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

NCT06124079 | Completed

• 1 other identifier: SURG-2023-32217
• Study Type: interventional
• Target: 3,442
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Opiate use at 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.

  14 days

Secondary Outcomes (15)

• Number of days between initiation of opioid therapy and opioid-free pain control

  24 months

• Interval time between opioid doses

  24 months

• Daily pain scores

  24 months

• Number and cause of patient initiated outreach events

  24 months

• Number of MyChart messages

  30 days post-op

Study Arms (2)

standard care

PLACEBO COMPARATOR

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

Other: Standard care

Interactive messaging service

EXPERIMENTAL

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

Other: OPY interactive messaging service

Interventions

Standard care OTHER

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

standard care

OPY interactive messaging service OTHER

2 specific versions of OPY. information. Each version will deliver the same instructions and information about pain management recommendations, and collect the same information about patient pain experience and side effects. The two versions differ in the motivational techniques interspersed throughout the OPY experience.

Interactive messaging service

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 18
• Chronic opiate use defined as:
• Patients aged 18 and older and
• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (1)

• Rizvi RF, Schoephoerster JA, Desphande SS, Usher M, Oien AE, Peters MM, Loth MS, Bahr MW, Ventz S, Koopmeiners JS, Melton GB. Decreasing Opioid Addiction and Diversion Using Behavioral Economics Applied Through a Digital Engagement Solution: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 8;13:e52882. doi: 10.2196/52882.

  PMID: 38457203 DERIVED

MeSH Terms

Conditions

Acute Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Genevieve Melton-Meaux, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 9, 2023
• Study Start: July 17, 2025
• Primary Completion: August 7, 2025
• Study Completion: November 5, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)