Chronic Pain, Opioid Dependence
Conditions
Brief 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 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.
Interventions
OTHEREnhanced 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.
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Screened Compared to Number of Eligible Participants to Determine Feasibility of Recruitment | 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 | 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 | 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 | 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. | 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. | approximately 3 months | Number of participants in the control group who were able to complete the peri-discharge evaluation to determine retention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Guideline-based Care Elements in Use Considered Guideline Concordant Care With Opioids for Pain During Hospitalization. | 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. |
| Count of Participants With Emergency Department Visit(s) at 30 Days After Hospitalization | 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. |
| Change in Pain Intensity Measured by the Brief Pain Inventory - Severity | 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). |
| Change in Pain Intensity Measured by the Brief Pain Inventory - Interference | 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). |
| Change in Depression Measured by the Patient Health Questionnaire | 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). |
| Patient Satisfaction Measured Using a Patient Satisfaction Survey | 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. |
| Count of Participants With Hospital Re-admissions at 30 Days After Hospitalization | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| Standard of Care Participants received standard of care services without the enhanced opioid stewardship program. | 16 |
| Total | 52 |
Baseline characteristics
| Characteristic | Enhanced Opioid Stewardship Program | Total | Standard of Care |
|---|---|---|---|
| Age, Continuous | 55.1 years STANDARD_DEVIATION 13.7 | 53.7 years STANDARD_DEVIATION 14 | 52.3 years STANDARD_DEVIATION 15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 11 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 41 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 19 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) White | 20 Participants | 29 Participants | 9 Participants |
| Region of Enrollment United States | 36 participants | 52 participants | 16 participants |
| Sex: Female, Male Female | 18 Participants | 28 Participants | 10 Participants |
| Sex: Female, Male Male | 18 Participants | 24 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 36 | 0 / 16 |
| other Total, other adverse events | 0 / 36 | 0 / 16 |
| serious Total, serious adverse events | 1 / 36 | 0 / 16 |
Outcome results
Primary
Days to Hospital Day of Enrollment
Days to hospital day of enrollment in relation to admission and discharge dates
Time frame: approximately 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Participants Screened | Days to Hospital Day of Enrollment | 9.66 days | Standard Error 1.12 |
| Standard of Care | Days to Hospital Day of Enrollment | 10.56 days | Standard Error 2.3 |
p-value: 0.6995% CI: [-3.67, 5.46]t-test, 2 sided
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.
Time frame: approximately 3 months
Population: Total number of eligible participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Participants Screened | Number of Eligible Participants Compared to Number of Enrolled Participants to Determine Feasibility of Recruitment | Declined to hear about study | 22 Participants |
| Total Participants Screened | Number of Eligible Participants Compared to Number of Enrolled Participants to Determine Feasibility of Recruitment | Agreed to hear about study: Consented | 52 Participants |
| Total Participants Screened | 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
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.
Time frame: approximately 3 months
Population: Only participants in the control group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Participants Screened | Number of Participants in Control Group Who Complete the Peri-discharge Evaluation. | Clinical outcomes provided | 16 Participants |
| Total Participants Screened | Number of Participants in Control Group Who Complete the Peri-discharge Evaluation. | Self-reported outcomes provided | 14 Participants |
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.
Time frame: approximately 3 months
Population: Only participants in the intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Participants Screened | Number of Participants in Intervention Group Who Complete the Peri-discharge Evaluation. | Clinical outcomes provided | 36 Participants |
| Total Participants Screened | Number of Participants in Intervention Group Who Complete the Peri-discharge Evaluation. | Self reported outcomes provided | 31 Participants |
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
Time frame: approximately 3 months
Population: Only participants in the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Participants Screened | Number of Participants in the Intervention Group Who Were Able to Receive the Full Enhanced Opioid Stewardship Intervention | 36 Participants |
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.
Time frame: approximately 3 months
Population: All participants that were screened for eligibility
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Participants Screened | Number of Participants Screened Compared to Number of Eligible Participants to Determine Feasibility of Recruitment | Eligible participants approached | 97 Participants |
| Total Participants Screened | Number of Participants Screened Compared to Number of Eligible Participants to Determine Feasibility of Recruitment | Ineligible participants due to Inclusion | 62 Participants |
| Total Participants Screened | Number of Participants Screened Compared to Number of Eligible Participants to Determine Feasibility of Recruitment | Ineligible participants due to Exclusion | 351 Participants |
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).
Time frame: Baseline and 48 hours prior to discharge from hospital
Population: Participants with complete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Participants Screened | Change in Depression Measured by the Patient Health Questionnaire | -0.56 score on a scale | Standard Error 0.38 |
| Standard of Care | Change in Depression Measured by the Patient Health Questionnaire | -0.35 score on a scale | Standard Error 0.43 |
p-value: 0.7495% CI: [-1.09, 1.51]t-test, 2 sided
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).
Time frame: Baseline and 48 hours prior to discharge from hospital
Population: Participants with complete data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Participants Screened | Change in Pain Intensity Measured by the Brief Pain Inventory - Interference | -1.21 score on a scale | Standard Error 0.5 |
| Standard of Care | Change in Pain Intensity Measured by the Brief Pain Inventory - Interference | -0.62 score on a scale | Standard Error 0.64 |
p-value: 0.595% CI: [-1.16, 2.34]t-test, 2 sided
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).
Time frame: Baseline and 48 hours prior to discharge from hospital
Population: Participants with complete data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Participants Screened | Change in Pain Intensity Measured by the Brief Pain Inventory - Severity | -0.46 score on a scale | Standard Error 0.26 |
| Standard of Care | Change in Pain Intensity Measured by the Brief Pain Inventory - Severity | -0.23 score on a scale | Standard Error 0.59 |
p-value: 0.6795% CI: [-0.89, 1.36]t-test, 2 sided
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.
Time frame: up to 30 days post hospitalization
Population: All participants
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Participants Screened | Count of Participants With Emergency Department Visit(s) at 30 Days After Hospitalization | ED Visit within 30 Days: Yes | 15 Participants |
| Total Participants Screened | Count of Participants With Emergency Department Visit(s) at 30 Days After Hospitalization | ED Visit within 30 Days: No | 21 Participants |
| Standard of Care | Count of Participants With Emergency Department Visit(s) at 30 Days After Hospitalization | ED Visit within 30 Days: Yes | 5 Participants |
| Standard of Care | Count of Participants With Emergency Department Visit(s) at 30 Days After Hospitalization | ED Visit within 30 Days: No | 11 Participants |
p-value: 0.47Chi-squared
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.
Time frame: up to 30 days post hospitalization
Population: All participants
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Participants Screened | Count of Participants With Hospital Re-admissions at 30 Days After Hospitalization | Readmission in 30 days: Yes | 14 Participants |
| Total Participants Screened | Count of Participants With Hospital Re-admissions at 30 Days After Hospitalization | Readmission in 30 days: No | 22 Participants |
| Standard of Care | Count of Participants With Hospital Re-admissions at 30 Days After Hospitalization | Readmission in 30 days: Yes | 4 Participants |
| Standard of Care | Count of Participants With Hospital Re-admissions at 30 Days After Hospitalization | Readmission in 30 days: No | 12 Participants |
p-value: 0.33Chi-squared
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.
Time frame: approximately 4 months
Population: Only those in Enhanced Opioid Stewardship Program
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Total Participants Screened | Number of Guideline-based Care Elements in Use Considered Guideline Concordant Care With Opioids for Pain During Hospitalization. | 4.4 Physician guideline-concordant recommend |
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.
Time frame: 48 hours prior to discharge from hospital
Population: These data were not collected.