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Mobile Educations Effect on Pain Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03301610
Recruitment Status : Completed
First Posted : October 4, 2017
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
George Washington University
Information provided by (Responsible Party):
Amber M. Stitz, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Total Joint Arthroplasty Pain, Postoperative Other: Mobile Education Delivery Other: Standard Verbal and Written Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: The Impact of Mobile Education Delivery on Postoperative Pain Outcomes
Actual Study Start Date : October 23, 2017
Actual Primary Completion Date : January 24, 2018
Actual Study Completion Date : February 28, 2018

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301610


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
George Washington University
Investigators
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Principal Investigator: Amber M Stitz Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Amber M. Stitz, Mayo Clinic:
Informed Consent Form  [PDF] August 14, 2017


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Responsible Party: Amber M. Stitz, Clinical Nurse Specialist, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03301610    
Other Study ID Numbers: 17-004771
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amber M. Stitz, Mayo Clinic:
Pain Education
Information Delivery
Mobile Application
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms