Feasibility and Preliminary Efficacy of an Opioid Stewardship Program in Hospitalized Patients With Chronic Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Pilot Trial to Evaluate Feasibility and Preliminary Efficacy of an Opioid Stewardship Program in Hospitalized Patients With Chronic Pain

Conditions
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Opioid Dependence, Chronic Pain

Intervention / Treatment
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* Other: Enhanced Opioid Stewardship Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: active cancer current pregnancy hospice care/comfort measures only admission to inpatient psychiatry completed or planned Addiction Medicine consult during hospitalization

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Opioid Stewardship Program<br>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 | Other: Enhanced Opioid Stewardship Program<br>* 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.<br>|
| No Intervention: Standard of care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 5 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. | up to 5 months | 
| Days to hospital day of enrollment | Days to hospital day of enrollment in relation to admission and discharge dates | From admission/discharge to hospital enrollment, up to 5 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 | up to 5 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. | up to 5 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. | up to 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | an average of 5 months | 
| Change in Pain intensity measured by the Brief Pain Inventory | 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). | 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). | 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) | 48 hours prior to discharge from hospital | 
| Number of hospital re-admissions at 30 days after hospitalization | The Number of hospital re-admissions at 30 days after hospitalization will be counted | up to 30 days post hospitalization | 
| Number of emergency department visits at 30 days after hospitalization | The Number of emergency department visits at 30 days after hospitalization will be counted | up to 30 days post hospitalization |