The investigator team proposes a randomized clinical trial (RCT) to test a discharge opioid taper support ("DOTS") intervention that is embedded in the providers' workflow in the EHR to prompt them to prescribe an opioid taper for patients after orthopedic surgery that is tailored to patients' expected analgesic needs. DOTS includes: 1) a recommendation for a patient-specific opioid taper schedule based on opioid use prior to discharge, 2) an automated discharge opioid prescription based on the recommended taper schedule that providers can override, 3) a patient facing handout and 4) post-discharge telephonic support for patients.
Providers will be randomly assigned 1:1 to 2 groups and who will each be assigned to DOTS ("DOTS providers") or TS ("TS providers") in a step-wedge design. EHR data will be extracted and telephone surveys of 100 patients over 12 weeks will be conducted after hospital discharge.
The two specific aims are:
1. To determine the effectiveness of DOTS for reducing excessive opioid prescribing after orthopedic surgery.
Hypothesis 1: Patients discharged by DOTS providers will be prescribed a lower initial mean morphine equivalent daily dose (MMED), fewer opioid pills, and over 12 weeks, will have fewer subsequent opioid prescriptions and incident long-term opioid therapy, compared to patients discharged by non-DOTS providers.
Hypothesis 2. Age and frailty will be moderators; DOTS will be more effective at reducing excessive prescribing to older (65 years and older) and frailer patients. 2. To determine the positive and negative impact of DOTS on patient outcomes.
Hypothesis 3: Compared to patients of non-DOTS providers, patients of DOTS providers will have improved pain and function, fewer adverse events, and less emergency post-operative care.
Hypothesis 4: Age and frailty will be moderators; DOTS will be more effective at improving positive and reducing negative outcomes in older and frailer patients.
Age ≥ 18 years
Any orthopedic surgery during hospitalization
No pre-operative opioid use (no opioids in EHR in past 1 month)
Opioid Use Disorder [by International Classification of Diseases, 10th revision (ICD-10), in past 6 months}
Cancer (by ICD-10, in past 6 months)
Receiving hospice care (by ICD-10, in past 6 months)
Meets criteria for inclusion in Aim 1
Sequential
Treatment as Usual (TAU)
Other interventionIn treatment as usual, orthopedic providers at the Hospital treat patients' pain after surgery with opioid medications as needed based on patients' level of pain on the 11-point visual analog scale (typically, 1 or 2 oxycodone 5mg tablets, taken up to 6 times per day, or 1 or 2 hydromorphone 2 mg tablets, for pain at least 6 out of 10). When a patient is ready for discharge, the orthopedic provider prepares Discharge Instructions for the patient to take home and completes a prescription for opioid and non-opioid medications (typically, acetaminophen, ibuprofen, and pregabalin) in the Hospital EHR (Epic). In New York State, all prescriptions are "e-prescribed" through the EHR and transmitted directly to the pharmacy; none are on paper.
Telephonic Support (TS) Providers
Other interventionProviders assigned to TS only arm will continue with their current post-operative discharge practices. The only new feature in the EHR is that the standard Discharge Instructions will provide a telephone number that patients can call after discharge for any questions relating to their pain and opioid medication management. The telephone number will reach a study physician assistant (PA) or voicemail. The study PA will be trained and licensed. The study PA will answer immediately or respond within 4 hours to address the patient's questions, triage the need for a higher level of care (such as contacting the surgeon, referring the patient to the emergency room, or scheduling an urgent appointment) and if necessary, modify the plan of care, including prescribe additional opioid medication if needed.
DOTS Intervention
Other interventionThe DOTS intervention consists of: 1) a recommendation for a patient-specific opioid taper schedule based on opioid use prior to discharge, 2) an automated discharge opioid prescription based on the recommended taper schedule that providers can override, 3) a patient facing handout, and 4) post-discharge telephonic support for patients. DOTS will be delivered to providers in the EHR as part of their discharge workflow.
Mean morphine equivalent daily dose (MMED) - Aim 1
The average (mean) daily dose of opioid medication prescribed in the week after hospital discharge will be assessed by using the initial opioid medication prescribed via the EHR at the time of hospital discharge to calculate the mean morphine equivalent daily dose over the week following hospital discharge. Mean results will be reported in morphine equivalents/day (MME/day).
Pain Intensity - Aim 2
Pain intensity will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) 3a subscale. In the PROMIS 3a subscale, the participant is asked to rate using a Likert scale of 1 ('no pain') to 5 ('severe pain') how intense over the last seven days was 1) pain at its worst, 2) average pain, and 3) pain right now. Higher subscale scores are indicative of greater pain intensity. Only the subscale result will be reported.
Number of Opioid Pills Prescribed at Discharge - Aim 1
The mean (average) number of opioid pills prescribed at the time of hospital discharge, based on electronic health records, will be assessed by calculating the mean number of pills prescribed in the initial opioid prescription at the time of hospital discharge. Results will be reported using basic descriptive statistics.
Subsequent Opioid Prescriptions - Aim 1
Whether a participant is prescribed any additional opioid prescriptions beyond the initial opioid prescription at hospital discharge will be assessed as a dichotomous outcome (Yes/No), using data obtained from EHR, where No is defined as not being prescribed any additional opioid prescriptions after the initial opioid prescription at the time of hospital discharge and Yes is defined as having been prescribed any subsequent opioid prescriptions in the 12 weeks following hospital discharge. The number/percentage of participants within each category (Yes/No) will be reported.
Incident Long-term Opioid Therapy - Aim 1
Whether a patient meets criteria for incident long term opioid therapy will be assessed as a dichotomous outcome (Yes/No), using data obtained from EHR. Yes is defined as having prescribed opioid medication coverage for at least 10 of the 12 weeks after hospital discharge (e.g. a 14-day maximum gap in coverage) with an active opioid prescription at 12 weeks after hospital discharge. No is defined as no longer having prescription opioid medication coverage 12 weeks after hospital discharge or having opioid prescription coverage for less than 10 weeks of the 12 weeks after hospital discharge (e.g. a gap of more than 14 days in coverage during the 12 weeks after hospital discharge). The number/percentage of participants within each category (Yes/No) will be reported.
Pain Interference - Aim 2
Pain interference will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference short form 4a scale in which participants are asked to use a Likert scale ranging from 1 ('not at all') to 5 ('very much') to rate, how much in the past seven days, pain interfered with 1) day to day activities, 2) work around the home, 3) ability to participate in social activities, and 4) household chores. Higher subscale scores are indicative of greater interference of pain on each activity. The subscale result will be reported.
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