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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Tapering
• Intervention / Treatment: Other: Treatment as Usual (TAU); Other: DOTS Intervention; Other: Telephonic Support (TS) Providers

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Justina Groeger, MD; Phone Number: 718-920-5387; Email: jugroege@montefiore.org

Study Locations

• United States
  • New York
    • The Bronx, New York, United States, 10466
      • Recruiting
      • Montefiore Wakefield Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Early-Step DOTS Intervention (TAU - DOTS - DOTS); The study will be divided into three equal time periods. Providers in this arm will conduct TAU in the first period, and be assigned to DOTS in the second and third period.	Other: Treatment as Usual (TAU); 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.; Other: DOTS Intervention; 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.
Other: Late-Step DOTS Intervention (TAU - TS - DOTS); The study will be divided into three equal time periods. Providers in this arm will conduct TAU in the first period, be assigned to TS in the second period, and be assigned to DOTS in the third period.	Other: Treatment as Usual (TAU); 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.; Other: DOTS Intervention; 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.; Other: Telephonic Support (TS) Providers; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Over the week after hospital discharge (HD), up to ~18 months
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.	At 1, 2, and 12 weeks after HD, up to ~18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the time of HD, up to ~18 months
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.	Over the 12 weeks after HD, up to ~18 months
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.	Over the 12 weeks after HD, up to ~18 months
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.	At weeks 1, 2, and 12 after HD, up to ~18 months
Pain Intensity by Activity - Aim 2	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.	At weeks 1, 2, and 12 after HD, up to ~18 months
Post-operative Care Encounters - Aim 2	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.	At weeks 1, 2, and 12 after HD and over 12 weeks after HD, up to ~18 months
Opioid Side Effects - Aim 2	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.	At weeks 1, 2, and 12 after HD, up to ~18 months
Opioid Withdrawal symptoms - Aim 2	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.	At weeks 1, 2, and 12 after HD, up to ~18 months
Opioid Overdose Events - Aim 2	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.	At weeks 1, 2, and 12 after HD, up to ~18 months

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Justina Groeger, MD, Montefiore Medical Center

Publications and helpful links

General Publications

• Hill MV, McMahon ML, Stucke RS, et al. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg 2017;265(4):709-14. doi: 10.1097/sla.0000000000001993 [published Online First: 2016/09/16]
• Bicket MC, White E, Pronovost PJ, et al. Opioid Oversupply After Joint and Spine Surgery: A Prospective Cohort Study. Anesth Analg 2019;128(2):358-64. doi: 10.1213/ane.0000000000003364 [published Online First: 2018/04/21]
• Benyamin R, Trescot AM, Datta S, et al. Opioid complications and side effects. Pain Physician 2008;11(2 Suppl):S105-20. [published Online First: 2008/06/17]
• Daoust R, Paquet J, Cournoyer A, et al. Side effects from opioids used for acute pain after emergency department discharge. Am J Emerg Med 2020;38(4):695-701. doi: 10.1016/j.ajem.2019.06.001 [published Online First: 2019/06/12]
• Weiner SG. Addressing the ignored complication: chronic opioid use after surgery. BMJ Qual Saf 2020 doi: 10.1136/bmjqs-2020-011841 [published Online First: 2020/09/30]
• Alam A, Gomes T, Zheng H, et al. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med 2012;172(5):425-30. doi: 10.1001/archinternmed.2011.1827 [published Online First: 2012/03/14]
• Brat GA, Agniel D, Beam A, et al. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. Bmj 2018;360:j5790. doi: 10.1136/bmj.j5790 [published Online First: 2018/01/19]
• Mosher HJ, Hofmeyer BA, Hadlandsmyth K, et al. Predictors of Long-Term Opioid Use After Opioid Initiation at Discharge From Medical and Surgical Hospitalizations. J Hosp Med 2018;13(4):243-48. doi: 10.12788/jhm.2930 [published Online First: 2018/04/07]
• Shah A, Hayes CJ, Martin BC. Factors Influencing Long-Term Opioid Use Among Opioid Naive Patients: An Examination of Initial Prescription Characteristics and Pain Etiologies. J Pain 2017;18(11):1374-83. doi: 10.1016/j.jpain.2017.06.010 [published Online First: 2017/07/18]
• Shah A, Hayes CJ, Martin BC. Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use - United States, 2006-2015. MMWR Morb Mortal Wkly Rep 2017;66(10):265-69. doi: 10.15585/mmwr.mm6610a1 [published Online First: 2017/03/17]
• Neuman MD, Bateman BT, Wunsch H. Inappropriate opioid prescription after surgery. Lancet 2019;393(10180):1547-57. doi: 10.1016/s0140-6736(19)30428-3 [published Online First: 2019/04/16]
• Colvin LA, Bull F, Hales TG. Perioperative opioid analgesia-when is enough too much? A review of opioid-induced tolerance and hyperalgesia. Lancet 2019;393(10180):1558-68. doi: 10.1016/s0140-6736(19)30430-1 [published Online First: 2019/04/16]
• Kessler ER, Shah M, Gruschkus SK, et al. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy 2013;33(4):383-91. doi: 10.1002/phar.1223 [published Online First: 2013/04/05]
• Dublin S, Walker RL, Gray SL, et al. Prescription Opioids and Risk of Dementia or Cognitive Decline: A Prospective Cohort Study. Journal of the American Geriatrics Society 2015;63(8):1519-26. doi: 10.1111/jgs.13562 [published Online First: 2015/08/21]

Helpful Links

• National Center for Health Statistics. 12 Month-ending Provisional Counts and Percent Change of Drug Overdose Deaths 2020

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Post-operative opioid prescribing
• Additional Relevant MeSH Terms: Therapeutics
• Other Study ID Numbers: 2021-13009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Contract pending

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No