Efficiency And Quality In Post-Surgical Pain Therapy After Discharge (EQUIPPED)

University of Nebraska

Status: Completed

Conditions: Opioid Use; Post-Surgical Complication; Opioid Misuse; Opioid Dependence

Treatments: Behavioral: Provider-facing Prescription Aid; Behavioral: Empowering Patient to Steer Their Pain Management After Surgery

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05221866

0724-21-FB

Details and patient eligibility

About

Following inpatient surgery, more than 80% of patients are prescribed opioids for use after discharge, yet up to 90% of patients report leftover opioids, and only 16% maximize non-opioid therapy. The proposed study seeks to test a provider-facing decision support tool and a participant-facing smartphone app to reduce the amount of opioids prescribed and taken following discharge, while ensuring effective treatment of pain after surgery. Adult participants with smart phones having had inpatient surgery requiring at least over-night hospitalization with anticipated discharge to home will be randomized to one of the two groups. Study measurements will include self-reported cumulative amounts of opioids taken after discharge, non-opioid analgesic taken, prescribed post-discharge opioid doses in morphine milligram equivalents (MME), pain intensity and pain interference scores (PROMIS), need for additional opioid prescriptions within one-month post-discharge, as well as any self-reported disposal of leftover medications.

Full description

Prior to discharge from the hospital, patients will be approached regarding interest in the study with an introductory letter that describes the content and purpose of the study. Following informed consent, participants will be randomized to receive the consumer health informatics app (UControlPain) versus provision of an app with only data collection function (no educational components). Randomization will be implemented via REDCap by the study coordinators. Further, information on which type of app was installed will not be shared with providers or participants.

During the second half of the trial, a provider-facing electronic decision support tool will be activated. This will create a 2:2 design to test the provider-facing tool. Four arms will be described: the UControlPain App with Only data collection, the UControlPain Educational app only, the UControlPain App and provider-facing tool, and the UControlPain App with only data collection function and provider-facing tool. Once half of the subjects are enrolled, the provider-facing tool will be turned on.

Enrollment: 711 patients

Sex: All

Ages: 19 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 19-89 years old
• Access to a smartphone (iOS or Android)
• Inpatient surgery requiring at least over-night hospitalization and anticipated discharge to home

Exclusion criteria

• Re-hospitalization within 30 days
• Pregnant
• Unable to read the English language
• Discharge to a post-acute care facility
• Contraindications to opioids, acetaminophen, or NSAIDs
• Long-term opioid therapy (AHRQ definition - opioid use on most days >3 months) prior to surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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711 participants in 4 patient groups

UControlPain App With Only Data Collection Function (Control)

No Intervention group

Description:

UControlPain App with only data collection function. No provider-facing prescription intervention.

UControlPain Educational App Only

Active Comparator group

Description:

UControlPain app with education components. No provider-facing prescription intervention.

Treatment:

Behavioral: Empowering Patient to Steer Their Pain Management After Surgery

UControlPain App and Provider Facing Tool

Active Comparator group

Description:

UControlPain app with education components and provider-facing prescription intervention. Once half of the subjects are enrolled, the provider-facing tool will be turned on. Participants will be masked to when the provider-facing tool is activated.

Treatment:

Behavioral: Empowering Patient to Steer Their Pain Management After Surgery

Behavioral: Provider-facing Prescription Aid

Provider Facing Tool Only

Active Comparator group

Description:

UControlPain App with only data collection function. Provider-facing prescription intervention. Once half of the subjects are enrolled, the provider-facing tool will be turned on. Participants will be masked to when the provider-facing tool is activated.

Treatment:

Behavioral: Provider-facing Prescription Aid