跳至主要内容
临床试验/NCT06084221
NCT06084221
Enrolling By Invitation
不适用

Fatal Overdose Review Teams - Research to Enhance Surveillance Systems (FORTRESS)

Indiana University1 个研究点 分布在 1 个国家目标入组 400 人2023年9月21日

概览

阶段
不适用
干预措施
OFR Team Practice as Usual
疾病 / 适应症
Substance-Related Disorders
发起方
Indiana University
入组人数
400
试验地点
1
主要终点
Cultural Exchange Inventory (adapted to evaluate OFR team alliance)
状态
Enrolling By Invitation
最后更新
2个月前

概览

简要总结

This project seeks to address the overdose epidemic by working with overdose fatality review (OFR) teams. Current OFR practices rely on a case review model where OFR teams assess one or two overdose cases to make policy and program recommendations. However, the continued rise in overdose rates and number of preventable overdose deaths suggest a need to shift OFR teams away from case review and toward using timely population-level data to better inform their recommendations and actions.

The goal of this project, Fatal Overdose Review Teams - Research to Enhance Surveillance Systems (FORTRESS), is to improve standard OFR practices by equipping OFRs with a data dashboard built on near real-time aggregate data, linked across multiple sources and presented in a way that helps identify common "overdose touchpoints," or opportunities to connect individuals at risk for overdose with evidence-based treatment.

During the first project phase, the FORTRESS team will design the "Overdose Touchpoints Dashboard'' (Aim 1). The FORTRESS team will also train OFR team members in "Data-Driven Decision Making" (DDDM) to effectively use the dashboard. The FORTRESS team also includes individuals involved in developing the CDC's OFR best practice guidelines and a pilot study of OFR adherence to these guidelines, which will inform the FORTRESS team's development of an "OFR Fidelity Tool'' (Aim 2). This tool will be the first of its kind.

For the second project phase, the FORTRESS team will conduct a cluster-randomized stepped-wedge trial comparing the impact of the intervention (dashboard + DDDM training) versus standard OFR practices on both implementation (Aim 3) and effectiveness outcomes (Aim 4). Implementation outcomes include implementation process fidelity (Stages of Implementation Completion), staff acceptance of harm reduction philosophies (qualitative interviews), OFR fidelity to CDC best practices (FORTRESS OFR Fidelity Tool), and usability of the Overdose Touchpoint Dashboard, (Systems Usability Scale). A statewide OFR data repository serves as a rich source of data on effectiveness outcomes, including OFR team recommendation quality and local actions to implement recommended overdose prevention strategies. The FORTRESS team will also survey OFR team members to assess changes in their attitudes toward evidence-based overdose prevention strategies. In sum, the FORTRESS team is uniquely qualified to help OFRs use more comprehensive available data to inform quality, action-oriented recommendations to reduce overdose. Funding for this project comes from the HEAL Initiative (https://heal.nih.gov/).

注册库
clinicaltrials.gov
开始日期
2023年9月21日
结束日期
2027年9月30日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Matthew Aalsma

Professor of Pediatrics

Indiana University

入排标准

入选标准

  • for FORTRESS staff personnel recruited to complete surveys, focus groups and/or interviews:
  • 1\) member of local overdose fatality review (OFR) team; OR 2) local county leader of organizations represented by OFR (OFR facilitator, public jail administrators, chief of police, judge, addiction treatment CEO/CFO, public health director, etc.).
  • Inclusion criteria for FORTRESS administrative data:
  • all residents of Indiana that have experienced fatal and/or non-fatal overdose as identified by administrative data sources.

排除标准

  • 未提供

研究组 & 干预措施

OFR Team Practice as Usual

Data are collected regarding standard OFR Team practice and outcomes before implementation of the FORTRESS Intervention

FORTRESS

Participating counties receive both training in data-driven decision making and inventory of overdose-prevention strategies

干预措施: Data-Driven Decision Making (DDDM)

FORTRESS

Participating counties receive both training in data-driven decision making and inventory of overdose-prevention strategies

干预措施: Overdose-prevention strategies inventory

结局指标

主要结局

Cultural Exchange Inventory (adapted to evaluate OFR team alliance)

时间窗: Months 18, 24, 30, 36, 42, 48, 54, & 60

15-items that measure knowledge and attitudes between organizations that will be administered to 15 OFR team members and 5 system leaders per each of 18 counties.

Dashboard Aggregate Usage

时间窗: Months 14-54

Web Cookies and anonymized IDs for each unique user to track dashboard usage that will be tracked on an on-going basis. Dr. Reda will review results monthly.

Organizational readiness to implement change

时间窗: Months 18, 24, 30, 36, 42, 48, 54, & 60

12-items that assess perceived readiness to implement new innovations that will be administered to 15 OFR team members and 5 system leaders per each of 18 counties.

Organization's implementation climate (adapted to evaluate overdose prevention strategies)

时间窗: Months 18, 24, 30, 36, 42, 48, 54, & 60

18-items that assesses the degree to which the climate is supportive of adopting new innovations that will be administered to 15 OFR team members and 5 system leaders per each of 18 counties.

Quality OFR Recommendations

时间窗: Months 14-54

OFR team recommendations will be gathered monthly. We will be coding the quality of OFR team recommendations using the coding system that we developed in phase 1 of our FORTRESS project. This measure involves qualitative assessments of whether a recommendation meets certain standards of quality. The qualitative coding will be conducted by research staff in a digital spreadsheet.

Harm reduction acceptability scale

时间窗: Months 18, 24, 30, 36, 42, 48, 54, & 60

25-items that measures the adoption of a harm reduction approach in responding to people who use substances that will be administered to 15 OFR team members and 5 system leaders per each of 18 counties.

Uptake of OFR Interventions

时间窗: Months 14-54

OFR team recommendations will be gathered monthly. Uptake of an intervention will be defined as implementation of the recommendation. OFR team overdose prevention recommendations will be coded for uptake (whether or not they were implemented). This measure involves quantitative assessment of the incidence of uptake.

Systems Usability Scale

时间窗: Months 18, 24, 30, 36, 42, 48, 54, & 60

10-items that assesses the usability of dashboard for OFRs that will be administered to 15 OFR team members and 5 system leaders per each of 18 counties.

Stages of Implementation Completion (SIC)

时间窗: Baseline through study completion, an average of 5 years

The SIC is a measure of implementation process fidelity and allows for continuous measurement of implementation success. The SIC is an observation-based assessment tool that qualitatively measures intervention implementation process and fidelity. Assessment of the SIC results will be ongoing across the intervention time period and into sustainment.

OFR Fidelity Tool

时间窗: Months 18-54

To be developed fidelity assessment tool that will be completed by each OFR facilitator after a monthly meeting.

Overdose

时间窗: Month 35-40 (interim) and month 53-57 (final)

Mortality data is collected via death certificates that are submitted by county coroners to the IDOH Division of Vital Records, which include information on underlying cause of Death. Data will include all fatal accidental drug overdose deaths (X40-X44).

研究点 (1)

Loading locations...

相似试验