Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634277
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-02-03
Brief Title:
Philly NavSTAR Implementation Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Implementing a Patient Navigation Intervention Across a Health System to Address Treatment Entry Inequities
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Philly NavSTAR
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 Proctors 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 teams 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 masters 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 N40 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 N32 of NavSTAR implementation The CABCAP feedback stakeholder interviews and results of the pilot testing cycles will inform the final implementation toolkit used in the R33 phase
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 masters 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 N40 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 N32 of NavSTAR implementation The CABCAP feedback stakeholder interviews and results of the pilot testing cycles will inform the final implementation toolkit used in the R33 phase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None