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

Study Overview
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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.

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.

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

Conditions
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Caregiver Stress Syndrome

Intervention / Treatment
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* Behavioral: Structured support of caregivers at the ICU


Participation Criteria
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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 Exclusion Criteria: • None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: Structured support of caregivers at the ICU<br>* Structured support of caregivers at the ICU provided by a trained group of 10-15 ICU nurses<br>|
| No Intervention: Follow up as usual (Control)<br>Follow up as usual at the ICU | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post traumatic stress | 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. | Group differences at f-up month 3 | 
| Post traumatic stress | 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. | Group differences at f-up month 6 | 
| Post traumatic stress | 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. | Group differences at f-up month 12 | 
| Anxiety and Depression | 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). | Change from baseline to f-up month 3 | 
| Anxiety and Depression | 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). | Change from baseline to f-up month 6 | 
| Anxiety and Depression | 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). | Change from baseline to f-up month 12 | 
| Quality Adjusted Life Years (QUALYs) | 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). | Group differences at f-up month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life | Health related quality of life will be measured with the RAND-12 (short form health survey, developed by the non profit RAND corporation). Units is summary score and sub-scale scores. Score range: 0-100 for all scales. Lower scores indicates more disability (0 = maximum disability, 100 = no disability). | Change from baseline to f-up month 3 | 
| Health related quality of life | Health related quality of life will be measured with the RAND-12 (short form health survey, developed by the non profit RAND corporation). Units is summary score and sub-scale scores. Score range: 0-100 for all scales. Lower scores indicates more disability (0 = maximum disability, 100 = no disability). | Change from baseline to f-up month 6 | 
| Health related quality of life | Health related quality of life will be measured with the RAND-12 (short form health survey, developed by the non profit RAND corporation). Units is summary score and sub-scale scores. Score range: 0-100 for all scales. Lower scores indicates more disability (0 = maximum disability, 100 = no disability). | Change from baseline to f-up month 12 | 
| Hope | Hope will be measured with Herth Hope Index (HHI). The summary score ranges between 12-48, and a higher score indicates a higher level of hope. | Change from baseline to f-up month 3 | 
| Hope | Hope will be measured with Herth Hope Index (HHI). The summary score ranges between 12-48, and a higher score indicates a higher level of hope. | Change from baseline to f-up month 6 | 
| Hope | Hope will be measured with Herth Hope Index (HHI). The summary score ranges between 12-48, and a higher score indicates a higher level of hope. | Change from baseline to f-up month 12 | 
| Self-Efficacy. | Self-efficacy will be measured with the General Self-Efficacy Scale (GSE). The summary score range between 10-40, and a higher score indicates higher perceived self-efficacy. | Change from baseline to f-up month 3 | 
| Self-Efficacy. | Self-efficacy will be measured with the General Self-Efficacy Scale (GSE). The summary score range between 10-40, and a higher score indicates higher perceived self-efficacy. | Change from baseline to f-up month 6 | 
| Self-Efficacy. | Self-efficacy will be measured with the General Self-Efficacy Scale (GSE). The summary score range between 10-40, and a higher score indicates higher perceived self-efficacy. | Change from baseline to f-up month 12 | 
| Caregiver satisfaction. | Caregiver satisfaction will be mesured with the Family satisfaction in the ICU questionnaire (FS-ICU-24). Score range: 0-100, a higher score indicates more satisfaction. | Group differences at f-up month 3 | 
| Caregivers burden | The Caregiver Reaction Assessment (CRA). Summary score range between 5 and 120. A higher score indicates a higher level of burden. | Group differences at f-up month 12 | 
| Complicated grief | Complicated grief will be measured with the Inventory of Complicated Grief (ICG). Summary score range between 0-76, and a higher score indicates risk of complicated grief. | Group differences at f-up month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregivers, Post traumatic stress, Health related quality of life, Intensive care