Efficiency And Quality In Post-Surgical Pain Therapy After Discharge

Opioid Use Clinical Trial

— EQUIPPED  

Official title:

Efficiency And Quality In Post-Surgical Pain Therapy After Discharge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05221866
• Other study ID #: 0724-21-FB
• Status: Completed
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: December 10, 2023

Study information

• Verified date: December 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 711
• Est. completion date: December 10, 2023
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid Misuse
• Opioid Use
• Opioid-Related Disorders
• Pain, Postoperative

Intervention

Behavioral:
• Empowering patient to steer their pain management after surgery
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.
• Provider-facing prescription aid
Providers will be given information to inform a patient-centered post-discharge pain management plan.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (89)

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* Note: There are 89 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Opioid disposal	Method of disposal of any left-over opioids (if applicable)	4 Weeks