Recruiting

DOTS

Sponsor:

Montefiore Medical Center

Code:

NCT07510373

Conditions

Opioid Tapering

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Treatment as Usual (TAU)

Telephonic Support (TS) Providers

DOTS Intervention

Study Details

Brief summary:

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.

Conditions

Opioid Tapering

Study ID

NCT07510373

Start date

Apr 12, 2026

Status verified date

May, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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: 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.

Interventions

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.

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.

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.

Primary outcome measure

  • Mean morphine equivalent daily dose (MMED) - Aim 1 [ Time Frame: Over the week after hospital discharge (HD), up to ~18 months ]
  • Pain Intensity - Aim 2 [ Time Frame: At 1, 2, and 12 weeks after HD, up to ~18 months ]

Central Contacts and Locations

Central contacts

Justina Groeger, MD

718-920-5387jugroege@montefiore.org

Locations

Montefiore Wakefield Campus

Recruiting

The Bronx, New York, United States, 10466

More Information

Sponsor

Montefiore Medical Center

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

  • Post-operative opioid prescribing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-05-11.