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Clinical Trials/NCT04673760
NCT04673760
Completed
Not Applicable

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

Insel Gruppe AG, University Hospital Bern1 site in 1 country149 target enrollmentSeptember 7, 2020
ConditionsPalliative Care

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Palliative Care
Sponsor
Insel Gruppe AG, University Hospital Bern
Enrollment
149
Locations
1
Primary Endpoint
Sense of security of patients
Status
Completed
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 7, 2020
End Date
August 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Steffen Eychmüller

Prof. dr. med.

Insel Gruppe AG, University Hospital Bern

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • 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)
  • 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).)

Study Sites (1)

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