Clinical trial NCT03372889: On-Q Catheter Caregiver Education
Official title: On-Q Catheter Caregiver Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Pain; Catheter (Other)
Satisfaction, Personal
Keywords: Anterior Cruciate Ligament
On-Q Catheter
nerve block
ACL reconstruction
patient education materials
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 178
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Patient satisfaction with Patient Education Materials (PEM).
timeFrame: Twenty-four to 48 hours post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Tessa N Mandler, MD
role: PRINCIPAL_INVESTIGATOR
References: