On-Q Catheter Caregiver Education

NCT03372889 | Completed

• 1 other identifier: 17-0638
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Anterior Cruciate Ligament; On-Q Catheter; nerve block; ACL reconstruction; patient education materials

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patient educaiton materials Print based

ACTIVE COMPARATOR

Patients are randomly assigned to view print based educational material.

Behavioral: Patient educaiton materials - Print based

Patient educaiton materials Media Based

ACTIVE COMPARATOR

Patients are randomly assigned to view media based educational material.

Behavioral: Patient educaiton materials - Media based

Interventions

Patient educaiton materials - Print based BEHAVIORAL

Print (paper) based materials

Also known as: Print based

Patient educaiton materials Print based

Patient educaiton materials - Media based BEHAVIORAL

Media (electronic) based materials

Also known as: Media based

Patient educaiton materials Media Based

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregivers of patients undergoing ACL repair/reconstruction. These caregivers are registered in the Children's Hospital of Colorado medical record.

You may not qualify if:

• Illiterate or blind individuals

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Tessa N Mandler, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 14, 2017
• Study Start: July 11, 2017
• Primary Completion: November 5, 2020
• Study Completion: November 5, 2020
• Last Updated: May 4, 2021

Record last verified: 2021-04

Locations

US (1)