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Completed

NCT Number: NCT05370326

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.

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Key information

Conditions

Opioid Dependence Chemically-Induced Disorders Chronic Pain Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital, 1450 Chapel Street, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Opioid Stewardship Program

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Days to Hospital Day of Enrollment

    Time frame: approximately 3 months

    Days to hospital day of enrollment in relation to admission and discharge dates

  4. 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

  5. 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.

  6. 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.

Secondary outcomes

  1. Number of Guideline-based Care Elements in Use Considered Guideline Concordant Care With Opioids for Pain During Hospitalization.

    Time frame: approximately 4 months

    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.

  2. Change in Pain Intensity Measured by the Brief Pain Inventory - Severity

    Time frame: Baseline and 48 hours prior to discharge from hospital

    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).

  3. Change in Pain Intensity Measured by the Brief Pain Inventory - Interference

    Time frame: Baseline and 48 hours prior to discharge from hospital

    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).

  4. Change in Depression Measured by the Patient Health Questionnaire

    Time frame: Baseline and 48 hours prior to discharge from hospital

    The Patient Health Questionnaire measures Change in depression. Scores range from 0 (no depression) to 27 (severe depression).

  5. Patient Satisfaction Measured Using a Patient Satisfaction Survey

    Time frame: 48 hours prior to discharge from hospital

    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.

  6. Count of Participants With Hospital Re-admissions at 30 Days After Hospitalization

    Time frame: up to 30 days post hospitalization

    The Number of participants with hospital re-admissions at 30 days after hospitalization. Outcome was updated upon results entry.

  7. Count of Participants With Emergency Department Visit(s) at 30 Days After Hospitalization

    Time frame: up to 30 days post hospitalization

    The count of participants with emergency department visits at 30 days after hospitalization. The outcome was updated when results were entered.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 11, 2022
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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