Acute PainNCT06124079
The Implementation of a Post-operative Communication App to Improve Pain Control and Opioid Use
A study testing OPY interactive messaging service in people with Acute Pain, run by University of Minnesota at 1 site in United States.
Trial summary
Digital communication tools are becoming ubiquitous in healthcare, though their impact on patient/provider communication, healthcare utilization, and outcomes remains poorly established. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- What is being tested?
- OPY interactive messaging service
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,442 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2025to 5 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
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.
- Conditions
- Acute Pain
- Being tested
- OPY interactive messaging service, Standard care
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPY interactive messaging serviceOther
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 careOther
Standard care currently consists of education materials with the after visit summary (available in MyChart) around opioid use and precautions and disposal information.
| Study group | Role | What they receive |
|---|---|---|
| standard care | Placebo comparator | Standard care currently consists of education materials with the after visit summary (available in MyChart) around opioid use and precautions and disposal information. Receives: Other: Standard care |
| Interactive messaging service | Experimental | Participants will be randomized to one of 2 specific versions of OPY. Receives: Other: OPY interactive messaging service |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (15)
Number of days between initiation of opioid therapy and opioid-free pain control
Measured: 24 months
Interval time between opioid doses
Measured: 24 months
Daily pain scores
Measured: 24 months
Number and cause of patient initiated outreach events
from the care companion app
Measured: 24 months
Number of MyChart messages
Measured: 30 days post-op
Number of Phone notes
Measured: 30 days post-op
90-day Hospitalization Rates
Measured: 90 days
Hospital length of stay
Measured: 24 months
Repeat Surgery Rates
Measured: 24 months
Outpatient encounter Rates
Measured: 24 months
Referral rates
Measured: 24 months
completion of referral of pain management rates
Measured: 24 months
Opiate use rates
Measured: 90 and 120 days
OPY utilization
Measured: 1,3,7, 14, and 30 days
all-cause mortality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start17 Jul 2025
- Primary completion7 Aug 2025
- Study completion5 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,442 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Genevieve Melton-Meaux, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124079
- Sponsor's protocol ID
- SURG-2023-32217
- Status last verified
- Apr 2026
- First submitted
- 3 Nov 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rizvi RF, Schoephoerster JA, Desphande SS, Usher M, Oien AE, Peters MM, Loth MS, Bahr MW, Ventz S, Koopmeiners JS, Melton GB. Decreasing Opioid Addiction and Diversion Using Behavioral Economics Applied Through a Digital Engagement Solution: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 8;13:e52882. doi: 10.2196/52882.
PubMed 38457203
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implementation of a Post-operative Communication App to Improve Pain Control and Opioid Use
- ClinicalTrials.gov ID
- NCT06124079
- Acronym / sponsor ID
- SURG-2023-32217
- Conditions
- Acute Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,442 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 7 Aug 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care | Placebo comparator | Other: Standard careStandard care currently consists of education materials with the after visit summary (available in MyChart) around opioid use and precautions and disposal information. |
| Interactive messaging service | Experimental | Other: OPY interactive messaging serviceParticipants will be randomized to one of 2 specific versions of OPY. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Surgery at The M Health Fairview Clinics and Surgery Center - Maple Grove (Maple Grove) or M Health Fairview Clinics and Surgery Center - Minneapolis (CSC)
- 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
Key exclusion criteria (9 listed)
- Age < 18
- Chronic opiate use defined as:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPY interactive messaging service2 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. | Other | Interactive messaging service |
| Standard careStandard 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 |
Primary outcome
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.
15 secondary outcomes
Number of days between initiation of opioid therapy and opioid-free pain control
Time frame: 24 months
Interval time between opioid doses
Time frame: 24 months
Daily pain scores
Time frame: 24 months
Number and cause of patient initiated outreach events
Time frame: 24 months
Number of MyChart messages
Time frame: 30 days post-op
Number of Phone notes
Time frame: 30 days post-op
90-day Hospitalization Rates
Time frame: 90 days
Hospital length of stay
Time frame: 24 months
Repeat Surgery Rates
Time frame: 24 months
Outpatient encounter Rates
Time frame: 24 months
Referral rates
Time frame: 24 months
completion of referral of pain management rates
Time frame: 24 months
Opiate use rates
Time frame: 90 and 120 days
OPY utilization
Time frame: 1,3,7, 14, and 30 days
all-cause mortality
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 38457203Rizvi RF, Schoephoerster JA, Desphande SS, Usher M, Oien AE, Peters MM, Loth MS, Bahr MW, Ventz S, Koopmeiners JS, Melton GB. Decreasing Opioid Addiction and Diversion Using Behavioral Economics Applied Through a Digital Engagement Solution: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 8;13:e52882. doi: 10.2196/52882.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Genevieve Melton-Meaux, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPY interactive messaging service in people with Acute Pain, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opiate use at 14 days (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06124079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.