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

Not Applicable

Recruiting

• Conditions: Acute Pain
• Interventions: Other: Standard care; Other: OPY interactive messaging service

• Registration Number: NCT06124079
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2023-11-03
• Study First Posted: 2023-11-09
• Study Start: 2024-07-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-07-17
• Study Completion: 2026-07-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard care	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.
Interactive messaging service	OPY interactive messaging service	Participants will be randomized to one of 3 specific versions of OPY.

Primary Outcome Measures

Name	Time	Method
Opiate use at 14 days	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 Outcome Measures

Name	Time	Method
Hospital length of stay	24 months
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
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	from the care companion app
Repeat Surgery Rates	24 months
Outpatient encounter Rates	24 months
completion of referral of pain management rates	24 months
all-cause mortality	90 days
Interval time between opioid doses	24 months
Number of MyChart messages	30 days post-op
Referral rates	24 months

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States