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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03372889
Other study ID # 17-0638
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 11, 2017
Est. completion date November 5, 2020

Study information

Verified date April 2021
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present study aims to compare caregiver satisfaction and efficacy between two modes of patient education materials (PEMs): media based and print based. The caregivers of patient's who undergo ACL (anterior cruciate ligament) reconstruction surgery and receive an On-Q Catheter pain block receive both a hand-out (print based PEM) and watch a short video (media-based PEM) describing how to care for their child's On-Q Catheter at home. Upon enrollment into the study, caregivers are randomly assigned to either first view the hand-out or the video, then complete a 10 questions standardized assessment of information that was presented in the PEMs. Caregivers are called the next day to assess caregiver satisfaction with the PEMs, which mode of PEM was more helpful to them, and how comfortable they felt managing their child's pain pump at home.


Description:

The present study aims to compare the efficacy and caregiver satisfaction between two modes of patient education materials (PEMs): media based and print based. The PEMs are designed to education caregivers on how to manage their child's On-Q catheter pain block at home. After caregivers have enrolled in the study and have been randomized to an education group, study interventions take place in the private family waiting room. Immediately after viewing their assigned PEM, the caregiver completes a 10 question standardized assessment, formatted as a multiple-choice quiz, of their understanding and knowledge of the information conveyed in both modes of PEM. The following day, caregivers are contacted by phone call to answer a number of questions to assess their satisfaction with the PEMs they received, the mode of PEM they preferred, and how comfortable they felt managing their child's pain pump at home. All information is stored in a secure database (REDCap).


Recruitment information / eligibility

Status Completed
Enrollment 178
Est. completion date November 5, 2020
Est. primary completion date November 5, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Caregivers of patients undergoing ACL repair/reconstruction. These caregivers are registered in the Children's Hospital of Colorado medical record. Exclusion Criteria: - Illiterate or blind individuals

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Patient educaiton materials - Print based
Print (paper) based materials
Patient educaiton materials - Media based
Media (electronic) based materials

Locations

Country Name City State
United States Children's Hospital Colorado Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient satisfaction with Patient Education Materials (PEM). Determine whether one of these forms, print-based PEMs or media-based PEMs, results in greater patient satisfaction versus the other. Twenty-four to 48 hours post-operatively
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