- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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)
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Clinical Project Manager
- Phone Number: 01223638000
- Email: jeong-min.chun@nhs.net
Study Locations
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
- Royal Papworth Hospital NHS Foundation Trust
-
Contact:
- Robert Gatherer, MBBS
- Phone Number: 01223638000
- Email: robert.gatherer@nhs.net
-
Principal Investigator:
- Robert Gatherer, MBBS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in response time to ventilator patient physiological alarms
Time Frame: 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
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement in practitioner heart rate variability during clinical practice
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Robert Gatherer, MBBS, Royal Papworth Hospital NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P03174
- 25/HRA/2201 (Other Identifier: Health Research Authority)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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