Video Training Supplementation for Patients Discharged on Home Parental Nutrition

NCT ID: NCT06169774

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2027-01-15

Brief Summary

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The goal of this clinical trial is to develop an educational video addressing the aseptic techniques to safely handle central catheters for administrating parenteral nutrition at home.

Detailed Description

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Home parenteral nutrition is an alternative form of providing nutrition to people whose digestive systems either can't absorb or tolerate food eaten by mouth. Parenteral nutrition provides liquid nutrients, including carbohydrates, proteins, fats, vitamins, minerals and electrolytes. In recent years, more emphasis has been placed on delivering parenteral nutrition to patients at home. Studies have shown that patients receiving home parenteral nutrition are at higher risk for bloodstream infections compared to other patients with chronic infusion needs. Catheter-related bloodstream infection is a major cause of mortality and morbidity in patients receiving parenteral nutrition. It is important to maintain safe vascular access to prevent life-threatening complications. This study aims to assess the effectiveness of the video training on the rate of catheter related bloodstream infection over a 12-month period of time.

Conditions

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Intestinal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Educational video

Participants will be asked to watch an education video addressing aseptic techniques to safely handle central catheters at home during parenteral nutrition infusions.

Group Type EXPERIMENTAL

Educational video

Intervention Type OTHER

Watch the 17-minute educational video as many times as needed within a 12-month period.

No educational video

Participants will be managed according to routine care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Educational video

Watch the 17-minute educational video as many times as needed within a 12-month period.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Taking home parenteral nutrition for the first time
* Willing to self-administer parenteral nutrition
* Age ≥ 18 yrs
* Able to provide informed consent
* Able speak and understand English

Exclusion Criteria

* Already taking home parenteral nutrition
* not willing to self-administer parenteral nutrition
* Age \< 18 years-old
* Unable to provide informed consent
* Non-English speakers
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dejan Micic, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dejan Micic, MD

Role: CONTACT

(773) 702-6140

Kristi Kearney, MD

Role: CONTACT

773-834-7414

Facility Contacts

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Dejan Micic, MD

Role: primary

773-702-6140

Kristi Kearney, RN

Role: backup

773-834-7414

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB23-1285

Identifier Type: -

Identifier Source: org_study_id

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