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

University of Oslo (UIO)

Status: Completed

Conditions: Caregiver Stress Syndrome

Treatments: Behavioral: Structured support of caregivers at the ICU

Study type: Interventional

Funder types: Other

Identifiers

NCT04839406

199446

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 196 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

• None

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

196 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Structured support of caregivers at the ICU

Follow up as usual (Control)

No Intervention group

Description:

Follow up as usual at the ICU