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Completed

NCT Number: NCT04673760

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.

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Key information

Conditions

Palliative Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Inselspital Bern

Bern, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Sense of security of patients

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

    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.

Secondary outcomes

  1. Number of patients who define advance directives

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

    Measured by questionnaire

  2. Access to advance directives of the patients for the ambulant care providers

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

    Measured by questionnaire

  3. Satisfaction with care of patient

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

    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"

  4. Satisfaction with care of GP

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

    Measured by questionnaire

Other outcomes

  1. Health care utilization

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

    Measured by questionnaire

  2. Health care costs

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

    Measured by administrative health care data

  3. Sense of security of family caregivers

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

    Measured by questionnaire

  4. Satisfaction with care of family caregivers

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

    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".

  5. Satisfaction with care of home care nurses

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

    Measured by questionnaire

  6. Performance Status of patient

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

    Measured by questionnaire , ECOG Scale of performance status.Grading 1 to 4 and higher score indicates lower performance status.

  7. Quality of life of patient

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

    Measured by questionnaire Functional Assessment of Chronic Illness Therapy - Palliative Care 14 Item Version (FACIT-Pal-14). (5 point Likert-type scale)

  8. Therapeutic alliance between patients and their home care team

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

    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)

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Swiss National Science Foundation
  • University of Bern

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Dec 17, 2020
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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