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The goal of this study is the assess the use of remote monitoring of vital signs using commercially available medical devices in patients with advanced cancer admitted to a hospice inpatient unit for end-of-life care.
The objectives of the study are:
This study will take place in the palliative care unit at Our Lady's Hospice & Care Services and will consist of applying a small, flexible, patch-like device to the participant's chest with an adhesive patch.
If the participant is happy to take part in the study, they will be visited by a member of the research team. This meeting provides the opportunity to discuss the study, answer any questions and complete a consent form.
The researcher will also collect some information about the participant's condition, and medication from their medical notes and drug chart. The participant will need to wear the device for the duration of their time in the hospice. The research team will remotely check that the device is working properly, and will change the device when the battery needs re-charging (every 14 days). The research team will review the participant after 24 hr (to ensure no problems), and then a couple of times a week during the study. The nursing team will check that the patch is sticking properly every day.
The medical / nursing team will not have access to the information from the device, and so will not make any clinical decisions on the basis of this information.
The device will continue to be worn until the patient dies, the patient withdraws, the patient is discharged, or the patient improves (and is no longer receiving end-of-life care). At the end of the participant's stay on the hospice the device will be removed and cleaned / sterilized according to the manufacturer's instructions (the adhesive patches that secure the device to the chest wall are disposable / not reusable).
The study will recruit 120 patients - this number is pragmatic, and based upon annual admission data for OLH&CS (and the likelihood of end-of-life patients to engage in research).
Currently, the plan is to use descriptive statistics, and standard statistical methods to analyse the study data. However, we are engaging with colleagues at UCD about using machine learning to undertake further analyses. A formal statistical analysis plan will be developed prior to the primary analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palliative Care Patients | Patients admitted to the specialist palliative care unit with a primary diagnosis of malignant disease |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean, standard deviation, median, and range of heart rate variability (HRV) at predefined time intervals prior to death | Summary statistics (mean, standard deviation, median, and range) of heart rate variability defined as the Root Mean Square of Successive Differences (RMSSD), measured using a wearable ECG patch at predefined time intervals prior to death (0-24 hours, 24-48 hours, 48-72 hours, 72 hours-7 days, and 7-14 days). | From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death |
| Measure | Description | Time Frame |
|---|---|---|
| Mean, standard deviation, median, and range of heart rate at predefined time intervals prior to death | Summary statistics (mean, standard deviation, median, and range) of heart rate measured using a wearable ECG patch at predefined time intervals prior to death (0-24 hours, 24-48 hours, 48-72 hours, 72 hours-7 days, and 7-14 days). | From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be recruited from the specialist palliative care unit at OLH&CS.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hailey Goffinet, MSN | Contact | +353 014982537 | hgoffinet@olh.ie | |
| Professor Andrew Davies | Contact | +353 014986235 | andavies@tcd.ie |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Our Lady's Hospice and Care Services | Recruiting | Dublin | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37760611 | Background | Power J, Gouldthorpe C, Davies A. Vital Signs in Palliative Care: A Scoping Review. Cancers (Basel). 2023 Sep 20;15(18):4641. doi: 10.3390/cancers15184641. | |
| 10452423 | Background | Seymour JE. Revisiting medicalisation and 'natural' death. Soc Sci Med. 1999 Sep;49(5):691-704. doi: 10.1016/s0277-9536(99)00170-7. |
| Label | URL |
|---|---|
| Information on validated wearable device used in this study. | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Mean, standard deviation, median, and range of respiratory rate at predefined time intervals prior to death | Summary statistics (mean, standard deviation, median, and range) of respiratory rate measured using a wearable ECG patch at predefined time intervals prior to death (0-24 hours, 24-48 hours, 48-72 hours, 72 hours-7 days, and 7-14 days). | From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death |
| Mean, standard deviation, median, and range of skin temperature at predefined time intervals prior to death | Summary statistics (mean, standard deviation, median, and range) of skin temperature measured using a wearable ECG patch at predefined time intervals prior to death (0-24 hours, 24-48 hours, 48-72 hours, 72 hours-7 days, and 7-14 days). | From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death |
| Number of participants with clinical events (e.g. increased PRN medication use) | Association between changes in physiological parameters (heart rate, respiratory rate, HRV, temperature, activity) measured using a wearable ECG patch and occurrence of increased PRN medication use collected through retrospective chart review. | From device initiation until death (up to 14 days) |
| Number of participants with clinical events (e.g. infection) | Association between changes in physiological parameters (heart rate, respiratory rate, HRV, temperature, activity) measured using a wearable ECG patch and occurrence of infection collected through retrospective chart review. | From device initiation until death (up to 14 days) |
| Background | Ellershaw J, Wilkinson S. Care of the dying. a pathway to excellence. Oxford University Press: Oxford, UK; 2003. |
| 17357794 | Background | Veerbeek L, van Zuylen L, Swart SJ, van der Maas PJ, van der Heide A. The last 3 days of life in three different care settings in The Netherlands. Support Care Cancer. 2007 Oct;15(10):1117-23. doi: 10.1007/s00520-006-0211-x. Epub 2007 Mar 15. |
| 15078500 | Background | Olsson T, Terent A, Lind L. Rapid Emergency Medicine score: a new prognostic tool for in-hospital mortality in nonsurgical emergency department patients. J Intern Med. 2004 May;255(5):579-87. doi: 10.1111/j.1365-2796.2004.01321.x. |