4006 776 356
免费咨询 9:00-18:00
免费获得国外相关药品，最快 1 个工作日回馈药物信息
Hypertension And Surgery Study: Evaluating the Implementation of a Hypertension Guideline Protocol (HASS-2)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypertension Metabolic Syndrome Non-Compliance, Medication | Drug: Antihypertensive medication according to the study's algorithm | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 106 participants |
| Allocation: | N/A |
| 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 |
| Actual Study Completion Date : | March 16, 2019 |
| 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. |
- 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
- 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
- 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
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
| 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 | |
| Study Director: | Bruce Biccard, MD, PhD | University of Cape Town |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | February 20, 2019 | ||||
| First Posted Date ICMJE | April 19, 2019 | ||||
| Last Update Posted Date | April 28, 2020 | ||||
| Actual Study Start Date ICMJE | January 14, 2019 | ||||
| Actual Primary Completion Date | March 15, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures |
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
|
||||
| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Hypertension And Surgery Study: Evaluating the Implementation of a Hypertension Guideline Protocol | ||||
| Official Title ICMJE | Hypertension And Surgery Study 2: A Multicentre, Cross-sectional Quality Improvement Project: Evaluating the Implementation of a Hypertensive Guideline Protocol by Perioperative Clinicians. | ||||
| 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A 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 |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | 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. |
||||
| Study Arms ICMJE | Hypertensive patients
Newly diagnosed or poorly controlled hypertensive patients will be initiated on appropriate therapy as per a specific algorithm.
Intervention: Drug: Antihypertensive medication according to the study's algorithm
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
106 | ||||
| Original Estimated Enrollment ICMJE |
100 | ||||
| Actual Study Completion Date ICMJE | March 16, 2019 | ||||
| Actual Primary Completion Date | March 15, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | South Africa | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03921086 | ||||
| Other Study ID Numbers ICMJE | HASS-2 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE |
|
||||
| Responsible Party | Bruce Biccard, University of Cape Town | ||||
| Study Sponsor ICMJE | University of Cape Town | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| PRS Account | University of Cape Town | ||||
| Verification Date | April 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||
