Clinical trial NCT03921086: Hypertension And Surgery Study: Evaluating the Implementation of a Hypertension Guideline Protocol
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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Metabolic Syndrome
Non-Compliance, Medication
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assessing physician compliance with prescription of in-hospital drugs according to hypertension algorithm
timeFrame: Five day period
measure: Assessing physician compliance with prescription of discharge drugs according to hypertension algorithm
timeFrame: Five day period
Secondary outcomes:
Other outcomes:
measure: Assessing patient compliance with antihypertensive medication dispensing following discharge.
timeFrame: Three and six months following discharge.
Locations:
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
state: Western Cape
city: Cape Town
country: South Africa
facility: Mitchells Plain Hospital
state: Western Cape
city: Cape Town
country: South Africa
facility: Somerset Hospital
state: Western Cape
city: Cape Town
country: South Africa
facility: Victoria Hospital
state: Western Cape
city: George
country: South Africa
facility: George Hospital
state: Western Cape
city: Paarl
country: South Africa
facility: Paarl Hospital
state: Western Cape
city: Worcester
country: South Africa
facility: Worcester Hospital
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Bruce Biccard, MD, PhD
role: STUDY_DIRECTOR
References: