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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 opio
• Другое 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 withi
• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (9)

• Number of Opioid Pills Prescribed at Discharge - Aim 1 [Срок оценки: At the time of HD, up to ~18 months]
• Subsequent Opioid Prescriptions - Aim 1 [Срок оценки: Over the 12 weeks after HD, up to ~18 months]
• Incident Long-term Opioid Therapy - Aim 1 [Срок оценки: Over the 12 weeks after HD, up to ~18 months]
• Pain Interference - Aim 2 [Срок оценки: At weeks 1, 2, and 12 after HD, up to ~18 months]
• Pain Intensity by Activity - Aim 2 [Срок оценки: At weeks 1, 2, and 12 after HD, up to ~18 months]
• Post-operative Care Encounters - Aim 2 [Срок оценки: At weeks 1, 2, and 12 after HD and over 12 weeks after HD, up to ~18 months]
• Opioid Side Effects - Aim 2 [Срок оценки: At weeks 1, 2, and 12 after HD, up to ~18 months]
• Opioid Withdrawal symptoms - Aim 2 [Срок оценки: At weeks 1, 2, and 12 after HD, up to ~18 months]
• Opioid Overdose Events - Aim 2 [Срок оценки: At weeks 1, 2, and 12 after HD, up to ~18 months]

Критерии участия

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Montefiore Wakefield Campus — The Bronx

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 29624187

Идентификаторы

NCT: NCT07510373 · 2021-13009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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