On-Q Catheter Caregiver Education | NCT03372889

Studies
On-Q Catheter Caregiver Education

NCT03372889

Sponsor

University of Colorado, Denver

Status

Completed

Last Update Posted

May 4, 2021Actual

Enrollment

178Actual

Phase

Not Applicable

Conditions

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

Interventions

Patient educaiton materials - Print based
Patient educaiton materials - Media based

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 11, 2017Actual

Primary Completion Date

Nov 5, 2020Actual

Completion Date

Nov 5, 2020Actual

First Submitted Date

Dec 1, 2017

First Submission Date that Met QC Criteria

Dec 8, 2017

First Posted Date

Dec 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2021

Last Update Posted Date

May 4, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

178Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Patient educaiton materials - Print based	Behavioral	Print (paper) based materials	Patient educaiton materials Print based

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tessa N Mandler, MD	Children's Hospital Colorado	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Colorado		Aurora	Colorado	80045	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

undecided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070598	Anterior Cruciate Ligament Injuries
D010146	Pain
D010549	Personal Satisfaction

Ancestor Terms

ID	Term
D007718	Knee Injuries
D007869	Leg Injuries
D014947	Wounds and Injuries
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

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.