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Multicenter Study Pragmatic Clinical Trial
Automating Collection of Pain-Related Patient-Reported Outcomes to Enhance Clinical Care and Research.
- Ashli Owen-Smith, Meghan Mayhew, Michael C Leo, Alexandra Varga, Lindsay Benes, Allison Bonifay, and Lynn DeBar.
- Division of Health Management and Policy, School of Public Health, Georgia State University, Atlanta, GA, USA. aowensmith@gsu.edu.
- J Gen Intern Med. 2018 May 1; 33 (Suppl 1): 31-37.
IntroductionChronic pain is highly prevalent, and the ability to routinely measure patients' pain and treatment response using validated patient-reported outcome (PRO) assessments is important to clinical care. Despite this recognition, systematic use in everyday clinical care is rare.AimsThe aims of this study were to (1) describe infrastructure designed to automate PRO data collection, (2) compare study-enhanced PRO completion rates to those in clinical care, and (3) evaluate patient response rates by method of PRO administration and sociodemographic and/or clinical characteristics.SettingThe Pain Program for Active Coping and Training (PPACT) is a pragmatic clinical trial conducted within three regions of the Kaiser Permanente health care system.Program DescriptionPPACT evaluates the effect of integrative primary care-based pain management services on outcomes for chronic pain patients on long-term opioid treatment. We implemented a tiered process for quarterly assessment of PROs to supplement clinical collection and ensure adequate trial data using three methods: web-based personal health records (PHR), automated interactive voice response (IVR) calls, and live outreach.Program EvaluationAmong a subset of PPACT participants examined (n = 632), the tiered study-enhanced PRO completion rates were higher than in clinical care: 96% completed ≥ 1 study-administered PRO with mean of 3.46 (SD = 0.85) vs. 74% completed in clinical care with a mean of 2.43 (SD = 2.08). Among all PPACT participants at 3 months (n = 831), PRO completion was 86% and analyses of response by key characteristics found only that participant age predicted an increased likelihood of responding to PHR and IVR outreach.DiscussionAdherence to pain-related PRO data collection using our enhanced tiered approach was high. No demographic or clinical identifiers other than age were associated with differential response by modality. Successful ancillary support should employ multimodal electronic health record functionalities for PRO administration. Using automated modalities is feasible and may facilitate better sustainability for regular PRO administration within health care systems. Clinical Trials Registration Number: NCT02113592.
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