The PROAKTIV Study

NCT04673760 | Completed DMC

• 2 other identifiers: DFL Nr. 4887SNCTP000003820
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Palliative Care

Keywords

palliative care; end of life care; home care services; primary care; primary care nursing; outpatient care; quality of healthcare; quality of life; advance care planning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of patients who define advance directives

  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

  From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).

• Satisfaction with care of patient

  From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).

• Satisfaction with care of GP

  From date of baseline measurement of patient to study completion, an average of 6 months, or shorter if patient deceases

Other Outcomes (8)

• Health care utilization

  From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).

• Health care costs

  From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).

• Sense of security of family caregivers

  From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).

Study Arms (2)

Arm 1: Structured specialized palliative home care

EXPERIMENTAL

Eligible specialist palliative home care teams provide ambulant specialised palliative care as usual

Behavioral: Specialized palliative home care

Arm 2: No care of specialist palliative home care teams at study inclusion

NO INTERVENTION

No care from specialist palliative home care teams at study inclusion

Interventions

Specialized palliative home care BEHAVIORAL

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.

Arm 1: Structured specialized palliative home care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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
• /7-availability of specialized palliative care
• Specialized palliative care team including nurses and consulting physician with specialized palliative care certification.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Swiss National Science Foundation: collaborator
• University of Bern: collaborator

Study Sites (1)

University Hospital Inselspital Bern

Bern, Switzerland

Location

Study Officials

• Steffen Eychmüller, Prof. dr.

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. med.

Model Details: Patients with a new medical indication for specialized palliative home care are assigned to intervention arm. Patients without a new indication for specialized palliative home care are controls .

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: December 17, 2020
• Study Start: September 7, 2020
• Primary Completion: April 10, 2022
• Study Completion: August 1, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)