Efficiency And Quality In Post-Surgical Pain Therapy After Discharge
NCT ID: NCT05221866
Last Updated: 2025-07-01
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
711 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-05-02
Study Completion Date
2023-12-10
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Opioid Use
Opioid Dependence
Opioid Misuse
Post-Surgical Complication
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
The participant-facing app will be trialed prior to and after implementation of a provider-facing prescription intervention using a 2x2 design. 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.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Investigators
Randomization to the participant facing app will be implemented via REDCap. There will be no randomization in regard to the provider-facing intervention.The provider-facing intervention will be turned on once half the subjects are enrolled.
Study Groups
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UControlPain App With Only Data Collection Function (Control)
UControlPain App with only data collection function. No provider-facing prescription intervention.
Group Type
NO_INTERVENTION
No interventions assigned to this group
UControlPain Educational App Only
UControlPain app with education components. No provider-facing prescription intervention.
Group Type
ACTIVE_COMPARATOR
Empowering Patient to Steer Their Pain Management After Surgery
Intervention Type
BEHAVIORAL
Participants will be randomized to receive the consumer health informatics app (UControlPain) versus an app with only data collection function (no educational components) in an intent-to-treat design. Randomization will be implemented via REDCap by the study coordinators so that all investigators will remain blind to group assignment. Further, information on which type of app was installed will not be shared with providers or participants.
UControlPain App and Provider Facing Tool
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.
Group Type
ACTIVE_COMPARATOR
Empowering Patient to Steer Their Pain Management After Surgery
Intervention Type
BEHAVIORAL
Participants will be randomized to receive the consumer health informatics app (UControlPain) versus an app with only data collection function (no educational components) in an intent-to-treat design. Randomization will be implemented via REDCap by the study coordinators so that all investigators will remain blind to group assignment. Further, information on which type of app was installed will not be shared with providers or participants.
Provider-facing Prescription Aid
Intervention Type
BEHAVIORAL
Providers will be given information to inform a participant-centered post-discharge pain management plan. This tool will be activated once half the subjects are enrolled. Participants will be masked when the provider-facing tool is turned on.
Provider Facing Tool Only
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.
Group Type
ACTIVE_COMPARATOR
Provider-facing Prescription Aid
Intervention Type
BEHAVIORAL
Providers will be given information to inform a participant-centered post-discharge pain management plan. This tool will be activated once half the subjects are enrolled. Participants will be masked when the provider-facing tool is turned on.
Interventions
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Empowering Patient to Steer Their Pain Management After Surgery
Participants will be randomized to receive the consumer health informatics app (UControlPain) versus an app with only data collection function (no educational components) in an intent-to-treat design. Randomization will be implemented via REDCap by the study coordinators so that all investigators will remain blind to group assignment. Further, information on which type of app was installed will not be shared with providers or participants.
Intervention Type
BEHAVIORAL
Provider-facing Prescription Aid
Providers will be given information to inform a participant-centered post-discharge pain management plan. This tool will be activated once half the subjects are enrolled. Participants will be masked when the provider-facing tool is turned on.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
19 Years
Maximum Eligible Age
89 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
Sponsor Role
collaborator
University of Nebraska
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Karsten Bartels, MD, PhD, MBA
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Locations
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University of Nebraska Medical Center
Omaha, Nebraska, United States
Site Status
Countries
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United States
References
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DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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0724-21-FB
Identifier Type: -
Identifier Source: org_study_id
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