Communication App for Post-Operative Pain Control

Overseen By Maya Peters

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must be taking: Opioids

Must not be taking: Long acting opioids

Disqualifiers: Chronic opiate use, Interpreter, others

Compensation: Varies

Number of Visits: Unknown

3500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves patients with active opioid prescriptions, it seems likely that you can continue taking your prescribed opioids.

Is the Communication App for Post-Operative Pain Control safe for use in humans?

The studies reviewed focus on the use of smartphone apps for managing postoperative pain, particularly in children, and suggest that these apps can be used safely to report pain and improve pain management. However, specific safety data for the Communication App for Post-Operative Pain Control itself is not provided. ^{1 2 3 4 5}

How is the Communication App for Post-Operative Pain Control treatment different from other treatments for post-operative pain?

The Communication App for Post-Operative Pain Control is unique because it uses an automated mobile phone messaging platform to communicate with patients after surgery, allowing for remote monitoring and management of pain without direct human intervention. This approach differs from traditional methods by providing continuous, real-time feedback and support, potentially reducing the need for opioids and improving patient outcomes. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment OPY, Epic-Care Companion for post-operative pain control?

Research shows that using mobile health apps and automated messaging can help manage post-operative pain and reduce opioid use. For example, a study found that a digital app combined with enhanced physician rounds reduced pain and opioid consumption after knee surgery. ^{1 7 9 10 11}

Who Is on the Research Team?

Genevieve Melton-Meaux, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for patients who have had outpatient surgery at M Health Fairview Clinics in Maple Grove or Minneapolis, with a new opioid prescription. They must never have used the OPY app before and should be classified as outpatients or same-day surgery patients.

Inclusion Criteria

I have never been part of a trial or taken OPY before.

My surgery is scheduled as an outpatient procedure.

I have been prescribed opioids within the month leading up to my surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-operative Engagement

Participants use the OPY app starting the same day they go home from surgery with a new opioid prescription. The app provides a daily interactive experience to collect pain and side-effect information, provide advice for pain management, and encourage responsible opioid use.

14 days

Daily interaction via app

Follow-up

Participants are monitored for opiate use and patient-initiated outreach events through the care companion app.

24 months

What Are the Treatments Tested in This Trial?

Interventions

• OPY

Trial Overview The study tests an interactive messaging service called OPY against standard care. OPY aims to improve post-surgery pain management and reduce opioid misuse by providing daily advice and behavioral nudges through MyChart's Epic-Care Companion.

How Is the Trial Designed?

Group I: Interactive messaging service Experimental Treatment 1 Intervention

Participants will be randomized to one of 2 specific versions of OPY.

Group II: standard care Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

A mobile phone messaging software robot effectively collected data on postoperative pain and opioid use from 47 patients after common hand surgeries, achieving a high response rate of 88.3%.

Patients reported a decrease in pain levels over the first week post-surgery, with an average consumption of 15.9 opioid tablets, indicating significant opioid use during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an Automated Mobile Phone Messaging Robot in Postoperative Patient Monitoring. Anthony, CA., Lawler, EA., Ward, CM., et al.[2018]

The iCanCope PostOp app was developed using user-centered design principles, incorporating feedback from 19 children, 19 parents, and 32 healthcare providers to address self-management challenges in postoperative pain for children and adolescents.

Key features of the app include pain tracking, self-management strategies, and goal setting, with a comprehensive pain care algorithm created to provide tailored pain management advice, setting the stage for future clinical trials and implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

iCanCope PostOp: User-Centered Design of a Smartphone-Based App for Self-Management of Postoperative Pain in Children and Adolescents. Birnie, KA., Campbell, F., Nguyen, C., et al.[2020]

In a study involving 96 patients undergoing total knee replacement, the combination of an iPad-based application and augmented physician rounds significantly improved postoperative pain relief and reduced opioid consumption compared to standard care.

Patients using the combined approach (APP+DOC) reported greater satisfaction with their treatment and required less oxycodone (72.9 mg) than those receiving standard care (87.9 mg), highlighting the effectiveness of integrating technology in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A digital application and augmented physician rounds reduce postoperative pain and opioid consumption after primary total knee replacement (TKR): a randomized clinical trial. Stuhlreyer, J., Roder, C., Krug, F., et al.[2022]

The mobile health platform Manage My Pain was well-accepted by patients at the Transitional Pain Service, with 67% of participants consenting to use it and 61% completing registration, indicating its potential as a valuable tool for pain self-management.

User retention rates were promising, with 67.9% of users continuing to engage with the app after 30 days and 43.2% after 90 days, suggesting that the app effectively supports ongoing pain monitoring and communication with healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement with Manage My Pain mobile health application among patients at the Transitional Pain Service. Slepian, PM., Peng, M., Janmohamed, T., et al.[2022]

An automated mobile phone messaging system successfully engaged 25 orthopedic trauma patients, achieving an impressive 87.5% response rate for pain and opioid use inquiries over a 2-week period, which is significantly better than traditional communication methods.

Patient-reported pain levels decreased from an average of 4.9 on postoperative day 3 to 3.0 by day 16-17, and opioid consumption dropped from 68% to 35% of the prescribed amount, indicating effective pain management and reduced reliance on opioids post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication with Orthopedic Trauma Patients via an Automated Mobile Phone Messaging Robot. Anthony, CA., Volkmar, AJ., Shah, AS., et al.[2021]

In a study involving 1573 pediatric patients undergoing outpatient surgery, the use of a smartphone app allowed parents to effectively report their child's pain levels, with average pain ratings not exceeding 3/10 during the follow-up period.

The study identified that factors such as age, type of surgery, and preoperative anxiety were linked to higher pain experiences, suggesting that while pain management was generally satisfactory, there is a need for better anxiety management in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A follow-up of pain reported by children undergoing outpatient surgery using a smartphone application: AlgoDARPEF multicenter descriptive prospective study. Walrave, Y., Carles, M., Evain, JN., et al.[2022]

The implementation of a pain management prescribing tool in a multihospital system had a minimal overall impact on opioid prescribing compliance, improving by less than 5% across all specialties.

However, among a subgroup of hand surgeons who actively supported the tool, there was a significant 26% reduction in prescribed morphine milligram equivalents (MMEs) after its introduction, without negatively affecting patient outcomes such as refills, emergency room visits, or readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an Electronic Health Record Pain Medication Prescribing Tool on Opioid Prescriptions for Postoperative Pain in Hand, Orthopedic, Plastic, and Spine Surgery Across a Health Care System. Kearney, AM., Kalainov, DM., Zumpf, KB., et al.[2022]

In a study of 13,389 opioid-free patients who underwent surgery, 9.1% experienced opioid-related adverse drug events (ORADEs) after receiving postoperative opioids, highlighting a significant risk in this population.

Patients with ORADEs faced severe consequences, including 32% higher hospitalization costs, 45% longer hospital stays, and 2.2 times the odds of mortality, emphasizing the need for careful management of opioid use post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Burden of Opioid-Related Adverse Drug Events on Hospitalized Previously Opioid-Free Surgical Patients. Urman, RD., Seger, DL., Fiskio, JM., et al.[2023]

A study of 389 women undergoing minimally invasive gynecologic surgery found that implementing a restrictive opioid prescribing initiative led to an 83% reduction in the amount of opioids prescribed at discharge, without increasing the rate of refill requests or hospital readmissions.

Despite the significant reduction in opioid prescriptions, there were no statistically significant differences in post-discharge symptom burdens, including pain and activity interference, suggesting that lower opioid use does not negatively impact recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal patient-reported outcomes and restrictive opioid prescribing after minimally invasive gynecologic surgery. Hillman, RT., Iniesta, MD., Shi, Q., et al.[2022]

A new cell phone application was developed to help monitor pain, medication use, and quality of life in patients with neurogenic pain, including those with limb loss, which could improve postoperative pain management.

Pilot testing with 21 participants showed that the app is quick to complete (averaging 158 seconds) and user-friendly, indicating its potential as a valuable tool for tracking pain and medication in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell Phone Application to Monitor Pain and Quality of Life in Neurogenic Pain Patients. Sood, R., Stoehr, JR., Janes, LE., et al.[2020]

A study evaluated 12 smartphone apps for self-managing pain, revealing significant differences in their quality, clinical content, and usability, with little user or clinician involvement in their development.

Usability testing showed that users preferred lighter color schemes and specific text fonts, highlighting the need for greater user engagement in app design to improve their effectiveness for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the quality and usability of smartphone apps for pain self-management. Reynoldson, C., Stones, C., Allsop, M., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Use of an Automated Mobile Phone Messaging Robot in Postoperative Patient Monitoring. [2018]

2. Canada pubmed.ncbi.nlm.nih.gov

iCanCope PostOp: User-Centered Design of a Smartphone-Based App for Self-Management of Postoperative Pain in Children and Adolescents. [2020]

3. England pubmed.ncbi.nlm.nih.gov

A digital application and augmented physician rounds reduce postoperative pain and opioid consumption after primary total knee replacement (TKR): a randomized clinical trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Engagement with Manage My Pain mobile health application among patients at the Transitional Pain Service. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Communication with Orthopedic Trauma Patients via an Automated Mobile Phone Messaging Robot. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A follow-up of pain reported by children undergoing outpatient surgery using a smartphone application: AlgoDARPEF multicenter descriptive prospective study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Impact of an Electronic Health Record Pain Medication Prescribing Tool on Opioid Prescriptions for Postoperative Pain in Hand, Orthopedic, Plastic, and Spine Surgery Across a Health Care System. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The Burden of Opioid-Related Adverse Drug Events on Hospitalized Previously Opioid-Free Surgical Patients. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Longitudinal patient-reported outcomes and restrictive opioid prescribing after minimally invasive gynecologic surgery. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Cell Phone Application to Monitor Pain and Quality of Life in Neurogenic Pain Patients. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Assessing the quality and usability of smartphone apps for pain self-management. [2022]