Clinical trial NCT06124079: The Implementation of a Post-operative Communication App to Improve Pain Control and Opioid Use
Official title: The Implementation of a Post-operative Communication App to Improve Pain Control and Opioid Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Opiate use at 14 days
timeFrame: 14 days
Secondary outcomes:
measure: Number of days between initiation of opioid therapy and opioid-free pain control
timeFrame: 24 months
measure: Interval time between opioid doses
timeFrame: 24 months
measure: Daily pain scores
timeFrame: 24 months
measure: Number and cause of patient initiated outreach events
timeFrame: 24 months
measure: Number of MyChart messages
timeFrame: 30 days post-op
measure: Number of Phone notes
timeFrame: 30 days post-op
measure: 90-day Hospitalization Rates
timeFrame: 90 days
measure: Hospital length of stay
timeFrame: 24 months
measure: Repeat Surgery Rates
timeFrame: 24 months
measure: Outpatient encounter Rates
timeFrame: 24 months
measure: Referral rates
timeFrame: 24 months
measure: completion of referral of pain management rates
timeFrame: 24 months
measure: Opiate use rates
timeFrame: 90 and 120 days
measure: OPY utilization
timeFrame: 1,3,7, 14, and 30 days
measure: all-cause mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Genevieve Melton-Meaux, PhD
role: PRINCIPAL_INVESTIGATOR
References: