High blood pressure Circulatory System Hypertension
Conditions
Interventions
The identification of potential participants whose blood pressure exceeds the index test threshold will be automated using live, computerised algorithms. Patients identified as potentially eligible by
Sponsors
Clinical Trials and Research Governance - University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to give written informed consent for participation in the study 2. Aged =18 years < 80 years 3. Admitted to hospital for an acute or elective medical or surgical condition 4. Pending discharge to a fixed abode within Oxford City 5. At least three in-hospital blood pressure recordings over a minimum of 24 hours for the index admission 6. At least one blood pressure measurement during the index admission being recorded during night time hours (00:00 to 06:00) and one recorded during day time hours (10:00 and 20:00) 7. Identified by the BP algorithm at any 24-hour interval during that index admission, to have a running mean blood pressure which meets the eligibility thresholds, which are defined as: mean systolic blood pressure = 120 mmHg 8. Registered with a General Practitioner and consents to his or her general practitioner to be notified of participation in the study and of results of investigations as part of this study 9. Able to comply with the study protocol
Exclusion criteria
Exclusion criteria: 1. Pre-existing diagnosis of hypertension or attending hospital with acute end-organ damage related to severe, undiagnosed hypertension including but not limited to: posterior reversible encephalopathy syndrome, hypertensive encephalopathy, ocular haemorrhage, hypertensive retinopathy, heart failure, acute vascular injury, stroke, myocardial infarction or angina 2. Pregnant, within three months post-partum or planning pregnancy during the course of the study 3. Receiving or requiring treatments which might be used for the management of hypertension, for reasons other than this, e.g. beta-blockers for migraine, angiotensin-converting-enzyme inhibitors for renal disease or aldosterone antagonists for the treatment of ascites 4. Diagnosed with terminal illness or cognitive impairment 5. Diagnosed with acute kidney injury on index admission or eGFR < 30 6. Cause for hypertension being toxicology, medical or recreational e.g. amphetamines and their derivatives or alcohol withdrawal syndrome 7. Post discharge destination being one of another hospital, medical treatment facility or prison 8. Receiving concomitant chemotherapy 9. Already recruited to a separate hypertension study 10. Presence of atrial fibrillation or another pulse irregularity which means automated blood pressure monitoring is not appropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the optimal in-hospital blood pressure threshold(s) (index test) above which patients should receive post-discharge ambulatory blood pressure monitoring in the community (gold standard test), to detect the presence of undiagnosed hypertension, using the following data: a. Percentage of patients in the eligible hospital population who have a mean in-hospital blood pressure above the eligibility threshold and a series of ordinal blood pressure thresholds. b. True positive, false positive, true negative and false negative classifications of hypertension at each of the index and ordinal thresholds, defined by ABPM as the gold standard test. c. Sensitivity and specificity of the index threshold and each ordinal blood pressure threshold as a diagnostic predictor for the presence of hypertension. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Test the feasibility of utilising blood pressures recorded electronically during routine practice to identify patients with a mean blood pressure which exceeds the pressure thresholds defined in the study protocol. Performance and boundaries of the algorithm will be tested against validation scenarios to ensure correct performance before study commencement. 2. Develop an effective clinical pathway to follow patients from hospital to community, integrating individual hospital patient data with primary care health records and preventing duplication of investigations between primary and secondary care. The clinical pathway will be assessed using data collected from primary care practitioner and patient surveys to include: 2.1 Feedback regarding communication streams and integration of data with primary care health records 2.2 Percentage of eligible patients who comply with the protocol to complete community ABPM and arrange follow up with their primary care provider 3. Test the feasibility and acceptability of following these patients up in the community to conduct ABPM as a gold standard test for the diagnosis of hypertension. The feasibility and acceptability of the follow-up procedures will be assessed using data collected from primary care practitioner and patient surveys to include: 3.1 Percentage of eligible patients who comply with the protocol to complete community ABPM and arrange follow up with their primary care provider 3.2 Acceptability of ABPM and follow up procedures used in this study 4. Identify a device that will monitor and record the ambulatory blood pressure of these patients following discharge from hospital. Suitability and performance of the device will be assessed based on the percentage successful recordings made by the ABPM per patient and per cohort and percentage participant adherence with 24-hour wear of the ABPM. 5. Identify patient factors which are associated with diagnostic accuracy. Subgroup analysis will be performed according to | — |
Countries
England, United Kingdom
Contacts
Public ContactPeter Watkinson
Outcome results
None listed