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
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Stepped care||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stepped Care to Optimize Pain Care Effectiveness (SCOPE)|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2015|
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.
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
No Intervention: Usual Care
Patients receive usual care for pain from their primary care physician
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926588
|United States, Indiana|
|Richard L. Roudebush VA Medical Center, Indianapolis, IN|
|Indianapolis, Indiana, United States, 46202-2884|
|Principal Investigator:||Kurt Kroenke, MD||Richard L. Roudebush VA Medical Center, Indianapolis, IN|