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

NCT07510373 | Recruiting

• 1 other identifier: 2021-13009
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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. 1.To determine the effectiveness of DOTS for reducing excessive opioid prescribing after orthopedic surgery.
2. 2.To determine the positive and negative impact of DOTS on patient outcomes.

Conditions

Opioid Tapering

Keywords

Post-operative opioid prescribing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Number of Opioid Pills Prescribed at Discharge - Aim 1

  At the time of HD, up to ~18 months

• Subsequent Opioid Prescriptions - Aim 1

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

• Incident Long-term Opioid Therapy - Aim 1

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

• Pain Interference - Aim 2

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

• Pain Intensity by Activity - Aim 2

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

Study Arms (2)

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.

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.

Other: Treatment as Usual (TAU); Other: Telephonic Support (TS) Providers; Other: DOTS Intervention

Interventions

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.

Early-Step DOTS Intervention (TAU - DOTS - DOTS); Late-Step DOTS Intervention (TAU - TS - DOTS)

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.

Late-Step DOTS Intervention (TAU - TS - DOTS)

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.

Early-Step DOTS Intervention (TAU - DOTS - DOTS); Late-Step DOTS Intervention (TAU - TS - DOTS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Wakefield Campus

The Bronx, New York, 10466, United States

RECRUITING

Related Publications (14)

• 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]

  BACKGROUND

• 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]

  BACKGROUND

• 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]

  BACKGROUND

• 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]

  BACKGROUND

• 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]

  BACKGROUND

• 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]

  BACKGROUND

• 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]

  BACKGROUND

• 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]

  BACKGROUND

• 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]

  BACKGROUND

• 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]

  BACKGROUND

• 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]

  BACKGROUND

• 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]

  BACKGROUND

• 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]

  BACKGROUND

• 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]

  BACKGROUND

Related Links

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

MeSH Terms

Interventions

Therapeutics

Study Officials

• Justina Groeger, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justina Groeger, MD

CONTACT

718-920-5387; jugroege@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Providers will be randomly assigned 1:1 to 2 groups (Early-Step DOTS vs Late-Step DOTS) and each will receive DOTS ("DOTS providers) or TS ("TS providers") in a stepped-wedge design.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 3, 2026
• Study Start: April 12, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

US (1)