N/A
N=479
Unmet Social Needs Study
Cardiovascular Disease · Hypertension · Diabetes Mellitus · Hyperlipidemia
Bottom Line
View on ClinicalTrials.gov: NCT04977583 ↗Enrolled (actual)
479
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Number of Participants Who Connected With a New Resource — 40; 41; 51 Participants — p=0.6243
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Unmet Need Screening (Behavioral); Unmet Need Referral - Resource Sheet (Behavioral); Unmet Need Referral Assistance (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Connected With a New Resource |
40; 41; 51 | 0.6243 |
| PRIMARY Mean Count of Resources Connected To |
0.40; 0.40; 0.47 | 0.856 |
| SECONDARY Unmet Need Reduction - Any |
82; 73; 74 | .5582 |
| SECONDARY Emergent Visits (Urgent Care and Emergency Department Visits) |
0.19; 0.53; -0.01 | 0.2105 |
| SECONDARY Medication Adherence |
0.01; 0.01; 0.03 | 0.9775 |
| SECONDARY Clinic Visit Appointment Attendance ("No-show") |
-0.14; -0.06; 0.22 | 0.8623 |
| SECONDARY Systolic Blood Pressure (BP) |
-1.20; -0.27; -0.23 | 0.5701 |
| SECONDARY Hemoglobin A1c (HbA1c) |
-0.42; -0.03; 0.11 | 0.0870 |
| SECONDARY Unmet Need Reduction - Percent |
30.37; 27.11; 27.88 | 0.3063 |
| SECONDARY Diastolic Blood Pressure (BP) |
-0.43; -1.17; -0.11 | 0.4134 |
Summary
The impacts of unmet social needs, such as homelessness, inconsistent access to food, and exposure to violence on health are well-established, especially for cardiovascular disease. A limited but growing body of evidence suggests that screening for and addressing these needs - also referred as social determinants of health -- in clinic settings helps to connect patients to resources to address unmet needs and has the potential to improve health outcomes. Veterans carry a high burden of unmet needs. At present, VA systematically screens for only two unmet needs; homelessness and food insecurity. The investigators propose to assess the efficacy of systematically screening Veterans for nine unmet needs (i.e., housing, food insecurity, utility insecurity, transportation, legal problems, employment, safety, stress, and social isolation), and compare the effect of referral mechanisms of varying intensity on Veterans' connection to resources, reduction of unmet needs, treatment adherence, reduced preventable hospitalizations, and clinical outcomes.
Eligibility Criteria
Inclusion Criteria
- Veterans enrolled in one of three VA medical centers:
- 1) VA Boston Healthcare System
- 2) Corporal Michael J. Crescenz VA Medical Center (Philadelphia)
- 2) Ralph H. Johnson VA Medical Center (Charleston)
- Veterans with, or at risk for, cardiovascular disease (CVD) who had at least 1 PC visit in the prior year
- CVD patients are defined as those with International Classification of Disease 10 (ICD10) diagnoses indicating:
- coronary artery disease
- cerebrovascular disease
- peripheral artery disease
- Patients at-risk for CVD are defined as having diagnoses of hypertension, diabetes mellitus (DM), or hyperlipidemia
Exclusion Criteria
- Impaired decision-making
- Illiterate or have limited or no English proficiency
Data sourced from ClinicalTrials.gov (NCT04977583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.