Ignite Creation Date:
2024-05-06 @ 8:23 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02724930
Status:
COMPLETED
Last Update Posted:
2022-09-22
First Post:
2016-03-22
Brief Title:
Cooperative Pain Education and Self-management
Sponsor:
VA Connecticut Healthcare System
Organization:
VA Connecticut Healthcare System
Study Overview
Official Title:
Cooperative Pain Education and Self-management
Status:
COMPLETED
Status Verified Date:
2022-09
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:
COPES
Brief Summary:
This study will test the effectiveness of using enhanced facilitation strategies on implementation of an automated Interactive Voice Response IVR system as a means to remotely deliver in-home self-management support to Veterans with chronic pain The implementation intervention uses an enhanced facilitation approach paired with automated case finding and direct patient outreach to encourage uptake of Cooperative Pain Education and Self-management COPES A nested effectiveness study will measure pre-post differences in pain-relevant outcomes pain intensity physical functioning and physical activity The investigators will use a stepped wedge cluster design in which clusters will be randomized to the timing of the introduction of enhanced COPES implementation Investigators will assess the efficacy of the facilitation based implementation strategy by evaluating COPES uptake in the implementation settings
Detailed Description:
Cognitive behavioral therapy CBT for chronic pain is a commonly used evidence-based self-management intervention Though effective CBT requires that patients attend multiple in-person visits and that highly trained staff be available to provide care For these reasons CBT is resource intensive often inaccessible to Veterans and delivered unevenly across patients and facilities In a Veterans Health Administration Office of Health Services Research and Development HSRD IIR-funded trial investigators found that CBT delivered primarily via an automated Interactive Voice Response IVR system Cooperative Pain Education and Self-management or COPES leads to patient-centered outcomes that are comparable to standard United States Department of Veterans Affairs VA approaches in which CBT is delivered in-person by a therapist over ten weekly sessions In this study implementation facilitation will be guided by the Consolidated Framework for Implementation Research CFIR which provides a set of constructs to identify potential barriers and facilitators to implementation The primary objective of this project is to evaluate the effectiveness of the facilitation approach paired with automated case finding and direct patient outreach on uptake of COPES in the clinical care setting Study investigators will specifically target Veterans who receive care at community-based outpatient clinics CBOCs because these sites typically have few or no therapists trained in CBT for chronic pain
Description of COPES COPES is a 10-week IVR-facilitated program of CBT for chronic pain The primary components of COPES include 1 a self-help handbook to teach Veterans pain self-management skills and describe the weekly skill practice goals 2 a pedometer-facilitated progressive walking program all COPES patients will be given an Omron Go Smart Model HJ-112 pocket pedometer at the time of enrollment and 3 daily automated IVR calls to collect patient-reported pain intensity and pain-related interference sleep quality pedometer-measured step count and adherence to the pain coping skill practice ratings Participants will also receive a weekly two to four minute pre-recorded personalized therapist message via the IVR system based on the participants IVR-recorded data Therapists provide feedback on the participants weekly average pain intensity sleep steps and pain coping skill practice note any changes from the prior week and comment on symptom or activity patterns Therapists also provide reinforcement for goal accomplishment help patients make connections among pain pain coping skill practice and goal accomplishment and assign a steps and skill practice goal for the upcoming week
Research Design Study investigators will test the effectiveness of the facilitation approach to implement COPES as a means to remotely deliver in-home self-management support to Veterans with chronic pain To evaluate the implementations success study investigators will conduct a multi-site stepped wedge Hybrid III trial in 17 CBOCs affiliated with three geographically dispersed sites VA Boston VA Palo Alto and Roudebush VA in Indianapolis Clusters k17 CBOCs will be randomized to 6 different time periods proportional to approximate eligible patient population size Each CBOC will serve as its own control for a period of time before transitioning into enhanced facilitation the time of this transition is randomized in a stepped fashion The primary outcome for evaluating implementation success will be patient enrollment in COPES The secondary outcome will be provider referral Other outcomes that will be investigated as part of the nested COPES effectiveness study will be Veterans physical functioning pain intensity and physical activity
Methodology Study investigators will evaluate the success of the implementation strategy by evaluating the proportion of patients who are offered enrollment in COPES who actually enroll Additionally study investigators will conduct a formative evaluation to inform refine and evaluate implementation of COPES The evaluation will include interviews with VA staff and patients with chronic back pain at the proposed implementation sites Interview guides will be based on CFIR model constructs using questions adapted from the CFIR interview guide Investigators will also measure pre-post differences in pain-relevant outcomes pain intensity physical functioning and physical activity
Description of COPES COPES is a 10-week IVR-facilitated program of CBT for chronic pain The primary components of COPES include 1 a self-help handbook to teach Veterans pain self-management skills and describe the weekly skill practice goals 2 a pedometer-facilitated progressive walking program all COPES patients will be given an Omron Go Smart Model HJ-112 pocket pedometer at the time of enrollment and 3 daily automated IVR calls to collect patient-reported pain intensity and pain-related interference sleep quality pedometer-measured step count and adherence to the pain coping skill practice ratings Participants will also receive a weekly two to four minute pre-recorded personalized therapist message via the IVR system based on the participants IVR-recorded data Therapists provide feedback on the participants weekly average pain intensity sleep steps and pain coping skill practice note any changes from the prior week and comment on symptom or activity patterns Therapists also provide reinforcement for goal accomplishment help patients make connections among pain pain coping skill practice and goal accomplishment and assign a steps and skill practice goal for the upcoming week
Research Design Study investigators will test the effectiveness of the facilitation approach to implement COPES as a means to remotely deliver in-home self-management support to Veterans with chronic pain To evaluate the implementations success study investigators will conduct a multi-site stepped wedge Hybrid III trial in 17 CBOCs affiliated with three geographically dispersed sites VA Boston VA Palo Alto and Roudebush VA in Indianapolis Clusters k17 CBOCs will be randomized to 6 different time periods proportional to approximate eligible patient population size Each CBOC will serve as its own control for a period of time before transitioning into enhanced facilitation the time of this transition is randomized in a stepped fashion The primary outcome for evaluating implementation success will be patient enrollment in COPES The secondary outcome will be provider referral Other outcomes that will be investigated as part of the nested COPES effectiveness study will be Veterans physical functioning pain intensity and physical activity
Methodology Study investigators will evaluate the success of the implementation strategy by evaluating the proportion of patients who are offered enrollment in COPES who actually enroll Additionally study investigators will conduct a formative evaluation to inform refine and evaluate implementation of COPES The evaluation will include interviews with VA staff and patients with chronic back pain at the proposed implementation sites Interview guides will be based on CFIR model constructs using questions adapted from the CFIR interview guide Investigators will also measure pre-post differences in pain-relevant outcomes pain intensity physical functioning and physical activity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None