Clinical trial NCT03879668: Monitoring of Palliative Care Needs in Specialized Palliative Home Care Using the Electronic Version of the Integrated Palliative Care Outcome Scale
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Disease
Keywords: Advanced disease
Specialised outpatient palliative care
IPOS
Electronical monitoring
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Convergent mixed methods design: Quantitative quasi-experimental study with retrospective and prospective control group; Qualitative interviews with patients and focus groups with professionals.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rates
timeFrame: 1 year
measure: Acceptance of electronical monitoring
timeFrame: up to 4 weeks after enrollment
measure: Technical feasibility of electronical monitoring: Integrated Palliative Care Outcome Scale
timeFrame: up to 4 weeks after enrollment
measure: Influence of electronical monitoring on provided care
timeFrame: up to 4 weeks after enrollment
Secondary outcomes:
measure: Palliative needs (IPOS)
timeFrame: up to 4 weeks after enrollment
measure: EORTC QLQ-C15-PAL
timeFrame: At baseline and 2 weeks
measure: Symptom burden (ESAS)
timeFrame: At baseline and 2 weeks
measure: Unplanned hospital submissions
timeFrame: up to 3 weeks after enrollment
Other outcomes:
Locations:
city: München
country: Germany
facility: Katerina Hriskova
state: Bavaria
Study officials:
References:
citation: Bolzani A, Ramsenthaler C, Hodiamont F, Burner-Fritsch IS, Bausewein C. Monitoring of Palliative Care Symptoms and Concerns in Specialized Palliative Home Care Using an Electronic Version of the Integrated Palliative care Outcome Scale (Palli-MONITOR): protocol for a mixed-methods study. BMJ Open. 2021 Jun 1;11(6):e042266. doi: 10.1136/bmjopen-2020-042266.