NCT03301610

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

October 23, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

September 13, 2017

Last Update Submit

February 28, 2018

Conditions

Total Joint ArthroplastyPain, Postoperative

Keywords

Pain EducationInformation DeliveryMobile Application

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in pain management knowledge

    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

    Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)

  • Difference in post-operative opioid requirements

    Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)

  • Difference in usefulness of education

    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

    Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)

Study Arms (2)

Mobile Education Delivery

EXPERIMENTAL

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

Standard verbal and written education

PLACEBO COMPARATOR

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

Interventions

Mobile Education DeliveryOTHER

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.

Mobile Education Delivery
Standard Verbal and Written EducationOTHER

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.

Standard verbal and written education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Amber M Stitz

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nurse Specialist

Study Record Dates

First Submitted

September 13, 2017

First Posted

October 4, 2017

Study Start

October 23, 2017

Primary Completion

January 24, 2018

Study Completion

February 28, 2018

Last Updated

March 1, 2018

Record last verified: 2018-02

Locations

US(1)