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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Pain

Intervention / Treatment
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* Other: OPY interactive messaging service
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: standard care<br>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<br>* Standard care currently consists of education materials with the after visit summary (available in MyChart) around opioid use and precautions and disposal information.<br>|
| Experimental: Interactive messaging service<br>Participants will be randomized to one of 3 specific versions of OPY. | Other: OPY interactive messaging service<br>* 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.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| all-cause mortality |  | 90 days |