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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06350968
Other study ID # MEC-2023-0151
Secondary ID 10200012110003
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date December 31, 2026

Study information

Verified date April 2024
Source Erasmus Medical Center
Contact Joica A.M. Benschop, MSc
Phone +31622586583
Email j.benschop@erasmusmc.nl
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this mixed-methods study is to describe both the implementation process and outcomes of the online module Advance Care Plan for (hemato-)oncology patients within the oncology-network CONCORD. The main question is: How is implementation and assurance of the advance care plan in daily care for (hemato-)oncological patients within CONCORD achieved, so that early integration of advance care planning in oncological care takes place and patient preferences are discussed? Healthcare providers and patients are asked to use the module and share their experiences with it.


Description:

Design Implementation research with a mixed-method design. Population The implementation of advance care planning should benefit the care of (hemato-)oncology patients aged 18 years and older during the palliative phase of their illness. The research focuses on: - Oncology patients who have been treated in one or more hospitals from the oncology-network CONCORD after their death (quantitative research) - Oncology patients treated with palliative intent in one or more hospitals from this network (interviews) - Healthcare providers and implementation staff in the relevant hospitals and from the service area (interviews) Goal The aim of this project is to implement advance care planning in (hemato-)oncology patients treated in one of the hospitals within the oncology-network CONCORD , so that personal preferences and treatment agreements lead to an appropriate treatment plan. This is examined through the process of implementation and assurance of advance care planning in oncological care. MAIN QUESTION: How is implementation and assurance of the online module advance care planning in daily care for (hemato-)oncological patients within the oncology-network CONCORD achieved, so that early integration of advance care planning in oncological care takes place and patient preferences are discussed? Method Qualitative research: Description of the initial situation and the context within each institution, but also of general practitioners and patients using the NASSS Framework. Interviews with project leader, project coordinators in each hospital, healthcare providers from 1st, 2nd and 3rd lines, patients and relatives at the start and end of the project (3-5 in each target group per hospital, taking into account the greatest possible degree of diversity in age, gender and background). At the end of the project, the interviews are repeated to gather information about the experiences and lessons learned and the experiences with facilitating and hindering factors. Each interview is transcribed and analyzed using NVivio or Atlas.ti, analysis programs for qualitative data. Quantitative research: EHR-research based on anonymized data using a dashboard. A dashboard is being built in each hospital to analyze data from (hemato-)oncological patients who have been treated in the relevant hospital and have died. The dashboard contains demographic and medical data, the use of the proactive care module and medical consumption in the last three months of their lives. In each of the participating hospitals, the (hemato-)oncological patients who died in the last 3 months of 2022, 2023, 2024 and 2025 are selected and it will be examined to what extent the advance care plan has been completed and what kind of care the patients have received. A 'Health economic analysis' is carried out using the data from the dashboard. On the one hand, this involves the costs of implementing the advance care planning module used. In addition, the dashboard maps medical consumption in the last three months of life (e.g. ICU admissions, ER visits, clinical admissions, etc.). This is translated into the nationally determined costs for this. This is done both before and after implementation has been mapped out among people who have died, making it possible to gain insight into the difference in costs incurred.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Cancer - Treated by hospital from the CONCORD-network Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Joica Benschop Rotterdam

Sponsors (9)

Lead Sponsor Collaborator
Erasmus Medical Center Albert Schweitzer Hospital, Beatrix hospital, Franciscus &Vlietland, IJsselland, Ikazia Hospital, Rotterdam, Maasstad Hospital, Spijkenisse Medical Center, Van Weel-Bethesda hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Implementation outcome Fidelity to the tailored implementation of the ACP-tool 3 years
Secondary Intervention outcome Healthcare use of patients with cancer in last phase of life (number of hospital admissions, ICU admissions, medication use, etc.) 3 years
Secondary Implementation outcome Number of filled-in ACP-tools in EHR 3 years
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