Trial Outcomes & Findings for Feasibility and Preliminary Efficacy of an Opioid Stewardship Program in Hospitalized Patients With Chronic Pain (NCT NCT05370326)

NCT ID: NCT05370326

Last Updated: 2024-03-05

Results Overview

Feasibility of recruitment will be determined by a count of the number of participants screened for the study compared to number of eligible participants.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: approximately 3 months
• Results posted on: 2024-03-05

Participant Flow

Participant milestones

Measure	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.	Standard of Care Participants received standard of care services without the enhanced opioid stewardship program.
Overall Study STARTED	36	16
Overall Study Complete Clinical Data	36	16
Overall Study Complete Self Report Data	31	14
Overall Study COMPLETED	36	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Enhanced Opioid Stewardship Program n=36 Participants 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.	Standard of Care n=16 Participants Participants received standard of care services without the enhanced opioid stewardship program.	Total n=52 Participants Total of all reporting groups
Age, Continuous	55.1 years STANDARD_DEVIATION 13.7 • n=5 Participants	52.3 years STANDARD_DEVIATION 15.0 • n=7 Participants	53.7 years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	10 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	6 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	10 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	4 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	9 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	16 participants n=7 Participants	52 participants n=5 Participants

PRIMARY outcome

Timeframe: approximately 3 months

Population: All participants that were screened for eligibility

Feasibility of recruitment will be determined by a count of the number of participants screened for the study compared to number of eligible participants.

Outcome measures

Measure	Total Participants Screened n=510 Participants This is the total number of participants that were screened for eligibility.	Standard of Care Participants received standard of care services without the enhanced opioid stewardship program.
Number of Participants Screened Compared to Number of Eligible Participants to Determine Feasibility of Recruitment Eligible participants approached	97 Participants	—
Number of Participants Screened Compared to Number of Eligible Participants to Determine Feasibility of Recruitment Ineligible participants due to Inclusion	62 Participants	—
Number of Participants Screened Compared to Number of Eligible Participants to Determine Feasibility of Recruitment Ineligible participants due to Exclusion	351 Participants	—

PRIMARY outcome

Timeframe: approximately 3 months

Population: Total number of eligible participants.

Feasibility of recruitment will be determined by a count of the number of participants eligible for the study compared to number of enrolled participants.

Outcome measures

Measure	Total Participants Screened n=97 Participants This is the total number of participants that were screened for eligibility.	Standard of Care Participants received standard of care services without the enhanced opioid stewardship program.
Number of Eligible Participants Compared to Number of Enrolled Participants to Determine Feasibility of Recruitment Declined to hear about study	22 Participants	—
Number of Eligible Participants Compared to Number of Enrolled Participants to Determine Feasibility of Recruitment Agreed to hear about study: Consented	52 Participants	—
Number of Eligible Participants Compared to Number of Enrolled Participants to Determine Feasibility of Recruitment Agreed to hear about study: Did not consent	23 Participants	—

PRIMARY outcome

Timeframe: approximately 3 months

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

Outcome measures

Measure	Total Participants Screened n=36 Participants This is the total number of participants that were screened for eligibility.	Standard of Care n=16 Participants Participants received standard of care services without the enhanced opioid stewardship program.
Days to Hospital Day of Enrollment	9.66 days Standard Error 1.12	10.56 days Standard Error 2.30

PRIMARY outcome

Timeframe: approximately 3 months

Population: Only participants in the intervention.

Number of participants in the intervention group who were able to receive the full enhanced opioid stewardship intervention to determine retention

Outcome measures

Measure	Total Participants Screened n=36 Participants This is the total number of participants that were screened for eligibility.	Standard of Care Participants received standard of care services without the enhanced opioid stewardship program.
Number of Participants in the Intervention Group Who Were Able to Receive the Full Enhanced Opioid Stewardship Intervention	36 Participants	—

PRIMARY outcome

Timeframe: approximately 3 months

Population: Only participants in the intervention.

Number of participants in the intervention group who were able to complete the peri-discharge evaluation to determine retention.

Outcome measures

Measure	Total Participants Screened n=36 Participants This is the total number of participants that were screened for eligibility.	Standard of Care Participants received standard of care services without the enhanced opioid stewardship program.
Number of Participants in Intervention Group Who Complete the Peri-discharge Evaluation. Clinical outcomes provided	36 Participants	—
Number of Participants in Intervention Group Who Complete the Peri-discharge Evaluation. Self reported outcomes provided	31 Participants	—

PRIMARY outcome

Timeframe: approximately 3 months

Population: Only participants in the control group.

Number of participants in the control group who were able to complete the peri-discharge evaluation to determine retention.

Outcome measures

Measure	Total Participants Screened n=16 Participants This is the total number of participants that were screened for eligibility.	Standard of Care Participants received standard of care services without the enhanced opioid stewardship program.
Number of Participants in Control Group Who Complete the Peri-discharge Evaluation. Clinical outcomes provided	16 Participants	—
Number of Participants in Control Group Who Complete the Peri-discharge Evaluation. Self-reported outcomes provided	14 Participants	—

SECONDARY outcome

Timeframe: approximately 4 months

Population: Only those in Enhanced Opioid Stewardship Program

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.

Outcome measures

Measure	Total Participants Screened n=36 Participants This is the total number of participants that were screened for eligibility.	Standard of Care Participants received standard of care services without the enhanced opioid stewardship program.
Number of Guideline-based Care Elements in Use Considered Guideline Concordant Care With Opioids for Pain During Hospitalization.	4.4 Physician guideline-concordant recommend Interval 2.0 to 8.0	—

SECONDARY outcome

Timeframe: Baseline and 48 hours prior to discharge from hospital

Population: Participants with complete data

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).

Outcome measures

Measure	Total Participants Screened n=30 Participants This is the total number of participants that were screened for eligibility.	Standard of Care n=14 Participants Participants received standard of care services without the enhanced opioid stewardship program.
Change in Pain Intensity Measured by the Brief Pain Inventory - Severity	-0.46 score on a scale Standard Error 0.26	-0.23 score on a scale Standard Error 0.59

SECONDARY outcome

Timeframe: Baseline and 48 hours prior to discharge from hospital

Population: Participants with complete data

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).

Outcome measures

Measure	Total Participants Screened n=30 Participants This is the total number of participants that were screened for eligibility.	Standard of Care n=14 Participants Participants received standard of care services without the enhanced opioid stewardship program.
Change in Pain Intensity Measured by the Brief Pain Inventory - Interference	-1.21 score on a scale Standard Error 0.50	-0.62 score on a scale Standard Error 0.64

SECONDARY outcome

Timeframe: Baseline and 48 hours prior to discharge from hospital

Population: Participants with complete data.

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

Outcome measures

Measure	Total Participants Screened n=30 Participants This is the total number of participants that were screened for eligibility.	Standard of Care n=14 Participants Participants received standard of care services without the enhanced opioid stewardship program.
Change in Depression Measured by the Patient Health Questionnaire	-0.56 score on a scale Standard Error 0.38	-0.35 score on a scale Standard Error 0.43

SECONDARY outcome

Timeframe: 48 hours prior to discharge from hospital

Population: These data were not collected.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 30 days post hospitalization

Population: All participants

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

Outcome measures

Measure	Total Participants Screened n=36 Participants This is the total number of participants that were screened for eligibility.	Standard of Care n=16 Participants Participants received standard of care services without the enhanced opioid stewardship program.
Count of Participants With Hospital Re-admissions at 30 Days After Hospitalization Readmission in 30 days: Yes	14 Participants	4 Participants
Count of Participants With Hospital Re-admissions at 30 Days After Hospitalization Readmission in 30 days: No	22 Participants	12 Participants

SECONDARY outcome

Timeframe: up to 30 days post hospitalization

Population: All participants

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

Outcome measures

Measure	Total Participants Screened n=36 Participants This is the total number of participants that were screened for eligibility.	Standard of Care n=16 Participants Participants received standard of care services without the enhanced opioid stewardship program.
Count of Participants With Emergency Department Visit(s) at 30 Days After Hospitalization ED Visit within 30 Days: Yes	15 Participants	5 Participants
Count of Participants With Emergency Department Visit(s) at 30 Days After Hospitalization ED Visit within 30 Days: No	21 Participants	11 Participants

Adverse Events

Enhanced Opioid Stewardship Program

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Enhanced Opioid Stewardship Program n=36 participants at risk 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.	Standard of Care n=16 participants at risk Participants received standard of care services without the enhanced opioid stewardship program.
Cardiac disorders Cardiorespiratory arrest	2.8% 1/36 • Number of events 1 • Up to 4 months	0.00% 0/16 • Up to 4 months

Other adverse events

Adverse event data not reported

Additional Information

Melissa B. Weimer, DO, MCR, DFASAM

Yale School of Medicine

Phone: (203) 859-2962

Email: melissa.weimer@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place