跳至主要内容
临床试验/NCT05886712
NCT05886712进行中(未招募)不适用

Improving Equitable Access to Naloxone to Prevent Opioid Overdose Deaths Within Syringe Service Programs

RTI International1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2023年7月1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
31
试验地点
1
主要终点
Reach (Aim 1)

研究概览

简要总结

The goal of this clinical trial is to compare the effectiveness of a multi-faceted implementation strategy, the Systems Analysis and Improvement Approach for Naloxone (SAIA-N), in syringe service programs (SSPs). The main questions it aims to answer are:

  • Does SAIA-N improve naloxone distribution (number of doses, number of people receiving naloxone) compared to implementation as usual (IAU)?
  • What are the costs associated with SAIA-N and how cost-effective is the strategy?

SSPs randomized to the SAIA-N arm will participate in the strategy for a period of 12-months during which they will meet 1-2 times each month with a SAIA coach who will assist the SSP in optimizing their naloxone distribution.

Researchers will compare SAIA-N to IAU to see if naloxone distribution and costs and cost-effectiveness differ by group.

详细描述

The investigators plan to examine SAIA-N's impact in SSPs compared to an implementation-as-usual (IAU) condition across three aims and several related hypotheses. Data collection will take place monthly across 21 months of SSP participation. These 21 months comprise a 3-month lead-in period to establish SSP outcome data characteristics, the 12-month active period during which site randomized to SAIA-N will meet with the SAIA coach, and for an additional 6 months afterward (sustainment period) to determine whether impacts are sustained.

Aim 1. This trial's first aim is to test the effectiveness of SAIA-N on improving naloxone distribution within SSPs. The investigators hypothesize that compared with SSPs receiving IAU, SSPs receiving SAIA-N will significantly increase the number of people receiving naloxone and number of naloxone doses distributed during the 12-month active period. Further, the investigators hypothesize that SSPs receiving SAIA-N will significantly increase the number of people receiving naloxone in the 6 months after the active period (the sustainment period) compared with SSPs receiving IAU.

Aim 2. This trial's second aim will estimate the cost and cost-effectiveness of SAIA-N on improving access to naloxone at SSPs, relative to IAU. The investigators hypothesize that, relative to IAU, SAIA-N will be cost-effective at increasing the number of people receiving naloxone from SSPs.

To evaluate these aims, the investigators plan a randomized controlled interrupted time series trial with 32 SSPs in California. Sixteen SSPs will be randomly assigned to the SAIA-N arm and 16 SSPs to IAU (Figure 1). SSPs randomized to the IAU arm will not receive support to improve naloxone distribution. SSPs in California have already adopted naloxone distribution. This trial therefore tests the ability of SAIA-N to optimize naloxone distribution within SSPs. Accordingly, the IAU condition is characterized by the absence of SAIA-N with the goal of comparing whether SAIA-N improves SSPs' Naloxone distribution.

The investigators' naloxone pilot study identified implementation climate and leadership engagement as important implementation determinants that can be influenced by SAIA-N and ultimately improve naloxone distribution among SSPs. Therefore, the present study assesses change in implementation climate and leadership engagement over time. The trial will first collect SSP-specific contextual data at randomization (baseline) and 12 months after randomization from all enrolled sites. The primary contact at each SSP will be asked about basic organizational characteristics (location, number of staff, budget, etc.). Next, the primary contacts as well as other staff involved with naloxone distribution at each SSP will be asked about contextual variables such as implementation climate and leadership engagement for improving naloxone distribution.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • •SSP is located and operates in California; SSP is authorized by CDPH; and SSP has distributed naloxone to participants in the past 30 days.

排除标准

  • •SSPs who participated in the SAIA-Naloxone pilot study (n = 2) or do not distribute naloxone (currently n = 0)

研究组 & 干预措施

SAIA-Naloxone

Experimental

SAIA-Naloxone is an intervention that facilitates an organizational SSP level analysis of naloxone delivery by assigning a trained SAIA-Naloxone coach to apply tools and techniques and engage staff to define barriers, identify solutions, and evaluate their success in cycles until achieving desired change regarding naloxone distribution. Coaches will meet with SSPs twice per month for the first 3 months and once per month for the remaining 9 months during the 12-month intervention period.

干预措施: Naloxone (Other)

Implementation as Usual

Other

SSPs randomized to the IAU arm will not receive support to improve naloxone distribution. SSPs in California have already adopted naloxone distribution. The investigators are therefore testing the ability of SAIA-Naloxone to optimize naloxone distribution within SSPs. Accordingly, IAU is characterized by the absence of SAIA-Naloxone with the goal of comparing whether SAIA-Naloxone improves SSPs' Naloxone distribution.

干预措施: Usual intervention (Other)

结局指标

主要结局

Reach (Aim 1)

时间窗: 21 months

Number of participants screened for naloxone engagement, while accounting for the total number of participants who present for services

Fidelity (Aim 1)

时间窗: 21 months

Number of people who receive naloxone, while accounting for the total number of SSP participants screened for naloxone distribution

Cost (Aim 2) (Substance Abuse Services Cost Analysis Program (SASCAP))

时间窗: 18 months

Dollar amount of cost estimates associated with SAIA-N at the SSP level

Cost-effectiveness (Incremental Cost-effectiveness Ratio (ICER))

时间窗: 18 months

The ratio of the difference in costs to the difference in outcomes between study groups

次要结局

未报告次要终点

研究者

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

Christopher Akiba

Research Public Health Analyst

RTI International

研究点 (1)

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