Clinical trial NCT03301610: Mobile Educations Effect on Pain Outcomes
Official title: The Impact of Mobile Education Delivery on Postoperative Pain Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Joint Arthroplasty
Pain, Postoperative
Keywords: Pain Education
Information Delivery
Mobile Application
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: George Washington University
First posted: 2017-10-04
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This prospective study has been designed as quasi-experimental study. This study seeks to explore both a treatment and control group in efforts to compare outcomes which are dependent on the type of intervention. Study participants will be assigned into one of two study arms, intervention or control, based on random assignment determined by the location they are bedded in hospital. One of two patient care units will offer standard education, the other unit will offer the mobile, iPad based education. The patient care unit to offer the mobile, iPad based education will be selected at random.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to explore the clinical impact of pain management education using a mobile web-based education delivery system compared to standard education delivery. This study seeks to understand the difference between two different education delivery methodologies and the effect on the postoperative pain experience, including participation in treatment plan, knowledge, pain outcomes, and opioid requirements in patients undergoing major hip (THA) and knee (TKA) arthroplasty. It is hypothesized that a real-time, interactive, mobile education system will demonstrate improved pain associated outcomes and higher patient participation when compared to the current standard education delivery method.


Eligibility criteria: Inclusion:

* Adult patients
* over the age of 18 years
* undergoing surgical intervention and inpatient care for one of the following procedures:
* total hip arthroplasty (THA) (primary, bilateral, and revision)
* total knee arthroplasty (TKA) (primary, bilateral, unicompartmental, and revision)
* Fluent in the English language

Exclusion:

* Undergoing more complex hip and knee procedures such as:
* implant resections with or without spacer placement
* liner exchange
* THA or unipolar hip arthroplasty related to repair of hip fracture.
* Preexisting physical or cognitive limitations that would hinder their ability to use the mobile application

Primary outcomes:
measure: Difference in self-reported pain scores
timeFrame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Secondary outcomes:
measure: Change in pain management knowledge
timeFrame: Pre-intervention (between 1 and 5 days before surgical procedure) and post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
measure: Difference in self-reported participation in pain management
timeFrame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
measure: Difference in post-operative opioid requirements
timeFrame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
measure: Difference in usefulness of education
timeFrame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
measure: Difference in use of non-pharmacologic pain modalities
timeFrame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amber M Stitz
role: PRINCIPAL_INVESTIGATOR
References: