The PROAKTIV Study

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

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.

Study Overview

• Status: Completed
• Conditions: Palliative Care
• Intervention / Treatment: Behavioral: Specialized palliative home care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland
    • University Hospital Inselspital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Structured specialized palliative home care; Eligible specialist palliative home care teams provide ambulant specialised palliative care as usual	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.
No Intervention: Arm 2: No care of specialist palliative home care teams at study inclusion; No care from specialist palliative home care teams at study inclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health care utilization	Measured by questionnaire	From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
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).
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).
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).
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
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).
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).
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).

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: Swiss National Science Foundation; University of Bern
• Investigators: Principal Investigator: Steffen Eychmüller, Prof. dr., University Hospital Inselspital, Bern

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2020
• Primary Completion (Actual): April 10, 2022
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: palliative care; quality of life; primary care; outpatient care; advance care planning; quality of healthcare; home care services; end of life care; primary care nursing
• Other Study ID Numbers: DFL Nr. 4887; SNCTP000003820 (Registry Identifier: Swiss National Clinical Trials Portal)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No