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

NCT03879668 | Completed

• 1 other identifier: 01VSF17014
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Disease

Keywords

Advanced disease; Specialised outpatient palliative care; IPOS; Electronical monitoring

Outcome Measures

Primary Outcomes (4)

• 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

• Acceptance of electronical monitoring

  Based on qualitative data

  up to 4 weeks after enrollment

• 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

• Influence of electronical monitoring on provided care

  Assess care modifications consecutive of initial care

  up to 4 weeks after enrollment

Secondary Outcomes (4)

• Palliative needs (IPOS)

  up to 4 weeks after enrollment

• EORTC QLQ-C15-PAL

  At baseline and 2 weeks

• Symptom burden (ESAS)

  At baseline and 2 weeks

• Unplanned hospital submissions

  up to 3 weeks after enrollment

Study Arms (3)

eIPOS

EXPERIMENTAL

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

Device: eIPOS

Historic control

NO INTERVENTION

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.

Prospective control

NO INTERVENTION

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.

Interventions

eIPOS DEVICE

Electronic version of IPOS

eIPOS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participants with cognitive impairment

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Katerina Hriskova

München, Bavaria, 81377, Germany

Location

Related Publications (3)

• 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.

  PMID: 37560175 DERIVED

• 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.

  PMID: 36856258 DERIVED

• 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.

  PMID: 34078632 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor for Palliative Medicine

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

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 19, 2019
• Study Start: January 1, 2019
• Primary Completion: August 31, 2021
• Study Completion: March 31, 2022
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)