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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assistance with Pain Treatment | Experimental | Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers |
|
| Treatment as usual | No Intervention | Treatment as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assistance with Pain treatment | Behavioral | Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Change in Depression Severity | Patient Health Questionnaire-9 depression rating scale. Range 0-27 with higher scores representing higher depression severity | 12 months |
| Adjusted Change in Pain Interference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven K. Dobscha, MD | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16937344 | Background | Otis JD, Macdonald A, Dobscha SK. Integration and coordination of pain management in primary care. J Clin Psychol. 2006 Nov;62(11):1333-43. doi: 10.1002/jclp.20313. | |
| 19318652 | Result | Dobscha SK, Corson K, Perrin NA, Hanson GC, Leibowitz RQ, Doak MN, Dickinson KC, Sullivan MD, Gerrity MS. Collaborative care for chronic pain in primary care: a cluster randomized trial. JAMA. 2009 Mar 25;301(12):1242-52. doi: 10.1001/jama.2009.377. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Treatment as Usual | Pain treatment as usual |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Veterans receiving healthcare in VA primary care
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven K. Dobscha MD | Portland VA Medical Center | 503-220-8262 | 52207 | steven.dobscha@va.gov |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D002908 | Chronic Disease |
| D003863 | Depression |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D007316 | Insemination, Artificial, Heterologous |
| D000698 | Analgesia |
| ID | Term |
|---|---|
| D007315 | Insemination, Artificial |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
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Chronic Pain Grade interference score. Range 0 to 100 with higher scores representing greater pain interference (worse outcome)
| 12 month |
| 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 | 12 months |
| Adjusted Change in Health Related Quality of Life | EQ-5D. Range 3-15 with higher scores representing worse health states | 12 months |
| 18291290 | Result | Morasco BJ, Dobscha SK. Prescription medication misuse and substance use disorder in VA primary care patients with chronic pain. Gen Hosp Psychiatry. 2008 Mar-Apr;30(2):93-9. doi: 10.1016/j.genhosppsych.2007.12.004. |
| 18565008 | Result | Dobscha SK, Corson K, Leibowitz RQ, Sullivan MD, Gerrity MS. Rationale, design, and baseline findings from a randomized trial of collaborative care for chronic musculoskeletal pain in primary care. Pain Med. 2008 Nov;9(8):1050-64. doi: 10.1111/j.1526-4637.2008.00457.x. Epub 2008 Jun 18. |
| 17537251 | Result | Dobscha SK, Leibowitz RQ, Flores JA, Doak M, Gerrity MS. Primary care provider preferences for working with a collaborative support team. Implement Sci. 2007 May 30;2:16. doi: 10.1186/1748-5908-2-16. |
| 19952802 | Result | Dickinson KC, Sharma R, Duckart JP, Corson K, Gerrity MS, Dobscha SK. VA healthcare costs of a collaborative intervention for chronic pain in primary care. Med Care. 2010 Jan;48(1):38-44. doi: 10.1097/MLR.0b013e3181bd49e2. |
| 20238191 | Result | Abstracts of the 2010 Annual Meeting of the Society of Behavioral Medicine. Ann Behav Med. 2010 Apr;39 Suppl 1:1-232. doi: 10.1007/s12160-010-9169-5. No abstract available. |
| 20851057 | Result | Morasco BJ, Corson K, Turk DC, Dobscha SK. Association between substance use disorder status and pain-related function following 12 months of treatment in primary care patients with musculoskeletal pain. J Pain. 2011 Mar;12(3):352-9. doi: 10.1016/j.jpain.2010.07.010. Epub 2010 Sep 20. |
| 21185119 | Result | Morasco BJ, Gritzner S, Lewis L, Oldham R, Turk DC, Dobscha SK. Systematic review of prevalence, correlates, and treatment outcomes for chronic non-cancer pain in patients with comorbid substance use disorder. Pain. 2011 Mar;152(3):488-497. doi: 10.1016/j.pain.2010.10.009. Epub 2010 Dec 23. |
| 18777608 | Result | Dobscha SK, Corson K, Flores JA, Tansill EC, Gerrity MS. Veterans affairs primary care clinicians' attitudes toward chronic pain and correlates of opioid prescribing rates. Pain Med. 2008 Jul-Aug;9(5):564-71. doi: 10.1111/j.1526-4637.2007.00330.x. |
| 22234716 | Result | Denneson LM, Corson K, Dobscha SK. Complementary and alternative medicine use among veterans with chronic noncancer pain. J Rehabil Res Dev. 2011;48(9):1119-28. doi: 10.1682/jrrd.2010.12.0243. |
| 21562923 | Result | Morasco BJ, Duckart JP, Dobscha SK. Adherence to clinical guidelines for opioid therapy for chronic pain in patients with substance use disorder. J Gen Intern Med. 2011 Sep;26(9):965-71. doi: 10.1007/s11606-011-1734-5. Epub 2011 May 12. |
| 21943325 | Result | Corson K, Doak MN, Denneson L, Crutchfield M, Soleck G, Dickinson KC, Gerrity MS, Dobscha SK. Primary care clinician adherence to guidelines for the management of chronic musculoskeletal pain: results from the study of the effectiveness of a collaborative approach to pain. Pain Med. 2011 Oct;12(10):1490-501. doi: 10.1111/j.1526-4637.2011.01231.x. Epub 2011 Sep 21. |
| 25554014 | Result | Thielke S, Corson K, Dobscha SK. Collaborative care for pain results in both symptom improvement and sustained reduction of pain and depression. Gen Hosp Psychiatry. 2015 Mar-Apr;37(2):139-43. doi: 10.1016/j.genhosppsych.2014.11.007. Epub 2014 Nov 21. |
| BG001 | Treatment as Usual | Treatment as usual which includes standard pain care, clinician generated referrals for additional consultation and ancillary services |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Treatment as Usual | Pain treatment as usual |
|
|
| Secondary | Adjusted Change in Depression Severity | Patient Health Questionnaire-9 depression rating scale. Range 0-27 with higher scores representing higher depression severity | Posted | Mean | 95% Confidence Interval | units on a scale | 12 months |
|
|
|
| Secondary | Adjusted Change in Pain Interference | Chronic Pain Grade interference score. Range 0 to 100 with higher scores representing greater pain interference (worse outcome) | Posted | Mean | 95% Confidence Interval | units on a scale | 12 month |
|
|
|
| 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 12 months |
|
|
|
| Secondary | Adjusted Change in Health Related Quality of Life | EQ-5D. Range 3-15 with higher scores representing worse health states | Posted | Mean | 95% Confidence Interval | units on a scale | 12 months |
|
|
|
| 0 |
| 187 |
| 0 |
| 187 |
| EG001 | Treatment as Usual | Treatment as usual, which includes standard pain care, clinician-generated referrals for additional consultation and ancillary services | 0 | 214 | 0 | 214 |
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| D010335 | Pathologic Processes |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D008919 | Investigative Techniques |
| D007314 | Insemination |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D000760 | Anesthesia and Analgesia |