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| ID | Type | Description | Link |
|---|---|---|---|
| 1RM1DA055310-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Standard of care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. | 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. | approximately 3 months |
| Days to Hospital Day of Enrollment | Days to hospital day of enrollment in relation to admission and discharge dates | 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 | 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. | 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. |
| 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. The number is out of a possible 12 recommendations- 12 would be the most recommendations a participant could have received. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Weimer, DO, MCR, FASAM | Yale University | Principal Investigator |
| Alexandra Hajduk, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital, 20 York Street | New Haven | Connecticut | 06510 | United States | ||
| Yale New Haven Hospital, 1450 Chapel Street |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Opioid Stewardship Program | 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 Enhanced Opioid Stewardship Program: 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. |
| FG001 | Standard of Care | Participants received standard of care services without the enhanced opioid stewardship program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants randomized in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Opioid Stewardship Program | 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 Enhanced Opioid Stewardship Program: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants that were screened for eligibility | Posted | Count of Participants | Participants | approximately 3 months |
|
|
Up to 4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enhanced Opioid Stewardship Program | 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 Enhanced Opioid Stewardship Program: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiorespiratory arrest | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa B. Weimer, DO, MCR, DFASAM | Yale School of Medicine | (203) 859-2962 | melissa.weimer@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2022 | Oct 27, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 4, 2022 | Feb 13, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| approximately 3 months |
| 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). | 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). | 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). These data were not collected as part of the completed study. | 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. | 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. | up to 30 days post hospitalization |
| New Haven |
| Connecticut |
| 06511 |
| United States |
| BG001 | Standard of Care | Participants received standard of care services without the enhanced opioid stewardship program. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | Total number of eligible participants. | Posted | Count of Participants | Participants | approximately 3 months |
|
|
|
| Primary | Days to Hospital Day of Enrollment | Days to hospital day of enrollment in relation to admission and discharge dates | Posted | Mean | Standard Error | days | approximately 3 months |
|
|
|
|
| Primary | 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 | Only participants in the intervention. | Posted | Count of Participants | Participants | approximately 3 months |
|
|
|
| Primary | 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. | Only participants in the intervention. | Posted | Count of Participants | Participants | approximately 3 months |
|
|
|
| Primary | 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. | Only participants in the control group. | Posted | Count of Participants | Participants | approximately 3 months |
|
|
|
| Secondary | 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. | Only those in Enhanced Opioid Stewardship Program | Posted | Mean | Full Range | Physician guideline-concordant recommend | approximately 4 months |
|
|
|
| Secondary | 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). | Participants with complete data | Posted | Mean | Standard Error | score on a scale | Baseline and 48 hours prior to discharge from hospital |
|
|
|
|
| Secondary | 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). | Participants with complete data | Posted | Mean | Standard Error | score on a scale | Baseline and 48 hours prior to discharge from hospital |
|
|
|
|
| Secondary | 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). | Participants with complete data. | Posted | Mean | Standard Error | score on a scale | Baseline and 48 hours prior to discharge from hospital |
|
|
|
|
| Secondary | 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. | These data were not collected. | Posted | 48 hours prior to discharge from hospital |
|
|
| Secondary | 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. | All participants | Posted | Count of Participants | Participants | up to 30 days post hospitalization |
|
|
|
|
| Secondary | 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. | All participants | Posted | Count of Participants | Participants | up to 30 days post hospitalization |
|
|
|
|
| 1 |
| 36 |
| 1 |
| 36 |
| 0 |
| 36 |
| EG001 | Standard of Care | Participants received standard of care services without the enhanced opioid stewardship program. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |