Diana J Burgess1,2, Emily Hagel Campbell3, Patrick Hammett3,4, Kelli D Allen5,6, Steven S Fu3,4, Alicia Heapy7,8, Robert D Kerns7,8, Sarah L Krein9,10, Laura A Meis3,4, Ann Bangerter3, Lee J S Cross3, Tam Do3, Michael Saenger11,12, Brent C Taylor3,4. 1. Center for Care Delivery and Outcomes Research, Veterans Affairs Medical Center, One Veterans Drive (152), Minneapolis, MN, 55417, USA. diana.burgess@va.gov. 2. Department of Medicine, University of Minnesota, Minneapolis, MN, USA. diana.burgess@va.gov. 3. Center for Care Delivery and Outcomes Research, Veterans Affairs Medical Center, One Veterans Drive (152), Minneapolis, MN, 55417, USA. 4. Department of Medicine, University of Minnesota, Minneapolis, MN, USA. 5. Center of Innovation to Accelerate Discovery and Practice Transformation, Veterans Affairs (a VA HSR&D Center of Excellence), Veterans Affairs Medical Center, Durham, NC, USA. 6. Department of Medicine & Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. 7. Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA. 8. Pain Research, Informatics, Multi-morbidities and Education (PRIME) Center of Innovation, VA Connecticut Healthcare System, West Haven, CT, USA. 9. Center for Clinical Management Research, Veterans Affairs Healthcare System, Ann Arbor, MI, USA. 10. Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA. 11. Atlanta Veterans Affairs Healthcare System, Atlanta, GA, USA. 12. Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.
Abstract
BACKGROUND: Black patients in the USA are disproportionately affected by chronic pain, yet there are few interventions that address these disparities. OBJECTIVE: To determine whether a walking-focused, proactive coaching intervention aimed at addressing contributors to racial disparities in pain would improve chronic pain outcomes among Black patients compared to usual care. DESIGN: Randomized controlled trial with masked outcome assessment ( Clinicaltrials.gov : NCT01983228). PARTICIPANTS: Three hundred eighty Black patients at the Atlanta VA Health Care System with moderate to severe chronic back, hip, or knee pain. INTERVENTION: Six telephone coaching sessions over 8-14 weeks, proactively delivered, using action planning and motivational interviewing to increase walking, or usual care. MAIN MEASURES: Primary outcome was a 30% improvement in pain-related physical functioning (Roland Morris Disability Questionnaire [RMDQ]) over 6 months among Black patients, using intention-to-treat. Secondary outcomes were improvements in pain intensity and interference, depression, anxiety, global impression of change in pain, and average daily steps. KEY RESULTS: The intervention did not produce statistically significant effects on the primary outcome (at 6 months, 32.4% of intervention participants had 30% improvement on the RMDQ vs. 24.7% of patients in usual care; aOR=1.61, 95% CI, 0.94 to 2.77), nor on other secondary outcomes assessed at 6 months, with the exception that intervention participants reported more favorable changes in pain relative to usual care (mean difference=-0.54, 95% CI, -0.85 to -0.23). Intervention participants also experienced a significant reduction in pain intensity and pain interference over 3 months (mean difference=-0.55, 95% CI, -0.88 to -0.22). CONCLUSIONS: A novel intervention to improve chronic pain among Black patients did not produce statistically significant improvements on the primary outcome relative to usual care. More intensive efforts are likely required among this population, many of whom were economically disadvantaged and had mental health comorbidities and physical limitations. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01983228.
BACKGROUND: Black patients in the USA are disproportionately affected by chronic pain, yet there are few interventions that address these disparities. OBJECTIVE: To determine whether a walking-focused, proactive coaching intervention aimed at addressing contributors to racial disparities in pain would improve chronic pain outcomes among Black patients compared to usual care. DESIGN: Randomized controlled trial with masked outcome assessment ( Clinicaltrials.gov : NCT01983228). PARTICIPANTS: Three hundred eighty Black patients at the Atlanta VA Health Care System with moderate to severe chronic back, hip, or knee pain. INTERVENTION: Six telephone coaching sessions over 8-14 weeks, proactively delivered, using action planning and motivational interviewing to increase walking, or usual care. MAIN MEASURES: Primary outcome was a 30% improvement in pain-related physical functioning (Roland Morris Disability Questionnaire [RMDQ]) over 6 months among Black patients, using intention-to-treat. Secondary outcomes were improvements in pain intensity and interference, depression, anxiety, global impression of change in pain, and average daily steps. KEY RESULTS: The intervention did not produce statistically significant effects on the primary outcome (at 6 months, 32.4% of intervention participants had 30% improvement on the RMDQ vs. 24.7% of patients in usual care; aOR=1.61, 95% CI, 0.94 to 2.77), nor on other secondary outcomes assessed at 6 months, with the exception that intervention participants reported more favorable changes in pain relative to usual care (mean difference=-0.54, 95% CI, -0.85 to -0.23). Intervention participants also experienced a significant reduction in pain intensity and pain interference over 3 months (mean difference=-0.55, 95% CI, -0.88 to -0.22). CONCLUSIONS: A novel intervention to improve chronic pain among Black patients did not produce statistically significant improvements on the primary outcome relative to usual care. More intensive efforts are likely required among this population, many of whom were economically disadvantaged and had mental health comorbidities and physical limitations. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01983228.
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