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Improving Chronic Pain Treatment in Primary Care

Improving the Treatment of Chronic Pain in Primary Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00129480
Acronym
SEACAP
Enrollment
401
Registered
2005-08-11
Start date
2006-01-31
Completion date
2010-07-31
Last updated
2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease, Depression, Pain

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

BEHAVIORALAssistance 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Adjusted Change in Pain-related Function (Roland Disability Score)12 monthsThe 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

MeasureTime frameDescription
Adjusted Change in Depression Severity12 monthsPatient Health Questionnaire-9 depression rating scale. Range 0-27 with higher scores representing higher depression severity
Adjusted Change in Pain Interference12 monthChronic Pain Grade interference score. Range 0 to 100 with higher scores representing greater pain interference (worse outcome)
Global Impression of Change12 monthsGlobal 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 Life12 monthsEQ-5D. Range 3-15 with higher scores representing worse health states

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total401

Baseline characteristics

CharacteristicAssistance With Pain TreatmentTreatment as UsualTotal
Age, Continuous61.3 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 Participants6 Participants13 Participants
Race/Ethnicity, Customized
Black
2 Participants5 Participants7 Participants
Race/Ethnicity, Customized
Unknown
10 Participants14 Participants24 Participants
Race/Ethnicity, Customized
White
168 Participants189 Participants357 Participants
Region of Enrollment
United States
187 Participants214 Participants401 Participants
Sex: Female, Male
Female
15 Participants18 Participants33 Participants
Sex: Female, Male
Male
172 Participants196 Participants368 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1870 / 214
serious
Total, serious adverse events
0 / 1870 / 214

Outcome results

Primary

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

ArmMeasureValue (MEAN)
Assistance With Pain Treatment (Intervention)Adjusted Change in Pain-related Function (Roland Disability Score)-1.4 units on a scale
Treatment as UsualAdjusted Change in Pain-related Function (Roland Disability Score)-0.2 units on a scale
Secondary

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

ArmMeasureValue (MEAN)
Assistance With Pain Treatment (Intervention)Adjusted Change in Depression Severity-3.7 units on a scale
Treatment as UsualAdjusted Change in Depression Severity-1.2 units on a scale
Secondary

Adjusted Change in Health Related Quality of Life

EQ-5D. Range 3-15 with higher scores representing worse health states

Time frame: 12 months

ArmMeasureValue (MEAN)
Assistance With Pain Treatment (Intervention)Adjusted Change in Health Related Quality of Life-0.02 units on a scale
Treatment as UsualAdjusted Change in Health Related Quality of Life-0.04 units on a scale
Secondary

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

ArmMeasureValue (MEAN)
Assistance With Pain Treatment (Intervention)Adjusted Change in Pain Interference-5.7 units on a scale
Treatment as UsualAdjusted Change in Pain Interference2.3 units on a scale
Secondary

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

ArmMeasureValue (MEAN)
Assistance With Pain Treatment (Intervention)Global Impression of Change3.7 units on a scale
Treatment as UsualGlobal Impression of Change4.4 units on a scale

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026