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

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06124079
• Other study ID #: SURG-2023-32217
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: February 2024
• Source: University of Minnesota
• Contact: Maya Peters
• Phone: 612-790-0401
• Email: mayap[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3500
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain

Intervention

Other:
• OPY interactive messaging service
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.
• Standard care
Standard care currently consists of education materials with the after visit summary (available in MyChart) around opioid use and precautions and disposal information.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of days between initiation of opioid therapy and opioid-free pain control		24 months
Secondary	Interval time between opioid doses		24 months
Secondary	Daily pain scores		24 months
Secondary	Number and cause of patient initiated outreach events	from the care companion app	24 months
Secondary	Number of MyChart messages		30 days post-op
Secondary	Number of Phone notes		30 days post-op
Secondary	90-day Hospitalization Rates		90 days
Secondary	Hospital length of stay		24 months
Secondary	Repeat Surgery Rates		24 months
Secondary	Outpatient encounter Rates		24 months
Secondary	Referral rates		24 months
Secondary	completion of referral of pain management rates		24 months
Secondary	Opiate use rates		90 and 120 days
Secondary	OPY utilization		1,3,7, 14, and 30 days
Secondary	all-cause mortality		90 days