PICU Patient Diary

Critical Illness Clinical Trial

Official title:

My PICU Diary: a Patient Diary for Critically Ill Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03777527
• Other study ID #: 5843
• Status: Active, not recruiting
• Start date: October 30, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2021
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The PICU-Diary study is a prospective single centre pilot study in the Pediatric Critical Care Unit at McMaster Children's Hospital. We will evaluate the impressions of family caregivers and healthcare providers on the PICU Patient Diary, and its acceptability for use in the PICU, using mixed methods. We will assess the feasibility of assessing the impact of a patient diary on PICU outcomes and psychological distress in critically ill children, 1 month following PICU discharge.

Description:

There is considerable need for research dedicated to exploring interventions to improve the psychological and functional effects of critical care admission on patients and families. Patient diaries are one approach that has been used in several adult critical care groups and has been shown to positively impact patient care by helping patients better understand their illness, acting as a therapeutic tool and debriefing aid, and providing an outlet for caregivers to participate in care plans. However, to date, there is minimal research available in the pediatric population.

The specific objectives of this study are to evaluate the acceptability and impressions of a patient diary as a supportive measure for critically ill children in the PICU. Our secondary objective is to evaluate the feasibility of measuring the impact of a patient diary on psychological distress in critically ill children, following discharge from the PICU.

The purpose of this diary is to support the recovery of critically ill children and their family members by:

1. Helping patients understand visually and in written form as age appropriate, what has happened to them during their PICU stay, how ill they were, and in so doing, reduce anxiety and post-traumatic stress symptoms; AND

2. Serving as an engagement tool to help families take on an informed, active role in their child's care plan.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Consecutive patients admitted to the PICU will be screened for eligibility to participate in the evaluation component of the PICU Diary study

• We will offer a PICU Diary to families of any critically ill children admitted to the PICU for at least 72 hours and who are fluent in the English language

• Eligible patients and their families will be approached for consent to participate, by a member of the investigator team (MB, KC, SB or CC). For those who consent to participate, they will be oriented to the diary and its use.

Exclusion Criteria:

• Stay less than 72 hours

• Not fluent in the English language

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Diary Acceptability	Acceptability of the diary to family members, patients, and healthcare providers in the PICU to determine the perception of impact of the diary on patient recovery. Information collected with surveys and qualitative interviews.	1 day
Primary	Feasability of measuring psychological well-being	Patient reported outcome measure of psychological well-being after critical illness with Children's Critical Illness Impact Scale	1 day