Plain English Summary
Background and study aims
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). 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 Vrije Universiteit Brussels (VUB) and Ghent University (Belgium)
When is the study starting and how long is it expected to run for?
The recruitment will start on 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?
1. Kim de Nooijer
Kim.De.Nooijer@vub.be
2. Prof. Dr Lieve Van den Block
Lieve.Van.den.Block@vub.be
3. Dr Lara Pivodic
Lara.Pivodic@vub.be
Trial website
Contact information
Type
Scientific
Primary contact
Dr Lara Pivodic
ORCID ID
http://orcid.org/0000-0002-8825-3699
Contact details
Laarbeeklaan 103
Brussels
1090
Belgium
+32 (0)2 477 4764
lara.pivodic@vub.be
Type
Scientific
Additional contact
Prof Lieve Van den Block
ORCID ID
http://orcid.org/0000-0002-7770-348X
Contact details
Laarbeeklaan 103
Brussels
1090
Belgium
+32 (0)2 477 4310
Lieve.Van.den.Block@vub.be
Type
Scientific
Additional contact
Dr Kim De Nooijer
ORCID ID
Contact details
Laarbeeklaan 103
Brussels
1090
Belgium
+32 (0)2 477 46 27
Kim.De.Nooijer@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
Approved 21/01/2020, Ethics Committee of Ghent University Hospital and Ghent University (C. Heymanslaan 10, 9000 Ghent, Belgium; +32 93326855; ethisch.comite@uzgent.be), ref: EC UZG 2019/1586
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
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: 76 patients (38 in each study arm). Of these, 52 patients (26 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
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