loading
loading
NIH grant 1R01DK142769-01A1: Enhancing Healthcare Access and Outcomes for High-Deductible Health Plan Enrollees with Type 2 Diabetes Mellitus: A Randomized Controlled Trial of the Save with Care Intervention
Institute: {'code': 'DK', 'abbreviation': 'NIDDK', 'name': 'National Institute of Diabetes and Digestive and Kidney Diseases', 'admin_org_id': '12500020', 'admin_funding_url': ''}. PI: JEFFREY KULLGREN. Award: $778769.
Start: 2026-08-27T00:00:00.
The growing number of patients with type 2 diabetes mellitus (T2DM) who are enrolled in a high-deductible
health plan (HDHP) face significant financial burden that can decrease their use of recommended care and
worsen their intermediate and long-term clinical outcomes. This financial burden could be mitigated if HDHP
enrollees with T2DM use specific cost-conscious strategies when seeking healthcare such as discussing costs
with clinicians, saving for anticipated medical expenses when possible, and using web-based price comparison
tools. Our research has shown that approximately half of HDHP enrollees who used such cost-conscious
strategies reported that these strategies helped them pay less for healthcare or better afford needed services,
yet few HDHP enrollees use them. One innovative, promising approach to support use of cost-conscious
strategies among HDHP enrollees with T2DM is Save with Care, our novel digital intervention that in a recent
pilot study was highly acceptable to patients, feasible to deliver and recruit for, and preliminarily effective. Our
team of experts in T2DM self-management, cost-related access barriers in HDHPs, behavioral science, and
randomized trials of behavioral interventions proposes to test the effects of an enhanced version of the Save
with Care intervention on out-of-pocket (OOP) healthcare costs and access to care, use of recommended care
for T2DM, and intermediate clinical outcomes in a 12-month hybrid type 1 effectiveness-implementation
randomized trial that will enroll 416 HDHP enrollees with T2DM. Aim 1: Compare the effectiveness of the
Save with Care intervention and usual care in reducing OOP healthcare costs, reducing forgone or
delayed care due to cost, and increasing use of recommended care for T2DM among HDHP enrollees
with T2DM. To assess the co-primary outcome of OOP healthcare costs and secondary outcomes of forgone
or delayed care due to cost and use of guideline-recommended care we will survey participants at baseline
and at 12 months. Aim 2: Compare the effectiveness of the Save with Care intervention and usual care
in improving intermediate clinical outcomes of hemoglobin A1c, lipids, and blood pressure among
HDHP enrollees with T2DM. We will assess the co-primary outcome of hemoglobin A1c and secondary
outcomes of lipid levels and blood pressure at baseline and at 6 and 12 months. Aim 3: Evaluate facilitators
of and barriers to acceptability, scalability, and sustainability of the Save with Care intervention. We will
use qualitative data from interviews with Save with Care Arm participants, their primary care providers, and
health system and workplace benefit stakeholders, as well as process measures and data on intervention
delivery costs, to evaluate intervention implementation and sustainability using an integration of the Reach,
Effectiveness, Adoption, Implementation, and Maintenance and Consolidated Framework for Implementation
Research frameworks. If effective, this approach could transform how health plans, health systems, and
employers support HDHP enrollees with T2DM and other common chronic conditions.document fetched 2026-09-06 02:47