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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06124079
Enrollment
3442
Registered
2023-11-09
Start date
2025-07-17
Completion date
2025-11-05
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

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.

Interventions

OTHEROPY interactive messaging service

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.

OTHERStandard care

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

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Opiate use at 14 days14 daysOpiate 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

MeasureTime frameDescription
Number of days between initiation of opioid therapy and opioid-free pain control24 months
Interval time between opioid doses24 months
Daily pain scores24 months
Number and cause of patient initiated outreach events24 monthsfrom the care companion app
Number of MyChart messages30 days post-op
Number of Phone notes30 days post-op
90-day Hospitalization Rates90 days
Hospital length of stay24 months
Repeat Surgery Rates24 months
Outpatient encounter Rates24 months
Referral rates24 months
completion of referral of pain management rates24 months
Opiate use rates90 and 120 days
OPY utilization1,3,7, 14, and 30 days
all-cause mortality90 days

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORGenevieve Melton-Meaux, PhD

University of Minnesota

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026