Mobile Educations Effect on Pain Outcomes

Pain, Postoperative Clinical Trial

Official title:

The Impact of Mobile Education Delivery on Postoperative Pain Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03301610
• Other study ID #: 17-004771
• 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
• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Total Joint Arthroplasty

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)