Monitoring of Palliative Care Needs in Specialized Palliative Home Care Using the Electronic Version of the Integrated Palliative Care Outcome Scale

Advanced Disease Clinical Trial

— Palli-MONITOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879668
• Other study ID #: 01VSF17014
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2023
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

1. A pilot study to develop an electronical monitoring that is acceptable for both palliative patients and professionals of specialist palliative home care teams.

2. A feasibility study to implement and test eIPOS in specialist palliative home care teams.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 31, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Disease

Intervention

Device:
• eIPOS
Electronic version of IPOS

Locations

Country	Name	City	State
Germany	Katerina Hriskova	München	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rates	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.	1 year
Primary	Acceptance of electronical monitoring	Based on qualitative data	up to 4 weeks after enrollment
Primary	Technical feasibility of electronical monitoring: Integrated Palliative Care Outcome Scale	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
Primary	Influence of electronical monitoring on provided care	Assess care modifications consecutive of initial care	up to 4 weeks after enrollment
Secondary	Palliative needs (IPOS)	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
Secondary	EORTC QLQ-C15-PAL	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
Secondary	Symptom burden (ESAS)	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
Secondary	Unplanned hospital submissions	Number of patients with unplanned hospitalization, assessed from medical record	up to 3 weeks after enrollment