Frailty, life-limiting diseases, old age Not Applicable
Conditions
Interventions
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 o
Sponsors
Vrije Universiteit Brussel
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium
Outcome results
None listed