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Design, methods, and recruitment outcomes of the Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) study.
Krebs EE, Becker WC, Nelson D, DeRonne BM, Nugent S, Jensen AC, Amundson EC, Manuel JK, Borsari B, Kats AM, Seal KH. Design, methods, and recruitment outcomes of the Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) study. Contemporary clinical trials. 2023 Jan 1; 124:107001.
The Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) study is a 12-month pragmatic randomized comparative effectiveness trial conducted at ten United States Veterans Affairs (VA) health care sites. The overall goal was to test interventions to improve pain while reducing opioid use among VA patients with moderate-severe chronic pain despite treatment with long-term opioid therapy (LTOT). Aims were 1) to compare lower-intensity telecare collaborative pain management (TCM) versus higher-intensity integrated pain team management (IPT), and 2) to test the option of switching to buprenorphine (versus no option) in a high-dose subgroup. Recruitment challenges included secular trends in opioid prescribing and the COVID-19 pandemic. Participants were recruited over 3.5 years. Of 6966 potentially eligible patients, 4731 (67.9%) were contacted for telephone eligibility interview; of those contacted, 3398 (71.8%) declined participation, 359 (7.6%) were ineligible, 821 (24.2%) enrolled, and 820 (24.1%) were randomized. The most common reason for declining was satisfaction with pain care (n = 731). The most common reason for ineligibility was not having moderate-severe chronic pain (n = 110). Compared with the potentially eligible population, randomized participants were slightly younger, more often female, had similar prescribed opioids, and had similar or higher rates of pain and mental health diagnoses. The enrolled patient number was lower than the original target, but sufficient to power planned analyses. In conclusion, the VOICE trial enrolled a diverse sample similar to the population of VA patients receiving LTOT. Results will add substantially to limited existing evidence for interventions to improve pain while reducing opioid use. ClinicalTrials.gov identifier: NCT03026790.