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Clinical Trials/NCT06124079
NCT06124079
Completed
Not Applicable

The Implementation of a Post-operative Communication App to Improve Pain Control and Opioid Use

University of Minnesota1 site in 1 country3,442 target enrollmentJuly 17, 2025

Overview

Phase
Not Applicable
Intervention
Standard care
Conditions
Acute Pain
Sponsor
University of Minnesota
Enrollment
3442
Locations
1
Primary Endpoint
Opiate use at 14 days
Status
Completed
Last Updated
19 days ago

Overview

Brief Summary

Digital communication tools are becoming ubiquitous in healthcare, though their impact on patient/provider communication, healthcare utilization, and outcomes remains poorly established. M Health Fairview (MHFV) in collaboration with the Center for Learning Health System Sciences (CLHSS) Rapid Eval team will be evaluating one such communication application: OPY, which leverages the Epic-Care Companion functionality to remove barriers in communicating with the patient's care team. This project will evaluate the effectiveness of a digital, post-operative patient engagement tool (Epic-Care Companion made available through MyChart), OPY, which has the goal of preventing patients from becoming addicted to opioids or to suffer from opioid misuse or diversion. In the proposed pragmatic trial, standard care with education available in MyChart and the patient after visit summary will be augmented by OPY. OPY is available to patients starting the same day they go home from surgery with a new opioid prescription. OPY provides a daily interactive experience that collects patient pain and side-effect information, provides advice for pain management, and uses behavioral "nudges" to encourage timely weaning and responsible disposal of opioid medications. The primary goal of this project is to evaluate the effect of two versions of OPY on measures of opiate use relative to the standard of care in a pragmatic randomized controlled trial.

Registry
clinicaltrials.gov
Start Date
July 17, 2025
End Date
November 5, 2025
Last Updated
19 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Surgery at The M Health Fairview Clinics and Surgery Center - Maple Grove (Maple Grove) or M Health Fairview Clinics and Surgery Center - Minneapolis (CSC)
  • ▪ Currently, only outpatient surgeries are performed at CSC and Maple Grove
  • Active opioid prescription (prescribed between 30 days prior to surgery, until day of surgery)
  • Patient class (outpatient or same day surgery)
  • Never previously randomized or exposed to OPY

Exclusion Criteria

  • Age \< 18
  • Chronic opiate use defined as:
  • Patients aged 18 and older and
  • 3 or more opioid dispensing events, in the last 12 months with at least 1 of these events in the last 6 months.
  • Any long acting opioid prescription in the last 6 months
  • Interpreter needed - YES selected (EPT840)
  • Patient has a Health Proxy (Legal Guardian) designated in Epic
  • Patients who have opted out of clinical research
  • Patients with an active palliative care referral

Arms & Interventions

standard care

Standard care currently consists of education materials with the after visit summary (available in MyChart) around opioid use and precautions and disposal information.

Intervention: Standard care

Interactive messaging service

Participants will be randomized to one of 2 specific versions of OPY.

Intervention: OPY interactive messaging service

Outcomes

Primary Outcomes

Opiate use at 14 days

Time Frame: 14 days

Opiate use at 14 days is defined as any active opioid script on day 14 post surgery. This information will be collected from the electronic health record.

Secondary Outcomes

  • Daily pain scores(24 months)
  • Number of Phone notes(30 days post-op)
  • 90-day Hospitalization Rates(90 days)
  • Opiate use rates(90 and 120 days)
  • OPY utilization(1,3,7, 14, and 30 days)
  • Hospital length of stay(24 months)
  • Number of days between initiation of opioid therapy and opioid-free pain control(24 months)
  • Number and cause of patient initiated outreach events(24 months)
  • Repeat Surgery Rates(24 months)
  • Outpatient encounter Rates(24 months)
  • completion of referral of pain management rates(24 months)
  • all-cause mortality(90 days)
  • Referral rates(24 months)
  • Interval time between opioid doses(24 months)
  • Number of MyChart messages(30 days post-op)

Study Sites (1)

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