Hypertension And Surgery Study: Evaluating the Implementation of a Hypertension Guideline Protocol

NCT03921086 | Completed

• 1 other identifier: HASS-2
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 7

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.

Conditions

Hypertension; Metabolic Syndrome; Non-Compliance, Medication

Outcome Measures

Primary Outcomes (2)

• Assessing physician compliance with prescription of in-hospital drugs according to hypertension algorithm

  Number of participants who have drugs prescribed in-hospital

  Five day period

• Assessing physician compliance with prescription of discharge drugs according to hypertension algorithm

  Number of participants who have drugs prescribed at hospital discharge

  Five day period

Other Outcomes (1)

• Assessing patient compliance with antihypertensive medication dispensing following discharge.

  Three and six months following discharge.

Study Arms (1)

Hypertensive patients

OTHER

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

Interventions

Antihypertensive medication according to the study's algorithm DRUG

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.

Hypertensive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cape Town: lead

Study Sites (7)

Groote Schuur Hospital

Cape Town, Western Cape, 7599, South Africa

Location

Mitchells Plain Hospital

Cape Town, Western Cape, 7599, South Africa

Location

Somerset Hospital

Cape Town, Western Cape, 7599, South Africa

Location

Victoria Hospital

Cape Town, Western Cape, 7599, South Africa

Location

George Hospital

George, Western Cape, 7599, South Africa

Location

Paarl Hospital

Paarl, Western Cape, 7599, South Africa

Location

Worcester Hospital

Worcester, Western Cape, 7599, South Africa

Location

MeSH Terms

Conditions

Hypertension; Metabolic Syndrome; Medication Adherence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Bruce Biccard, MD, PhD

  University of Cape Town

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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)

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: April 19, 2019
• Study Start: January 14, 2019
• Primary Completion: March 15, 2019
• Study Completion: March 16, 2019
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (7)