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The Family-ICU Trial

NCT ID: NCT06586541

Last Updated: 2024-12-20

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

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-18

Study Completion Date

2027-09-30

Brief Summary

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Family inclusion in adult intensive care unit (ICU) rounds is recommended by critical care professional societies, yet widespread uptake of this practice is limited. A key barrier cited by ICU clinicians is insufficient evidence to support this practice. There is a need for robust evidence to support family participation in adult ICU rounds and influence change to routine clinical care. The primary purpose of this study is to assess whether family participation in adult ICU rounds improves family engagement in care. The secondary objectives are to assess family satisfaction, and anxiety and depression, to explore user experiences of family participation in ICU rounds, and to evaluate strategies to improve family member recruitment and retention rates. This is a stepped-wedge cluster randomized trial (n=194) at 6 Canadian ICUs. The stepped wedge cluster randomized trial is a pragmatic study design that overcomes methodological limitations in evaluating a healthcare service delivery intervention. In the stepped-wedge cluster design, there is random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The stepped-wedge design also allows each site to function as its own control. The stepped-wedge design is more powerful than a parallel design when substantial cluster level effects are present.

Detailed Description

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Conditions

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Virtual Care Family Engagement Patient and Family Engagement Health Care Delivery Family-centered Care Physician Rounds Critical Care, Intensive Care

Keywords

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Patient- and Family-Centered Patient- and Family-Centered Care Family Engagement Critical Care Intensive Care Unit Person-Centered Care Delivery of Health Care Virtual Rounds Family Participation in Rounds Physician Rounds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Phase 1 (Control group)

Participants will be able to engage in care as per current family engagement practices. Family members in the usual care group will not participate in daily ICU rounds. In-person or virtual family participation in rounds is not routinely performed at any of the trial sites.

Group Type NO_INTERVENTION

No interventions assigned to this group

Phase 2 (Intervention)

Participants in the Intervention group will be invited to participate in attending team rounds.

Group Type EXPERIMENTAL

Participation in attending team rounds

Intervention Type OTHER

Family members can participate both in-person and virtually, which can vary daily if desired. If the family member wishes to participate in-person, they will be invited to be present when the team rounds in the ICU. If the family member wishes to participate virtually, they will be provided with a personalized link by email to attend rounds.

Interventions

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Participation in attending team rounds

Family members can participate both in-person and virtually, which can vary daily if desired. If the family member wishes to participate in-person, they will be invited to be present when the team rounds in the ICU. If the family member wishes to participate virtually, they will be provided with a personalized link by email to attend rounds.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult family members (age ≥ 18 years) of ICU patients
* Expected ICU stay ≥ 48 hours
* Family members wishing to participate in rounds virtually must have the technological capability and understanding to participate virtually (must have a phone or computer with internet and audio/video capabilities)

Exclusion Criteria

* Family members who do not wish to participate in care
* Repeat admissions within the study period
* Another family member has already participated in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Lady Davis Institute

OTHER

Sponsor Role lead

Responsible Party

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Michael Goldfarb

Attending Staff, Division of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael J Goldfarb, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Lady Davis Institute, McGill University, Jewish General Hospital

Locations

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Jewish General Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

Site Status NOT_YET_RECRUITING

Countries

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Canada

Central Contacts

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Jillian Kifell, MSc

Role: CONTACT

Phone: 5143408222

Email: [email protected]

Facility Contacts

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Jillian Kifell, MSc

Role: primary

Michael J Goldfarb, MD, MSc

Role: backup

Jillian Kifell, MSc

Role: primary

Michael J Goldfarb, MD, MSc

Role: backup

Other Identifiers

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2025-4182

Identifier Type: -

Identifier Source: org_study_id