- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03879668
Monitoring of Palliative Care Needs in Specialized Palliative Home Care Using the Electronic Version of the Integrated Palliative Care Outcome Scale (Palli-MONITOR)
Palli-MONITOR: A Phase II Mixed-Methods Study to Implement and Test the Electronic Version of the Integrated Palliative Care Outcome Scale (eIPOS) in an Specialist Palliative Home Care
In palliative care, the Integrated Palliative Care Outcome Scale (IPOS) is widely used as a patient reported outcome measure (PROM) and covers patients' main concerns, common symptoms, patient and family distress, existential wellbeing, sharing feelings with family, information received, and practical concerns. The IPOS is validated for patients with advanced cancer or non-cancer disease and is available as patients and professional carer version.
The implementation of a PROM in the home care setting is more challenging compared to the inpatient setting.
Palli-MONITOR will develop, implement and test the feasibility of an internet-based real-time monitoring of palliative needs of patients with advanced diseases using the electronic version of IPOS (eIPOS) including a clinical decision support tool for specialist palliative home care.
The project is conducted in two parts:
- A pilot study to develop an electronical monitoring that is acceptable for both palliative patients and professionals of specialist palliative home care teams.
- A feasibility study to implement and test eIPOS in specialist palliative home care teams.
Study Overview
Detailed Description
In palliative care, the Integrated Palliative Care Outcome Scale (IPOS) is widely used as a patient reported outcome measure. IPOS covers patients' main concerns, common symptoms, patient and family distress, existential wellbeing, sharing feelings with family, information received, and practical concerns. IPOS is validated for patients with advanced cancer or non-cancer disease and is available as patients and professional carer version.
The implementation of a PROM in the home care setting is more challenging compared to the inpatient setting. Furthermore, IPOS currently only exists as a paper version. If patients complete the IPOS at home, there is a potential delay until the home care team receives the information and a potential benefit through patient reported outcome measurement might be missed.
Palli-MONITOR will develop, implement and test the feasibility an internet-based real-time monitoring of palliative needs of patients with advanced disease using the electronic version of IPOS (eIPOS) including a clinical decision support tool for specialist palliative home care.
The project is conducted in two parts (phase I and phase II). Phase I will consist of two components and serve as a pilot study: a qualitative part and a cross-over randomised controlled trial (RCT). In the qualitative part, the investigators will conduct semi-structured interviews and focus groups with patients and professionals of the participating specialist palliative home care teams. In the RCT, the investigators will determine the validity of the eIPOS in comparison to IPOS in paper version. The investigators will also develop an evidence-based Clinical Decision Support Tool (CDS), using guidelines and a Delphi study for evaluation of the proposed CDS.
Phase II (study design described in more detail below) will serve as a feasibility study and consist of an observational case-control study as well as a qualitative part, which again will include semi-structured interviews and focus groups.
This mixed-methods approach will help to implement eIPOS while ensuring at the same time that the quality of palliative care during the process will meet at least the current standards.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bavaria
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München, Bavaria, Germany, 81377
- Katerina Hriskova
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
Description
Inclusion Criteria:
- Participants cared for by one of the participating specialist palliative home care teams
- Participants who have the capacity to give informed consent to participate the study in writing and are able to participate in research
- Participants who are not too distressed or ill to participate in the study
Exclusion Criteria:
- Participants with cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: eIPOS
The cohort will include all participants who are cared for by the participating specialist palliative home care teams when implementing eIPOS.
|
Electronic version of IPOS
|
No Intervention: Historic control
The cohort will include all participants that were cared for by the participating specialist palliative home care teams in the last 6 months before the implementation of eIPOS.
|
|
No Intervention: Prospective control
The cohort will include participants who are in the care of the participating specialist palliative home care teams at the same time as the eIPOS group, but who do not use eIPOS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment rates
Time Frame: 1 year
|
The recruitment rates of each specialist palliative home care teams will be calculated as the percentage of eligible participants who agreed to participate in the study divided by the total number of eligible participants approached to participate in the study.
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1 year
|
Acceptance of electronical monitoring
Time Frame: up to 4 weeks after enrollment
|
Based on qualitative data
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up to 4 weeks after enrollment
|
Influence of electronical monitoring on provided care
Time Frame: up to 4 weeks after enrollment
|
Assess care modifications consecutive of initial care
|
up to 4 weeks after enrollment
|
Technical feasibility of electronical monitoring: Integrated Palliative Care Outcome Scale
Time Frame: up to 4 weeks after enrollment
|
Completeness of the electronic Integrated Palliative Care Outcome Scale (eIPOS).
IPOS includes 10 symptoms and 7 questions on patients and carers emotional situation, spiritual concerns, and provision of information and support.
Five answer options for each question are possible (scored 0 to 4; higher scores indicate higher burden).
The overall IPOS score is the sum of the scores from each of the 17 questions.
The overall IPOS score can therefore range from zero to 68.
|
up to 4 weeks after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Palliative needs (IPOS)
Time Frame: up to 4 weeks after enrollment
|
Change in palliative care needs and specific symptoms assessed with the Integrated Palliative Care Outcome Scale (IPOS).
IPOS includes 10 symptoms and 7 questions on patients and carers emotional situation, spiritual concerns, and provision of information and support.
Five answer options for each question are possible (scored 0 to 4; higher scores indicate higher burden).
The overall IPOS score is the sum of the scores from each of the 17 questions.
The overall IPOS score can therefore range from zero to 68.
|
up to 4 weeks after enrollment
|
EORTC QLQ-C15-PAL
Time Frame: At baseline and 2 weeks
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Change from baseline in quality of life (at 2 weeks) assessed with the European Organization for Research and Treatment of Cancer (EORTC) questionnaire of life quality (QLQ). The adapted version for palliative (PAL) cancer care patients will be used. One item, scored from 1 to 7 (higher scores indicate better quality of life), gives an overall score corresponding to the quality of life that the patient feels he or she has. |
At baseline and 2 weeks
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Symptom burden (ESAS)
Time Frame: At baseline and 2 weeks
|
Change from baseline in symptom burden (at 2 weeks) assessed with the Edmonton Symptom Assessment Scale (ESAS).
ESAS includes 9 common symptoms.
The severity of each symptom is rated from 0 to 10 on a numerical scale (higher scores indicate higher intensity).
|
At baseline and 2 weeks
|
Unplanned hospital submissions
Time Frame: up to 3 weeks after enrollment
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Number of patients with unplanned hospitalization, assessed from medical record
|
up to 3 weeks after enrollment
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 01VSF17014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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