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

NCT ID: NCT03879668

Last Updated: 2023-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-03-31

Brief Summary

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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

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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.

Conditions

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Advanced Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Convergent mixed methods design: Quantitative quasi-experimental study with retrospective and prospective control group; Qualitative interviews with patients and focus groups with professionals.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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eIPOS

The cohort will include all participants who are cared for by the participating specialist palliative home care teams when implementing eIPOS.

Group Type EXPERIMENTAL

eIPOS

Intervention Type DEVICE

Electronic version of IPOS

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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eIPOS

Electronic version of IPOS

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Claudia Bausewein

Professor for Palliative Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Katerina Hriskova

München, Bavaria, Germany

Site Status

Countries

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Germany

References

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Burner-Fritsch I, Kolmhuber S, Hodiamont F, Bausewein C, Hriskova K. Implementing ePROM in specialist palliative home care: the professionals' perspective - a mixed-methods study. Palliat Care Soc Pract. 2023 Aug 6;17:26323524231186827. doi: 10.1177/26323524231186827. eCollection 2023.

Reference Type DERIVED
PMID: 37560175 (View on PubMed)

Bolzani A, Kupf S, Hodiamont F, Burner-Fritsch I, Bausewein C, Ramsenthaler C. Measurement equivalence of the paper-based and electronic version of the Integrated Palliative care Outcome Scale (IPOS): A randomised crossover trial. Palliat Med. 2023 May;37(5):760-770. doi: 10.1177/02692163231157871. Epub 2023 Mar 1.

Reference Type DERIVED
PMID: 36856258 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34078632 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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01VSF17014

Identifier Type: -

Identifier Source: org_study_id

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