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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

Tracking Information
First Submitted Date  ICMJE December 1, 2017
First Posted Date  ICMJE December 14, 2017
Last Update Posted Date June 28, 2019
Actual Study Start Date  ICMJE July 11, 2017
Estimated Primary Completion Date January 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03372889 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE On-Q Catheter Caregiver Education
Official Title  ICMJE On-Q Catheter Caregiver Education
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Anterior Cruciate Ligament Injury
  • Pain; Catheter (Other)
  • Satisfaction, Personal
Intervention  ICMJE
  • Behavioral: Patient educaiton materials - Print based
    Print (paper) based materials
    Other Name: Print based
  • Behavioral: Patient educaiton materials - Media based
    Media (electronic) based materials
    Other Name: Media based
Study Arms  ICMJE
  • Active Comparator: Patient educaiton materials Print based
    Patients are randomly assigned to view print based educational material.
    Intervention: Behavioral: Patient educaiton materials - Print based
  • Active Comparator: Patient educaiton materials Media Based
    Patients are randomly assigned to view media based educational material.
    Intervention: Behavioral: Patient educaiton materials - Media based
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 8, 2017)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 16, 2020
Estimated Primary Completion Date January 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alexia G Gagliardi, BA 4062391335 alexia.gagliardi@childrenscolorado.org
Contact: Harin B Parikh, BS harin.parikh@ucdenver.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03372889
Other Study ID Numbers  ICMJE 17-0638
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: undecided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tessa N Mandler, MD Children's Hospital Colorado
PRS Account University of Colorado, Denver
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP