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

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Begins enrollment this month

Conditions

Acute Pain

Treatments

Other: OPY interactive messaging service
Other: Standard care

Study type

Interventional

Funder types

Other

Identifiers

NCT06124079
SURG-2023-32217

Details and patient eligibility

About

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 three versions of OPY on measures of opiate use relative to the standard of care in a pragmatic randomized controlled trial.

Enrollment

3,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

3,500 participants in 2 patient groups, including a placebo group

standard care
Placebo Comparator group
Description:
Standard care currently consists of education materials with the after visit summary (available in MyChart) around opioid use and precautions and disposal information.
Treatment:
Other: Standard care
Interactive messaging service
Experimental group
Description:
Participants will be randomized to one of 3 specific versions of OPY.
Treatment:
Other: OPY interactive messaging service

Trial contacts and locations

0

Loading...

Central trial contact

Maya Peters

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems