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-occuring 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 and chronic disease Depression	Behavior: Assist w/pain treat, ie provider/patient assessment, education/activation, symptom monitoring, feedback/recommendations, facilitate speciality care

Further Study Details: 

Primary Outcomes: Pain-related function (score on SF-36V Physical Functioning scale at 12 months) and pain severity (score on SF-36V Bodily Pain scale at 12 months)
Secondary Outcomes: Depression severity (Patient Health Questionnaire-9 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
Expected Total Enrollment:  400

BACKGROUND / RATIONALE: Chronic pain is very common, and associated with substantial physical and psychosocial impairment and increased healthcare utilization. Depression is often comorbid with pain and limits treatment response. Although standards and guidelines for chronic pain treatment have been developed, implementation of guidelines has been problematic, and chronic pain remains undertreated. Among veterans, there is a high prevalence of chronic pain, and the VHA has created a National Pain Management Strategy to reduce suffering from pain, and adopted pain as the "5th vital sign." Among veterans with chronic pain, comorbid depression is very common and physical functioning is significantly impacted.

OBJECTIVE(S): 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 comorbid depression, 2) adherence of providers to guidelines for chronic pain, and 3) patient and provider satisfaction and attitudes related to chronic pain treatment.

METHODS: The study is a randomized, controlled trial of "Assistance with Pain Treatment" (APT) versus usual care and will last 39 months. APT is based on previously studied collaborative interventions for chronic illness, and designed to efficiently deliver data, reminders and resources necessary to optimize primary care provider (PCP) adherence to key treatment guidelines. APT includes provider and patient assessment, education and activation, symptom monitoring, feedback and recommendations, and facilitation of specialty/multidisciplinary care.

400 patients and 46 primary care providers will participate. We will randomize by PCP, and nest patients within PCP intervention status. Participants will be followed for 12 months. To recruit participants, we will mail letters to patients with upcoming primary care appointments, and post and distribute advertising flyers in clinics and other prominent hospital locations. Patients with chart-documented musculoskeletal pain diagnoses who report during phone screening at least moderate pain and physical dysfunction (SF-36V bodily pain [BP] and physical functioning [PF]) lasting at least 12 weeks will be invited to participate. Patients with terminal illness, or cognitive disorders will be excluded. There will be no restrictions by age or sex. Primary outcomes are SF-36V BP and PF scores, and will be measured at 6 and 12 months. Random effects (multilevel) regression models will be used for the primary analysis. Covariates include age, medical comorbidity, baseline BP and PF, baseline depression severity, and duration of pre-entry opioid treatment. We will explore interrelationships of depression severity, adherence of providers to key guideline criteria, substance abuse status, patient and provider attitudes, and patient outcomes including aberrant opioid-related patient behaviors. We will measure how APT impacts VA healthcare utilization and costs; if the intervention is effective, we will calculate incremental cost-effectiveness.

IMPACT: This is the first study to rigorously evaluate a collaborative care approach to chronic pain in the VA. If the intervention is effective, it will improve care of patients with chronic pain. This study will enhance our knowledge of veterans with chronic pain, adherence of VA providers to treatment guidelines, and outcomes of patients with comorbid depression and chronic pain.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Eligible to receive 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 Terminal illness Designated guardian Drug-seeking behavior flag in medical record

Please refer to this study by ClinicalTrials.gov identifier  NCT00129480

Oregon
      VA Medical Center, Portland,  Oregon,  97201,  United States

Study chairs or principal investigators

Steven K. Dobscha, MD,  Principal Investigator,  Department of Veterans Affairs   

Study ID Numbers:  PMI 03-195
Last Updated:  August 10, 2005
Record first received:  August 9, 2005
ClinicalTrials.gov Identifier:  NCT00129480
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23