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?

This trial tests a communication app called OPY (also known as Epic-Care Companion) to help manage post-surgery pain and prevent opioid addiction. The app interacts with patients daily, collecting information about pain and side effects, providing pain management advice, and promoting safe opioid use and disposal. Participants will use one of two versions of OPY or receive standard care, which includes educational materials. Patients who have undergone outpatient surgery at specific M Health Fairview locations and have a new opioid prescription may be suitable for this trial. As an unphased trial, this study allows patients to contribute to innovative pain management solutions.

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.

What prior data suggests that this communication app is safe for post-operative pain control?

Research shows that digital tools like OPY are being tested to help manage opioid use after surgery. These tools aim to improve communication between patients and healthcare providers, potentially reducing the risk of opioid addiction or misuse.

Previous studies on similar digital health tools have shown that patients generally tolerate them well, with no major reports of problems related to their use. This suggests that OPY is likely safe for managing pain after surgery and supporting patients in their recovery.

Although specific safety data on OPY is not yet available, its development and testing focus on enhancing patient care without introducing new risks. This suggests it is likely a safe option for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for post-operative pain, which typically involves education materials and MyChart resources about opioid use, this trial is exploring the potential of OPY, an interactive messaging service. Researchers are excited about this approach because it introduces a digital element aimed at improving communication between patients and healthcare providers regarding pain management. The use of interactive messaging allows for real-time support and personalized guidance, which could lead to more effective pain control and reduced reliance on opioids. This innovative method of engagement may offer a more responsive and tailored experience for patients recovering from surgery.

What evidence suggests that this communication app is effective for post-operative pain control?

Research has shown that digital tools like OPY can help manage opioid use after surgery. In this trial, participants will be randomized to receive one of two specific versions of OPY, an interactive messaging service. Studies have found that OPY supports patients in using opioids safely by encouraging responsible use, gradual reduction, and proper disposal of medications. The app uses interactive features to remind patients to manage their pain effectively without over-relying on opioids. Early findings suggest that these digital tools can lower the risk of addiction and misuse by keeping patients informed and involved in their pain management. While more research is needed, this approach appears promising for improving patient outcomes and reducing opioid-related risks. ^{2 3 4 6 7}

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.

You are receiving treatment as an outpatient or undergoing same-day surgery.

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

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 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]

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]

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 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 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]

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]

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]

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 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]

Citations

1. researchgate.net researchgate.net/publication/378827101_Decreasing_Opioid_Addiction_and_Diversion_Using_Behavioral_Economics_Applied_Through_a_Digital_Engagement_Solution_Protocol_for_a_Randomized_Controlled_Trial

(PDF) Decreasing Opioid Addiction and Diversion Using ... Many apps deliver educational interventions, such as Opioid Management for You (OPY) tool, which aims to facilitate safe opioid use in the ...

2. withpower.com withpower.com/clinical-trials/for-acute-pain

Top Acute Pain Clinical Trials | Power This project will evaluate the effectiveness of a digital, post-operative patient engagement tool (Epic-Care Companion made available through MyChart), OPY, ...

3. researchgate.net researchgate.net/publication/377693705_Development_and_Usability_Evaluation_of_an_Opioid_Management_App

(PDF) Development and Usability Evaluation of an Opioid ... The tool is aimed at engaging patients in positive behaviors surrounding the use, weaning, and disposal of opioid medications in the post-surgical setting.

4. researchprotocols.org researchprotocols.org/2024/1/e52882/

Decreasing Opioid Addiction and Diversion Using ... The primary goal of this project is to evaluate the effect of the 3 versions of the Opioid Management for You (OPY) tool on measures of opioid use relative to ...

5. shrinerschildrens.org shrinerschildrens.org/en/news-and-media/news/2024/10/adolescent-opioid-use

Saving Kids From Addiction Recognizing the need for data to guide safe and effective opioid use in adolescent pain management, Dr. Tumber and colleagues from 10 other ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10960208/

Decreasing Opioid Addiction and Diversion Using ... The primary goal of this project is to evaluate the effect of the 3 versions of the Opioid Management for You (OPY) tool on measures of opioid use relative to ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06469177

Patient Centered Post-Op Pain Management Software Tool ... The goal of this clinical trial is to learn if the Pain Coach App will result in less opioids being prescribed to and used by patients undergoing ...