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
|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|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|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|
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
- 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.
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
|Contact: Alexia G Gagliardi, BAfirstname.lastname@example.org|
|Contact: Harin B Parikh, BSemail@example.com|
|United States, Colorado|
|Children's Hospital Colorado||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Alexia G Gagliardi, BA 406-239-1335 firstname.lastname@example.org|
|Principal Investigator:||Tessa N Mandler, MD||Children's Hospital Colorado|