Grants and Contracts Details
Description
Scope of Project
Our proposal aims to develop a stepped care randomized controlled trial (RCT) among
Medicaid adults with hypertension residing in high poverty rural and urban areas, recruited from
three large healthcare systems across Kentucky. This large-scale proposal takes lessons
learned from the current American Heart Association Health Care by Food™ grant (PI:
Gustafson) related to screening, referral, enrollment, and engagement to now test a full
powered RCT to determine the incremental effect of a more intensive food and nutrition support
plus counseling service program. This study will be able to answer at what level of care and
for whom are these services clinically meaningful and cost-effective. Lastly, the proposed
study incorporates referral services after the study ends to ensure sustainability after completion
of the program. The proposed aims of the future large-scale study are as follows:
Aim 1) Determine effectiveness of a stepped care food is medicine intervention among Medicaid
adults diagnosed hypertension on primary outcome of blood pressure (systolic and diastolic)
and secondary outcomes of (hemoglobinA1C, quality of life, food security, nutrition security, and
family stress (anxiety, depression, and stress).
Aim 2) Examine the lived experience in the entire Health Care by Food system at key time
points in screening, referral, enrollment, and engagement throughout the stepped care process
to enhance scalability across multiple healthcare sectors (health departments, hospitals,
federally qualified health centers, managed care organizations, and food providers).
AIM 3) Evaluate the cost effectiveness of the interventions from a healthcare and societal
perspective, expressing cost effectiveness as: 1) cost per percentage point reduction in systolic
and diastolic blood pressure and 2) cost per quality adjusted life year gained, assessed with a
generic preference-based health utility measure (PROPr).
Our study takes our previous three years of experience in building a statewide food is
medicine system to develop a stepped-care model with nutrition and mental health
counseling including referral systems into federal nutrition programs for sustained
clinical improvements. The stepped care model allows for testing the incremental effect of
more intensive food, nutrition, and counseling services which can answer at what level of care
and for whom are these services clinically meaningful and cost-effective. This study also
balances the importance of the user experience to allow for long-term success and
engagement.
| Status | Active |
|---|---|
| Effective start/end date | 7/1/25 → 6/30/26 |
Funding
- American Heart Association: $97,020.00
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