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On-Q Catheter Caregiver Education

Primary Purpose

Anterior Cruciate Ligament Injury, Pain; Catheter (Other), Satisfaction, Personal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient educaiton materials - Print based
Patient educaiton materials - Media based
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anterior Cruciate Ligament Injury focused on measuring Anterior Cruciate Ligament, On-Q Catheter, nerve block, ACL reconstruction, patient education materials

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patient educaiton materials Print based

Patient educaiton materials Media Based

Arm Description

Patients are randomly assigned to view print based educational material.

Patients are randomly assigned to view media based educational material.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 1, 2017
Last Updated
April 30, 2021
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03372889
Brief Title
On-Q Catheter Caregiver Education
Official Title
On-Q Catheter Caregiver Education
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
November 5, 2020 (Actual)
Study Completion Date
November 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury, Pain; Catheter (Other), Satisfaction, Personal
Keywords
Anterior Cruciate Ligament, On-Q Catheter, nerve block, ACL reconstruction, patient education materials

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient educaiton materials Print based
Arm Type
Active Comparator
Arm Description
Patients are randomly assigned to view print based educational material.
Arm Title
Patient educaiton materials Media Based
Arm Type
Active Comparator
Arm Description
Patients are randomly assigned to view media based educational material.
Intervention Type
Behavioral
Intervention Name(s)
Patient educaiton materials - Print based
Other Intervention Name(s)
Print based
Intervention Description
Print (paper) based materials
Intervention Type
Behavioral
Intervention Name(s)
Patient educaiton materials - Media based
Other Intervention Name(s)
Media based
Intervention Description
Media (electronic) based materials
Primary Outcome Measure Information:
Title
Patient satisfaction with Patient Education Materials (PEM).
Description
Determine whether one of these forms, print-based PEMs or media-based PEMs, results in greater patient satisfaction versus the other.
Time Frame
Twenty-four to 48 hours post-operatively

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tessa N Mandler, MD
Organizational Affiliation
Children's Hospital Colorado
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
undecided

Learn more about this trial

On-Q Catheter Caregiver Education

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