Efficiency And Quality In Post-Surgical Pain Therapy After Discharge

Study Overview
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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 research seeks to test a provider-facing decision support tool and a patient-facing smartphone app to reduce the amounts of opioids prescribed and taken following discharge, while ensuring effective treatment of pain after surgery.

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, patients 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 patients.

Official Title
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Efficiency And Quality In Post-Surgical Pain Therapy After Discharge

Conditions
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Opioid Use, Opioid Dependence, Opioid Misuse, Post-Surgical Complication

Intervention / Treatment
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* Behavioral: Empowering patient to steer their pain management after surgery
* Behavioral: Provider-facing prescription aid


Participation Criteria
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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 with anticipated discharge to home Exclusion Criteria: Patients re-hospitalized within 30 days of previous hospitalization Pregnant patients Patients not able to read the English language Patients discharged to a post-acute care facility Patients with contraindications to opioids, acetaminophen, or NSAIDs Patients meeting the AHRQ definition of long-term opioid therapy (opioid use on most days >3 months) prior to surgery.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The patient-facing app will be trialed prior to and after implementation of a provider-facing prescription intervention using a 2x2 design.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>UControlPain App with only data collection function. No provider-facing prescription intervention. | |
| Active Comparator: UControlPain educational app only<br>UControlPain app with education components. No provider-facing prescription intervention. | Behavioral: Empowering patient to steer their pain management after surgery<br>* 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, patients will be randomized to receive the consumer health informatics app (UControlPain) versus provision of 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 patients.<br>|
| Active Comparator: UControlPain app AND provider facing tool<br>UControlPain app with education components and provider-facing prescription intervention. | Behavioral: Empowering patient to steer their pain management after surgery<br>* 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, patients will be randomized to receive the consumer health informatics app (UControlPain) versus provision of 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 patients.<br>Behavioral: Provider-facing prescription aid<br>* Providers will be given information to inform a patient-centered post-discharge pain management plan.<br>|
| Active Comparator: Provider facing tool only<br>UControlPain App with only data collection function. Provider-facing prescription intervention. | Behavioral: Provider-facing prescription aid<br>* Providers will be given information to inform a patient-centered post-discharge pain management plan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative weekly opioid intake after discharge | Opioids reported taken will be recorded by type of opioid, unit, and total amount taken within the first 4 weeks after hospital discharge. To account for different opioid potencies, the cumulative dose of opioids will be expressed in milligram morphine equivalents (MME). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessment-Pain Intensity | The Patient-Reported Outcomes Measurement Information System (PROMIS) will be used to measure pain intensity. On the PROMIS 4-item scale pain intensity scores, higher scores indicating higher pain intensity. All PROMIS scores are analyzed as standardized T-scores (mean=50, SD=10). | 4 weeks | 
| Pain Assessment-Pain Interference | The Patient-Reported Outcomes Measurement Information System (PROMIS) will be used to measure pain interference. On the PROMIS 4-item scale pain interference scores, higher scores indicating higher pain interference. All PROMIS scores are analyzed as standardized T-scores (mean=50, SD=10). | 4 Weeks | 
| Opioid prescription on day of discharge | Opioids prescribed will be recorded by type of opioid, unit dispensed, and total amount dispensed. To account for different opioid potencies, the cumulative dose of opioids will be expressed in milligram morphine equivalents. | 4 Weeks | 
| Opioids prescribed from day of discharge + 1 until 28 days after discharge | To account for opioids prescribed to patients because they run out prematurely, we will calculate opioid prescriptions from day of discharge +1 until 28 days after dis-charge. | 4 Weeks | 
| Opioid disposal | Method of disposal of any left-over opioids (if applicable) | 4 Weeks |