Randomised controlled trial evaluating the effects of screening and referral for social determinants of health on Veterans' outcomes: protocol

Abstract

Introduction: Health policy leaders recommend screening and referral (S&R) for unmet social needs (eg, food) in clinical settings, and the American Heart Association recently concluded that the most significant opportunities for reducing cardiovascular disease (CVD) death and disability lie with addressing the social determinants of CVD outcomes. A limited but promising evidence base supports these recommendations, but more rigorous research is needed to guide health care-based S&R efforts. Funded by the Veteran Health Administration (VA), the study described in this paper will assess the efficacy of S&R on Veterans' connections to new resources to address social needs, reduction of unmet needs and health-related outcomes (adherence, utilisation and clinical outcomes).

Methods and analysis: We will conduct a 1-year mixed-methods randomised controlled trial at three VA sites, enrolling Veterans with CVD and CVD-risk. 880 Veterans experiencing one or more social needs will be randomised within each site (n=293 per site) to one of three study arms representing referral mechanisms of varying intensity (screening only, screening and provision of resource sheet(s), screening and provision of resource sheet(s) plus social work assistance). For each Veteran, we will examine associations of unmet social needs with health-related outcomes at baseline, and longitudinally compare the impact of each approach on connection to new resources (primary outcome) and follow-up outcomes over a 12-month period. We will additionally conduct qualitative interviews with key stakeholders, including Veterans to identify potential explanatory factors related to the relative success of the interventions.

Ethics and dissemination: Ethics approval was obtained from the VA Central Internal Review Board on 13 July 2021 (reference #: 20-07-Amendment No. 02). Findings will be disseminated through reports, lay summaries, policy briefs, academic publications, and conference presentations.

Trial registration number: NCT04977583.

Keywords: adult cardiology; health policy; organisation of health services.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

On a weekly basis for the 12-month trial, we will identify potentially eligible Veterans with upcoming primary care appointments. Trained Research Assistants (RA) will contact Veterans to explain the research protocol, review the elements of informed consent, and secure verbal consent. During this phone call, if verbal informed consent is obtained, the RA will screen for unmet needs (hereafter, ‘index screen’). If a Veteran reports no unmet needs, their study participation will be restricted to objective 1. If a Veteran reports one or more unmet needs, the RA will randomise them to one of the three trial arms. Trial participants will be re-surveyed 8 weeks after the index screen to assess resource connection and 6 months after the index screen to assess unmet need reduction. CDW, Corporate Data Warehouse; RCT, randomised controlled trials.

Figure 2

Green links are supported by data; blue links need further investigation. AFor patients with multiple unmet social needs, resolution of one need may enable them to address another. Reduced competing demands include freeing up various resources (money, time and energy) to address other needs, which in turn can affect health outcomes. BClinical outcomes may include but are not limited to conditions where adherence to therapy directly impacts outcomes, such as hypertension, diabetes and asthma. CIdentification of unmet social needs may be beneficial, even without referring to resources. For patients with transportation problems, for example, delivering prescriptions through mail order can bypass the barrier posed by the unmet transportation need without directly addressing it. DImproved outcomes, such as improved well-being, may help patients connect to resources. ECosts may be reduced through improved control of chronic conditions, such as hypertension, which could avert costly future admissions for stroke or target organ damage. But increased costs to address unmet social needs may affect the equation for other conditions.