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Stepped Care to Optimize Pain Care Effectiveness (SCOPE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00926588
First received: June 18, 2009
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

Pain is the most common physical symptom in primary care, accounting for an enormous burden in terms of patient suffering, quality of life, work and social disability, and health care and societal costs. Pain is particularly prevalent among veterans. Four major barriers to optimal care include underdetection of pain, inadequate initial treatment, failure to monitor adherence and symptom response, and failure to adjust treatment in patients not responding or intolerant of initial therapy. Therefore, we propose to conduct the Stepped Care to Optimize Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial in primary care.


Condition Intervention Phase
Pain
Drug: Stepped care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stepped Care to Optimize Pain Care Effectiveness (SCOPE)

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Brief Pain Inventory (pain) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Self-reported pain severity and interference


Enrollment: 250
Study Start Date: October 2009
Estimated Study Completion Date: June 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stepped Care
Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.
Drug: Stepped care
Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study.
Other Name: Optimized analgesics with collaborative care management
No Intervention: Usual Care
Patients receive usual care for pain from their primary care physician

Detailed Description:

SCOPE will enroll 250 primary care veterans with persistent (3 months or longer) musculoskeletal pain of moderate severity, and randomize them to either the stepped care intervention or usual care control group. The intervention will be based upon the empirically-validated Three-Component Model which in SCOPE will involve collaboration between the primary care physician, a nurse pain care manager, and a supervising physician pain specialist. SCOPE will involve a telemedicine approach coupling automated home-based symptom monitoring with telephone-based nurse care management. The intervention will consist of optimized analgesic management using a stepped care approach to drug selection, symptom monitoring, dose adjustment, and switching or adding medications. All subjects will undergo comprehensive outcome assessment at baseline, 1, 3, 6 and 12 months by interviewers blinded to treatment group. Our principal aim is to test whether SCOPE is more effective than usual care in reducing pain as measured by the Brief Pain Inventory. Secondarily, we will test the impact on other pain outcomes (e.g., severity, self-efficacy, use of self-management strategies), emotional functioning, health-related quality of life, and treatment satisfaction.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

SCOPE will enroll 250 primary care veterans with persistent (3 months or longer) musculoskeletal pain of moderate severity and randomize them to either the stepped care intervention or usual care control group.

Exclusion Criteria:

Individuals who:

  • have filed a pain-related disability claim in the last 6 months;
  • do not speak English;
  • have moderately severe cognitive impairment;
  • have schizophrenia, bipolar disorder, or other psychosis;
  • are actively suicidal;
  • have current illicit drug use; or
  • have an anticipated life expectancy of less than 12 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926588

Locations
United States, Indiana
Richard Roudebush VA Medical Center
Indianapolis, Indiana, United States, 46202-2884
Sponsors and Collaborators
Investigators
Principal Investigator: Kurt Kroenke, MD Richard Roudebush VA Medical Center, Indianapolis
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00926588     History of Changes
Other Study ID Numbers: IIR 07-119
Study First Received: June 18, 2009
Last Updated: August 11, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Pain
Telecare
Collaborative care

Additional relevant MeSH terms:
Analgesics
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014