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OpenTrials
Completed

NCT Number: NCT06124079

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

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPY interactive messaging service

Other

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.

Standard care

Other

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

Primary outcomes

  1. Opiate use at 14 days

    Time frame: 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.

Secondary outcomes

  1. Number of days between initiation of opioid therapy and opioid-free pain control

    Time frame: 24 months

  2. Interval time between opioid doses

    Time frame: 24 months

  3. Daily pain scores

    Time frame: 24 months

  4. Number and cause of patient initiated outreach events

    Time frame: 24 months

    from the care companion app

  5. Number of MyChart messages

    Time frame: 30 days post-op

  6. Number of Phone notes

    Time frame: 30 days post-op

  7. 90-day Hospitalization Rates

    Time frame: 90 days

  8. Hospital length of stay

    Time frame: 24 months

  9. Repeat Surgery Rates

    Time frame: 24 months

  10. Outpatient encounter Rates

    Time frame: 24 months

  11. Referral rates

    Time frame: 24 months

  12. completion of referral of pain management rates

    Time frame: 24 months

  13. Opiate use rates

    Time frame: 90 and 120 days

  14. OPY utilization

    Time frame: 1,3,7, 14, and 30 days

  15. all-cause mortality

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 9, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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