Opioid DependenceNCT05370326
Feasibility and Preliminary Efficacy of an Opioid Stewardship Program in Hospitalized Patients With Chronic Pain
A study testing Enhanced Opioid Stewardship Program in people with Opioid Dependence and Chronic Pain, run by Yale University at 2 sites in United States.
Trial summary
This study aims to investigate the feasibility and preliminary efficacy of an enhanced opioid stewardship program, tailored to the needs of hospitalized patients with chronic pain with opioid dependence, incorporating real-time guidance from an addiction medicine and pain-trained physician/pharmacist team, using a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence, Chronic Pain
- What is being tested?
- Enhanced Opioid Stewardship Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jul 2022to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- admitted at Yale New Haven Hospital (YSC and SRC) on medical units
- identified as having chronic pain and prescribed opioids
- have opioid dependence (evidenced by ongoing opioid prescription, meeting Diagnostic and Statistical Manual of Mental Disorders-5 criteria for Opioid Use Disorder, or clinical history)
Who cannot join
- active cancer
- current pregnancy
- hospice care/comfort measures only
- admission to inpatient psychiatry
- completed or planned Addiction Medicine consult during hospitalization
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale New Haven Hospital, 20 York Street
New Haven, Connecticut, 06510
Yale New Haven Hospital, 1450 Chapel Street
New Haven, Connecticut, 06511
About this study
Official title: Randomized Controlled Pilot Trial to Evaluate Feasibility and Preliminary Efficacy of an Opioid Stewardship Program in Hospitalized Patients With Chronic Pain
This study aims to investigate the feasibility and preliminary efficacy of an enhanced opioid stewardship program, tailored to the needs of hospitalized patients with chronic pain with opioid dependence, incorporating real-time guidance from an addiction medicine and pain-trained physician/pharmacist team, using a pilot randomized clinical trial format. Findings from this research may improve pain management and decrease risk of opioid-related adverse events among patients with chronic pain.
Read the detailed description
The primary objective of this study is to determine whether an enhanced opioid stewardship program, tailored to the needs of patients with chronic pain, is feasible to implement in a hospital setting.
One secondary objective is to determine whether an enhanced opioid stewardship program increases use of guideline-based opioid care. The other secondary objective of this study is to determine whether an enhanced opioid stewardship program reduces pain frequency, intensity, and interference and decreases the risk for opioid-related adverse events among adult patients with chronic pain hospitalized on medical units at Yale-New Haven Hospital, York Street and Saint Raphael campuses.
This is a pilot randomized controlled trial of 100 adult participants. It is prospective and focus primarily on feasibility. There will be up to 3 study visits with each participant, which will take place during hospitalization or in the first week after hospital discharge.
- Conditions
- Opioid Dependence, Chronic Pain
- Being tested
- Enhanced Opioid Stewardship Program
- Medical subject headings
- Opioid-Related Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Opioid Stewardship ProgramOther
The goal of the enhanced opioid stewardship intervention is to manage chronic pain while reducing risk of inappropriate/risky opioid use and preventing harms of opioid use.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Opioid Stewardship Program | Experimental | Enhanced opioid stewardship program, tailored to the needs of hospitalized patients with chronic pain with opioid dependence, incorporating real-time guidance from an addiction medicine and pain-trained physician/pharmacist team Receives: Other: Enhanced Opioid Stewardship Program |
| Standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Screened Compared to Number of Eligible Participants to Determine Feasibility of Recruitment
Feasibility of recruitment will be determined by a count of the number of participants screened for the study compared to number of eligible participants.
Measured: approximately 3 months
Number of Eligible Participants Compared to Number of Enrolled Participants to Determine Feasibility of Recruitment
Feasibility of recruitment will be determined by a count of the number of participants eligible for the study compared to number of enrolled participants.
Measured: approximately 3 months
Days to Hospital Day of Enrollment
Days to hospital day of enrollment in relation to admission and discharge dates
Measured: approximately 3 months
Number of Participants in the Intervention Group Who Were Able to Receive the Full Enhanced Opioid Stewardship Intervention
Number of participants in the intervention group who were able to receive the full enhanced opioid stewardship intervention to determine retention
Measured: approximately 3 months
Number of Participants in Intervention Group Who Complete the Peri-discharge Evaluation.
Number of participants in the intervention group who were able to complete the peri-discharge evaluation to determine retention.
Measured: approximately 3 months
Number of Participants in Control Group Who Complete the Peri-discharge Evaluation.
Number of participants in the control group who were able to complete the peri-discharge evaluation to determine retention.
Measured: approximately 3 months
Secondary outcomes (7)
Number of Guideline-based Care Elements in Use Considered Guideline Concordant Care With Opioids for Pain During Hospitalization.
A a count of guideline-based care elements considered to be "best practices" for opioid stewardship in the setting of chronic pain will be collected during hospitalizations. These include ordering of alternative pain relief medications (e.g., acetaminophen), ordering of a bowel regimen, ordering of medication to treat opioid use disorder, order of urine toxicology screen, ordering of ECG for patients prescribed methadone, avoidance of co-prescriptions of benzodiazepines, and other associate "best care" practices. These metrics will be abstracted from the medical record. The number is out of a possible 12 recommendations- 12 would be the most recommendations a participant could have received.
Measured: approximately 4 months
Change in Pain Intensity Measured by the Brief Pain Inventory - Severity
The Brief Pain Inventory measures the intensity of pain, along with the degree to which the pain interferes with the everyday functioning of life. Scores range from 0 (no pain) to 10 (severe pain).
Measured: Baseline and 48 hours prior to discharge from hospital
Change in Pain Intensity Measured by the Brief Pain Inventory - Interference
The Brief Pain Inventory measures the intensity of pain, along with the degree to which the pain interferes with the everyday functioning of life. Scores range from 0 (no life interference) to 10 (complete interference).
Measured: Baseline and 48 hours prior to discharge from hospital
Change in Depression Measured by the Patient Health Questionnaire
The Patient Health Questionnaire measures Change in depression. Scores range from 0 (no depression) to 27 (severe depression).
Measured: Baseline and 48 hours prior to discharge from hospital
Patient Satisfaction Measured Using a Patient Satisfaction Survey
Patient satisfaction will be measured using a Likert scale with scores ranging from a scale of 1-5 (1 not satisfied, 5 very satisfied). These data were not collected as part of the completed study.
Measured: 48 hours prior to discharge from hospital
Count of Participants With Hospital Re-admissions at 30 Days After Hospitalization
The Number of participants with hospital re-admissions at 30 days after hospitalization. Outcome was updated upon results entry.
Measured: up to 30 days post hospitalization
Count of Participants With Emergency Department Visit(s) at 30 Days After Hospitalization
The count of participants with emergency department visits at 30 days after hospitalization. The outcome was updated when results were entered.
Measured: up to 30 days post hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start7 Jul 2022
- Primary completion1 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Melissa Weimer, DO, MCR, FASAM, Principal investigator, Yale UniversityAlexandra Hajduk, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370326
- Sponsor's protocol ID
- 2000032638
- Other IDs
- 1RM1DA055310-01
- Status last verified
- Feb 2024
- First submitted
- 4 May 2022
- Last updated
- 5 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pilot Trial to Evaluate Feasibility and Preliminary Efficacy of an Opioid Stewardship Program in Hospitalized Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT05370326
- Acronym / sponsor ID
- 2000032638
- Conditions
- Opioid Dependence, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the feasibility and preliminary efficacy of an enhanced opioid stewardship program, tailored to the needs of hospitalized patients with chronic pain with opioid dependence, incorporating real-time guidance from an addiction medicine and pain-trained physician/pharmacist team, using a pilot randomized clinical trial format. Findings from this research may improve pain management and decrease risk of opioid-related adverse events among patients with chronic pain.
Detailed description
The primary objective of this study is to determine whether an enhanced opioid stewardship program, tailored to the needs of patients with chronic pain, is feasible to implement in a hospital setting.
One secondary objective is to determine whether an enhanced opioid stewardship program increases use of guideline-based opioid care. The other secondary objective of this study is to determine whether an enhanced opioid stewardship program reduces pain frequency, intensity, and interference and decreases the risk for opioid-related adverse events among adult patients with chronic pain hospitalized on medical units at Yale-New Haven Hospital, York Street and Saint Raphael campuses.
This is a pilot randomized controlled trial of 100 adult participants. It is prospective and focus primarily on feasibility. There will be up to 3 study visits with each participant, which will take place during hospitalization or in the first week after hospital discharge.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Opioid Stewardship Program | Experimental | Other: Enhanced Opioid Stewardship ProgramEnhanced opioid stewardship program, tailored to the needs of hospitalized patients with chronic pain with opioid dependence, incorporating real-time guidance from an addiction medicine and pain-trained physician/pharmacist team |
| Standard of care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- admitted at Yale New Haven Hospital (YSC and SRC) on medical units
- identified as having chronic pain and prescribed opioids
- have opioid dependence (evidenced by ongoing opioid prescription, meeting Diagnostic and Statistical Manual of Mental Disorders-5 criteria for Opioid Use Disorder, or clinical history)
Key exclusion criteria (5 listed)
- active cancer
- current pregnancy
- hospice care/comfort measures only
- admission to inpatient psychiatry
- completed or planned Addiction Medicine consult during hospitalization
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 |
|---|---|---|
| Enhanced Opioid Stewardship ProgramThe goal of the enhanced opioid stewardship intervention is to manage chronic pain while reducing risk of inappropriate/risky opioid use and preventing harms of opioid use. | Other | Enhanced Opioid Stewardship Program |
Primary outcome
Number of Participants Screened Compared to Number of Eligible Participants to Determine Feasibility of Recruitment
Time frame: approximately 3 months
Feasibility of recruitment will be determined by a count of the number of participants screened for the study compared to number of eligible participants.
Number of Eligible Participants Compared to Number of Enrolled Participants to Determine Feasibility of Recruitment
Time frame: approximately 3 months
Feasibility of recruitment will be determined by a count of the number of participants eligible for the study compared to number of enrolled participants.
Days to Hospital Day of Enrollment
Time frame: approximately 3 months
Days to hospital day of enrollment in relation to admission and discharge dates
Number of Participants in the Intervention Group Who Were Able to Receive the Full Enhanced Opioid Stewardship Intervention
Time frame: approximately 3 months
Number of participants in the intervention group who were able to receive the full enhanced opioid stewardship intervention to determine retention
Number of Participants in Intervention Group Who Complete the Peri-discharge Evaluation.
Time frame: approximately 3 months
Number of participants in the intervention group who were able to complete the peri-discharge evaluation to determine retention.
Number of Participants in Control Group Who Complete the Peri-discharge Evaluation.
Time frame: approximately 3 months
Number of participants in the control group who were able to complete the peri-discharge evaluation to determine retention.
7 secondary outcomes
Number of Guideline-based Care Elements in Use Considered Guideline Concordant Care With Opioids for Pain During Hospitalization.
Time frame: approximately 4 months
Change in Pain Intensity Measured by the Brief Pain Inventory - Severity
Time frame: Baseline and 48 hours prior to discharge from hospital
Change in Pain Intensity Measured by the Brief Pain Inventory - Interference
Time frame: Baseline and 48 hours prior to discharge from hospital
Change in Depression Measured by the Patient Health Questionnaire
Time frame: Baseline and 48 hours prior to discharge from hospital
Patient Satisfaction Measured Using a Patient Satisfaction Survey
Time frame: 48 hours prior to discharge from hospital
Count of Participants With Hospital Re-admissions at 30 Days After Hospitalization
Time frame: up to 30 days post hospitalization
Count of Participants With Emergency Department Visit(s) at 30 Days After Hospitalization
Time frame: up to 30 days post hospitalization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Melissa Weimer, DO, MCR, FASAM principal investigator
Yale University
Alexandra Hajduk, PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Opioid Stewardship Program in people with Opioid Dependence and Chronic Pain, run by Yale University at 2 sites 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: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Screened Compared to Number of Eligible Participants to Determine Feasibility of Recruitment (time frame: approximately 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2024.