PainSEACAPNCT00129480
Improving Chronic Pain Treatment in Primary Care
A study testing Assistance with Pain treatment in people with Pain and Chronic Disease, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic Disease, Depression
- What is being tested?
- Assistance with Pain treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Dementia or cognitive disturbance
- Diagnoses of fibromyalgia, chronic fatigue or somatization disorder Terminal illness
- Designated guardian
- Drug-seeking behavior flag in medical record
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
About this study
Official title: Improving the Treatment of Chronic Pain in Primary Care
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.
Read the 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.
- Conditions
- Pain, Chronic Disease, Depression
- Being tested
- Assistance with Pain treatment
- Keywords
- veterans, pain and chronic disease, disease management, depression, primary health care, practice guidelines, guideline adherence, narcotics, patient compliance, randomized controlled trial
- Medical subject headings
- Pain, Chronic Disease, Depression, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assistance with Pain treatmentBehavioural
Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Assistance with Pain Treatment | Experimental | Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers Receives: Behavioral: Assistance with Pain treatment |
| Treatment as usual | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
Adjusted Change in Depression Severity
Patient Health Questionnaire-9 depression rating scale. Range 0-27 with higher scores representing higher depression severity
Measured: 12 months
Adjusted Change in Pain Interference
Chronic Pain Grade interference score. Range 0 to 100 with higher scores representing greater pain interference (worse outcome)
Measured: 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
Measured: 12 months
Adjusted Change in Health Related Quality of Life
EQ-5D. Range 3-15 with higher scores representing worse health states
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2005 (estimated)
- Study startJan 2006
- Primary completionJan 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Steven K. Dobscha, MD, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129480
- Sponsor's protocol ID
- PMI 03-195
- Acronym
- SEACAP
- Status last verified
- Jan 2019
- First submitted
- 9 Aug 2005
- Last updated
- 23 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 16937344Dobscha 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.
PubMed 19318652Morasco 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.
PubMed 18291290Dobscha 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.
PubMed 18565008Dobscha 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.
PubMed 17537251Dickinson 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.
PubMed 19952802Abstracts 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.
PubMed 20238191Morasco 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.
PubMed 20851057Morasco 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.
PubMed 21185119Dobscha 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.
PubMed 18777608Denneson 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.
PubMed 22234716Morasco 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.
PubMed 21562923Corson 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.
PubMed 21943325Thielke 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.
PubMed 25554014
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Treatment of Chronic Pain in Primary Care
- ClinicalTrials.gov ID
- NCT00129480
- Acronym / sponsor ID
- SEACAP / PMI 03-195
- Conditions
- Pain, Chronic Disease, Depression
- Keywords
- veterans, pain and chronic disease, disease management, depression, primary health care, practice guidelines, guideline adherence, narcotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jan 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 11 Aug 2005 (estimated)
- Results
- Posted 24 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assistance with Pain Treatment | Experimental | Behavioral: Assistance with Pain treatmentCare management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers |
| Treatment as usual | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Dementia or cognitive disturbance
- Diagnoses of fibromyalgia, chronic fatigue or somatization disorder Terminal illness
- Designated guardian
- Drug-seeking behavior flag in medical record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assistance with Pain treatmentCare management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months. | Behavioural | Assistance with Pain Treatment |
Primary outcome
Adjusted Change in Pain-related Function (Roland Disability Score)
Time frame: 12 months
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.
4 secondary outcomes
Adjusted Change in Depression Severity
Time frame: 12 months
Adjusted Change in Pain Interference
Time frame: 12 month
Global Impression of Change
Time frame: 12 months
Adjusted Change in Health Related Quality of Life
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16937344Otis 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.
- Results publication: PubMed 19318652Dobscha 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.
- Results publication: PubMed 18291290Morasco 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.
- Results publication: PubMed 18565008Dobscha 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.
- Results publication: PubMed 17537251Dobscha 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.
- Results publication: PubMed 19952802Dickinson 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.
- Results publication: PubMed 20238191Abstracts 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.
- Results publication: PubMed 20851057Morasco 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.
- Results publication: PubMed 21185119Morasco 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.
- Results publication: PubMed 18777608Dobscha 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.
- Results publication: PubMed 22234716Denneson 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.
- Results publication: PubMed 21562923Morasco 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven K. Dobscha, MD principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assistance with Pain treatment in people with Pain and Chronic Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjusted Change in Pain-related Function (Roland Disability Score) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00129480, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.