PICU Patient Diary

My PICU Diary: a Patient Diary for Critically Ill Children

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Critical Illness

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S4K1
      • McMaster Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients and their families admitted to the PICU at McMaster Children's Hospital

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Karen Choong, MD, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 5843

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No