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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Pain
• Intervention / Treatment: Other: Standard care; Other: OPY interactive messaging service

• Study Type: Interventional
• Enrollment (Estimated): 3500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maya Peters; Phone Number: 612-790-0401; Email: mayap@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Other: 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.
Experimental: Interactive messaging service; Participants will be randomized to one of 3 specific versions of OPY.	Other: OPY interactive messaging service; 3 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 three versions differ in the motivational techniques interspersed throughout the OPY experience.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality		90 days
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	from the care companion app	24 months
Number of MyChart messages		30 days post-op
Number of Phone notes		30 days post-op
90-day Hospitalization Rates		90 days
Hospital length of stay		24 months
Repeat Surgery Rates		24 months
Outpatient encounter Rates		24 months
Referral rates		24 months
completion of referral of pain management rates		24 months
Opiate use rates		90 and 120 days
OPY utilization		1,3,7, 14, and 30 days

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Genevieve Melton-Meaux, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: SURG-2023-32217

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No