professional or 2) to receive hypertension care directly from our team. With either method, the study will continue to monitor their blood pressure regularly. If they continue to receive care from their personal professional, participants will be offered support in following that professional's plan and the study will communicate and coordinate with their professional as appropriate. If they chose our team, a treatment algorithm will be used to help them get to their BP goal. Community health workers will be employed for participant enrollment and follow-up care (e.g., health education, blood pressure monitoring, treatment implementation, and navigation within health systems). Team care will include working with local health care professionals and institutions to advance a mutual mission, not replace their function. If successful, funds for a definitive trial will be sought with the long-term goal of targeting more risk factors and expanding to more communities.

Eligibility

Age range: 40+ years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: * Resident of Derby, Connecticut * Age ≥40 years * Able to provide informed consent or has a LAR who could consent * Ability to speak English or Spanish Exclusion Criteria: * Definite intent to move out of town in the next 6 months * Pregnancy or intention to become pregnant in the next 6 months. * Participation in another clinical trial that prohibits co-participation in PROSPER. * Considered by the investigator to have a condition that precludes safe participation in the trial

Interventions

Other
: Implementation strategy to improve hypertension care in geopolitically defined communities
The implementation strategy has two stages. The first stage uses methods to reach adult residents of Derby for blood pressure measurement and enrollment in the PROSPER Clinical Trial for hypertension care (i.e., marketing to change how residents regard hypertension and cardiovascular health, social contagion techniques based on social network science to draw residents to PROSPER and develop interest in cardiovascular health, and financial incentives). The second stage adapts implementation methods developed for high performing practices and health systems to improve delivery of evidence-based hypertension care in a different context, which is the community (e.g., task-shifting and team care, standardized and client centered care, and audit and feedback with rapid small cycles of change).

Location

Yale University
Derby, Connecticut
walter.kernan@yale.edu 203-530-1756

Summary

Eligibility

Age range

40+ years

Sex

All

Healthy volunteers

Yes

Detailed criteria

Interventions

Other

: Implementation strategy to improve hypertension care in geopolitically defined communities

The implementation strategy has two stages. The first stage uses methods to reach adult residents of Derby for blood pressure measurement and enrollment in the PROSPER Clinical Trial for hypertension care (i.e., marketing to change how residents regard hypertension and cardiovascular health, social contagion techniques based on social network science to draw residents to PROSPER and develop interest in cardiovascular health, and financial incentives). The second stage adapts implementation methods developed for high performing practices and health systems to improve delivery of evidence-based hypertension care in a different context, which is the community (e.g., task-shifting and team care, standardized and client centered care, and audit and feedback with rapid small cycles of change).