Stepped Care to Optimize Pain Care Effectiveness (SCOPE)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Other: perplexing and prevalent problem of chronic pain |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Stepped Care to Optimize Pain Care Effectiveness (SCOPE) |
- 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: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm 1
There are two major innovations in SCOPE. It is one of the few collaborative care interventions developed specifically for the perplexing and prevalent problem of chronic pain. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study
|
Other: perplexing and prevalent problem of chronic pain
Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study.
Other Name: care management strategies
|
|
Arm 2
Second, SCOPE represents not only an innovative systems-based approach to pain management but also the "next generation" of care management strategies more likely to be implemented. Innovative features include asynchronous symptom monitoring, triggered rather than mandated phone contacts, coupling depression with pain management for these two commonly co-occurring conditions in primary care veterans, and applying the TCM model to VA care.
|
Other: perplexing and prevalent problem of chronic pain
Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study.
Other Name: care management strategies
|
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. Additionally, subjects with comorbid depression will be treated with evidence-based guidelines for depression management. 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 |
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| United States, Indiana | |
| Richard Roudebush VA Medical Center | |
| Indianapolis, Indiana, United States, 46202-2884 | |
| Principal Investigator: | Kurt Kroenke, MD | Richard Roudebush VA Medical Center, Indianapolis |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | November 14, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Pain |
ClinicalTrials.gov processed this record on May 21, 2013