Systematic Support for Relatives of Palliative Care Patients

Study Overview
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Brief Summary
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The primary purpose of this study is to validate the prognostic screening tool from The Aarhus Bereavement Study (TABS) and to implement a systematic support for relatives of palliative care patients in order to prevent the development of prolonged grief disorder. Depending on their identified support needs, the relatives are offered different interventions. It is evaluated whether this procedure of screening and intervening are able to reduce the risk of developing prolonged grief disorder.

Detailed Description
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PRIMARY OUTCOME: identification of the support needs of relatives of palliative care patients SECONDARY OUTCOME: evaluation of the initiated interventions and whether these are able to reduce the risk of developing prolonged grief disorder PARTICIPANTS: Relatives (age 18-90) of patients affiliated with specialized palliative care in The Capital Region of Denmark. The relatives will complete a survey and prognostic screening tool at respectively 2 weeks (T1) and every 6 months (T2) from the time that the patients is affiliated to the specialized palliative care and until the death of the patient. This will happen regardless the status of the patient - that is, whether or not the patient continues being affiliated with specialized palliative care, or the patient is being referred to another palliative care units or doesn't need palliative care anymore. Furthermore the relatives will complete a follow-up survey and the diagnostic questionnaire PGD-13 at respectively 6 months (T3) and 18 months (T4) after the death of the patient (post loss). It will be evaluated whether there are any diffences in the grief symptoms of relatives of patients with a malign versus non-malign disease. It will also be evaluated whether there is an association between the intervention the relatives received from the palliative care unit at Rigshospital and their grief symptoms post loss.

Official Title
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Implementation of Systematic Support of Relatives of Palliative Care Patients : a Cohort Study

Conditions
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Prolonged Grief Disorder

Intervention / Treatment
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* Other: Support of relatives


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: relatives of palliative care patients with relation to Department of Palliative Care, (Rigshospitalet) relatives identified by the patient Exclusion Criteria: relatives who do not read or understand danish relatives who are cognitive disabled

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Identified support needs<br>Identified need of either support from a psychologist, nurse, doctor, socialworker or a combination of theese. | Other: Support of relatives<br>* Screening of the support needs of relatives<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Support needs of relatives of palliative patients (baseline) | Identification of support needs of relatives assessed by the prognostic screening tool from The Aarhus Bereavement Study (TABS). | 1 month from the time that the patient is referred to the palliative care team. | 
| Change in Support needs of relatives of palliative patients from baseline | Identification of support needs of relatives assessed by the prognostic screening tool from | 6 months | 
| Change in Support needs of relatives of palliative patients from baseline | Identification of support needs of relatives assessed by the prognostic screening tool from | 12 months | 
| Change in Support needs of relatives of palliative patients from baseline | Identification of support needs of relatives assessed by the prognostic screening tool from | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonged grief | Symptoms of prolonged grief measured using the Prolonged Grief Disorder - 13 (PG-13, Prigerson et al, 2009). Scores ranging from 11 to 55 are used in the current study, and a higher score indicates a worse outcome. However, there are no officially recommended cut-off scores (Pohlkamp et al, 2018). | 6 months post-loss. | 
| Prolonged grief | Symptoms of prolonged grief measured using the Prolonged Grief Disorder - 13 (PG-13, Prigerson et al, 2009). Scores ranging from 11 to 55 are used in the current study, and a higher score indicates a worse outcome. However, there are no officially recommended cut-off scores (Pohlkamp et al, 2018). | 18 months post-loss. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative Care, Screening tool, Assessment tool, Relatives, Support needs, Anticipatory Grief, Palliative patients, Caregivers