Stepped Care to Optimize Pain Care Effectiveness

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Stepped care

Intervention Type DRUG

Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study.

Usual Care

Patients receive usual care for pain from their primary care physician

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stepped care

Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study.

Intervention Type DRUG

Other Intervention Names

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Optimized analgesics with collaborative care management

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No