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Mobile Educations Effect on Pain Outcomes

Primary Purpose

Total Joint Arthroplasty, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Education Delivery
Standard Verbal and Written Education
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Total Joint Arthroplasty focused on measuring Pain Education, Information Delivery, Mobile Application

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mobile Education Delivery

Standard verbal and written education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Difference in self-reported pain scores
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.

Secondary Outcome Measures

Change in pain management knowledge
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.
Difference in self-reported participation in pain management
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.
Difference in post-operative opioid requirements
Total opioid requirements, converted to morphine milligram equivalents
Difference in usefulness of education
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.
Difference in use of non-pharmacologic pain modalities
Results are tabulated for a descriptive selection list for patients to report what interventions were used.

Full Information

First Posted
September 13, 2017
Last Updated
February 28, 2018
Sponsor
Mayo Clinic
Collaborators
George Washington University
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1. Study Identification

Unique Protocol Identification Number
NCT03301610
Brief Title
Mobile Educations Effect on Pain Outcomes
Official Title
The Impact of Mobile Education Delivery on Postoperative Pain Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
January 24, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
George Washington University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Joint Arthroplasty, Pain, Postoperative
Keywords
Pain Education, Information Delivery, Mobile Application

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile Education Delivery
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard verbal and written education
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mobile Education Delivery
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Verbal and Written Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in self-reported pain scores
Description
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.
Time Frame
Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Secondary Outcome Measure Information:
Title
Change in pain management knowledge
Description
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.
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)
Title
Difference in self-reported participation in pain management
Description
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.
Time Frame
Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Title
Difference in post-operative opioid requirements
Description
Total opioid requirements, converted to morphine milligram equivalents
Time Frame
Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Title
Difference in usefulness of education
Description
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.
Time Frame
Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Title
Difference in use of non-pharmacologic pain modalities
Description
Results are tabulated for a descriptive selection list for patients to report what interventions were used.
Time Frame
Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amber M Stitz
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Mobile Educations Effect on Pain Outcomes

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