title: Taking ACTION to reduce pain: ACTION study rationale, design and protocol of a randomized trial of a proactive telephone-based coaching intervention for chronic musculoskeletal pain among African Americans.
abstract: Rates of chronic pain are rising sharply in the United States and worldwide. Presently, there is evidence of racial disparities in pain treatment and treatment outcomes in the United States but few interventions designed to address these disparities. There is growing consensus that chronic musculoskeletal pain is best addressed by a biopsychosocial approach that acknowledges the role of psychological and environmental factors, some of which differ by race.
  
  
  
  The primary aim of this randomized controlled trial is to test the effectiveness of a non-pharmacological, self-regulatory intervention, administered proactively by telephone, at improving pain outcomes and increasing walking among African American patients with hip, back and knee pain. Participants assigned to the intervention will receive a telephone counselor delivered pedometer-mediated walking intervention that incorporates action planning and motivational interviewing. The intervention will consist of 6 telephone counseling sessions over an 8-10 week period. Participants randomly assigned to Usual Care will receive an informational brochure and a pedometer. The primary outcome is chronic pain-related physical functioning, assessed at 6 months, by the revised Roland and Morris Disability Questionnaire, a measure recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). We will also examine whether the intervention improves other IMMPACT-recommended domains (pain intensity, emotional functioning, and ratings of overall improvement). Secondary objectives include examining whether the intervention reduces health care service utilization and use of opioid analgesics and whether key contributors to racial/ethnic disparities targeted by the intervention mediate improvement in chronic pain outcomes Measures will be assessed by mail and phone surveys at baseline, three months, and six months. Data analysis of primary aims will follow intent-to-treat methodology.
  
  
  
  We will tailor our intervention to address key contributors to racial pain disparities and examine the effects of the intervention on important pain treatment outcomes for African Americans with chronic musculoskeletal pain.
  
  
  
  ClinicalTrials.gov: NCT01983228 . Registered 6 November 2013.
authors.affiliation: School of Nursing, AGH Cooperative, University of Minnesota, Minneapolis, MN, USA.|Center for Chronic Disease Outcomes Research (a VA HSR&D Center of Excellence), Veterans Affairs Medical Center, Minneapolis, MN, USA.
authors.forename: Rozina H
authors.initials: RH
authors.lastname: Bhimani
authors.affiliation: Center for Chronic Disease Outcomes Research (a VA HSR&D Center of Excellence), Veterans Affairs Medical Center, Minneapolis, MN, USA.
authors.forename: Lee J S
authors.initials: LJ
authors.lastname: Cross
authors.affiliation: Center for Chronic Disease Outcomes Research (a VA HSR&D Center of Excellence), Veterans Affairs Medical Center, Minneapolis, MN, USA.|Department of Medicine, University of Minnesota, Minneapolis, MN, USA.
authors.forename: Brent C
authors.initials: BC
authors.lastname: Taylor
authors.affiliation: Center for Chronic Disease Outcomes Research (a VA HSR&D Center of Excellence), Veterans Affairs Medical Center, Minneapolis, MN, USA.|Department of Medicine, University of Minnesota, Minneapolis, MN, USA.
authors.forename: Laura A
authors.initials: LA
authors.lastname: Meis
authors.affiliation: Center for Chronic Disease Outcomes Research (a VA HSR&D Center of Excellence), Veterans Affairs Medical Center, Minneapolis, MN, USA.|Department of Medicine, University of Minnesota, Minneapolis, MN, USA.
authors.forename: Steven S
authors.initials: SS
authors.lastname: Fu
authors.affiliation: Center for Health Services Research in Primary Care, Veterans Affairs (a VA HSR&D Center of Excellence), Veterans Affairs Medical Center, Durham, NC, USA.|Department of Medicine & Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Kelli D
authors.initials: KD
authors.lastname: Allen
authors.affiliation: Center for Clinical Management Research, Veterans Affairs Healthcare System, Ann Arbor, MI, USA.|Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Sarah L
authors.initials: SL
authors.lastname: Krein
authors.affiliation: Center for Chronic Disease Outcomes Research (a VA HSR&D Center of Excellence), Veterans Affairs Medical Center, Minneapolis, MN, USA.
authors.forename: Tam
authors.initials: T
authors.lastname: Do
authors.affiliation: Departments of Psychiatry, Neurology and Psychology, Yale University, New Haven, CT, USA.|Pain Research, Informatics, Multimorbidities and Education (PRIME) Center of Innovation, VA Connecticut Healthcare System, West Haven, CT, USA.
authors.forename: Robert D
authors.initials: RD
authors.lastname: Kerns
authors.affiliation: Center for Chronic Disease Outcomes Research (a VA HSR&D Center of Excellence), Veterans Affairs Medical Center, Minneapolis, MN, USA. diana.burgess@va.gov.|Department of Medicine, University of Minnesota, Minneapolis, MN, USA. diana.burgess@va.gov.
authors.forename: Diana J
authors.initials: DJ
authors.lastname: Burgess
mesh_terms: D001741:Black or African American / Q000193:education; D059350:Chronic Pain / Q000628:therapy*; D003376:Counseling / Q000379:methods*; D007722:Health Knowledge, Attitudes, Practice; D054625:Healthcare Disparities; D006801:Humans; D000071252:Mentoring / Q000379:methods*; D059352:Musculoskeletal Pain / Q000628:therapy*; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D010174:Pamphlets; D012107:Research Design; D011795:Surveys and Questionnaires; D013689:Telephone; D016896:Treatment Outcome; D014481:United States
keywords: African American; Chronic musculoskeletal pain; Randomized control trial; Veterans administration