Improving Chronic Pain Treatment in Primary Care (SEACAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00129480
First received: August 9, 2005
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Pain
Chronic Disease
Depression
Behavioral: Assistance with Pain treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving the Treatment of Chronic Pain in Primary Care

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Pain-related function (Roland Disability score, 6 and 12 months) and pain severity (Chronic Pain Grade pain severity items, 6 and 12 months) [ Time Frame: baseline, 3 month, 6 month, 12 month, 30 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression severity (Patient Health Questionnaire-depression rating scale at 6 and 12 months); Clinician adherence to clinical guidelines for chronic pain (chart review conducted at 12 months); Patient and provider satisfaction questionnaires completed [ Time Frame: baseline, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]

Enrollment: 401
Study Start Date: January 2006
Study Completion Date: July 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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: Arm 2
Treatment as usual

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129480

Locations
United States, Oregon
Portland VA Medical Center
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Investigators
Principal Investigator: Steven K. Dobscha, MD VA Medical Center, Portland
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00129480     History of Changes
Other Study ID Numbers: PMI 03-195
Study First Received: August 9, 2005
Last Updated: May 21, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
veterans
pain and chronic disease
disease management
depression
primary health care
practice guidelines
guideline adherence
narcotics
patient compliance
randomized controlled trial

Additional relevant MeSH terms:
Chronic Disease
Depression
Depressive Disorder
Chronic Pain
Disease Attributes
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014