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CRE 12-306 – HSR&D Study

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CRE 12-306
Risk Stratification and Tailoring of Prevention Programs
Matthew L Maciejewski PhD
Durham VA Medical Center, Durham, NC
Durham, NC
Funding Period: April 2016 - March 2019

Veterans are likely to vary in their response to any given program among the range of prevention programs in VHA. This variation is known as heterogeneity of treatment effects. To improve the effectiveness of new VA investments in prevention programs, it will be necessary to identify which Veterans have a better response to each program and which characteristics identify Veterans who might require alternative prevention programs. This project is part of a CREATE Program (Collaborative Research to Enhance and Advance Transformation and Excellence) focused on Transforming Prevention into Action. The purpose of this particular CREATE project is to systematically evaluate the heterogeneity of treatment effects (HTE) across the three prevention trials to be conducted as part of the Prevention CREATE. The study will be conducted in close collaboration with the National Center for Health Promotion and Disease Prevention (NCP), which is the VACO Program Office charged with implementing several major programs as part of VHA's Preventive Care Program transformational sub-initiative. These programs include an enterprise-wide Health Risk Assessment (HRA), a two-site group prevention coaching intervention, and a virtual physical activity intervention. HTE assessment is critical to understand which Veterans are most likely to benefit, because the effect of these prevention interventions are unlikely to be equally effective for all veterans. VA needs a rigorous method for determining how to prioritize resources to realize the greater return on investment in prevention, and the proposed CREATE study addresses this need.

The purpose of this project is to leverage a comprehensive set of patient characteristics to be captured in the three other CREATE trials (CREATE projects 1-3) to determine which Veterans realize the greatest benefit from PACT (Patient-Aligned Care Team) HRA shared decision-making, prevention group visits, and web-based physical activity interventions. This study addresses the Prevention CREATE's overall goal by assessing heterogeneity in treatment effects, which will inform VHA how to target programs to Veteran needs resulting in the largest impact at the lowest possible cost. The proposed study has two primary aims:

Aim #1: Determine the participant characteristics associated with response to treatment in the 3 interventions in the Prevention CREATE Program.
Aim #2: Determine the relationship between VA expenditures and participant characteristics associated with response to treatment. That is, do patterns of heterogeneity in treatment effects translate to similar patterns of heterogeneity in VA expenditures?
Secondary Aim: Determine the participant characteristics associated with increased per-protocol adherence in the 3 interventions in the Prevention CREATE program.

For behavioral interventions, patient factors expected to be associated with risk of adverse events in the absence of treatment or risk reduction in the presence of treatment are likely to be psychological (e.g., patient activation) and social factors that are only available through survey data, in addition to clinical factors available in medical records and administrative claims data. Therefore, we intend to capture a broad array of patient factors through several data sources to ensure that we accurately reflect the sources of variation in patient response to treatment and a more comprehensive array of self-reported and clinical outcomes.

The study population will comprise all VHA outpatients enrolled in each of CREATE Projects 1-3 (n=417 in the HRA shared decision-making trial, n=400 in the group prevention coaching trial, n=350 in the virtual physical activity trial). Participant characteristics and setting will be determined by CREATE Projects 1-3. At the completion of CREATE Projects 1-3, factors from the HRA, VA claims, and baseline survey data will be examined as predictors and moderators of treatment response, economic outcomes, and intervention adherence. To examine HTE, we will compare subgroups identified via a data-driven method and a predictive risk model approach.

Not yet available.

Results from the proposed study will complement analyses of the 3 CREATE trials that will assess overall effectiveness of the HRA shared decision-making program, group prevention coaching, and web-based physical activity interventions. In addition, the results will enable VHA to determine which subgroups of Veterans would be best served by each of the interventions if scaled at a national level. This proposal addresses a long-term goal of developing decision support that VHA can use in prevention programming to effectively improve the health of Veterans.


Journal Articles

  1. Shepherd-Banigan M, Smith VA, Maciejewski ML, Stechuchak KM, Hastings SN, Wieland GD, Miller KEM, Kabat M, Henius J, Campbell-Kotler M, Van Houtven CH. The Effect of Support and Training for Family Members on Access to Outpatient Services for Veterans with Posttraumatic Stress Disorder (PTSD). Administration and policy in mental health. 2018 Jul 1; 45(4):550-564.

DRA: Health Systems
DRE: Epidemiology, Prevention
Keywords: Adherence, Best Practices, Decision-Making, Outcomes - Patient, Risk Factors, Symptom Management
MeSH Terms: none