Opioid TaperingDOTSNCT07510373

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

A study testing Treatment as Usual (TAU), Telephonic Support (TS) Providers and DOTS Intervention in people with Opioid Tapering, run by Montefiore Medical Center at 1 site in United States.

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Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Opioid Tapering
What is being tested?: Treatment as Usual (TAU), Telephonic Support (TS) Providers and DOTS Intervention
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: 12 Apr 2026to Apr 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)
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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Justina Groeger, MD contact

718-920-5387

jugroege@montefiore.org

United States1 site, 1 recruiting

Montefiore Wakefield Campus
The Bronx, New York, 10466
Recruiting

Other trials in United States

About this study

Official title: 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:

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.
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.

Read the 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.

Conditions: Opioid Tapering
Being tested: Treatment as Usual (TAU), Telephonic Support (TS) Providers, DOTS Intervention
Keywords: Post-operative opioid prescribing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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) ProvidersOther
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 InterventionOther
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.

Study groups in NCT07510373
Study group	Role	What they receive
Early-Step DOTS Intervention (TAU - DOTS - DOTS)	Other	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. Receives: Other: Treatment as Usual (TAU); Other: DOTS Intervention
Late-Step DOTS Intervention (TAU - TS - DOTS)	Other	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. Receives: Other: Treatment as Usual (TAU); Other: Telephonic Support (TS) Providers; Other: DOTS Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: At 1, 2, and 12 weeks after HD, up to ~18 months

Secondary outcomes (9)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At weeks 1, 2, and 12 after HD, up to ~18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Apr 2026Apr 2028

First posted3 Apr 2026
Study start12 Apr 2026
Primary completionApr 2028 (estimated)
Study completionApr 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Opioid TaperingStudies of the same condition, open and under way.
More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 42 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07510373
Sponsor's protocol ID: 2021-13009
Acronym: DOTS
Status last verified: May 2026
First submitted: 30 Mar 2026
Last updated: 11 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Contract pending

Publications

Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
PubMed 27631771
Bicket MC, White E, Pronovost PJ, Wu CL, Yaster M, Alexander GC. Opioid Oversupply After Joint and Spine Surgery: A Prospective Cohort Study. Anesth Analg. 2019 Feb;128(2):358-364. doi: 10.1213/ANE.0000000000003364.
PubMed 29677062
Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
PubMed 18443635
Daoust R, Paquet J, Cournoyer A, Piette E, Morris J, Lessard J, Castonguay V, Williamson D, Chauny JM. Side effects from opioids used for acute pain after emergency department discharge. Am J Emerg Med. 2020 Apr;38(4):695-701. doi: 10.1016/j.ajem.2019.06.001. Epub 2019 Jun 3.
PubMed 31182367
Weiner SG. Addressing the ignored complication: chronic opioid use after surgery. BMJ Qual Saf. 2021 Mar;30(3):180-182. doi: 10.1136/bmjqs-2020-011841. Epub 2020 Sep 28. No abstract available.
PubMed 32989013
Alam A, Gomes T, Zheng H, Mamdani MM, Juurlink DN, Bell CM. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med. 2012 Mar 12;172(5):425-30. doi: 10.1001/archinternmed.2011.1827.
PubMed 22412106
Brat GA, Agniel D, Beam A, Yorkgitis B, Bicket M, Homer M, Fox KP, Knecht DB, McMahill-Walraven CN, Palmer N, Kohane I. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018 Jan 17;360:j5790. doi: 10.1136/bmj.j5790.
PubMed 29343479
Mosher HJ, Hofmeyer BA, Hadlandsmyth K, Richardson KK, Lund BC. Predictors of Long-Term Opioid Use After Opioid Initiation at Discharge From Medical and Surgical Hospitalizations. J Hosp Med. 2018 Apr;13(4):243-248. doi: 10.12788/jhm.2930.
PubMed 29624187
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 Nov;18(11):1374-1383. doi: 10.1016/j.jpain.2017.06.010. Epub 2017 Jul 13.
PubMed 28711636
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 Mar 17;66(10):265-269. doi: 10.15585/mmwr.mm6610a1.
PubMed 28301454
Neuman MD, Bateman BT, Wunsch H. Inappropriate opioid prescription after surgery. Lancet. 2019 Apr 13;393(10180):1547-1557. doi: 10.1016/S0140-6736(19)30428-3.
PubMed 30983590
Colvin LA, Bull F, Hales TG. Perioperative opioid analgesia-when is enough too much? A review of opioid-induced tolerance and hyperalgesia. Lancet. 2019 Apr 13;393(10180):1558-1568. doi: 10.1016/S0140-6736(19)30430-1.
PubMed 30983591
Kessler ER, Shah M, Gruschkus SK, Raju A. 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 Apr;33(4):383-91. doi: 10.1002/phar.1223.
PubMed 23553809
Dublin S, Walker RL, Gray SL, Hubbard RA, Anderson ML, Yu O, Crane PK, Larson EB. Prescription Opioids and Risk of Dementia or Cognitive Decline: A Prospective Cohort Study. J Am Geriatr Soc. 2015 Aug;63(8):1519-26. doi: 10.1111/jgs.13562.
PubMed 26289681

Interested in taking part?

Justina Groeger, MD

718-920-5387

jugroege@montefiore.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Medrol Dosepak for Outpatient Total Knee Arthroplasty
Total Knee Arthroplasty
RecruitingPhase 3
CARES (Comprehensive Analgesic, Recovery, and Education Support) for Surgery Trial
Chronic Pain, Back Pain
RecruitingPhase 2
Novel Use of Probenecid to Alleviate Symptoms of Opioid Withdrawal
Chronic Pain, Drug Dependence of Morphine Type

All Opioid Tapering trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Opioid Tapering After Hospital Discharge: Testing an Intervention to Improve Post-operative
ClinicalTrials.gov ID: NCT07510373
Acronym / sponsor ID: DOTS / 2021-13009
Conditions: Opioid Tapering
Keywords: Post-operative opioid prescribing
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 42 participants (estimated)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Study start: 12 Apr 2026 (actual)
Primary completion: Apr 2028 (estimated)
Study completion: Apr 2028 (estimated)
First posted: 3 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The two specific aims are:

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.
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Early-Step DOTS Intervention (TAU - DOTS - DOTS)	Other	Other: Treatment as Usual (TAU), Other: DOTS InterventionThe 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.
Late-Step DOTS Intervention (TAU - TS - DOTS)	Other	Other: Treatment as Usual (TAU), Other: Telephonic Support (TS) Providers, Other: DOTS InterventionThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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)
Not fluent in English
Do not manage their own medications

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Early-Step DOTS Intervention (TAU - DOTS - DOTS), Late-Step DOTS Intervention (TAU - TS - DOTS)
Telephonic Support (TS) ProvidersProviders 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.	Other	Late-Step DOTS Intervention (TAU - TS - DOTS)
DOTS 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.	Other	Early-Step DOTS Intervention (TAU - DOTS - DOTS), Late-Step DOTS Intervention (TAU - TS - DOTS)

Primary outcome

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).
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.

9 secondary outcomes

Number of Opioid Pills Prescribed at Discharge - Aim 1
Time frame: At the time of HD, up to ~18 months
Subsequent Opioid Prescriptions - Aim 1
Time frame: Over the 12 weeks after HD, up to ~18 months
Incident Long-term Opioid Therapy - Aim 1
Time frame: Over the 12 weeks after HD, up to ~18 months
Pain Interference - Aim 2
Time frame: At weeks 1, 2, and 12 after HD, up to ~18 months
Pain Intensity by Activity - Aim 2
Time frame: At weeks 1, 2, and 12 after HD, up to ~18 months
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
Opioid Side Effects - Aim 2
Time frame: At weeks 1, 2, and 12 after HD, up to ~18 months
Opioid Withdrawal symptoms - Aim 2
Time frame: At weeks 1, 2, and 12 after HD, up to ~18 months
Opioid Overdose Events - Aim 2
Time frame: At weeks 1, 2, and 12 after HD, up to ~18 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
Background: PubMed 27631771Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
Background: PubMed 29677062Bicket MC, White E, Pronovost PJ, Wu CL, Yaster M, Alexander GC. Opioid Oversupply After Joint and Spine Surgery: A Prospective Cohort Study. Anesth Analg. 2019 Feb;128(2):358-364. doi: 10.1213/ANE.0000000000003364.
Background: PubMed 18443635Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
Background: PubMed 31182367Daoust R, Paquet J, Cournoyer A, Piette E, Morris J, Lessard J, Castonguay V, Williamson D, Chauny JM. Side effects from opioids used for acute pain after emergency department discharge. Am J Emerg Med. 2020 Apr;38(4):695-701. doi: 10.1016/j.ajem.2019.06.001. Epub 2019 Jun 3.
Background: PubMed 32989013Weiner SG. Addressing the ignored complication: chronic opioid use after surgery. BMJ Qual Saf. 2021 Mar;30(3):180-182. doi: 10.1136/bmjqs-2020-011841. Epub 2020 Sep 28. No abstract available.
Background: PubMed 22412106Alam A, Gomes T, Zheng H, Mamdani MM, Juurlink DN, Bell CM. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med. 2012 Mar 12;172(5):425-30. doi: 10.1001/archinternmed.2011.1827.
Background: PubMed 29343479Brat GA, Agniel D, Beam A, Yorkgitis B, Bicket M, Homer M, Fox KP, Knecht DB, McMahill-Walraven CN, Palmer N, Kohane I. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018 Jan 17;360:j5790. doi: 10.1136/bmj.j5790.
Background: PubMed 29624187Mosher HJ, Hofmeyer BA, Hadlandsmyth K, Richardson KK, Lund BC. Predictors of Long-Term Opioid Use After Opioid Initiation at Discharge From Medical and Surgical Hospitalizations. J Hosp Med. 2018 Apr;13(4):243-248. doi: 10.12788/jhm.2930.
Background: PubMed 28711636Shah 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 Nov;18(11):1374-1383. doi: 10.1016/j.jpain.2017.06.010. Epub 2017 Jul 13.
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Individual participant dataSharing planned: Undecided. Contract pending

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Justina Groeger, MD contact

718-920-5387

jugroege@montefiore.org

Justina Groeger, MD principal investigator

Montefiore Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Treatment as Usual (TAU), Telephonic Support (TS) Providers and DOTS Intervention in people with Opioid Tapering, run by Montefiore Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Justina Groeger, MD (718-920-5387, jugroege@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean morphine equivalent daily dose (MMED) - Aim 1 (time frame: Over the week after hospital discharge (HD), up to ~18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07510373, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.