The Caregiver Pathway - An Intervention to Support Caregivers of Critically Ill Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Caregiver Stress Syndrome
- Sponsor
- Oslo University Hospital
- Enrollment
- 196
- Locations
- 1
- Primary Endpoint
- Post traumatic stress
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
Elin Børøsund
Senior researcher
Oslo University Hospital
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
- Not provided
Outcomes
Primary Outcomes
Post traumatic stress
Time Frame: Group differences at f-up month 12
Post traumatic stress will be measured with the Impact of Event Scale-Revised (IES_R). The total score for the IES_R ranges from 0 to 88. A higher score represents more severe symptoms of post traumatic stress disorder.
Anxiety and Depression
Time Frame: Change from baseline to f-up month 12
Anxiety and Depression will be measured with the Hospital Anxiety and Depression Scale (HADS). HADS consists of 14 items, and two subscales with seven items respectively. Score range is 0-21 for each subcale. Scores: 0-7= Normal, 8-10= Borderline abnormal (borderline case), 11-21= abnormal (case).
Quality Adjusted Life Years (QUALYs)
Time Frame: Group differences at f-up month 12
Quality Adjusted Life Years (QUALYs), an economic evaluation of the quality and quantity of life lived, will be derived from the RAND-12 (Short form health survey, developed by the non profit RAND corporation). QUALY scores range from 1 (perfect health) to 0 (death).
Secondary Outcomes
- Health related quality of life(Change from baseline to f-up month 12)
- Hope(Change from baseline to f-up month 12)
- Caregiver satisfaction.(Group differences at f-up month 3)
- Caregivers burden(Group differences at f-up month 12)
- Self-Efficacy.(Change from baseline to f-up month 12)
- Complicated grief(Group differences at f-up month 12)