Comparing Medication Maintenance in Comprehensive Community and Pharmacy Settings to Enhance Engagement
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Lifespan
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Pharmacists' monitoring of MAT care
研究概览
简要总结
The goal of this study is to examine how the pharmacy can better optimize treatment expansion by providing pharmacy-based medication assisted treatment (MAT) for maintenance under a collaborative pharmacy practice agreement.
详细描述
This study will be the first to develop and use a collaborative pharmacy practice agreement (CPA) for medication assisted treatment (MAT) intended for statewide application. This will also be the first study to use a randomized controlled trial design to test the multisite implementation of known effective interventions to treat opioid use disorder and prevent fatal opioid overdose (treatment with buprenorphine and natlrexone) in a pharmacy setting. Understanding how this model can improve engagement in care within innovative systems of MAT delivery like the Rhode Island Centers of Excellence in MAT model as well as the more traditional office based opioid therapy (OBOT) arrangement, and for patients with shorter and longer time on stabilized MAT doses advances the science of addiction health services.
This study presents an opportunity to compare clinical outcomes of patients randomized to receive the same medications but in different settings that are equipped with differing levels of counseling expectations and access to wrap-around services. In this way, the trial helps to inform whether-and for whom--the limited support services in the pharmacy are sufficient to engage and retain patients in MAT, or if ready access to comprehensive services are necessary. Approximately 86% of Americans live within 5 miles of a pharmacy, making pharmacists the most accessible health care professionals. This model could redefine the role of the pharmacy.
The initial phase of the study (Phase 1) involves preparation for and conduct of a pilot study of the pharmacy MAT care model.
The aims of the first study phase (R21 grant) are:
- Aim 1: Develop a pharmacy CPA for the management of opioid use disorder using buprenorphine and naltrexone.
- Aim 2: For patient inmates maintained at the Rhode Island Department of Corrections, assess the feasibility and timing of randomization and transfer to a CPA pharmacy providing MAT post-release. This targeted assessment will inform the R33 design.
- Aim 3: Pilot test the pharmacy MAT model with up to 12 patients, assessing feasibility of medication dispensing, administration, and monitoring in the pharmacy, and determining patient acceptability of this model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •18 years of age or older;
- •English speaking; currently enrolled at a CODAC site in Rhode Island for the treatment of opioid use disorder;
- •maintained on a stable dose of buprenorphine or injectable naltrexone for at least 2 days;
- •no stable co-morbid illnesses likely to progress clinically during the pilot study;
- •able and willing to provide written informed consent and locator information (working telephone and >2 contacts) to participate.
排除标准
- •currently pregnant or trying to get pregnant;
- •plans to move or leave the state during the study, including pending legal action;
- •self reported past year suicide attempt or self-reported past year suicidal thoughts with a plan;
- •any condition that, in the researchers' judgment, interferes with safe study participation or adherence to study procedures, including but not limited to a mental, medical or other substance use disorder that is likely to require ongoing, intense clinical management during the pilot study.
研究组 & 干预措施
Pharmacy based opioid use disorder care
A single-arm pilot study to test the collaborative pharmacy practice agreement for MAT (using the medications buprenorphine or injectable naltrexone) care model with up to 12 patients with opioid use disorder, assessing feasibility of medication dispensing, administration, and monitoring in the pharmacy, and determining patient acceptability of this model.
干预措施: Buprenorphine / Naloxone Oral Product (Drug)
Pharmacy based opioid use disorder care
A single-arm pilot study to test the collaborative pharmacy practice agreement for MAT (using the medications buprenorphine or injectable naltrexone) care model with up to 12 patients with opioid use disorder, assessing feasibility of medication dispensing, administration, and monitoring in the pharmacy, and determining patient acceptability of this model.
干预措施: injectable naltrexone (Drug)
Pharmacy based opioid use disorder care
A single-arm pilot study to test the collaborative pharmacy practice agreement for MAT (using the medications buprenorphine or injectable naltrexone) care model with up to 12 patients with opioid use disorder, assessing feasibility of medication dispensing, administration, and monitoring in the pharmacy, and determining patient acceptability of this model.
干预措施: Pharmacy maintenance addiction care (Other)
结局指标
主要结局
Pharmacists' monitoring of MAT care
时间窗: up to one month
Measured by the number of toxicological drug screens performed at a study pharmacy over the one month pilot period.
Pharmacists' dispensing of MAT medications
时间窗: up to one month
Measured by the number of MAT medications dispensed from a study pharmacy according to the pharmacy records, over the one month pilot period.
Pharmacist-reported feasibility of executing the collaborative pharmacy practice: agreement for MAT: Likert scale
时间窗: up to one month
7-point Likert scale item assessing the pharmacist's view of the overall model feasibility. The item asks: How acceptable is providing buprenorphine/Suboxone care at the pharmacy? With responses ranging from 1 to 7 as: 1. totally unacceptable 2. unacceptable 3. slightly unacceptable 4. neutral 5. slightly acceptable 6. acceptable 7. perfectly acceptable Higher scores represent better outcome (i.e., endorsement of acceptability of the model), according to the pharmacists.
Patient acceptability of pharmacy-provided MAT care: Likert scale
时间窗: up to one month
7-point Likert scale item assessing overall acceptability of the pharmacy MAT model. The item asks: How acceptable is going to the pharmacy for your buprenorphine/Suboxone care? With responses ranging from 1 to 7 as: 1. totally unacceptable 2. unacceptable 3. slightly unacceptable 4. neutral 5. slightly acceptable 6. acceptable 7. perfectly acceptable Higher scores represent better outcome (i.e., high endorsement of acceptability of the model), according to the patients.
次要结局
未报告次要终点
研究者
Traci Green
Senior Research Scientist, Associate Professor of Emergency Medicine
Lifespan