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

Primary Purpose

Opioid Use, Opioid Dependence, Opioid Misuse

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Empowering patient to steer their pain management after surgery
Provider-facing prescription aid
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use

Eligibility Criteria

19 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. >19-89 years old
  2. Access to a smartphone (iOS or Android)
  3. inpatient surgery requiring at least over-night hospitalization with anticipated discharge to home

Exclusion Criteria:

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

Sites / Locations

  • University of Nebraska Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control

UControlPain educational app only

UControlPain app AND provider facing tool

Provider facing tool only

Arm Description

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

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

UControlPain app with education components and provider-facing prescription intervention.

UControlPain App with only data collection function. Provider-facing prescription intervention.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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.
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.
Opioid disposal
Method of disposal of any left-over opioids (if applicable)

Full Information

First Posted
October 26, 2021
Last Updated
September 29, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT05221866
Brief Title
Efficiency And Quality In Post-Surgical Pain Therapy After Discharge
Acronym
EQUIPPED
Official Title
Efficiency And Quality In Post-Surgical Pain Therapy After Discharge
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
November 14, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Opioid Dependence, Opioid Misuse, Post-Surgical Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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
Investigator
Masking Description
Randomization to the patient facing app will be implemented via REDCap. There will be no randomization in regard to the provider-facing intervention.
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
UControlPain App with only data collection function. No provider-facing prescription intervention.
Arm Title
UControlPain educational app only
Arm Type
Active Comparator
Arm Description
UControlPain app with education components. No provider-facing prescription intervention.
Arm Title
UControlPain app AND provider facing tool
Arm Type
Active Comparator
Arm Description
UControlPain app with education components and provider-facing prescription intervention.
Arm Title
Provider facing tool only
Arm Type
Active Comparator
Arm Description
UControlPain App with only data collection function. Provider-facing prescription intervention.
Intervention Type
Behavioral
Intervention Name(s)
Empowering patient to steer their pain management after surgery
Intervention 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, 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.
Intervention Type
Behavioral
Intervention Name(s)
Provider-facing prescription aid
Intervention Description
Providers will be given information to inform a patient-centered post-discharge pain management plan.
Primary Outcome Measure Information:
Title
Cumulative weekly opioid intake after discharge
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pain Assessment-Pain Intensity
Description
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).
Time Frame
4 weeks
Title
Pain Assessment-Pain Interference
Description
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).
Time Frame
4 Weeks
Title
Opioid prescription on day of discharge
Description
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.
Time Frame
4 Weeks
Title
Opioids prescribed from "day of discharge + 1" until 28 days after discharge
Description
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.
Time Frame
4 Weeks
Title
Opioid disposal
Description
Method of disposal of any left-over opioids (if applicable)
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia T Hoffman, MSN, RN
Phone
402-559-8299
Email
jthoffma@unmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel M Harper, BSN, RN
Phone
402-559-2905
Email
raharper@unmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karsten Bartels, MD, PhD, MBA
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karsten Bartels, MD, PhD, MBA
Phone
402-559-4081
Email
karbartels@unmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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Efficiency And Quality In Post-Surgical Pain Therapy After Discharge

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