Improving Chronic Pain Treatment in Primary Care (SEACAP)

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VA Office of Research and Development

Status

Completed

Conditions

Chronic Disease
Depression
Pain

Treatments

Behavioral: Assistance with Pain treatment

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00129480
PMI 03-195

Details and patient eligibility

About

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.

Full 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.

Enrollment

401 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

401 participants in 2 patient groups

Assistance with Pain Treatment
Experimental group
Description:
Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers
Treatment:
Behavioral: Assistance with Pain treatment
Treatment as usual
No Intervention group
Description:
Treatment as usual

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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