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临床试验/NCT05897788
NCT05897788进行中(未招募)不适用

Text-Messaging Telehealth and Contingency Management for Opioid Use Disorder Treatment Engagement

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 1,808 人开始时间: 2024年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,808
试验地点
1
主要终点
Engagement in any addiction treatment at 30 days of randomization

研究概览

简要总结

There is growing recognition of the need for approaches to initiate treatment wherever patients touch the health care system, including the Emergency Department (ED). Most research has focused on initiation of medications for opioid use disorder (MOUDs) in the ED rather than ensuring continued treatment post-discharge. The investigators propose to adapt evidence-based interventions to support patients' complex needs and facilitate continued treatment, rather than discharging them and having them navigate outpatient treatment systems with limited support. The research team will randomize participants into 1 of 4 arms to receive varying degrees of augmented usual care, including daily check-ins and contingency management. The investigators plan to examine the effects of check-ins and contingency management on engagement with addiction treatment and equity of treatment effects among racial and ethnic subgroups and assess important moderators of treatment effects.

详细描述

The investigators are proposing to conduct a randomized controlled trial to determine the effectiveness of various text-based and contingency management interventions on Opioid Use Disorder patients. Our goals are to measure their engagement with recovery treatment. The research team plan to enroll 1,649 participants into one of the following 4 arms.

Patients enrolled into the Way to Health CareConnect text line as part of usual care and meeting eligibility criteria will be enrolled in this randomized control trial and randomized to:

Augmented usual care (standard Way to HealthCareConnect text line) Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week.

Augmented usual care + text-message check-ins (standard Way to Health CareConnect Text line) Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week AND (text-message check-ins) patients will receive automated text-message check-ins up to once per day for 30 days to see if the patient needs help with anything.

Augmented usual care + contingency management (standard Way to Health CareConnect Text line) and, participants will be compensated for going to their follow-up appointments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must be 18 or older
  • Screen positive for OUD
  • Bridge buprenorphine prescription (emergency department (ED) enrollment - Buprenorphine prescription at ED discharge; Bridge clinic enrollment - new buprenorphine prescription associated with on-demand or drop-in encounter
  • English reading ability
  • Have a mobile phone capable of receiving text messages

排除标准

  • Not being up to date with requirements above

研究组 & 干预措施

Augmented usual care + text-message check-ins

Active Comparator

AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week.

Text check-in: Patients will also receive incentives for engagement with treatment and

Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6.

干预措施: Text Message Check-ins (Behavioral)

Augmented Usual care + Contingency Management (CM)

Active Comparator

AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week.

Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6.

CM: Patients will also receive incentives for engagement with treatment.

干预措施: Contingency Management (Behavioral)

Augmented usual care + text-message check-ins + contingency management

Active Comparator

AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week.

Text check-in: Patients will also receive incentives for engagement with treatment and

Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6.

CM: Patients will also receive incentives for engagement with treatment.

干预措施: Text Message Check-ins (Behavioral)

Augmented usual care + text-message check-ins + contingency management

Active Comparator

AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week.

Text check-in: Patients will also receive incentives for engagement with treatment and

Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6.

CM: Patients will also receive incentives for engagement with treatment.

干预措施: Contingency Management (Behavioral)

Augmented Usual Care (AUC)

No Intervention

AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week.

Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6.

结局指标

主要结局

Engagement in any addiction treatment at 30 days of randomization

时间窗: 31 days

Engagement in any addiction treatment within 30 days of randomization (measured on day 31)

次要结局

  • ED and Hospital Utilization and mortality(6 months)
  • Engagement in addition treatment within 14 days(15 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

M. Kit Delgado, MD

Assistant Professor of Emergency Medicine and Epidemiology

University of Pennsylvania

研究点 (1)

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