A Phase 3 interventional study of Stepped care in Pain, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-08-07.
Sponsored by US Department of Veterans Affairs · Phase 3, Interventional, and Treatment
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.
US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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
Patients receive usual care for pain from their primary care physician
Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study.
Also known as: Optimized analgesics with collaborative care management
Brief Pain Inventory (Pain)
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).
Time frame: 1 year
Participants were recruited from June 2010 through May 2012. Patients and physicians in 5 primary care clinics in the Roudebush Veterans Administration Medical Center in Indianapolis participated.
| Milestone | Stepped Care | Usual Care |
|---|---|---|
| Started | 124 | 126 |
| Completed | 116 | 122 |
| Not completed | 8 | 4 |
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).
| units on a scale | Stepped Care | Usual Care |
|---|---|---|
| Brief Pain Inventory (Pain) | 3.57 ± 2.22 | 4.59 ± 2.13 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stepped Care | — | 22/124 (17.7%) | 0/124 (0%) |
| Usual Care | — | 8/126 (6.3%) | 0/126 (0%) |
| Event | Stepped Care | Usual Care |
|---|---|---|
| Cardiac hospitalizationCardiac disorders | 5/124 | 1/126 |
| Hospitalization due to knee replacementMusculoskeletal and connective tissue disorders | 3/124 | 0/126 |
| Hospitalization due to infectionInfections and infestations | 2/124 | 0/126 |
| Hospitalization due to coronary artery bypass surgeryCardiac disorders | 2/124 | 0/126 |
| Hospitalization due to renal failureRenal and urinary disorders | 1/124 | 0/126 |
| Hospitalization due to motor vehicle accidentInjury, poisoning and procedural complications | 1/124 | 0/126 |
| Bladder repair surgery and hospitalizationRenal and urinary disorders | 1/124 | 0/126 |
| Hospitalization due to removal of fibroidsSurgical and medical procedures | 1/124 | 0/126 |
| Hospitalization due to planned hysterectomyReproductive system and breast disorders | 1/124 | 0/126 |
| Hospitalization due to appendicitisGastrointestinal disorders | 1/124 | 0/126 |
| Age, Categorical(Participants) | Stepped Care | Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 124 | 126 | 250 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Stepped Care | Usual Care | Total |
|---|---|---|---|
| Female | 15 | 28 | 43 |
| Male | 109 | 98 | 207 |
| Race (NIH/OMB)(Participants) | Stepped Care | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 3 | 4 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 31 | 17 | 48 |
| White | 89 | 103 | 192 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Region of Enrollment(participants) | Stepped Care | Usual Care | Total |
|---|---|---|---|
| United States | 124 | 126 | 250 |
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs