Prevention of Opioid Use Disorder After Surgery
Prevention of Opioid Use Disorder After Surgery
The objective of this study is to design, implement, and pilot test a multi-faceted
 intervention to support safer opioid prescribing, self-administration, and monitoring and
 reduce persistent opioid use and opioid use disorder for patients transitioning to the
 community setting after major orthopedic surgery. The multi-faceted intervention includes: 1)
 communication with outpatient providers and counseling of patients and caregivers at hospital
 discharge; 2) standardized opioid prescribing discharge order sets for each type of surgery;
 3) an outpatient pain management follow-up visit embedded within routine post-operative care
 for managing pain and opioid use, and 4) a mobile patient-reported outcomes application for
 assessing pain, function, and possible development of opioid use disorder (OUD). The primary
 outcome will be persistent opioid use (in the 6 months after surgery) based on state-wide
 prescription data. Secondary outcomes will include the total morphine-equivalent dose of
 opioids prescribed at discharge; total post-operative opioids dispensed in the 6 months after
 surgery; and self-reported opioid misuse, pain and function 90 and 180 days after surgery.
In this study, we will enroll patients who are both opioid-naïve and non-naïve who have
 undergone orthopedic surgery. To minimize contamination and best evaluate implementation, we
 will conduct a before-after study. The intervention will consist of four main components: 1)
 pharmacist-led discharge counseling and communication, 2) discharge order sets, 3)
 post-discharge pain management follow-up visits; and 4) a patient engagement pain management
 app. The intervention will last for 6 months following hospital discharge. We plan to enroll
 270 patients over a 6-month period to demonstrate the feasibility of the intervention and
 provide reasonable precision on an effect size to inform power calculations on a subsequent
 larger scale clinical trial. During implementation, we will measure intervention fidelity and
 conduct qualitative interviews of stakeholders regarding facilitators and barriers to
 implementation. Throughout the study, we will engage a patient-family advisory council, other
 stakeholders, and a Steering Committee and Working Group to guide development and refinement
 of the intervention, execution of the implementation and evaluation plan, and the
 communication plan.

 Specific Aims:

 -  Aim 1: To design and implement a multi-faceted intervention (MOPP) to minimize
 persistent post-operative opioid use while providing adequate analgesia in patients who
 are status post major orthopedic surgery.

 -  Aim 2: To pilot test and evaluate the efficacy of MOPP on preventing persistent
 postoperative opioid use while maintaining adequate analgesia and functional status.

 -  Aim 3: To evaluate the feasibility and the success of implementation of MOPP and
 identify barriers to and facilitators of implementation by using mixed methods and the
 Consolidated Framework for Implementation Research (CFIR).

 In the first 3 months of the study, patients will be assigned to usual care, including 1)
 multimodal analgesia after surgery; 2) unit-based pharmacists as available to monitor the
 appropriateness of inpatient medication orders, including opioids; 3) the standard discharge
 medication reconciliation module in the electronic health record (EHR) that compares
 preadmission and current inpatient medications to facilitate writing of safe medication
 orders; 4) general guidelines to limit the dose and duration of discharge opioids and to
 council patients about tapering opioids at home and to stop them by 4-6 weeks
 post-operatively unless instructed otherwise; and 5) standard follow-up in the outpatient
 orthopedics clinic within a time frame judged to be appropriate by each inpatient team. In
 months 4-6 of the study, patients will be assigned to the intervention. The intervention,
 which we will refer to as MOPP, will consist of four complementary components, as explained
 below. Each of these is in addition to usual care, as described above.

 1. Pharmacist-Led Discharge Counseling and Communication: Based on previously designed and
 evaluated interventions, an inpatient pharmacist will visit each intervention patient on
 two occasions: 1) An initial intake visit to screen for previous barriers to safe
 medication use, including lack of understanding of medication regimens, non-adherence,
 previous side effects, prior substance use disorder or current misuse of substances
 other than opioids, and lack of monitoring; 2) Prior to discharge and after the
 discharge opioid regimen has been determined, to provide counseling regarding safe
 medication use after discharge, address any of the barriers identified from the intake
 visit, and specifically cover several topics related to safe opioid use.

 2. Discharge Order Sets: One of the challenges to opioid safety following surgery is the
 large variation in the dose and duration of opioids prescribed at hospital discharge.
 Therefore, the first step in developing a discharge order set will be generating
 consensus among the orthopedic surgeons for a recommended dose and duration of opioids
 for each commonly performed orthopedic surgery. Following this standardization process,
 we will work with Partners Information Systems to create a discharge order set for all
 orthopedic patients. It will include embedded decision support where providers can enter
 the orthopedic surgery type and receive the recommended discharge opioid regimen.
 Ordering providers will still be able to prescribe doses, frequencies, and durations
 other than the recommended amount, but the order set will provide a default.

 3. Post-Discharge Pain Management Follow-Up: We've chosen to utilize a clinical pharmacist
 trained in the principles of safe opioid use and pain management to serve as the
 outpatient pain management follow-up clinician. Follow-up will take place in the
 outpatient orthopedics department so that patients can see this follow-up clinician as
 part of already scheduled visits with the orthopedic surgeon and staff after returning
 home. During the initial post-discharge visit, the focus will be on pain control,
 functional status, use of opioids and other analgesics, and screening for any possible
 misuse of opioids. Based on this information, the pharmacist will work with the
 patient's orthopedist on an action plan, including changes to the patient's opioid
 regimen, plans for tapers or discontinuation, etc. If there are concerns for development
 of OUD, then proper referrals and communication will be made to the outpatient addiction
 psychiatry service. Finally, additional office visits and/or follow-up phone calls will
 be scheduled as needed. We will maintain an electronic registry of all the patients in
 the intervention arm so the outpatient pharmacist can track all patients who may have
 been lost to follow-up, readmitted to the hospital, or have concerning opioid orders,
 and intervene as necessary.

 4. Patient Engagement Pain Management App: Based on the version already created for
 patients with chronic opioid use, the app will be designed to collect and communicate
 patient-reported outcomes regarding pain management after discharge. Using the app,
 patients will be able to rate their current pain, including its effects on sleep,
 function, and mood, and whether their pain is improving or getting worse. We also plan
 to link the app to the patient's currently prescribed analgesic regimen so that patients
 can quickly record how they are taking their medications (compared with how they are
 prescribed). Patients will also have the ability to securely communicate with their
 outpatient pain management pharmacist for concerns or questions. The research staff will
 check the server daily for 2-way messages and link the data to the electronic medical
 record. Other modifications, including a Spanish version and changes unique to this
 post-orthopedic surgery patient population, will be made during the first 9 months of
 the study period based on user input and pilot testing.
Inclusion Criteria:

 -  Adult patients admitted to orthopedic surgical services at Brigham and Women's
 Hospital during the 6 month enrollment period

 -  English or Spanish speakers

 -  Live in Massachusetts

 -  Patients who are and are not opioid-naïve for 30 days prior to admission based on
 their verified preadmission medication list and state-wide opioid prescription
 information.

 -  Undergo one of several designated orthopedic surgeries, including trauma and
 arthroplasty surgeries.

 -  Age 18 or older

 -  Clinical discharge plan to home or short-term rehabilitation facility.

 Exclusion Criteria:

 -  Not pregnant women, prisoners or institutionalized individuals

 -  Under the age of 18

 -  Current illicit opioid use.

 -  Patient is unable to provide informed consent.

 -  Plan to be discharged to an acute care facility.

 -  Patient requires a second surgery or has medical condition requiring opioid use during
 the 6-month follow-up period.