The Caregiver Pathway - An Intervention to Support Caregivers of Critically Ill Patients

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

COMPLETED

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-22

Study Completion Date

2024-10-21

Brief Summary

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The aim of the project is to test the efficacy of a systematic intervention for individual follow-up of caregivers at the intensive care unit during a 12 month randomized controlled trial.

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Detailed Description

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Caregivers of patients admitted to an intensive care unit (ICU) often experience the situation as traumatic and stressful. Long term consequences such as fatigue, anxiety, depression and symptoms of post-traumatic stress are reported among 30-50 percent of the caregivers of critically ill patients. The need for supportive interventions is called for.

The overall goal of this project is to improve the support for caregivers of intensive care patients. A systematic intervention for individual support of caregivers, The Caregiver Pathway Intervention, has been developed with a multidisciplinary approach, based on existing evidence, through interviews with former caregivers, workshops with health care personnel and user input and testing. The intervention consist of mapping of caregivers' prioritized symptoms, needs and preferences with a digital assessment tool, followed by a meeting with a nurse to address these issues, a structured conversation at discharge, and an invitation to a follow-up conversation 4-6 weeks after discharge/patients death.

The aim of the project is to test the efficacy of The Caregiver Pathway Intervention among caregivers at the ICU in a randomized controlled trial, using outcome measures such as symptoms of post-traumatic stress, anxiety/depression, cost-utility measures and health-related quality of life. The participants will be randomly assigned to The Caregiver Pathway Intervention or the follow-up as usual group. Both groups will receive outcome measures at baseline and at 3, 6 and 12 months.

Conditions

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Caregiver Stress Syndrome

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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Intervention

Structured follow up at the ICU

* 1-3 days after admittance: Map caregivers' prioritized symptoms, needs and preferences with a digital assessment tool, followed by a meeting with a nurse to address these issues.
* Every 1-2 weeks: Repeat assessment of symptoms and needs with the assessment tool followed by a meeting with a nurse.
* At discharge: Structured conversation focusing on information and preparation for the transition to a regular ward or to another hospital including a card with information and support.
* Bereavement: Individualized support based on caregiver expressed needs, preferences and previous mapping, including a card with information and support.
* Follow up: Caregivers or bereaved will be contacted after 4-6 weeks, and will be offered a follow up conversation either on phone or at the unit.

Group Type EXPERIMENTAL

Structured support of caregivers at the ICU

Intervention Type BEHAVIORAL

Structured support of caregivers at the ICU provided by a trained group of 10-15 ICU nurses

Follow up as usual (Control)

Follow up as usual at the ICU

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Structured support of caregivers at the ICU

Structured support of caregivers at the ICU provided by a trained group of 10-15 ICU nurses

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Caregivers of patients admitted to the intensive care unit that is expected to receive invasive mechanical ventilation for at least 48 hours
* Between 18 and 70 years old
* Able to understand and speak Norwegian