Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341608
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-11
Brief Title:
Improving Access to Opioid Use Disorder Treatment Among Marginalized Patients With a Tailored Telehealth Intervention
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Improving Access to Opioid Use Disorder Treatment Among Marginalized Patients With a Tailored Telehealth Intervention
Status:
RECRUITING
Status Verified Date:
2024-03
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:
The goal of this pilot trial is to develop and test a telehealth intervention for OUD care delivery and refine measurement strategies
The specific aims are to 1 identify components of an effective telehealth intervention and barriers to implementation 2 partner with an advisory board of OUD treatment stakeholders from different settings to develop a telehealth intervention for OUD treatment with buprenorphine and 3 conduct a pilot trial of the telehealth intervention for OUD treatment
The investigators will enroll 60 patients 30 individuals who are currently enrolled in in-person OUD treatment with buprenorphine with a treatment episode duration of 1-3 months and 30 individuals who are not currently receiving OUD treatment but approved for treatment intake at buprenorphine clinic by an OUD treatment clinician to receive the telehealth for OUD care delivery intervention The investigators will measure clinical implementation and patient satisfaction outcomes
The specific aims are to 1 identify components of an effective telehealth intervention and barriers to implementation 2 partner with an advisory board of OUD treatment stakeholders from different settings to develop a telehealth intervention for OUD treatment with buprenorphine and 3 conduct a pilot trial of the telehealth intervention for OUD treatment
The investigators will enroll 60 patients 30 individuals who are currently enrolled in in-person OUD treatment with buprenorphine with a treatment episode duration of 1-3 months and 30 individuals who are not currently receiving OUD treatment but approved for treatment intake at buprenorphine clinic by an OUD treatment clinician to receive the telehealth for OUD care delivery intervention The investigators will measure clinical implementation and patient satisfaction outcomes
Detailed Description:
OUD continues to be a leading cause of morbidity and mortality in the United States Substantial evidence supports the use of medications for OUD MOUD like buprenorphine however 80 of people with OUD receive no treatment of those who receive treatment only a third receive MOUD Preliminary evidence suggests that a COVID-era policy change allowing for buprenorphine induction and management via telehealth expanded access There is little evidence however about how to tailor telehealth models to promote equitable and effective OUD care Providers may hesitate to offer MOUD via telehealth to patients they deem unstable even if these patients lack other treatment options Given the dearth of accessible treatment options for many individuals the decision not to offer telehealth may result in a patient receiving no OUD treatment Therefore clinicians need evidence to guide how and to whom they deliver telehealth OUD treatment Dr Aronowitz will develop and test a telehealth model in partnership with Prevention Point Philadelphia a harm reduction organization providing MOUD and other services to the most marginalized people with OUD in the city The specific aims are to 1 identify components of an effective telehealth intervention and barriers to implementation 2 partner with an advisory board of OUD treatment stakeholders from different settings to develop a telehealth intervention for OUD treatment with buprenorphine and 3 conduct a pilot trial of the telehealth intervention for OUD treatment
The purpose of the pilot trial is to refine the telehealth for OUD care delivery intervention and measurement strategies and for the PI to gain experience conducting a trial For the pilot trial we will enroll 60 Prevention Point patients 30 individuals who are currently enrolled in in-person OUD treatment with buprenorphine at Prevention Point with a treatment episode duration of 1-3 months and 30 individuals who are not currently receiving OUD treatment but approved for treatment intake at buprenorphine clinic by Prevention Point clinician to receive the telehealth for OUD care delivery intervention The investigators will measure clinical implementation and patient satisfaction outcomes The investigators anticipate that the intervention will include both patient and provider-facing components The strategy will be developed based on formative work in Aim 1 and 2 and the investigators anticipate that it may include the following components 1 user-friendly telehealth platform 2 integrated case management 3 text message scheduling reminders and 4 mailed saliva urine drug screen testing The investigators will collect patient data from medical records and patient interviews at study visits Study visits will occur at baseline at Prevention Point and at weeks 2 4 and 12
The investigators will measure clinical treatment implementation and satisfaction The primary outcome will be treatment engagement at 30 days and secondary outcomes will be days of buprenorphine use days of opioid and non-opioid substance use treatment engagement at 90 days patient satisfaction and feasibility and acceptability to both patients and staff The primary outcome of treatment engagement at 30 days will be defined as enrolled in care not dropped out or discharged attended scheduled follow-up visits or has rescheduled missed visits with care team and has a filled active buprenorphine prescription Treatment engagement will be measured with patient self-report at study follow-up visits and verified through the EHR Secondary outcomes will include 1 proportion of scheduled visits attended 2 days of buprenorphine prescribed 3 opioid and non-opioid substance use measured by self-report and EHR 4 treatment engagement at 90 days measured with self-report and verified through the EHR The investigators will also conduct a matched analysis using Prevention Point electronic health record data to compare outcomes among patients in our trial to those of patients who received usual care at Prevention Point within the previous year The investigators will use de-identified Prevention Point EHR data to conduct optimal matching based on estimated propensity scores Trial participants will be matched with historical controls based on demographic characteristics employment and housing status buprenorphine dose comorbidities poly-substance use social supports and time in treatment Historical controls will be patients who received care at Prevention Point within the previous year to reduce the potential impact of secular trends in patient characteristics or responsiveness
The investigators will also measure whether the intervention is feasible and acceptable to stakeholders and will measure these outcomes among patient participants as well as providers and staff involved in delivering the intervention The investigators will ask patients brief semi-structured questions about feasibility and acceptability at study visits The investigators will also recruit a sample of 20 providers and staff who were involved in delivering the intervention to conduct brief semi-structured interviews assessing feasibility and acceptability of the telehealth intervention Finally the investigators will collect patient satisfaction from patients at 30 days using a standard questionnaire As a pilot study this project will have a small sample size but will produce results that can support evaluation of feasibility for a subsequent effectiveness-implementation hybrid trial of the telehealth model that will be tested in multiple settings with underserved populations This design will also achieve the career development goals of the proposed Mentored Patient-Oriented Research Development Award The purpose of this aim is to hone the intervention and study methods and to gain critical experience in conducting field trials in addition to gathering evidence regarding logistics participant recruitment and retention intervention delivery and study parameters before conducting an RCT
The purpose of the pilot trial is to refine the telehealth for OUD care delivery intervention and measurement strategies and for the PI to gain experience conducting a trial For the pilot trial we will enroll 60 Prevention Point patients 30 individuals who are currently enrolled in in-person OUD treatment with buprenorphine at Prevention Point with a treatment episode duration of 1-3 months and 30 individuals who are not currently receiving OUD treatment but approved for treatment intake at buprenorphine clinic by Prevention Point clinician to receive the telehealth for OUD care delivery intervention The investigators will measure clinical implementation and patient satisfaction outcomes The investigators anticipate that the intervention will include both patient and provider-facing components The strategy will be developed based on formative work in Aim 1 and 2 and the investigators anticipate that it may include the following components 1 user-friendly telehealth platform 2 integrated case management 3 text message scheduling reminders and 4 mailed saliva urine drug screen testing The investigators will collect patient data from medical records and patient interviews at study visits Study visits will occur at baseline at Prevention Point and at weeks 2 4 and 12
The investigators will measure clinical treatment implementation and satisfaction The primary outcome will be treatment engagement at 30 days and secondary outcomes will be days of buprenorphine use days of opioid and non-opioid substance use treatment engagement at 90 days patient satisfaction and feasibility and acceptability to both patients and staff The primary outcome of treatment engagement at 30 days will be defined as enrolled in care not dropped out or discharged attended scheduled follow-up visits or has rescheduled missed visits with care team and has a filled active buprenorphine prescription Treatment engagement will be measured with patient self-report at study follow-up visits and verified through the EHR Secondary outcomes will include 1 proportion of scheduled visits attended 2 days of buprenorphine prescribed 3 opioid and non-opioid substance use measured by self-report and EHR 4 treatment engagement at 90 days measured with self-report and verified through the EHR The investigators will also conduct a matched analysis using Prevention Point electronic health record data to compare outcomes among patients in our trial to those of patients who received usual care at Prevention Point within the previous year The investigators will use de-identified Prevention Point EHR data to conduct optimal matching based on estimated propensity scores Trial participants will be matched with historical controls based on demographic characteristics employment and housing status buprenorphine dose comorbidities poly-substance use social supports and time in treatment Historical controls will be patients who received care at Prevention Point within the previous year to reduce the potential impact of secular trends in patient characteristics or responsiveness
The investigators will also measure whether the intervention is feasible and acceptable to stakeholders and will measure these outcomes among patient participants as well as providers and staff involved in delivering the intervention The investigators will ask patients brief semi-structured questions about feasibility and acceptability at study visits The investigators will also recruit a sample of 20 providers and staff who were involved in delivering the intervention to conduct brief semi-structured interviews assessing feasibility and acceptability of the telehealth intervention Finally the investigators will collect patient satisfaction from patients at 30 days using a standard questionnaire As a pilot study this project will have a small sample size but will produce results that can support evaluation of feasibility for a subsequent effectiveness-implementation hybrid trial of the telehealth model that will be tested in multiple settings with underserved populations This design will also achieve the career development goals of the proposed Mentored Patient-Oriented Research Development Award The purpose of this aim is to hone the intervention and study methods and to gain critical experience in conducting field trials in addition to gathering evidence regarding logistics participant recruitment and retention intervention delivery and study parameters before conducting an RCT
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