Improving Chronic Pain Treatment in Primary Care (SEACAP)
|ClinicalTrials.gov Identifier: NCT00129480|
Recruitment Status : Completed
First Posted : August 11, 2005
Results First Posted : February 24, 2015
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain Chronic Disease Depression||Behavioral: Assistance with Pain treatment||Not Applicable|
Chronic pain is very common, and associated with substantial impairment and increased healthcare utilization. Implementation of treatment guidelines has been problematic, and chronic pain remains undertreated. Because of the prevalence of chronic pain among veterans, the VHA created a National Pain Management Strategy and adopted pain as the "5th vital sign."
Our primary objective was to determine to what extent a collaborative intervention improves chronic pain-related outcomes (pain-related function, pain severity and depression severity) in a VA primary care setting over six and 12 months. We also investigated to what extent the intervention affected 1) treatment of comorbid depression, 2) adherence of providers to guidelines for chronic pain, 3) patient and provider satisfaction and attitudes related to chronic pain treatment, and 4) incremental benefit (pain disability-free days) and incremental health services costs.
The study was a cluster randomized controlled trial of a collaborative care intervention "Assistance with Pain Treatment" (APT) versus treatment as usual (TAU) at five primary care clinics of one Department of Veterans Affairs Medical Center.
401 patients and 42 primary care clinicians participated. APT included a 2-session clinician education program, patient assessment, education and activation, symptom monitoring, feedback and recommendations to clinicians and facilitation of specialty care. We randomized clinicians to APT or TAU, and nested patients within clinician intervention status.
Patients were recruited via mailings and advertising flyers; those with chart-documented musculoskeletal pain diagnoses who reported at least moderate pain severity and pain-related function (Chronic Pain Grade [CPG]) lasting at least 12 weeks were invited to participate. Participants completed questionnaires at baseline, 3, 6 and 12 months, with a subset re-assessed at 30 months. Primary outcomes were Roland-Morris Disability scores and CPG pain intensity scale scores over 12 months. Depression was assessed using Patient Health Questionnaire 9 [PHQ-9] scores. Intervention effects on patient outcome variables were tested using intention-to-treat analyses with multilevel models; patient-level covariates of age, sex, baseline depression severity, baseline opioid status (yes/no), and medical morbidity were included. To quantify provider adherence to pain treatment guidelines, we created the Pain Process Measure (PPM), a chart review checklist. Clinicians completed a baseline 23-item survey of attitudes and behaviors related to chronic pain management, job satisfaction, and satisfaction with local pain resources. Patient satisfaction measures included patient-rated global impression of change, global VA health care satisfaction, health-related quality of life, and receipt and rating of effectiveness of VA chronic pain treatment. Pain disability-free days were calculated from Roland-Morris Disability Questionnaire scores. Data on VA treatment costs were obtained from the VA's Decision Support System for all utilization except certain intervention activities that were tracked in a separate study database.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||401 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving the Treatment of Chronic Pain in Primary Care|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||July 2010|
Experimental: Assistance with Pain Treatment
Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers
Behavioral: Assistance with Pain treatment
Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months.
No Intervention: Treatment as usual
Treatment as usual
- Adjusted Change in Pain-related Function (Roland Disability Score) [ Time Frame: 12 months ]The Roland Morris Disability Questionnaire has 24 yes or no items. Each item is scored as 0 or 1. Item scores or summed to create total score with range 0 to 24. Higher scores represent greater disability. The Roland Morris has been widely used, has content and construct validity, internal consistency, and responsiveness to change among patients with chronic pain.
- Adjusted Change in Depression Severity [ Time Frame: 12 months ]Patient Health Questionnaire-9 depression rating scale. Range 0-27 with higher scores representing higher depression severity
- Adjusted Change in Pain Interference [ Time Frame: 12 month ]Chronic Pain Grade interference score. Range 0 to 100 with higher scores representing greater pain interference (worse outcome)
- Global Impression of Change [ Time Frame: 12 months ]Global impression of change score. Rated at 12 months capturing patient impression of change over past 6 months. Range 1-7 with lower scores representing greater improvement
- Adjusted Change in Health Related Quality of Life [ Time Frame: 12 months ]EQ-5D. Range 3-15 with higher scores representing worse health states
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129480
|United States, Oregon|
|VA Portland Health Care System, Portland, OR|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Steven K. Dobscha, MD||VA Portland Health Care System, Portland, OR|