STorytelling to Improve DiseasE outcomes in GoUT: The STRIDE-GO Study

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 DESCRIPTION (provided by applicant): Background and Objective: Low medication adherence in chronic diseases is a problem that costs over $100 billion a year in excess hospitalizations in the US. Patients often do not perceive disease severity and susceptibility to disease complications in chronic symptomatic diseases such as Chronic Obstructive Pulmonary disease (COPD), Congestive Heart Failure (CHF), gout, etc., since severe disease symptoms are intermittent. Our objective is to test the efficacy of a patient-centered, culturally relevant, narrative intervention, or "storytelling", basd on the solid conceptual foundation of the narrative communication theory and the Health Belief Model to improve medication adherence and outcomes in chronic diseases among African- American veterans, using gout as a test case. African-Americans (AAs) with gout have lower adherence to gout medications compared to Caucasians. Funded by the Veterans Affairs (VA) HSR&D pilot study program, we have completed the development and iterative modification of a powerful "storytelling" intervention consisting of messages from AA veterans with higher ULT adherence at Birmingham, AL and Philadelphia, PA. This final intervention has been tested for feasibility, acceptability, content and narrative strength in the target population at these sites and endorsed to be powerful by the target population. Project Objectives and Aims: Our long-term objective is to reduce health disparities in veterans and improve their health outcomes. The objective of the proposed study is to assess the efficacy of a novel storytelling intervention in veterans' own voices to improve medication adherence and patient outcomes in African- American veterans with gout. Our Specific Aim (SA)s are to assess the efficacy of storytelling intervention in African-American veterans with gout for improving: SA1: Improving ULT adherence, directly measured by using MEMS (Medication Event Monitoring System) Caps at 3, 6 and 9 months (assess intervention's effect) and 12 months (assess durability of effect), SA2: Improving Gout flare rate, patient satisfaction and target serum urate (sUA) <6 mg/dl achievement, as indirect measures of better ULT adherence and important gout outcomes. Project Methods: We will conduct a 12-month, multicenter, randomized controlled trial among 250 African- American veterans with gout with ULT medication possession ratio of <80% at Birmingham, St. Louis and Philadelphia VA clinics. We will compare the efficacy of the storytelling intervention to usual care in improving ULT adherence, assessed with MEMSCaps (electronic monitoring) at 6-months (primary outcome); reducing gout flares needing treatment, improving patient satisfaction, improving the ability to achieve target serum urate <6 mg/dl and improving self-reported ULT adherence at 6-months (secondary outcomes). We will assess these outcomes at 12-months as evidence for sustenance of the effect of intervention. Alignment with VA mission and priorities: This study serves the VA's mission of improving the health of veterans and addresses two priority areas, 1) decreasing health care disparities and 2) improving health care delivery using a low-cost, technology-based solution to poor medication adherence. Study results will lead to a ready-to-implement low cost patient-centered intervention for AA veterans with gout to improve medication adherence and patient outcomes. Our study will provide the proof of efficacy of "storytelling" for improving medication adherence in chronic symptomatic diseases. The "storytelling" intervention can be easily adapted for similar chronic symptomatic conditions such as COPD and CHF.