Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04394559 |
| Other study ID # |
2020P001387 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2, 2021 |
| Est. completion date |
January 1, 2024 |
Study information
| Verified date |
August 2023 |
| Source |
Brigham and Women's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
