Kurt Kroenke1,2,3, Fitsum Baye4, Spencer G Lourens4, Erica Evans5, Sharon Weitlauf5, Stephanie McCalley5, Brian Porter5, Marianne S Matthias5,6,7, Matthew J Bair5,6,8. 1. VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA. kkroenke@regenstrief.org. 2. Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA. kkroenke@regenstrief.org. 3. Regenstrief Institute, Inc., Indianapolis, IN, USA. kkroenke@regenstrief.org. 4. Department of Biostatistics, Fairbanks School of Public Health, Indianapolis, IN, USA. 5. VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA. 6. Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA. 7. Department of Communication Studies, Indianapolis University-Purdue University at Indianapolis, Indianapolis, IN, USA. 8. Regenstrief Institute, Inc., Indianapolis, IN, USA.
Abstract
BACKGROUND:Chronic musculoskeletal pain is often accompanied by depression or anxiety wherein co-occurring pain and mood symptoms can be more difficult to treat than either alone. However, few clinical trials have examined interventions that simultaneously target both pain and mood conditions. OBJECTIVE: To determine the comparative effectiveness of automated self-management (ASM) vs. ASM-enhanced collaborative care. DESIGN: Randomized clinical trial conducted in six primary care clinics in a VA medical center. PARTICIPANTS: Two hundred ninety-four patients with chronic musculoskeletal pain of at least moderate intensity and clinically significant depressive and/or anxiety symptoms. INTERVENTION: ASM consisted of automated monitoring and 9 web-based self-management modules. Comprehensive symptom management (CSM) combined ASM with collaborative care management by a nurse-physician team. Both interventions were delivered for 12 months. MAIN MEASURES: Primary outcome was a composite pain-anxiety-depression (PAD) z-score consisting of the mean of the BPI, PHQ-9, and GAD-7 z-scores: 0.2, 0.5, and 0.8 represent potentially small, moderate, and large clinical differences. Secondary outcomes included global improvement, health-related quality of life, treatment satisfaction, and health services use. KEY RESULTS: Both CSM and ASM groups had moderate PAD score improvement at 12 months (z = - 0.65 and - 0.52, respectively). Compared to the ASM group, the CSM group had a - 0.23 (95% CI, - 0.38 to - 0.08; overall P = .003) greater decline in composite PAD z-score over 12 months. CSM patients were also more likely to report global improvement and less likely to report worsening at 6 (P = .004) and 12 months (P = .013). CONCLUSIONS: Two intervention models relying heavily on telecare delivery but differing in resource intensity both produced moderate improvements in pain and mood symptoms. However, the model combining collaborative care led by a nurse-physician team with web-based self-management was superior to self-management alone. TRIAL REGISTRATION: ClinicalTrials.gov : NCT0175730.
RCT Entities:
BACKGROUND:Chronic musculoskeletal pain is often accompanied by depression or anxiety wherein co-occurring pain and mood symptoms can be more difficult to treat than either alone. However, few clinical trials have examined interventions that simultaneously target both pain and mood conditions. OBJECTIVE: To determine the comparative effectiveness of automated self-management (ASM) vs. ASM-enhanced collaborative care. DESIGN: Randomized clinical trial conducted in six primary care clinics in a VA medical center. PARTICIPANTS: Two hundred ninety-four patients with chronic musculoskeletal pain of at least moderate intensity and clinically significant depressive and/or anxiety symptoms. INTERVENTION: ASM consisted of automated monitoring and 9 web-based self-management modules. Comprehensive symptom management (CSM) combined ASM with collaborative care management by a nurse-physician team. Both interventions were delivered for 12 months. MAIN MEASURES: Primary outcome was a composite pain-anxiety-depression (PAD) z-score consisting of the mean of the BPI, PHQ-9, and GAD-7 z-scores: 0.2, 0.5, and 0.8 represent potentially small, moderate, and large clinical differences. Secondary outcomes included global improvement, health-related quality of life, treatment satisfaction, and health services use. KEY RESULTS: Both CSM and ASM groups had moderate PAD score improvement at 12 months (z = - 0.65 and - 0.52, respectively). Compared to the ASM group, the CSM group had a - 0.23 (95% CI, - 0.38 to - 0.08; overall P = .003) greater decline in composite PAD z-score over 12 months. CSM patients were also more likely to report global improvement and less likely to report worsening at 6 (P = .004) and 12 months (P = .013). CONCLUSIONS: Two intervention models relying heavily on telecare delivery but differing in resource intensity both produced moderate improvements in pain and mood symptoms. However, the model combining collaborative care led by a nurse-physician team with web-based self-management was superior to self-management alone. TRIAL REGISTRATION: ClinicalTrials.gov : NCT0175730.
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