Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129480
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2005-08-09
Brief Title:
Improving Chronic Pain Treatment in Primary Care
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Improving the Treatment of Chronic Pain in Primary Care
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEACAP
Brief 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 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 yesno 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 VAs Decision Support System for all utilization except certain intervention activities that were tracked in a separate study database
Status
Complete
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 yesno 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 VAs Decision Support System for all utilization except certain intervention activities that were tracked in a separate study database
Status
Complete
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None