Unmet Social Needs Study

Hypertension Clinical Trial

Official title:

The Effect of Screening and Referral for Social Determinants of Health on Veterans' Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04977583
• Other study ID #: IIR 19-013
• Status: Completed
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Background: Despite medical advances, up to 70% of health outcomes are due to social determinants of health (SDoH) - the conditions in which people live and work that shape whether basic needs (e.g., housing, food) are met. These associations are especially well documented for cardiovascular disease (CVD). In response, health policy leaders recommend screening and referral (S&R) for unmet needs in clinical settings, and the American Heart Association recently concluded that the most significant opportunities for reducing CVD death and disability lie with addressing the social determinants of cardiovascular outcomes. A limited but promising evidence base supports these recommendations but more rigorous research is needed to guide how best to intervene on unmet needs that affect health. Significance/Impact: This project addresses the Office of Social Work's priority to link Veterans with resources and services in support of treatment goals, the Office of Patient Centered Care and Cultural Transformation's priority to enhance the physical, emotional, and social well-being of the whole person, the Office of Health Equity's priority to reduce disparities, and the HSR&D priorities of health equity and population health. Our study will provide much-needed evidence to document the burden of Veterans' unmet needs, inform how best to address unmet needs, and assess how such a process can affect adherence (to medications and appointments), utilization, and clinical outcomes. Innovation: VA currently systematically screens for only two unmet needs (homelessness and food insecurity). Identification of other unmet needs (and referral to address them) occurs on an ad hoc basis, with varying approaches among clinics/ clinicians. The investigators will implement comprehensive screening of eight unmet needs and systematic referral, developing tools and processes that, if efficacious, can be implemented within VA (and other) clinical systems. VA is currently funding several studies related to SDoH, but none test interventions that systematically identify a wide range of unmet social needs among Veterans and connect Veterans with identified needs to social service resources. Specific Aims: 1) Describe the burden and distribution of nine unmet needs (i.e., housing; food insecurity; utility insecurity; transportation; legal guidance; employment; safety; and social isolation) among Veterans with or at-risk for CVD, and identify their associations with sociodemographic characteristics, and baseline health-related behaviors and clinical outcomes; 2) Compare the effects of three S&R study intervention conditions of varying intensity on Veterans' connection to new SDoH resources (primary outcome), reduction of unmet needs, adherence, and clinical outcomes, and 3) Identify barriers and facilitators to Veterans' connecting with social services and having needs met, and explanatory factors for observed RCT outcomes. Methodology: The investigators propose a 3-year, two-phased mixed methods study. In Phase One (Aims 1 and 2), the investigators will implement a three-armed randomized controlled trial at three VA sites to compare outcomes among Veterans randomized within each site to one of three study conditions: screening only; screening plus provision of tailored resource sheets; or screening plus resource sheets plus social work support. For each Veteran, the investigators will examine associations of unmet needs with baseline outcomes (Aim 1), and longitudinally examine the impact of each approach on connection to new SDoH resources and follow-up outcomes over a 12-month period (Aim 2). In Phase Two (Aim 3), the investigators will conduct interviews with Veterans and representatives of the VA- and community-based programs to which Veterans are referred because of the trial to identify facilitators and barriers and potential explanatory factors related to the relative success of the interventions. Implementation/Next Steps: If the intervention yields positive results, findings will be used by partners to support more widespread implementation of it throughout VA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 713
• Est. completion date: December 15, 2023
• Est. primary completion date: June 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus
• Hyperlipidemia
• Hyperlipidemias
• Hypertension

Intervention

Behavioral:
• Unmet Need Screening
Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.
• Unmet Need Referral - Resource Sheet
Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
• Unmet Need Referral Assistance
Participants receive assistance from a Social Worker (SW) to facilitate connection to resources that can help to address unmet need(s) identified in the index screen. Assistance includes 1) conducting a standardized bio-psychosocial assessment; 2) motivational interviewing methods to uncover details of the Veteran's unmet needs and identify barriers to resolving the unmet needs, and; 3) developing an action plan for the Veteran to connect with resources and address needs. The SW will conduct initial follow-up by phone one week after the interview/action plan development, with planned subsequent phone outreach every two weeks for up to seven weeks.

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina
United States	Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
VA Office of Research and Development	Corporal Michael J. Crescenz VA Medical Center, Ralph H. Johnson VA Medical Center, VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gurewich D, Kressin N, Bokhour BG, Linsky AM, Dichter ME, Hunt KJ, Fix GM, Niles BL. Randomised controlled trial evaluating the effects of screening and referral for social determinants of health on Veterans' outcomes: protocol. BMJ Open. 2022 Sep 23;12(9 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Connection to New Resources	Defined as participant connecting to one or more resources since the index unmet need screen and assessed via a participant survey administered 8 weeks following the index unmet need screen. The survey will ask: "Since you completed the unmet social need screen on (insert date), were you able to connect with any of the programs or resources for help with (insert need(s) identified)".	8 weeks
Secondary	Unmet Need Reduction	The investigators will compare the results from the index screen for unmet needs to those from the unmet needs screen administered six months after the index screen. The investigators will define unmet need reduction in two ways: 1) one or more of baseline unmet needs no longer identified as an unmet need at the 6-month rescreen, and; 2) percentage of baseline needs not reported as unmet needs at 6-month rescreen.	6 months
Secondary	Preventable Hospitalization	Also know as Ambulatory Care Sensitive Conditions (ACSCs). This indicator has been adopted by Agency for Healthcare Research and Quality (AHRQ) under the label "Prevention Quality Indicators" (PQI). The investigators will examine effects on all 13 admission conditions identified using AHRQ criteria. The investigators will assess this measure using VA Corporate Warehouse Data (CDW).	6 and 12 months
Secondary	Urgent Care Utilization	Emergency Department and urgent care visits. The investigators will assess this measure using CDW.	6 and 12 months
Secondary	Medication Adherence	The investigators will assess adherence to CVD and CVD risk factor medications, including all possible drug class codes (CV000-CV900, encompassing Antilipemic agents and antihypertensives for the subsets of patients prescribed these medications) and, among the subset of patients with DM, diabetes medications (HS501-509). The investigators will measure this outcome using pharmacy dispensing data from CDW to specify the proportion of days covered (PDC) of each medication, using well-established methods from prior studies. To calculate this, the investigators will count the number of days dispensed in relation to the dispensing period. The numerator will be based on the prescription fill dates and number of days dispensed to determine the number of outpatient days for which each medication was supplied. Patients will be considered adherent if they achieved a PDC > 80%, a commonly used threshold of adherence which is positively associated with clinical outcomes.	6 and 12 months
Secondary	Clinic Visit Appointment Attendance ("no-show")	For each patient, the investigators will calculate a no-show rate, or the proportion of primary care and cardiology appointments that are classified as no-show, relative to the total number of appointments scheduled in both, following the approach taken by other VA investigators using CDW data to assess this metric. The numerator ("no-shows") consists of appointments marked as a no-show and appointments canceled by the patient or clinic after the appointment time. The denominator ("total appointments") consists of no-shows and completed appointments.	6 and 12 months
Secondary	Blood Pressure (BP)	BP is measured at every PC visit, and the investigators will obtain these measurements from CDW. In the rare case of missing BP data, the investigators will exclude such Veterans from the analysis. Because BP outcomes are also affected by clinicians' adjustment or titration of antihypertensive medications, the investigators will assess the effects of controlling for treatment intensification (TI), using methods similar to the published approaches used in prior work. The investigators will use the following formula to measure TI: (visits with medication changes-visits with elevated BP) / (number of clinic visits).	6 and 12 months
Secondary	Hemoglobin A1c (HbA1c)	HbA1c is available from CDW. The investigators anticipate approximately 40% of our RCT sample to have DM, based on a preparatory-to-research analysis of CDW data. To ensure the values reflect health status around the time of the index screen and the 6 and 12-month follow-up window, the investigators will only include Veterans with DM who have an Hba1c in the 6 months prior to each time point. Approximately 17% of patients with DM do not have an HbA1c test within VA in the prior year.	6 and 12 months