On-Q Catheter Caregiver Education

NCT ID: NCT03372889

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-11
• Study Completion Date: 2020-11-05

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patient educaiton materials Print based

Patients are randomly assigned to view print based educational material.

Group Type: ACTIVE_COMPARATOR

Patient educaiton materials - Print based

Intervention Type: BEHAVIORAL

Print (paper) based materials

Patient educaiton materials Media Based

Patients are randomly assigned to view media based educational material.

Group Type: ACTIVE_COMPARATOR

Patient educaiton materials - Media based

Intervention Type: BEHAVIORAL

Media (electronic) based materials

Interventions

Patient educaiton materials - Print based

Print (paper) based materials

Intervention Type: BEHAVIORAL

Patient educaiton materials - Media based

Media (electronic) based materials

Intervention Type: BEHAVIORAL

Other Intervention Names

Print based; Media based

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tessa N Mandler, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

17-0638

Identifier Type: -

Identifier Source: org_study_id