Ignite Creation Date:
2024-05-06 @ 4:33 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05028998
Status:
RECRUITING
Last Update Posted:
2023-08-01
First Post:
2021-08-27
Brief Title:
COVID-19-Related Opioid Treatment Policy Evaluation
Sponsor:
Boston VA Research Institute Inc
Organization:
Boston VA Research Institute Inc
Study Overview
Official Title:
The Impact of COVID-19-related Medication Assisted Treatment Policy Changes on Care and Outcomes for Patients With Opioid Use Disorder
Status:
RECRUITING
Status Verified Date:
2023-07
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:
COPE
Brief Summary:
Our nation is facing the COVID-19 pandemic during an ongoing opioid epidemic Effective treatment for patients with opioid use problems involves a treatment method called Medication-Assisted Treatment or MAT In MAT patients receive a medication that reduces cravings and withdrawal symptoms and can prevent overdose Patients also receive counseling Because the medications that are used in MAT are controlled substances this treatment is subject to a number of federal regulations The need for social-distancing during the pandemic would have made following these regulations very difficult for patients and their providers Because of these difficulties the federal government eased regulations in March 2020 making it easier for patients to receive MAT with fewer if any in-person visits for medication and counseling Our team is studying the effects of these policy changes on the treatment that patients with opioid use disorder receive and on their outcomes We are using both quantitative analyses of large existing databases and qualitative analyses of interviews with patients providers and policy-makers to study these effects
Detailed Description:
The COVID-19 disease outbreak has occurred in the midst of a national opioid crisis and poses significant risk for individuals with opioid use disorder OUD If existing in-person care delivery systems continued patients would need to choose between risking exposure to the virus or foregoing OUD treatment Medication-assisted treatment MAT the gold-standard for treating OUD involves daily medication ie methadone or buprenorphine close medication monitoring and counseling sessions all typically occurring in person The medications used are schedule II and III controlled substances and are subject to greater federal regulations than medications for other substance use disorders SUD such as alcohol use disorder AUD3 To temper the impact of COVID-19 on OUD patients in March 2020 the federal government temporarily but dramatically loosened MAT restrictions to expand treatment options require fewer in-person visits and prevent disruption to life-saving treatment
This rapid shift in policy created a natural experiment allowing for the evaluation of this MAT policy intervention on OUD patient care and outcomes To examine the unknown effects of this intervention we propose a mixed-methods naturalistic experimental design involving quantitative analysis of large administrative and healthcare utilization datasets to evaluate the impact of MAT policy changes on patient care and outcomes We will also compare OUD patient outcomes to those of AUD patients analogue comparison group for whom treatment was unaffected by MAT policy changes We will then conduct interviews with patients providers and key MAT policy stakeholders to understand perspectives on the impact of these COVID-19 related MAT policy changes on the lives and well-being of OUD patients and guide policy decisions regarding whether or not to make these changes permanent Given the general impact of the COVID-19 pandemic on patients and systems we will compare outcomes for patients with OUD to analogue AUD patients for whom there were no comparable medication policy changes in response to COVID-19
Patients with OUD across three healthcare systems will be engaged in all steps of the research including influencing the research design assisting in determining key variables for Aims 1 and 2 collaborating in drafting our interview scripts for Aim 3 and assisting in interpreting our results and disseminating findings to patient stakeholders
Aim 1 Using existing datasets examine the effect of federal regulation changes on trends in delivery of MAT for OUD before and after pandemic onset with a particular focus on prescription access refills and dosing schedules as well as rates of in-person vs telehealth medical and counseling visits
Aim 2 Estimate the impact of the changes in OUD healthcare delivery on crucial patient outcomes eg emergency department visits detoxification treatment retention relapse overdose and mortality by comparing patients with OUD vs AUD clinical analogue comparison group across time pre- and post-MAT policy changes
Aim 3 Through in-depth qualitative interviews and analyses characterize patient provider and decision-maker perspectives on the impact of MAT policy changes in response to COVID-19 on patient access to MAT health functioning and well-being
Built-in reporting milestones will expedite data sharing to guide policy provider and patient decision-making as health care systems determine how to prepare for future pandemics and post-COVID-19 pandemic care for OUD patients
This rapid shift in policy created a natural experiment allowing for the evaluation of this MAT policy intervention on OUD patient care and outcomes To examine the unknown effects of this intervention we propose a mixed-methods naturalistic experimental design involving quantitative analysis of large administrative and healthcare utilization datasets to evaluate the impact of MAT policy changes on patient care and outcomes We will also compare OUD patient outcomes to those of AUD patients analogue comparison group for whom treatment was unaffected by MAT policy changes We will then conduct interviews with patients providers and key MAT policy stakeholders to understand perspectives on the impact of these COVID-19 related MAT policy changes on the lives and well-being of OUD patients and guide policy decisions regarding whether or not to make these changes permanent Given the general impact of the COVID-19 pandemic on patients and systems we will compare outcomes for patients with OUD to analogue AUD patients for whom there were no comparable medication policy changes in response to COVID-19
Patients with OUD across three healthcare systems will be engaged in all steps of the research including influencing the research design assisting in determining key variables for Aims 1 and 2 collaborating in drafting our interview scripts for Aim 3 and assisting in interpreting our results and disseminating findings to patient stakeholders
Aim 1 Using existing datasets examine the effect of federal regulation changes on trends in delivery of MAT for OUD before and after pandemic onset with a particular focus on prescription access refills and dosing schedules as well as rates of in-person vs telehealth medical and counseling visits
Aim 2 Estimate the impact of the changes in OUD healthcare delivery on crucial patient outcomes eg emergency department visits detoxification treatment retention relapse overdose and mortality by comparing patients with OUD vs AUD clinical analogue comparison group across time pre- and post-MAT policy changes
Aim 3 Through in-depth qualitative interviews and analyses characterize patient provider and decision-maker perspectives on the impact of MAT policy changes in response to COVID-19 on patient access to MAT health functioning and well-being
Built-in reporting milestones will expedite data sharing to guide policy provider and patient decision-making as health care systems determine how to prepare for future pandemics and post-COVID-19 pandemic care for OUD patients
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