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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03301610
Other study ID # 17-004771
Secondary ID
Status Completed
Phase N/A
First received September 13, 2017
Last updated February 28, 2018
Start date October 23, 2017
Est. completion date February 28, 2018

Study information

Verified date February 2018
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 133
Est. completion date February 28, 2018
Est. primary completion date January 24, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Secondary 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. 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)
Secondary 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. Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Secondary Difference in post-operative opioid requirements 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)
Secondary 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. Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
Secondary Difference in use of non-pharmacologic pain modalities 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)
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