Opioid Use DisorderPhilly NavSTARNCT07262190
NavSTAR Implementation Effectiveness Trial Across a Health System
A study testing NavSTAR (Philly adaptation) in people with Opioid Use Disorder, run by Friends Research Institute, Inc. at 1 site in United States.
Trial summary
Patient Navigation (PN) interventions following hospitalization can improve outcomes for people with opioid use disorder treatment. Delivering PN interventions on a wide scale requires many resources and coordination across institutions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- NavSTAR (Philly adaptation)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2025to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 or older;
- current DSM-5 criteria for moderate to severe OUD;
- willing and able to provide informed consent in English.
Who cannot join
- enrollment in OUD treatment 30-days prior to hospitalization;
- residency outside the City of Philadelphia;
- pregnancy;
- planned discharge to a long-term inpatient care facility (e.g., hospice);
- hospitalization for a suicide attempt.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Jefferson Health
Philadelphia, Pennsylvania, 19107
Karen Alexander, PhD, 267-398-3560, kalexander@friendsresearch.org
About this study
Official title: Implementing a Patient Navigation Intervention Across a Health System to Improve Outcomes for Patients With Opioid Use Disorder
Patient Navigation (PN) interventions following hospitalization can improve outcomes for people with opioid use disorder treatment. 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. The 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, a large trial with 720 patient participants will be conducted to see if people who need the intervention are reached, and a sustainable plan will be created to continue the intervention after the grant award period.
Read the 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. Patient navigation (PN) interventions following hospital discharge can help patients engage in OAT and navigate complex systems of care. However, challenges persist in implementing PN interventions on a wide scale, as they require coordination across organizations, data sharing, dedicated personnel, and resources. To bring these interventions to scale, strategies are needed to determine 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). The research team showed in a single-site randomized trial with 400 participants that NavSTAR significantly improved OAT entry, reduced readmissions, and was highly cost-effective compared to treatment as usual. The present study will test an Implementation Facilitation (IF) strategy to provide training, resources, and performance feedback to implement NavSTAR in five hospitals in Philadelphia. It is hypothesized that engaging stakeholders in an IF strategy will yield an implementation process that is feasible, acceptable, and effective in improving outcomes for patients with OUD. During the R33 phase, a type II hybrid-implementation-effectiveness trial of NavSTAR will be conducted with 720 participants using a randomized stepped-wedge design.
The proposed study is a type II hybrid implementation-effectiveness trial of Navigation Services to Avoid Rehospitalization (NavSTAR). The present study will test an Implementation Facilitation (IF) strategy following Proctor's conceptual model of implementation, using an external facilitator and internal local clinical champions to provide training, resources and performance feedback to implement NavSTAR in five hospitals. It is hypothesized that engaging stakeholders in an IF strategy will yield an implementation process that is feasible, acceptable, and effective in expanding engagement in OAT post-discharge. This type II hybrid implementation-effectiveness randomized stepped-wedge trial (N=720) will examine NavSTAR's sustained use in a hospital system to improve outcomes for patients with OUD.
R33 Specific Aims:
- Aim 1: Determine the successful implementation of NavSTAR in terms of a) feasibility, b) reach, and c) sustainability using the newly developed hospital system protocol.
- Aim 2: Determine the effectiveness of NavSTAR to a) improve OAT initiation in the three months post-discharge, b) decrease hospital utilization (inpatient readmissions and emergency department visits), c) reduce overdoses (fatal and non-fatal), and d) improve other patient outcomes (e.g., quality of life, substance use).
The proposed study has high public health significance because it will develop and test an implementation strategy for an intervention (NavSTAR) to improve OAT engagement and outcomes for patients with OUD. The study will yield novel data on how best to implement NavSTAR across a health system operating in an epicenter of the OUD crisis. Study findings will help to develop a path to scale-up this important intervention to address the opioid epidemic.
- Conditions
- Opioid Use Disorder
- Being tested
- NavSTAR (Philly adaptation)
- Keywords
- patient navigation
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavSTAR (Philly adaptation)Behavioural
NavSTAR consists of TAU plus contact with a trained patient navigator who delivers the NavSTAR intervention, inclusive of theory-based motivational content, during and after discharge from the hospital. The patient navigator also has access to a small participant fund to assist with overcoming structural barriers to care (e.g., phone, obtaining IDs, a meal, a taxi ride etc.). Using the NavSTAR PN manual, the PN will address internal and external barriers to engagement in OAT through motivational intervention techniques and proactive case management and care coordination services. Contact with the PN begins at the bedside while the participant is admitted to the hospital and continues for 3 months after discharge
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | Treatment as usual consists of standard management by the medical or surgical team during inpatient admission, and usual care from the addiction consult service, if applicable, which provides social work consults, withdrawal symptom management, and initiation of naltrexone, buprenorphine, or methadone. All standard hospital services will be available to participants. |
| NavSTAR | Experimental | NavSTAR consists of TAU plus contact with a trained patient navigator who delivers the NavSTAR intervention, inclusive of theory-based motivational content, during and after discharge from the hospital. The patient navigator also has access to a small participant fund to assist with overcoming structural barriers to care (e.g., phone, obtaining IDs, a meal, a taxi ride etc.). Using the NavSTAR PN manual, the PN will address internal and external barriers to engagement in OAT through motivational intervention techniques and proactive case management and care coordination services. Contact with the PN begins at the bedside while the participant is admitted to the hospital and continues for 3 months after discharge Receives: Behavioral: NavSTAR (Philly adaptation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Opioid Agonist Treatment initiation
Post-discharge rate of OAT initiation will be ascertained via health record review and self-report with verification through records where applicable (e.g., Community Behavioral Health system).
Measured: 3 months
Secondary outcomes (10)
Feasibility: Demonstrated ability to enroll participants in the intervention
Feasibility will be measured based on the number of participants who received the intervention during the implementation period.
Measured: From baseline until end of study, approximately 30 months
Inpatient readmissions (30 days)
Information on acute care hospital inpatient readmission within 30 days will be assessed using health records and self-report (in the event of inconsistency, objective data will dominate).
Measured: 30 days
Inpatient readmissions
Inpatient hospital readmissions (number of events) will be assessed using health record review and self-report (in the event of inconsistencies, objective data will dominate).
Measured: through 3, 6, and 12 months
Emergency department visits
Emergency Department utilization (number of events) will be assessed via health record review and self-report (in the event of inconsistency, objective data will dominate).
Measured: through 3, 6, and 12 months
Self-reported days of opioid use in the past 30 days
Self-reported days of non-prescribed opioid use in the past 30 days will be assessed at each interview.
Measured: Baseline to 3-, 6-, and 12-months
Opioid use
Positive oral fluid test for non-prescribed opioids (e.g., fentanyl, heroin, etc.)
Measured: 3-, 6-, and 12-month follow-up
Overdose events
Overdose events will be assessed by self-report and health records (for non-fatal events) and death records (for fatal events)
Measured: through 3, 6, and 12 months
Changes in Social Support from Baseline to Follow-up
Social support will be measured using the Social Support Scale to determine the extent to which services influenced social support. It is a numeric scale from 0 to 100, with higher scores indicating greater social support.
Measured: Baseline to 3-, 6-, and 12-month follow-up
Changes in Quality of Life from Baseline to Follow-up
Quality of life will be measured via the World Health Organization Quality of Life instrument. It is a numeric scale with scores possible from 4-20, with higher scores indicating higher quality of life.
Measured: Baseline to 3-, 6-, and 12-month follow up
Changes in Psychological distress from baseline
Kessler Psychological Distress Scale will be used to assess how participants have been feeling (nervous, hopeless, restless, depressed, worthless, etc) during their last 30 days. It is a numeric scale with scores ranging from 0 to 24, with higher scores indicating greater psychological distress.
Measured: Baseline to 3-, 6- and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start27 Oct 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A stepped wedge cluster randomized design will be used, in which all five sites begin in a control phase and are sequentially randomized to cross over to the intervention at staggered time points, permitting both within-site and between-site comparisons over time
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262190
- Sponsor's protocol ID
- R33DA059033
- Other IDs
- R33DA059033
- Acronym
- Philly NavSTAR
- Status last verified
- Sep 2025
- First submitted
- 23 Oct 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants will complete baseline surveys and follow-up study surveys, and some participants will complete qualitative interviews. The raw interview and survey data will be stored within a secure computing environment. Metadata, study protocols, data collection instruments (surveys, interview guides), codebooks, and de-identified versions of participant data will be preserved and shared as appropriate to facilitate interpretation and reuse.
Publications
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.
PubMed 33819055
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Patient Navigation Intervention Across a Health System to Improve Outcomes for Patients With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT07262190
- Acronym / sponsor ID
- Philly NavSTAR / R33DA059033
- Conditions
- Opioid Use Disorder
- Keywords
- patient navigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- Thomas Jefferson University, National Institute on Drug Abuse (NIDA)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patient Navigation (PN) interventions following hospitalization can improve outcomes for people with opioid use disorder treatment. 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. The 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, a large trial with 720 patient participants will be conducted to see if people who need the intervention are reached, and a sustainable plan will be created 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. Patient navigation (PN) interventions following hospital discharge can help patients engage in OAT and navigate complex systems of care. However, challenges persist in implementing PN interventions on a wide scale, as they require coordination across organizations, data sharing, dedicated personnel, and resources. To bring these interventions to scale, strategies are needed to determine 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). The research team showed in a single-site randomized trial with 400 participants that NavSTAR significantly improved OAT entry, reduced readmissions, and was highly cost-effective compared to treatment as usual. The present study will test an Implementation Facilitation (IF) strategy to provide training, resources, and performance feedback to implement NavSTAR in five hospitals in Philadelphia. It is hypothesized that engaging stakeholders in an IF strategy will yield an implementation process that is feasible, acceptable, and effective in improving outcomes for patients with OUD. During the R33 phase, a type II hybrid-implementation-effectiveness trial of NavSTAR will be conducted with 720 participants using a randomized stepped-wedge design.
The proposed study is a type II hybrid implementation-effectiveness trial of Navigation Services to Avoid Rehospitalization (NavSTAR). The present study will test an Implementation Facilitation (IF) strategy following Proctor's conceptual model of implementation, using an external facilitator and internal local clinical champions to provide training, resources and performance feedback to implement NavSTAR in five hospitals. It is hypothesized that engaging stakeholders in an IF strategy will yield an implementation process that is feasible, acceptable, and effective in expanding engagement in OAT post-discharge. This type II hybrid implementation-effectiveness randomized stepped-wedge trial (N=720) will examine NavSTAR's sustained use in a hospital system to improve outcomes for patients with OUD.
R33 Specific Aims:
- Aim 1: Determine the successful implementation of NavSTAR in terms of a) feasibility, b) reach, and c) sustainability using the newly developed hospital system protocol.
- Aim 2: Determine the effectiveness of NavSTAR to a) improve OAT initiation in the three months post-discharge, b) decrease hospital utilization (inpatient readmissions and emergency department visits), c) reduce overdoses (fatal and non-fatal), and d) improve other patient outcomes (e.g., quality of life, substance use).
The proposed study has high public health significance because it will develop and test an implementation strategy for an intervention (NavSTAR) to improve OAT engagement and outcomes for patients with OUD. The study will yield novel data on how best to implement NavSTAR across a health system operating in an epicenter of the OUD crisis. Study findings will help to develop a path to scale-up this important intervention to address the opioid epidemic.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A stepped wedge cluster randomized design will be used, in which all five sites begin in a control phase and are sequentially randomized to cross over to the intervention at staggered time points, permitting both within-site and between-site comparisons over time
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | –Treatment as usual consists of standard management by the medical or surgical team during inpatient admission, and usual care from the addiction consult service, if applicable, which provides social work consults, withdrawal symptom management, and initiation of naltrexone, buprenorphine, or methadone. All standard hospital services will be available to participants. |
| NavSTAR | Experimental | Behavioral: NavSTAR (Philly adaptation)NavSTAR consists of TAU plus contact with a trained patient navigator who delivers the NavSTAR intervention, inclusive of theory-based motivational content, during and after discharge from the hospital. The patient navigator also has access to a small participant fund to assist with overcoming structural barriers to care (e.g., phone, obtaining IDs, a meal, a taxi ride etc.). Using the NavSTAR PN manual, the PN will address internal and external barriers to engagement in OAT through motivational intervention techniques and proactive case management and care coordination services. Contact with the PN begins at the bedside while the participant is admitted to the hospital and continues for 3 months after discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 or older;
- current DSM-5 criteria for moderate to severe OUD;
- willing and able to provide informed consent in English.
Key exclusion criteria (5 listed)
- enrollment in OUD treatment 30-days prior to hospitalization;
- residency outside the City of Philadelphia;
- pregnancy;
- planned discharge to a long-term inpatient care facility (e.g., hospice);
- hospitalization for a suicide attempt.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NavSTAR (Philly adaptation)NavSTAR consists of TAU plus contact with a trained patient navigator who delivers the NavSTAR intervention, inclusive of theory-based motivational content, during and after discharge from the hospital. The patient navigator also has access to a small participant fund to assist with overcoming structural barriers to care (e.g., phone, obtaining IDs, a meal, a taxi ride etc.). Using the NavSTAR PN manual, the PN will address internal and external barriers to engagement in OAT through motivational intervention techniques and proactive case management and care coordination services. Contact with the PN begins at the bedside while the participant is admitted to the hospital and continues for 3 months after discharge | Behavioural | NavSTAR |
Primary outcome
Rate of Opioid Agonist Treatment initiation
Time frame: 3 months
Post-discharge rate of OAT initiation will be ascertained via health record review and self-report with verification through records where applicable (e.g., Community Behavioral Health system).
10 secondary outcomes
Feasibility: Demonstrated ability to enroll participants in the intervention
Time frame: From baseline until end of study, approximately 30 months
Inpatient readmissions (30 days)
Time frame: 30 days
Inpatient readmissions
Time frame: through 3, 6, and 12 months
Emergency department visits
Time frame: through 3, 6, and 12 months
Self-reported days of opioid use in the past 30 days
Time frame: Baseline to 3-, 6-, and 12-months
Opioid use
Time frame: 3-, 6-, and 12-month follow-up
Overdose events
Time frame: through 3, 6, and 12 months
Changes in Social Support from Baseline to Follow-up
Time frame: Baseline to 3-, 6-, and 12-month follow-up
Changes in Quality of Life from Baseline to Follow-up
Time frame: Baseline to 3-, 6-, and 12-month follow up
Changes in Psychological distress from baseline
Time frame: Baseline to 3-, 6- and 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 33819055Gryczynski 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.
- Individual participant dataSharing planned: Yes. Participants will complete baseline surveys and follow-up study surveys, and some participants will complete qualitative interviews. The raw interview and survey data will be stored within a secure computing environment. Metadata, study protocols, data collection instruments (surveys, interview guides), codebooks, and de-identified versions of participant data will be preserved and shared as appropriate to facilitate interpretation and reuse.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NavSTAR (Philly adaptation) in people with Opioid Use Disorder, run by Friends Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Alexander, PhD (2673983560, kalexander@friendsresearch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Opioid Agonist Treatment initiation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07262190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.