- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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)
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Clinical Project Manager
- Telefonnummer: 01223638000
- E-mail: jeong-min.chun@nhs.net
Studiesteder
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Cambridgeshire
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Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 0AY
- Royal Papworth Hospital NHS Foundation Trust
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Kontakt:
- Robert Gatherer, MBBS
- Telefonnummer: 01223638000
- E-mail: robert.gatherer@nhs.net
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Ledende efterforsker:
- Robert Gatherer, MBBS
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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).
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Reduction in response time to ventilator patient physiological alarms
Tidsramme: At completion of 20th clinical shift (each shift is 12 hours)
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Practitioner response time (in seconds) to ventilator-related physiological alarm events measured using ventilator event logs and bedside monitoring system records.
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At completion of 20th clinical shift (each shift is 12 hours)
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Adherence to bedside noise level targets
Tidsramme: At completion of 20th clinical shift (each shift is 12 hours)
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Duration of time (seconds) bedside noise levels remain outside predefined acceptable clinical thresholds, measured using bedside environmental noise monitoring during clinical shifts.
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At completion of 20th clinical shift (each shift is 12 hours)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Improvement in practitioner heart rate variability during clinical practice
Tidsramme: At completion of 20th clinical shift (each shift is 12 hours)
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Can practitioners improve their HRV through the iterative stimulated reflection intervention.
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At completion of 20th clinical shift (each shift is 12 hours)
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Participant-reported work effectiveness, job satisfaction, and stress levels
Tidsramme: At completion of 20th clinical shift (each shift is 12 hours)
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Participant-reported perceptions of work effectiveness, job satisfaction, and stress levels measured using study questionnaires
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At completion of 20th clinical shift (each shift is 12 hours)
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Robert Gatherer, MBBS, Royal Papworth Hospital NHS Foundation Trust
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- P03174
- 25/HRA/2201 (Anden identifikator: Health Research Authority)
Plan for individuelle deltagerdata (IPD)
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Kliniske forsøg med Critical Participatory Action Intervention with HRV Feedback
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