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Hypertension And Surgery Study: Evaluating the Implementation of a Hypertension Guideline Protocol (HASS-2)

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ClinicalTrials.gov Identifier: NCT03921086
Recruitment Status : Active, not recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Bruce Biccard, University of Cape Town

Brief Summary:
HASS-2 is a multi-center, cross-sectional quality improvement project: evaluating the implementation of a hypertension guideline protocol by perioperative clinicians, as a model for improving various aspects of public health. The study will also describe the co-morbid risk profile of these newly identified or poorly controlled hypertensive patients. In addition, as a sub-study, these patients will be followed up at monthly intervals for 3 months after discharge, in order to quantify the rates of compliance with their prescribed treatment.

Condition or disease Intervention/treatment Phase
Hypertension Metabolic Syndrome Non-Compliance, Medication Drug: Antihypertensive medication according to the study's algorithm Not Applicable

Detailed Description:

Globally, cardiovascular disease is the leading cause of death. Hypertension is the commonest risk factor underlying cardiovascular disease, and, uncontrolled, is a risk for myocardial infarction, heart failure, stroke and renal disease. Hypertension is common, affecting over 1 billion people worldwide. In modern practice, failure to treat hypertension is regarded as poor medicine, and potentially indefensible.Hypertension remains a global health problem and one that is usually identified and treated in the primary health care setting. However, in South Africa, which is a resource-limited environment, it can burden an already strained primary health care system. The prevalence of hypertension in the adult population of South Africa is approximately 30%. With urbanisation, an ageing population, amongst other developing trends, this number is projected to increase significantly in the future.The perioperative period therefore presents a unique opportunity for clinicians to identify, educate and appropriately initiate or escalate management of these patients, thereby alleviating the burden on the primary health care system.

A short-term quality improvement intervention has the potential to improve quality of care in cardiovascular disease, in a low- to middle-income country like South Africa. This can be done by educating health care providers and implementing a guideline which will lead to improved, standardised and sustained quality of care for patients with hypertension. This will lead to a reduction in blood pressure, and further improve long-term morbidity and mortality of patients, and ultimately reduce the burden on an already strained health care system. Such guidelines could be modified to address other public health care challenges.

Within the African context, South Africans are recognised as being at a significant risk of cardiovascular disease, with the population having the highest prevalence of smoking, dyslipidemia, elevated fasting glucose and abdominal obesity, features of metabolic syndrome.

Metabolic syndrome found in hypertensive patients increases their risk of morbidity and mortality. This, in addition to the added physiological stress of surgery, may dramatically increase cardiovascular risk and complications in this cohort.

Prescribed medications for chronic conditions such as hypertension require a consistent level of patient compliance to the treatment regime. Compliance has been defined as "the extent to which a person's behaviour (in terms of taking medications, following diets or executing lifestyle changes) coincides with medical or health advice". Non-compliance can result in significant implications for not only the patient's health outcomes, but a considerable wastage of resources in an already limited setting. The World Health Organisation has highlighted the considerable economic and health benefits associated with improving compliance with treatments for conditions such as diabetes, hyperlipidaemia and hypertension. Similar to other non-communicable diseases, the ultimate goal of managing hypertension is achieve target control and prevent complications.The secondary aim of the HASS-2 study is to quantify the rates of compliance to antihypertensive medication following discharge from the patient's respective hospitals.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Initiate anti-hypertensive therapy in surgical patients who are identified as hypertensive at the time of their admission. Identify the co-morbidities of these patients (diabetes mellitus, dyslipidemia, renal impairment, obesity and ECG changes)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypertension And Surgery Study 2: A Multicentre, Cross-sectional Quality Improvement Project: Evaluating the Implementation of a Hypertensive Guideline Protocol by Perioperative Clinicians.
Actual Study Start Date : January 14, 2019
Actual Primary Completion Date : March 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Hypertensive patients
Newly diagnosed or poorly controlled hypertensive patients will be initiated on appropriate therapy as per a specific algorithm.
Drug: Antihypertensive medication according to the study's algorithm

Patients with stage 1 hypertension will receive monotherapy and risks of hypotension are negligible. A single antihypertensive lowers blood pressure (BP) on average by 10/5 mmHg.

Patients with stage 2 hypertension will be initiated on two medications and this is recommended by all international hypertension guidelines and studies have shown prompt BP control with minimal side effects.

For borderline patients, the investigators will elect to not treat them for blood pressure ranges of BP: 135-140/85-90 mmHg and give them a letter on discharge to be followed up at their local clinic. The letter will detail that they are potentially hypertensive patients and need to be followed up closely in future.

Patients with Stage 3 hypertension will be referred to the in-hospital physician as per the algorithm.





Primary Outcome Measures :
  1. Assessing physician compliance with prescription of in-hospital drugs according to hypertension algorithm [ Time Frame: Five day period ]
    Number of participants who have drugs prescribed in-hospital

  2. Assessing physician compliance with prescription of discharge drugs according to hypertension algorithm [ Time Frame: Five day period ]
    Number of participants who have drugs prescribed at hospital discharge


Other Outcome Measures:
  1. Assessing patient compliance with antihypertensive medication dispensing following discharge. [ Time Frame: Three and six months following discharge. ]
    Number of participants who have drugs dispensed following hospital discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult (older than 18 years)
  • Elective surgery at preoperative in-hospital visit
  • All stage 1 and stage 2 hypertensive patients as defined by the South African Hypertension Practice Guideline 2014

Exclusion Criteria:

  • Patient refusal
  • Day case surgery
  • Obstetric and cardiac surgery
  • Patients with severe hypertension (>180/110 mmHg) as defined by the South African Hypertension Practice Guideline 2014

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921086


Locations
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South Africa
Groote Schuur Hospital
Cape Town, Western Cape, South Africa, 7599
Mitchells Plain Hospital
Cape Town, Western Cape, South Africa, 7599
Somerset Hospital
Cape Town, Western Cape, South Africa, 7599
Victoria Hospital
Cape Town, Western Cape, South Africa, 7599
George Hospital
George, Western Cape, South Africa, 7599
Paarl Hospital
Paarl, Western Cape, South Africa, 7599
Worcester Hospital
Worcester, Western Cape, South Africa, 7599
Sponsors and Collaborators
University of Cape Town
Investigators
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Study Director: Bruce Biccard, MD, PhD University of Cape Town

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Responsible Party: Bruce Biccard, Clinical Professor, University of Cape Town
ClinicalTrials.gov Identifier: NCT03921086     History of Changes
Other Study ID Numbers: HASS-2
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypertension
Metabolic Syndrome
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antihypertensive Agents