Improving Chronic Pain Treatment in Primary Care

Study Overview
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Brief Summary
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The primary objective of this study is to determine to what extent a collaborative intervention improves chronic pain-related outcomes in a VA primary care setting. We will also determine to what extent the intervention affects 1) treatment of co-occurring depression, 2) adherence of providers to guidelines for treating chronic pain, and 3) patient and provider satisfaction and attitudes related to chronic pain treatment.

Detailed Description
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Background: 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. Objectives: 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. Methods: 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. Status: Complete.

Official Title
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Improving the Treatment of Chronic Pain in Primary Care

Conditions
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Pain, Chronic Disease, Depression

Intervention / Treatment
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* Behavioral: Assistance with Pain treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients currently receiving primary care at Portland VAMC Diagnosed musculoskeletal chronic pain condition lasting at least 3 months Currently experiencing moderate to severe symptoms as per screening Willingness to complete 6 and 12 month interviews Regular access to a telephone Exclusion Criteria: Dementia or cognitive disturbance Diagnoses of fibromyalgia, chronic fatigue or somatization disorder Terminal illness Designated guardian Drug-seeking behavior flag in medical record

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assistance with Pain Treatment<br>Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers | Behavioral: Assistance with Pain treatment<br>* Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months.<br>|
| No Intervention: Treatment as usual<br>Treatment as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Change in Pain-related Function (Roland Disability Score) | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Change in Depression Severity | Patient Health Questionnaire-9 depression rating scale. Range 0-27 with higher scores representing higher depression severity | 12 months | 
| Adjusted Change in Pain Interference | Chronic Pain Grade interference score. Range 0 to 100 with higher scores representing greater pain interference (worse outcome) | 12 month | 
| Global Impression of Change | 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 | 12 months | 
| Adjusted Change in Health Related Quality of Life | EQ-5D. Range 3-15 with higher scores representing worse health states | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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veterans, pain and chronic disease, disease management, depression, primary health care, practice guidelines, guideline adherence, narcotics, patient compliance, randomized controlled trial