Clinical trial NCT04839406: The Caregiver Pathway - An Intervention to Support Caregivers of Critically Ill Patients
Official title: The Caregiver Pathway - An Intervention to Support Caregivers of Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Stress Syndrome
Keywords: Caregivers
Post traumatic stress
Health related quality of life
Intensive care
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Dam Foundation
First posted: 2021-04-09
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Post traumatic stress
timeFrame: Group differences at f-up month 3
measure: Post traumatic stress
timeFrame: Group differences at f-up month 6
measure: Post traumatic stress
timeFrame: Group differences at f-up month 12
measure: Anxiety and Depression
timeFrame: Change from baseline to f-up month 3
measure: Anxiety and Depression
timeFrame: Change from baseline to f-up month 6
measure: Anxiety and Depression
timeFrame: Change from baseline to f-up month 12
measure: Quality Adjusted Life Years (QUALYs)
timeFrame: Group differences at f-up month 12
Secondary outcomes:
measure: Health related quality of life
timeFrame: Change from baseline to f-up month 3
measure: Health related quality of life
timeFrame: Change from baseline to f-up month 6
measure: Health related quality of life
timeFrame: Change from baseline to f-up month 12
measure: Hope
timeFrame: Change from baseline to f-up month 3
measure: Hope
timeFrame: Change from baseline to f-up month 6
measure: Hope
timeFrame: Change from baseline to f-up month 12
measure: Self-Efficacy.
timeFrame: Change from baseline to f-up month 3
measure: Self-Efficacy.
timeFrame: Change from baseline to f-up month 6
measure: Self-Efficacy.
timeFrame: Change from baseline to f-up month 12
measure: Caregiver satisfaction.
timeFrame: Group differences at f-up month 3
measure: Caregivers burden
timeFrame: Group differences at f-up month 12
measure: Complicated grief
timeFrame: Group differences at f-up month 12
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Elin Børøsund, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Watland S, Solberg Nes L, Hanson E, Ekstedt M, Stenberg U, Borosund E. The Caregiver Pathway, a Model for the Systematic and Individualized Follow-up of Family Caregivers at Intensive Care Units: Development Study. JMIR Form Res. 2023 Apr 25;7:e46299. doi: 10.2196/46299.
citation: Watland S, Solberg Nes L, Ekeberg O, Rostrup M, Hanson E, Ekstedt M, Stenberg U, Hagen M, Borosund E. The Caregiver Pathway Intervention Can Contribute to Reduced Post-Intensive Care Syndrome Among Family Caregivers of ICU Survivors: A Randomized Controlled Trial. Crit Care Med. 2025 Mar 1;53(3):e555-e566. doi: 10.1097/CCM.0000000000006546. Epub 2024 Dec 24.