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Stepped Care to Optimize Pain Care Effectiveness (SCOPE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00926588
First Posted: June 23, 2009
Last Update Posted: August 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stepped Care to Optimize Pain Care Effectiveness (SCOPE)

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Brief Pain Inventory (Pain) [ Time Frame: 1 year ]
    The full scale name is the Brief Pain Inventory. This 11-item scale measures self-reported pain severity and interference. It consists of 4 pain severity items and 7 pain interference items. Each item is scored from 0 (no pain) to 10 (worse pain imaginable). There is a pain severity score (average of 4 pain severity items), pain interference score (average of 7 pain interference items), and total pain score (average of all 11 items). For all 3 scores, 0 represents the best score (i.e., least pain) and 10 represents the worst score (i.e., greatest pain).


Enrollment: 250
Study Start Date: October 2009
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926588


Locations
United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Kurt Kroenke, MD Richard L. Roudebush VA Medical Center, Indianapolis, IN
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00926588     History of Changes
Other Study ID Numbers: IIR 07-119
First Submitted: June 18, 2009
First Posted: June 23, 2009
Results First Submitted: November 7, 2014
Results First Posted: December 19, 2014
Last Update Posted: August 7, 2015
Last Verified: July 2015

Keywords provided by VA Office of Research and Development:
Pain
Telecare
Collaborative care

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs