Chronic Disease, Depression, Pain
Conditions
Keywords
veterans, pain and chronic disease, disease management, depression, primary health care, practice guidelines, guideline adherence, narcotics, patient compliance, randomized controlled trial
Brief summary
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
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.
Interventions
Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Change in Pain-related Function (Roland Disability Score) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Change in Depression Severity | 12 months | Patient Health Questionnaire-9 depression rating scale. Range 0-27 with higher scores representing higher depression severity |
| Adjusted Change in Pain Interference | 12 month | Chronic Pain Grade interference score. Range 0 to 100 with higher scores representing greater pain interference (worse outcome) |
| Global Impression of Change | 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 | 12 months | EQ-5D. Range 3-15 with higher scores representing worse health states |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Assistance With Pain Treatment Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers
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. | 187 |
| Treatment as Usual Treatment as usual which includes standard pain care, clinician generated referrals for additional consultation and ancillary services | 214 |
| Total | 401 |
Baseline characteristics
| Characteristic | Assistance With Pain Treatment | Treatment as Usual | Total |
|---|---|---|---|
| Age, Continuous | 61.3 years STANDARD_DEVIATION 12.3 | 62.1 years STANDARD_DEVIATION 11.2 | 61.7 years STANDARD_DEVIATION 11.8 |
| Race/Ethnicity, Customized American Indian/Alaska Native | 7 Participants | 6 Participants | 13 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized Unknown | 10 Participants | 14 Participants | 24 Participants |
| Race/Ethnicity, Customized White | 168 Participants | 189 Participants | 357 Participants |
| Region of Enrollment United States | 187 Participants | 214 Participants | 401 Participants |
| Sex: Female, Male Female | 15 Participants | 18 Participants | 33 Participants |
| Sex: Female, Male Male | 172 Participants | 196 Participants | 368 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 187 | 0 / 214 |
| serious Total, serious adverse events | 0 / 187 | 0 / 214 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Assistance With Pain Treatment (Intervention) | Adjusted Change in Pain-related Function (Roland Disability Score) | -1.4 units on a scale |
| Treatment as Usual | Adjusted Change in Pain-related Function (Roland Disability Score) | -0.2 units on a scale |
Adjusted Change in Depression Severity
Patient Health Questionnaire-9 depression rating scale. Range 0-27 with higher scores representing higher depression severity
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Assistance With Pain Treatment (Intervention) | Adjusted Change in Depression Severity | -3.7 units on a scale |
| Treatment as Usual | Adjusted Change in Depression Severity | -1.2 units on a scale |
Adjusted Change in Health Related Quality of Life
EQ-5D. Range 3-15 with higher scores representing worse health states
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Assistance With Pain Treatment (Intervention) | Adjusted Change in Health Related Quality of Life | -0.02 units on a scale |
| Treatment as Usual | Adjusted Change in Health Related Quality of Life | -0.04 units on a scale |
Adjusted Change in Pain Interference
Chronic Pain Grade interference score. Range 0 to 100 with higher scores representing greater pain interference (worse outcome)
Time frame: 12 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Assistance With Pain Treatment (Intervention) | Adjusted Change in Pain Interference | -5.7 units on a scale |
| Treatment as Usual | Adjusted Change in Pain Interference | 2.3 units on a scale |
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
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Assistance With Pain Treatment (Intervention) | Global Impression of Change | 3.7 units on a scale |
| Treatment as Usual | Global Impression of Change | 4.4 units on a scale |