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On-Q Catheter Caregiver Education

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ClinicalTrials.gov Identifier: NCT03372889
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injury Pain; Catheter (Other) Satisfaction, Personal Behavioral: Patient educaiton materials - Print based Behavioral: Patient educaiton materials - Media based Not Applicable

Detailed 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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Subjects are randomized into one of the following two groups:

Group 1: Print based PEM Group 2: Media based PEM All study outcomes are compared between the two groups.

Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: On-Q Catheter Caregiver Education
Actual Study Start Date : July 11, 2017
Estimated Primary Completion Date : January 15, 2020
Estimated Study Completion Date : January 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Active Comparator: Patient educaiton materials Print based
Patients are randomly assigned to view print based educational material.
Behavioral: Patient educaiton materials - Print based
Print (paper) based materials
Other Name: Print based

Active Comparator: Patient educaiton materials Media Based
Patients are randomly assigned to view media based educational material.
Behavioral: Patient educaiton materials - Media based
Media (electronic) based materials
Other Name: Media based




Primary Outcome Measures :
  1. Patient satisfaction with Patient Education Materials (PEM). [ Time Frame: Twenty-four to 48 hours post-operatively ]
    Determine whether one of these forms, print-based PEMs or media-based PEMs, results in greater patient satisfaction versus the other.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03372889


Contacts
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Contact: Alexia G Gagliardi, BA 4062391335 alexia.gagliardi@childrenscolorado.org
Contact: Harin B Parikh, BS harin.parikh@ucdenver.edu

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Alexia G Gagliardi, BA    406-239-1335    alexia.gagliardi@childrenscolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Tessa N Mandler, MD Children's Hospital Colorado

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03372889     History of Changes
Other Study ID Numbers: 17-0638
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

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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 University of Colorado, Denver:
Anterior Cruciate Ligament
On-Q Catheter
nerve block
ACL reconstruction
patient education materials
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries