Clinical trial NCT06634277: Philly NavSTAR Implementation Trial
Official title: Implementing a Patient Navigation Intervention Across a Health System to Address Treatment Entry Inequities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: patient navigation
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
name: National Institute on Drug Abuse (NIDA)
First posted: 2024-10-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Single group pilot study with sequential implementation in 4 hospitals
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patient Navigation (PN) interventions following hospitalization can reduce the differences that certain groups have been trying to access opioid use disorder treatment. These differences, which affect racial minority groups the most, contribute to the opioid overdose epidemic. However, delivering PN interventions on a wide scale requires many resources and coordination across institutions. This will use an evidence-based process to find solutions to these significant barriers by engaging community, hospital, and patient partners. This study is being conducted to learn more about how to implement NavSTAR, a patient navigation intervention for people with opioid use disorder, across a health system. Our research team showed in a previous study with 400 participants that NavSTAR significantly increased entry into opioid use disorder treatment, reduced readmissions to the hospital, and was highly cost- effective compared to treatment as usual. This study will first pilot NavSTAR with 32 patient participants across 4 hospitals in the City of Philadelphia. Then, we will conduct a large trial with 720 patient participants to see if we can reach people who need the intervention, and create a sustainable plan to continue the intervention after the grant award period.

Detailed description: Opioid agonist treatment (OAT) is protective against overdose, yet less than 20% of people with opioid use disorder (OUD) engage in such treatment. Hospital utilization is high among people with OUD and can be a 'reachable moment' to initiate OAT. However, most hospitals lack the capacity to follow up with patients after discharge. Theory-based, empirically supported patient navigator (PN) interventions following hospital discharge reduce inequities in accessing community-based OAT by helping patients navigate complex systems of care. However, challenges persist in implementing PN interventions on a wide scale, as they require coordination across institutions, data sharing, dedicated personnel, and community resources. This is especially true in settings that reach diverse, resource-challenged communities. To bring these interventions to scale, strategies are needed to assess factors that influence PN implementation in hospitals to increase feasibility, reach, and sustainability. Testing innovative implementation strategies for PN interventions has the potential for significant impact, as it will demonstrate implementation success of an intervention that can address the opioid epidemic in real-world settings and close the research-to-practice translation gap. The proposed study is a type II hybrid implementation-effectiveness trial of Navigation Services To Avoid Rehospitalization (NavSTAR). Our research team showed in a single-site randomized trial with 400 participants that NavSTAR significantly increased OAT entry, reduced readmissions, and was highly cost-effective compared to treatment as usual. The present study will test an Implementation Facilitation (IF) strategy following Proctor's conceptual model using an external facilitator and an internal local clinical champion to provide training, resources, and performance feedback to implement NavSTAR in four hospitals. We hypothesize that engaging stakeholders (including patients, clinicians, and community leaders) in an IF strategy will create and test an implementation process that is feasible, acceptable, and effective in expanding access to OAT post-discharge. The R61 phase will conduct process mapping to identify existing hospital workflow and then refine an IF strategy through sequential pilot trials at 4 hospital sites in preparation for the R33 phase. The team's NavSTAR operations manual will be adapted to the sites to train the existing staff. R61 milestones include the creation of an implementation toolkit and data-sharing agreements.

The developmental R61 phase will focus on needs assessment and identifying IF strategies for system-wide adoption of NavSTAR in preparation for the R33 trial phase. This will be accomplished through four inter-related processes: 1) Process mapping with the CAB and CAP, 2) Conducting qualitative interviews to gain diverse stakeholder input, 3) Modifying the IF strategy, and 4) Conducting four short-duration, iterative pilot testing cycles in four hospitals to examine the IF strategy for feasibility and acceptability. Pilot testing will occur with existing personnel (master's level social workers) utilizing the NavSTAR manual of operations. Interviews with current participants in the pilot testing, organizational stakeholders, navigators, and clinician champions will be conducted both before and after the pilot testing cycles.

Aim 1: Providers, staff, organizational leadership, and patients at the four hospitals will be asked to participate in the study (N=40) by completing interviews about current navigation/ discharge processes and optimal IF strategies.

Aim 2: Patients will be recruited across four hospitals (8 at each hospital) to conduct a pilot trial (N=32) of NavSTAR implementation. The CAB/CAP feedback, stakeholder interviews, and results of the pilot testing cycles will inform the final implementation toolkit used in the R33 phase.

Eligibility criteria: Inclusion criteria:

1. age 18 or older;
2. current DSM-5 criteria for moderate to severe OUD;
3. willing and able to provide informed consent in English.

Exclusion criteria:

1. enrollment in OUD treatment 30-days prior to hospitalization;
2. residency outside the City of Philadelphia;
3. pregnancy;
4. planned discharge to a long-term inpatient care facility (e.g., hospice);
5. hospitalization for a suicide attempt.

Primary outcomes:
measure: Opioid Agonist Treatment (OAT) initiation
timeFrame: 3 months
Secondary outcomes:
measure: Acceptability: Extent to which the intervention will be deemed acceptable by participants
timeFrame: 3 months
measure: Appropriateness: Extent to which the intervention will be deemed appropriate by participants
timeFrame: 3 months
measure: Changes in Psychological distress from baseline to 3 months
timeFrame: Baseline to 3-month follow-up
measure: Opioid use (oral fluid)
timeFrame: 3 months
measure: Changes in Social Support from Baseline to Follow-up
timeFrame: Baseline to 3 month follow-up
measure: Change in Recovery Capital from baseline to follow-up
timeFrame: Baseline to 3 month follow-up
measure: Changes in Quality of Life from Baseline to Follow-up
timeFrame: Baseline to 3 month follow-up
measure: Self-reported days of opioid use in the past 30 days
timeFrame: Baseline to 3 month follow-up
measure: Hospital Utilization
timeFrame: 3 months
measure: Feasibility: Demonstrated ability to enroll participants in the intervention
timeFrame: From enrollment until end of follow-up (10 months)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Jefferson Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Friends Research Institute
state: Pennsylvania
Study officials:
affiliation: Friends Research Institute, Inc.
name: Karen Alexander, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Friends Research Institute, Inc.
name: Jan Gryczynski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gryczynski J, Nordeck CD, Welsh C, Mitchell SG, O'Grady KE, Schwartz RP. Preventing Hospital Readmission for Patients With Comorbid Substance Use Disorder : A Randomized Trial. Ann Intern Med. 2021 Jul;174(7):899-909. doi: 10.7326/M20-5475. Epub 2021 Apr 6.