Mobile Educations Effect on Pain Outcomes

February 28, 2018 updated by: Amber M. Stitz, Mayo Clinic

The Impact of Mobile Education Delivery on Postoperative Pain Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile Education Delivery
The participants in the study arm will receive comprehensive pain management education delivered using mobile iPads at the point of care. The mobile based education modules will be inclusive of the use of the pain rating scale and assessment of pain; communication with healthcare providers; daily expectations for pain and pain management; pharmacologic and non-pharmacologic treatment options; medication side effects and safety; and discharge instructions including safe handling of opioids, disposal, tapering, and when to call the provider. It will also include an interactive pain and discomfort menu, knowledge based questions, and medication tracking log.
Other: Mobile Education Delivery
Patients will be provided with an iPad on admission to the post-surgical unit and will remain with the patient until discharge. The patient, independently or with the nurse, may use the program at any point during the inpatient care experience. The RN will use the iPad to engage patients in their pain management.
Placebo Comparator: Standard verbal and written education
The control group will receive the current standard of care which consists of verbal instruction and pain management educational pamphlets. At a minimum, the patients will receive two educational pamphlets titled Your Pain and Discomfort Management Menu and Communicating About Your Pain. Verbal instruction is nurse dependent. At a minimum the nurse will provide the two pamphlets to the patient and follow-up with the patient to address any questions.
Other: Standard Verbal and Written Education
Patients will be provided with two pamphlets on pain management on admission to the post-surgical unit. Nurses will follow-up with verbal instruction based on patient need. This will continue through hospital stay. Additional printed education materials are available through the department of patient education and verbal instruction may be tailored based on nursing assessment and patient need.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in self-reported pain scores
Time Frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Scores are measured using a 10 point (Lickert) pain rating scale. The scale ranges from 0 to 10 with the lower score indicating less pain and the higher score indicating greater pain.
Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain management knowledge
Time Frame: 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)
Scores are measured using a modified Patient Pain Questionnaire; 9 knowledge based questions use a ten-point (0-10) ordinal scale to assess patients' agreement or disagreement with specific statements. All items have been formatted so that zero indicates the most positive outcome and a ten indicates the most negative outcome.
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)
Difference in self-reported participation in pain management
Time Frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Scores are measured using a 10 point Lickert scale measuring patients perception of participation in pain management/treatment decisions. The scale ranges from 0 to 10 with the lower score indicating less perceived participation and the higher score indicating greater perceived participation.
Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Difference in post-operative opioid requirements
Time Frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Total opioid requirements, converted to morphine milligram equivalents
Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Difference in usefulness of education
Time Frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Scores are measured using a 10 point Lickert rating scale. The scale ranges from 0 to 10 with the lower score indicating lower perceived usefulness and the higher score indicating greater perceived usefulness.
Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Difference in use of non-pharmacologic pain modalities
Time Frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Results are tabulated for a descriptive selection list for patients to report what interventions were used.
Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

George Washington University

Investigators

  • Principal Investigator: Amber M Stitz, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2017

Primary Completion (Actual)

January 24, 2018

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

October 3, 2017

First Posted (Actual)

October 4, 2017

Study Record Updates

Last Update Posted (Actual)

March 1, 2018

Last Update Submitted That Met QC Criteria

February 28, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-004771

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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