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

• ClinicalTrials.gov Identifier: NCT04839406
• Recruitment Status: Recruiting
• First Posted: April 9, 2021
• Last Update Posted: April 26, 2021
• Sponsor: Oslo University Hospital
• Collaborator: The Dam Foundation
• Information provided by (Responsible Party): Elin Børøsund, Oslo University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Caregiver Stress Syndrome	Behavioral: Structured support of caregivers at the ICU	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 196 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Caregiver Pathway - An Intervention to Support Caregivers of Critically Ill Patients
• Actual Study Start Date: April 22, 2021
• Estimated Primary Completion Date: July 1, 2023
• Estimated Study Completion Date: July 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: Structured support of caregivers at the ICU; Structured support of caregivers at the ICU provided by a trained group of 10-15 ICU nurses
No Intervention: Follow up as usual (Control); Follow up as usual at the ICU

Outcome Measures

Primary Outcome Measures :

1. Post traumatic stress [ Time Frame: Group differences at f-up month 3 ]
   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.
2. Post traumatic stress [ Time Frame: Group differences at f-up month 6 ]
   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.
3. 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.
4. Anxiety and Depression [ Time Frame: Change from baseline to f-up month 3 ]

   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).

5. Anxiety and Depression [ Time Frame: Change from baseline to f-up month 6 ]

   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).

6. 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).

7. 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 Outcome Measures :

1. Health related quality of life [ Time Frame: Change from baseline to f-up month 3 ]
   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).
2. Health related quality of life [ Time Frame: Change from baseline to f-up month 6 ]
   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).
3. Health related quality of life [ Time Frame: Change from baseline to f-up month 12 ]
   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).
4. Hope [ Time Frame: Change from baseline to f-up month 3 ]
   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.
5. Hope [ Time Frame: Change from baseline to f-up month 6 ]
   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.
6. Hope [ Time Frame: Change from baseline to f-up month 12 ]
   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.
7. Self-Efficacy. [ Time Frame: Change from baseline to f-up month 3 ]
   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.
8. Self-Efficacy. [ Time Frame: Change from baseline to f-up month 6 ]
   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.
9. Self-Efficacy. [ Time Frame: Change from baseline to f-up month 12 ]
   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.
10. Caregiver satisfaction. [ Time Frame: Group differences at f-up month 3 ]
    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.
11. Caregivers burden [ Time Frame: Group differences at f-up month 12 ]
    The Caregiver Reaction Assessment (CRA). Summary score range between 5 and 120. A higher score indicates a higher level of burden.
12. Complicated grief [ Time Frame: Group differences at f-up month 12 ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Solbjørg Watland, MS; 90662155 ext +47; solbjorg.watland@rr-research.no

Contact: Elin Børøsund, PhD; 92667161 ext +47; elin.borosund@rr-research.no

Locations

Norway

Oslo University Hospital; Recruiting

Oslo, Norway, 0424

Contact: Solbjørg Watland, MS 90662155 ext 47 solbjorg.watland@rr-research.no

Sponsors and Collaborators

Oslo University Hospital

The Dam Foundation

Investigators

• Principal Investigator: Elin Børøsund, PhD; Oslo University Hospital

More Information

• Responsible Party: Elin Børøsund, Senior researcher, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT04839406
• Other Study ID Numbers: 199446
• First Posted: April 9, 2021
• Last Update Posted: April 26, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elin Børøsund, Oslo University Hospital:

Caregivers; Post traumatic stress; Health related quality of life; Intensive care

Additional relevant MeSH terms:

Critical Illness; Disease Attributes; Pathologic Processes