- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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)
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Clinical Project Manager
- Telefonnummer: 01223638000
- E-post: jeong-min.chun@nhs.net
Studieorter
-
-
Cambridgeshire
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Cambridge, Cambridgeshire, Storbritannien, CB2 0AY
- Rekrytering
- Royal Papworth Hospital NHS Foundation Trust
-
Kontakt:
- Robert Gatherer, MBBS
- Telefonnummer: 01223638000
- E-post: robert.gatherer@nhs.net
-
Huvudutredare:
- Robert Gatherer, MBBS
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Reduction in response time to ventilator patient physiological alarms
Tidsram: 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.
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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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Improvement in practitioner heart rate variability during clinical practice
Tidsram: 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)
|
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Participant-reported work effectiveness, job satisfaction, and stress levels
Tidsram: 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)
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Robert Gatherer, MBBS, Papworth Hospital NHS Foundation Trust
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- P03174
- 25/HRA/2201 (Annan identifierare: Health Research Authority)
Plan för individuella deltagardata (IPD)
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