Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05333341
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2022-04-11
Brief Title:
Pain Care at Home to Amplify Function Pain CHAMP
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Pain Care at Home to Amplify Function Pain CHAMP
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
This project aims to test simultaneously the effectiveness of telemedicine and collaborative management TCM vs TCM plus Cooperative Pain Education and Self-Management COPES on patient level outcomes and the impact of site-tailored Implementation Facilitation to work toward long term opioid therapy dose reduction Pain CHAMP is a patient-level randomized hybrid II effectiveness-implementation trial comparing TCM vs TCM COPES on the primary composite outcome of pain interference and OUDmisuse symptoms
Detailed Description:
Pain CHAMP is a patient-level randomized hybrid II effectiveness-implementation trial comparing TCM vs TCM COPES on the primary composite outcome of pain interference and OUDmisuse symptoms The investigators have developed two evidence-based collaborative care interventions that use focused resources to assist primary care providers PCPs in meeting the two main challenges in managing care for patients on long-term opioid therapy LTOT with chronic pain CP and opioid use disorder OUDmisuse 1 reassessment of LTOT and switch to medication for opioid use disorder MOUD as indicated and 2 ready access to evidence-based behavioral pain treatment Both interventions are entirely virtual and thus serve the needs of many underserved populations Telemedicine Collaborative Management TCM features clinical pharmacists leading LTOT reassessment and buprenorphine BUP initiation in consultation with a BUP-prescribing physician The TCM model is effective in decreasing pain interference achieving LTOT dose reduction BUP initiation and continuation and shows greater patient engagement than the more resource intensive Integrated Pain Team comparator arm Cooperative Pain Education and Self-Management COPES a cognitive-behavioral therapy CBT program delivered via telehealth that improves pain interference improves access to evidence-based behavioral pain treatment
While TCM and COPES are established interventions the additional value of COPES-as a behavioral CP intervention paired with the pharmacologic-focused TCM for chronic pain and LTOT misuseOUD--has not been tested To advance systems-level approaches to addressing co-occurring CP LTOT and OUDmisuse this study will make two important steps forward First the investigators will use a pragmatic approach and randomize at the site-level so all eligible patients will receive standard-of-care treatment Second the study will train PCPs in how to re-assume care of patients post-collaborative care to maintain gains made during the interventions To meet these goals the team of investigators with expertise conducting high-impact CP and OUD research propose Pain Care at Home to Amplify Function Pain CHAMP a hybrid II trial to test simultaneously the effectiveness of TCM vs TCM plus COPES on patient level outcomes and the impact of site-tailored Implementation Facilitation on successful uptake of each intervention with the following specific aims
Aim 1 Compare the effectiveness of pharmacist-led TCM vs TCM plus COPES on the primary composite outcome of improved pain interference and opioid safety as measured by opioid misuse or opioid use disorder As secondary outcomes we will compare groups on alcohol use anxiety depression and sleep
Aim 2 Evaluate the effectiveness of Implementation Facilitation for TCM and COPES on Reach Effectiveness Adoption Implementation and Maintenance RE-AIM guided outcomes using mixed qualitative-quantitative methods
Targeted numbers of participants are
Developmental formative evaluation interviews
participants 48
pharmacists and physicians 32
peer support specialists 32
primary care providers 48
clinic directors and hospital administrators max 32
Implementation-focused Formative Evaluation
participants 48
pharmacists and physicians 32
peer support specialists max 32
primary care providers 48
clinic directors and hospital administrators 32
Aim 3 Examine the cost-effectiveness of TCM plus COPES relative to TCM on the primary composite outcome
While TCM and COPES are established interventions the additional value of COPES-as a behavioral CP intervention paired with the pharmacologic-focused TCM for chronic pain and LTOT misuseOUD--has not been tested To advance systems-level approaches to addressing co-occurring CP LTOT and OUDmisuse this study will make two important steps forward First the investigators will use a pragmatic approach and randomize at the site-level so all eligible patients will receive standard-of-care treatment Second the study will train PCPs in how to re-assume care of patients post-collaborative care to maintain gains made during the interventions To meet these goals the team of investigators with expertise conducting high-impact CP and OUD research propose Pain Care at Home to Amplify Function Pain CHAMP a hybrid II trial to test simultaneously the effectiveness of TCM vs TCM plus COPES on patient level outcomes and the impact of site-tailored Implementation Facilitation on successful uptake of each intervention with the following specific aims
Aim 1 Compare the effectiveness of pharmacist-led TCM vs TCM plus COPES on the primary composite outcome of improved pain interference and opioid safety as measured by opioid misuse or opioid use disorder As secondary outcomes we will compare groups on alcohol use anxiety depression and sleep
Aim 2 Evaluate the effectiveness of Implementation Facilitation for TCM and COPES on Reach Effectiveness Adoption Implementation and Maintenance RE-AIM guided outcomes using mixed qualitative-quantitative methods
Targeted numbers of participants are
Developmental formative evaluation interviews
participants 48
pharmacists and physicians 32
peer support specialists 32
primary care providers 48
clinic directors and hospital administrators max 32
Implementation-focused Formative Evaluation
participants 48
pharmacists and physicians 32
peer support specialists max 32
primary care providers 48
clinic directors and hospital administrators 32
Aim 3 Examine the cost-effectiveness of TCM plus COPES relative to TCM on the primary composite outcome
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1RM1DA055310-01 | NIH | None | httpsreporternihgovquickSearch1RM1DA055310-01 |