The PROAKTIV Study

Palliative Care Clinical Trial

Official title:

Palliative Needs Assessment and Palliative Care in Primary Care: The PROAKTIV Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04673760
• Other study ID #: DFL Nr. 4887
• Secondary ID: SNCTP000003820
• Status: Completed
• Phase: N/A
• Start date: September 7, 2020
• Est. completion date: August 1, 2023

Study information

• Verified date: November 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objective of this study is to identify whether the systematic anticipation of highly structured specialized palliative home care into primary care influences the quality of care and care utilization. Quality of care focusses on the sense of security of patients and family caregivers, satisfaction with care of patients, family caregivers, general practitioners, home care nurses and specialized palliative care nurses, and availability and access to advanced directives. Health care utilization focus on the number of hospitalizations and the length of hospital stays.

Description:

The University Center for Palliative Care from the Inselspital Bern conducts this monocentric mixed-methods controlled study and is responsible for informed consent. Data consists of questionnaires of patients, their family caregivers, general practitioners, home care nurses and if involved specialized palliative home care nurses. Patients and their family caregivers will fill out baseline questionnaires and follow-up questionnaires at 2, 8, 16 and 24 weeks. Patient follow-up will end if the patient dies or the study ends. Family caregivers will be asked to fill out a questionnaire two months after the patient's death. General practitioners, home care nurses and specialised palliative home care nurses will fill out questionnaires after the patient's death or at the end of the study. Patient survival data will be collected from administrative health data after the end of the study. Additionally, a nested qualitative study with semi-structured qualitative interviews with patients, family caregivers and care providers will provide an in-depth understanding of preferences, needs, experiences from this phase of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: August 1, 2023
• Est. primary completion date: April 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Patients inclusion criteria:

• 18 years or older
• Able to read and understand German
• Able to fill out questionnaires with only minimal assistance
• Live in the catchment area of SPHC
• Positive screening on the palliative care screening tools
• Expected survival time of approximately six months or less
• Have a GP (or GP medical substitute)
• Registered with Spitex care
• Wish to live at home as long as possible (no plans for long term nursing home uptake)
• Written informed consent

Patients exclusion criteria:

• Planned discharged from hospitals to institutions (e.g. other hospitals, rehabilitations, nursing homes)
• Live permanently in nursing homes
• Cognitive impairments that make it impossible to follow the study (e.g. psychological disorders, dementia, loss of judgement).

Family caregivers inclusion criteria:

• 18 years or older
• Able to read and understand German
• Familiar with the care situation patient
• Written informed consent

Specialized palliative home care team:

• Provide care in German speaking part of canton Bern
• 24/7-availability of specialized palliative care
• Specialized palliative care team including nurses and consulting physician with specialized palliative care certification.

Related Conditions & MeSH terms

• Palliative Care

Intervention

Behavioral:
• Specialized palliative home care
Specialist palliative home care teams will initiate care as usual, including managing a systematic and collaborative process of advance care planning with patients, family caregivers, GPs and SPITEX nurses using the "Betreuungsplan", information packages and regular case meetings. The GP was additionally provided with educational palliative care information by the study team.

Locations

Country	Name	City	State
Switzerland	University Hospital Inselspital Bern	Bern

Sponsors (3)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	Swiss National Science Foundation, University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health care utilization	Measured by questionnaire	From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Other	Health care costs	Measured by administrative health care data	From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Other	Sense of security of family caregivers	Measured by questionnaire	From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Other	Satisfaction with care of family caregivers	Measured by questionnaire FAMCARE-2 Scale. 17 questions on care with answers ( Likert-type scale 1 to 5) ranging from "very satisfied with care" to "very dissatisfied with care".	From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Other	Satisfaction with care of home care nurses	Measured by questionnaire	From the date of baseline measurement of patient to study completion, an average of 6 months, or shorter if patient deceases
Other	Performance Status of patient	Measured by questionnaire , ECOG Scale of performance status.Grading 1 to 4 and higher score indicates lower performance status.	From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Other	Quality of life of patient	Measured by questionnaire Functional Assessment of Chronic Illness Therapy - Palliative Care 14 Item Version (FACIT-Pal-14). (5 point Likert-type scale)	From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Other	Therapeutic alliance between patients and their home care team	Measured by questionnaire The Human Connection Scale (THC) measures the extent to which patients felt a sense of mutual understanding, caring, and trust with their GP, (specialized palliative) home care nurses ( Likert-type scale 1 to 5)	From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Primary	Sense of security of patients	Measured by questionnaire Sense of Security in Care - Patients' Evaluation (SEC-P), This questionnaire has 3 subscales namely, the Care Interaction scale; the Identity scale and the Mastery scale. Higher score indicate a higher level of sens of security at home of the patient.	From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Secondary	Number of patients who define advance directives	Measured by questionnaire	From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Secondary	Access to advance directives of the patients for the ambulant care providers	Measured by questionnaire	From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Secondary	Satisfaction with care of patient	Measured by questionnaire Modified FAMCARE Scale P16. 16 Questions on care with answers (Likert-type scale 1 to 5) ranging from "very satisfied with care" to "very dissatisfied with care"	From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Secondary	Satisfaction with care of GP	Measured by questionnaire	From date of baseline measurement of patient to study completion, an average of 6 months, or shorter if patient deceases