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Stepped Care to Optimize Pain Care Effectiveness (SCOPE)

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ClinicalTrials.gov Identifier: NCT00926588
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : December 19, 2014
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

June 18, 2009
June 23, 2009
November 7, 2014
December 19, 2014
August 7, 2015
October 2009
June 2013   (Final data collection date for primary outcome measure)
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).
SCOPE has the potential to improve care in veterans for whom a high prevalence and severity of pain results in substantial disability, impaired quality of life, and high medical costs. [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00926588 on ClinicalTrials.gov Archive Site
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Stepped Care to Optimize Pain Care Effectiveness
Stepped Care to Optimize Pain Care Effectiveness (SCOPE)
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pain
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
  • 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.
    Intervention: Drug: Stepped care
  • No Intervention: Usual Care
    Patients receive usual care for pain from their primary care physician

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
Same as current
June 2015
June 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00926588
IIR 07-119
Yes
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VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Kurt Kroenke, MD Richard L. Roudebush VA Medical Center, Indianapolis, IN
VA Office of Research and Development
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP