Phase 3
Completed N=250
Stepped Care to Optimize Pain Care Effectiveness
Source: ClinicalTrials.gov NCT00926588 ↗Enrolled (actual)
250
Serious AEs
12.0%
Results posted
Dec 2014
Primary outcomePrimary: Brief Pain Inventory (Pain) — 3.57; 4.59 units on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Pain Inventory (Pain) |
3.57; 4.59 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00926588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.