Condition category
Not Applicable
Date applied
06/09/2019
Date assigned
10/09/2019
Last edited
09/09/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background
There is recognition that older people with incurable diseases should have access to palliative care. Palliative care aims to improve the quality of life of patients with incurable diseases and their families through a holistic approach, by addressing their physical, emotional, social and spiritual needs. Palliative care could be divided into two complementary models: 1) generalist palliative care, which is provided by physicians and other health care professionals that are not specialized in palliative care, and 2) specialized palliative care, provided by a multidisciplinary service or clinician specifically trained in palliative care who support primary care professionals in caring for patients and family carers when needs become particularly complex. Involvement of these specialized services is proposed for periods in which the patient’s and their family carers’ palliative care needs become too complex to be handled by generalist palliative care providers alone. We have developed and modelled a short-term specialized palliative care intervention for frail older people and their family carers in primary care in Belgium (Frailty+ intervention).

Study aims
We aim to assess the feasibility and preliminary effectiveness of the Frailty+ intervention, a short-term specialized palliative care intervention in primary care for older people and their family carers in Belgium.

Who can participate?
Frail older people aged 70 years or older and their family carers.

What does the study involve?
The intervention will be provided alongside any standard care. At the core of the Frailty+ intervention is the provision of needs- and capacity-based, goal-oriented, person-centred, pro-active, and integrated palliative care, for older people and their family carers over a period of two months, facilitated by a specialist palliative home care service. This involves contacts with GPs and referring clinicians, home visits, advice, liaise and referring roles, and the organisation of at least one multidisciplinary meeting with involved primary care providers.
Patients in the control group will receive standard best practice care from the primary care providers (e.g. general practitioner, district nurses).

What are the possible benefits and risks of participating?
This study will help to inform how we should continue our work to see if this is the best way to deliver specialized palliative care for frail older people and their family carers in primary care. There are minimal risks to participate.

Where is the study run from?
The study is run from the University Hospital Ghent, Sint-Vincentiusziekenhuis Deinze, and AZ Sint-Blasius Dendermonde. Two specialized palliative home care services will collaborate with us: Gent - Eeklo and Dendermonde - Aalst - Ninove.

When is the study starting and how long is it expected to run for?
The recruitment will start November 1, 2019 and will run for 14 months (until December 31, 2020).

Who is funding the study?
The Research Foundation - Flanders (Belgium) (Fonds Wetenschappelijk Onderzoek)

Who is the main contact?
Kim de Nooijer
Kim.De.Nooijer@vub.be

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lara Pivodic

ORCID ID

http://orcid.org/0000-0001-5578-8550

Contact details

Laarbeeklaan 103
Brussels
1090
Belgium
+3224774754
lara.pivodic@vub.be

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

30-08-2019

Study information

Scientific title

Short-term specialized palliative care intervention in primary care for frail older people and their family carers

Acronym

Frailty+

Study hypothesis

This study is a pilot randomized controlled trial (RCT) to pilot and assess the feasibility and preliminary effectiveness of the Frailty+ intervention, a short-term specialized palliative care intervention in primary care for older people and their family carers in Belgium

Ethics approval

Approval pending, Ethics Committee of Ghent University Hospital, submitted on Sept. 6th 2019

Study design

Pilot randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Frailty, life-limiting diseases, old age

Intervention

The intervention group will receive the Frailty+ intervention in addition to standard care. The control group will receive standard care. Patients who gave their consent will be randomly assigned to one of the groups after baseline assessment has been done.

The intervention will be provided alongside any standard care. At the core of the Frailty+ intervention is the provision of needs- and capacity-based, goal-oriented, person-centred, pro-active, and integrated palliative care, for older people and their family carers over a period of two months, facilitated by a specialist palliative home care service. This involves contacts with GPs and referring clinicians, home visits, advice/liaison/referral, and the organisation of at least one multidisciplinary meeting among relevant primary care providers.

Standard care (control) group: Patients in the control group will receive standard best practice care.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Five key symptoms that are amenable to change (i.e. breathlessness, pain, anxiety, constipation, fatigue), measured using the integrated Palliative care Outcome Scale at baseline (before randomisation) i.e. T0, and 8 weeks after the baseline measurement, i.e. T1

Secondary outcome measures

1. Well-being of the patient is measured using the ICECAP-SCM
2. Sense of security of the patient is measured using the SEC-P
3. Continuity of care is measured using the NCQ
4. Views on care of the patient is measured using the IPOS-VoC
5. Coping strategies used by the patient is measured using the brief COPE
6. Sense of security of main family carer is measured using the SEC-R
7. Carer support needs is measured using the CSNAT at baseline

All measures will be administered at baseline and 8 weeks after baseline

Overall trial start date

01/04/2019

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 70 years or over
2. Clinical Frailty Scale (CFS) score > 5 (mild to severe)
3. One or more unresolved or complex* symptoms or problems (as judged by clinicians)
4. In a hospital and referred to return to their home in the region Gent-Eeklo or Dendermonde-Aalst-Ninove
5. Speak and understand Dutch, and provide informed consent to participate in the study OR when a person lacks capacity to consent for themselves the procedures detailed in the Belgian law for patient rights are adhered to
6. Have a family carer who is eligible and willing to participate (see below for inclusion criteria for family carers) OR does not have a family member corresponding to the inclusion criteria

*one or more unresolved or complex symptoms or problems can include a multitude of different situations such as:
3.1 Complex patients’ needs on the physical, psychological, social and/or spiritual domain
3.2 Complex end-of-life issues such as being ‘tired of living’, highly conflicted decision-making, consideration of palliative sedation, requests for assisted dying or euthanasia
3.3 Difficulties with advance care planning
3.4 Complex patient characteristics such as multimorbidity, or complexity due to cumulation of problems
3.5 Cre-existing complexity, for example, long-standing difficulties with finances/housing, mental health needs
3.6 Difficult interactions between the patient, family and healthcare professionals (for example, dissonance or conflicts, older patients who do not seek help etc)

7. To pilot the trial and evaluate the intervention specifically in the population of frail older people with cancer, we will oversample people with a cancer diagnosis into the study sample. To do so, we will apply the following inclusion critierion, in addition to the ones specified above:
7.1 Advanced-stage solid tumor or hematologic malignancy

8. Inclusion criteria for family carers:
8.1 Patient (or health care provider if patient does not have capacity) indicated that they are the patients’ main family carer or representative
8.2 This person lives with the patient or has in-person contact with him or her at least twice a week

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned sample size: 78 patients (39 in each study arm). Of these, 50 patients (25 in each study arm) will have a cancer diagnosis

Participant exclusion criteria

1. One or more palliative care consultations (i.e. specialized palliative home care team and/or palliative care unit) in the 6 months prior to inclusion in the study
2. Taken/are taking part in another research study that is evaluating palliative care services
3. Urgent palliative care needs (and should be referred to specialized palliative care) and/or deteriorate rapidly
4. Do not speak and/or understand Dutch

5. Exclusion criteria for family carers:
5.1 Have taken/are taking part in another research study that is evaluating palliative care services
5.2 Do not speak and/or understand Dutch

Recruitment start date

01/11/2019

Recruitment end date

01/11/2020

Locations

Countries of recruitment

Belgium

Trial participating centre

University Hospital Ghent
Corneel Heymanslaan 10
Ghent
9000
Belgium

Trial participating centre

AZ Sint-Blasius Dendermonde
Kroonveldlaan 50
Dendermonde
9200
Belgium

Trial participating centre

Sint-Vincentiusziekenhuis
Schutterijstraat 34
Deinze
9800
Belgium

Trial participating centre

Vrije Universiteit Brussel
Laarbeeklaan 103
Brussels
1090
Belgium

Trial participating centre

Netwerk Palliatieve Zorg Gent-Eeklo
Bilksken 36
Lovendegem
9920
Belgium

Trial participating centre

Netwerk Palliatieve Zorg Aalst - Dendermonde - Ninove
Gentsesteenweg 355
Aalst
9300
Belgium

Sponsor information

Organisation

Vrije Universiteit Brussel

Sponsor details

Laarbeeklaan 103
Brussels
1090
Belgium
+32 2 629 20 10
info@vub.ac.be

Sponsor type

University/education

Website

http://www.vub.be

Funders

Funder type

Research council

Funder name

Fonds Wetenschappelijk Onderzoek

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request from lara.pivodic@vub.be. Data will be available after the main paper of the pilot RCT has been published. They will remain available for at least 25 years. Data will be shared with members of universities, scientific research institutions, or clearly separate and independent research departments of public institutions or non-profit organisations. Data may be used for scientific research only (commercial use of data will not be permitted).

Intention to publish date

31/12/2020

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/09/2019: Trial’s existence confirmed by Fonds Wetenschappelijk Onderzoek