- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07709364
Heart Rate Variability for Practitioner Stimulated Reflection and Decision-making Optimisation (HRV-PRO)
At the heart of healthcare is the interaction between healthcare practitioners and patients. It is believed that optimisation of this interaction can improve patient relevant outcomes, safety and patient experience. Through utilisation of practitioner physiological data, heart rate variability (HRV), to help practitioners make better decisions and optimise practice, it is considered possible to improve decision making around patient care and improve outcomes and safety.
The modern intensive care unit (ICU) is a dynamic data rich environment requiring rapid and accurate decision making. Advances in ventilator technology, electronic patient monitoring and electronic health records (EHR) have provided exponential growth in data produced for patients and the need for complex decision making. However, data overload and alarm fatigue can result in poor understanding and a delayed response from the practitioner in addressing the patient's needs.
The aim of this study is to present and evaluate a psychophysiology training approach for practitioners derived from their cardiovascular response through the course of the working day, this will be measured using heart rate variability (HRV). Practitioner HRV has been shown to be linked to work related stress and is considered a biomarker of decision-making.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
A Critical Participatory Action Research learning model is proposed, whereby practitioners can explore the nature and consequences of their practice utilising their HRV during two intervention periods. The aim is to improve practitioner performance and develop a more context aware approach to patient care.
Impact will be measured through:
- improvement in HRV of the practitioners
- measurement of response times to ventilator related events (decreased response times)
- improvement of time spent at bedside
- improvement in ventilation related outcomes for the patients.
- Reduction in bedside noise (reduced response time to alarms and reduction in inappropriate alarms)
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Clinical Project Manager
- Telefoonnummer: 01223638000
- E-mail: jeong-min.chun@nhs.net
Studie Locaties
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, Verenigd Koninkrijk, CB2 0AY
- Werving
- Royal Papworth Hospital NHS Foundation Trust
-
Contact:
- Robert Gatherer, MBBS
- Telefoonnummer: 01223638000
- E-mail: robert.gatherer@nhs.net
-
Hoofdonderzoeker:
- Robert Gatherer, MBBS
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Nurse working in Enhanced Recovery Unit at Royal Papworth Hospital NHS Foundation Trust
- Willingness to participate in the trial
Exclusion Criteria:
- Staff with permanent pacemakers
- Staff on medication that could affect HRV (e.g. b-blockers)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Bedside nurses in Enhanced Recovery Unit
Baseline collection will consist of data from 20 bedside nurses over 10 shifts (12 hours +/- 3 hrs) each.
5 shifts post first intervention (1st workshop) and 5 shifts post second intervention (2nd workshop).
|
The intervention is based on a Critical Participatory Action Research learning model, using the participant's heart rate variability data collected during clinical shifts.
Before the intervention, participants will complete repeated HRV monitoring and use a diary to record clinical events and reflections.
The intervention includes facilitated workshops introducing reflective practice, cognitive bandwidth, and related educational concepts.
Participants will receive individual coaching to review their HRV data and identify patterns and triggers in their clinical work, followed by group discussions to share experiences and develop strategies to adapt practice.
A second workshop builds on this process with further reflection, additional HRV analysis, and collaborative strategy development.
Between and after sessions, participants continue data collection and apply insights in practice, aiming to enhance clinical performance and develop a more context-aware approach to patient care.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Reduction in response time to ventilator patient physiological alarms
Tijdsspanne: At completion of 20th clinical shift (each shift is 12 hours)
|
Practitioner response time (in seconds) to ventilator-related physiological alarm events measured using ventilator event logs and bedside monitoring system records.
|
At completion of 20th clinical shift (each shift is 12 hours)
|
|
Adherence to bedside noise level targets
Tijdsspanne: At completion of 20th clinical shift (each shift is 12 hours)
|
Duration of time (seconds) bedside noise levels remain outside predefined acceptable clinical thresholds, measured using bedside environmental noise monitoring during clinical shifts.
|
At completion of 20th clinical shift (each shift is 12 hours)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Improvement in practitioner heart rate variability during clinical practice
Tijdsspanne: At completion of 20th clinical shift (each shift is 12 hours)
|
Can practitioners improve their HRV through the iterative stimulated reflection intervention.
|
At completion of 20th clinical shift (each shift is 12 hours)
|
|
Participant-reported work effectiveness, job satisfaction, and stress levels
Tijdsspanne: At completion of 20th clinical shift (each shift is 12 hours)
|
Participant-reported perceptions of work effectiveness, job satisfaction, and stress levels measured using study questionnaires
|
At completion of 20th clinical shift (each shift is 12 hours)
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Robert Gatherer, MBBS, Papworth Hospital NHS Foundation Trust
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- P03174
- 25/HRA/2201 (Andere identificatie: Health Research Authority)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .