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NCT Number: NCT07510373

Opioid Tapering After Hospital Discharge: Testing an Intervention to Improve Post-operative Opioid Prescribing

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.

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Key information

Conditions

Opioid Tapering

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Wakefield Campus

The Bronx, New York, 10466, United States

Location status: Recruiting

About this study

The opioid epidemic in the U.S. resulted in >50,000 opioid overdose deaths in 2019. Prescription opioids cause a third of opioid overdose deaths overall and 80% of those among older adults (aged ≥ 65). Surgery is a critical event when excessive opioids are prescribed. After surgery, 90% of patients are prescribed more opioids than they use and 90% of those with unused pills do not safely store or dispose of them. Excessive opioid prescribing after surgery can lead to long-term use, diversion, and opioid-related harms including sedation, constipation, hyperalgesia, physical dependence, opioid use disorder, or overdose.

Curbing excessive opioid prescribing after orthopedic surgeries such as knee or hip replacement is particularly important. These surgeries have more than doubled since 2000, opioids are typically required for post-operative pain, and patients undergoing these surgeries tend to be frail or older adults who have high risk for opioid-related harm. Compared with adults under age 65, older adults have twice the risk of post-surgical opioid-related sedation or delirium and increased risk of opioid-related falls, fractures, overdose, hospitalization, and all-cause mortality. Frailty, a syndrome of physiologic decline that is often but not always age-related is associated with increased sensitivity to analgesia and opioid-related harms.

Surgical providers often prescribe excessive opioids at the time of hospital discharge without patient instructions for gradually reducing use over time (tapering). A tapered dose schedule can provide effective post-operative pain control, guide patients to cease opioids within 7 days, and minimizes opioid withdrawal symptoms. Previous K12-funded work and other studies have found that surgical providers fear causing opioid-related harm particularly to older and frailer adults, but prescribe excessive opioids out of concern that patients would have poorly controlled pain, call for more medication or care, or be dissatisfied. In addition, opioid tapers are not prescribed due to the lack of knowledge and standardized procedures.

An algorithm was developed for patient-specific, post-operative opioid taper schedules that considers the patient's opioid requirements while hospitalized. Each taper was manually calculated and was not fully integrated into the electronic health record (EHR) in which the discharging providers work. Studies show that embedding default prescriptions in the EHR is effective at changing prescribing behavior. One pre-post observational study of a patient-specific, post-operative taper calculated outside the EHR reduced excessive prescribing. However, no clinical trials have examined patient-specific, post-operative opioid taper interventions that are embedded as defaults in the EHR. No studies have rigorously examined their impact on patient outcomes or the provider- patient-, and contextual factors that influence whether providers use the intervention with patients.

Excessive opioid prescribing after surgery remains a major driver of morbidity and mortality. EHR-embedded interventions with default settings have the potential to create scalable and lasting changes in provider prescribing practices to reduce excessive post-operative opioid prescribing and encourage tapers but have not been rigorously tested. Thus, this randomized controlled trial is proposed to test the effectiveness of DOTS to reduce excessive opioid prescribing and its impact on patient outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(Aim 1):

  • Age ≥ 18 years
  • Any orthopedic surgery during hospitalization
  • No pre-operative opioid use (no opioids in EHR in past 1 month)

Exclusion criteria

(Aim 1):

  • 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)

Inclusion criteria

(Aim 2):

  • Meets criteria for inclusion in Aim 1

Exclusion criteria

(Aim 2):

  • Not fluent in English
  • Do not manage their own medications
  • Unable to provide consent over the phone
  • Orthopedic surgery due to cancer-related bone disease
  • No pre-operative opioid use (no opioids per New York state prescription drug monitoring program in past 1 month)

Treatment and study plan

Treatment as usual (TAU)

Other

In 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

Providers 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

The 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.

Primary outcomes

  1. Mean morphine equivalent daily dose (MMED) - Aim 1

    Time frame: Over the week after hospital discharge (HD), up to ~18 months

    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).

  2. Pain Intensity - Aim 2

    Time frame: At 1, 2, and 12 weeks after HD, up to ~18 months

    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.

Secondary outcomes

  1. Number of Opioid Pills Prescribed at Discharge - Aim 1

    Time frame: At the time of HD, up to ~18 months

    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.

  2. Subsequent Opioid Prescriptions - Aim 1

    Time frame: Over the 12 weeks after HD, up to ~18 months

    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.

  3. Incident Long-term Opioid Therapy - Aim 1

    Time frame: Over the 12 weeks after HD, up to ~18 months

    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.

  4. Pain Interference - Aim 2

    Time frame: At weeks 1, 2, and 12 after HD, up to ~18 months

    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.

  5. Pain Intensity by Activity - Aim 2

    Time frame: At weeks 1, 2, and 12 after HD, up to ~18 months

    Pain intensity by activity will be assessed by using the pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a disease-specific questionnaire containing a pain subscale which assesses clinically important, participant-relevant symptoms for pain in participants with osteoarthritis (OA). The pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of the index joint during the past 48 hours during five pre-specified activities and it has a possible score range of 0-20. Higher scores indicate greater pain intensity. Only the pain subscore will be reported.

  6. Post-operative Care Encounters - Aim 2

    Time frame: At weeks 1, 2, and 12 after HD and over 12 weeks after HD, up to ~18 months

    Post-operative care will be assessed by reporting the mean number of post-operative care (defined to include any orthopedic surgery appointments, emergency department visits, and hospitalizations) encounters. The initial hospitalization qualifying them for inclusion will be excluded. This will be reported over the prior week (at weeks 1, 2, and 12 in the patient surveys) and over the 12 weeks after HD (per EHR). The mean number of post-operative care encounters will be summarized using descriptive statistics.

  7. Opioid Side Effects - Aim 2

    Time frame: At weeks 1, 2, and 12 after HD, up to ~18 months

    Side effects will be assessed by reporting the mean number of opioid-related side effects reported per participant over the last week. The opioid-related side effects are pre-specified and each participant will be asked if they experienced each pre-specified side effect (Yes/No) during the last week. The number/percentage of Yes/No responses will be reported.

  8. Opioid Withdrawal symptoms - Aim 2

    Time frame: At weeks 1, 2, and 12 after HD, up to ~18 months

    Opioid withdrawal symptoms will be assessed by reporting the mean number of opioid withdrawal symptoms reported per participant over the last week. The opioid symptoms are pre-specified and each participant will be asked if they experienced each pre-specified withdrawal symptom (Yes/No) during the last week. The number/percentage of Yes/No responses will be reported.

  9. Opioid Overdose Events - Aim 2

    Time frame: At weeks 1, 2, and 12 after HD, up to ~18 months

    Opioid overdose will be assessed by reporting whether a participant experienced an overdose event over the last week. Each participant will be asked if they experienced any opioid overdose. The number/percentage of Yes/No responses will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Justina Groeger, MD

CONTACT

[email protected]

718-920-5387

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Opioid Tapering After Hospital Discharge: Testing an Intervention to Improve Post-operative

Acronym: DOTS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 3, 2026
Registry last updated
May 11, 2026

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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