Hypertension And Surgery Study: Evaluating the Implementation of a Hypertension Guideline Protocol (HASS-2)
Primary Purpose
Hypertension, Metabolic Syndrome, Non-Compliance, Medication
Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Antihypertensive medication according to the study's algorithm
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility 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
Sites / Locations
- Groote Schuur Hospital
- Mitchells Plain Hospital
- Somerset Hospital
- Victoria Hospital
- George Hospital
- Paarl Hospital
- Worcester Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Hypertensive patients
Arm Description
Newly diagnosed or poorly controlled hypertensive patients will be initiated on appropriate therapy as per a specific algorithm.
Outcomes
Primary Outcome Measures
Assessing physician compliance with prescription of in-hospital drugs according to hypertension algorithm
Number of participants who have drugs prescribed in-hospital
Assessing physician compliance with prescription of discharge drugs according to hypertension algorithm
Number of participants who have drugs prescribed at hospital discharge
Secondary Outcome Measures
Full Information
NCT ID
NCT03921086
First Posted
February 20, 2019
Last Updated
April 27, 2020
Sponsor
University of Cape Town
1. Study Identification
Unique Protocol Identification Number
NCT03921086
Brief Title
Hypertension And Surgery Study: Evaluating the Implementation of a Hypertension Guideline Protocol
Acronym
HASS-2
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cape Town
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Metabolic Syndrome, Non-Compliance, Medication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypertensive patients
Arm Type
Other
Arm Description
Newly diagnosed or poorly controlled hypertensive patients will be initiated on appropriate therapy as per a specific algorithm.
Intervention Type
Drug
Intervention Name(s)
Antihypertensive medication according to the study's algorithm
Intervention Description
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 Measure Information:
Title
Assessing physician compliance with prescription of in-hospital drugs according to hypertension algorithm
Description
Number of participants who have drugs prescribed in-hospital
Time Frame
Five day period
Title
Assessing physician compliance with prescription of discharge drugs according to hypertension algorithm
Description
Number of participants who have drugs prescribed at hospital discharge
Time Frame
Five day period
Other Pre-specified Outcome Measures:
Title
Assessing patient compliance with antihypertensive medication dispensing following discharge.
Description
Number of participants who have drugs dispensed following hospital discharge
Time Frame
Three and six months following discharge.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Biccard, MD, PhD
Organizational Affiliation
University of Cape Town
Official's Role
Study Director
Facility Information:
Facility Name
Groote Schuur Hospital
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7599
Country
South Africa
Facility Name
Mitchells Plain Hospital
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7599
Country
South Africa
Facility Name
Somerset Hospital
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7599
Country
South Africa
Facility Name
Victoria Hospital
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7599
Country
South Africa
Facility Name
George Hospital
City
George
State/Province
Western Cape
ZIP/Postal Code
7599
Country
South Africa
Facility Name
Paarl Hospital
City
Paarl
State/Province
Western Cape
ZIP/Postal Code
7599
Country
South Africa
Facility Name
Worcester Hospital
City
Worcester
State/Province
Western Cape
ZIP/Postal Code
7599
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
No
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Hypertension And Surgery Study: Evaluating the Implementation of a Hypertension Guideline Protocol
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