Integrated Primary Care for Diabetes and Cardiovascular Disease (PACKBrazDCVD)

Integrated Primary Care for Diabetes and Cardiovascular Disease in Less Developed Countries: Pragmatic Trial of the Practical Approach to Care Kit

This study will evaluate a complex intervention based on a patient management tool (PMT), combined with educational outreach to primary care doctors, nurses and other health workers, in the Brazilian city of Florianopolis. The intervention is aimed at improving the quality of primary health care and health outcomes, in adults with diabetes and cardiovascular disease (CVD). The effectiveness of the intervention will be assessed by randomly allocating 48 primary care clinics to receive the intervention or not, and comparing patient and clinic level endpoints that reflect the health and quality of care provided over the following year. About 11000 patients known to have been diagnosed with diabetes mellitus and 32000 with CVD (defined as having a diagnosis of hypertension, ischemic heart disease, heart failure or cerebrovascular disease) in participating clinics will be included in the study. About 7800 of them have diagnoses of both CVD and stroke. The primary endpoints will be 1. Number of participants in whom at least one of the following tests was recorded: body mass index, plasma glucose, serum cholesterol, electrocardiogram, and 2. in participants with a diagnosis of hypertension recorded previously, average systolic blood pressure recorded. Secondary endpoints will include the individual components of the composite scores, health measures (hospital admissions and deaths), and indicators of appropriate diagnosis of comorbid conditions such as depression. Eligible patients will be identified and outcomes measured using electronic medical records.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Hypertension; Diabetes Mellitus; Ischemic Heart Disease; Cerebrovascular Disease
• Intervention / Treatment: Behavioral: Outreach education training; Behavioral: No outreach education training

Detailed Description

Diabetes mellitus and cardiovascular disease (diabetes and CVD) place a heavy and growing burden on people living in low and middle income countries. Many of them could be healthier if their disease was accurately diagnosed and correctly treated, but many are not. Doctors and nurses working in primary health care clinic are best placed people to diagnose and treat, especially where local clinics are near and free. But this raises two questions: 1. How to ensure that diabetes and CVD get the priority they need in overloaded clinics? 2. How to ensure rational evidence-based diagnosis and prescribing for diabetes and CVD? The investigators have developed a way of improving primary health care for people who have long term health conditions. It is a patient management tool (PMT), that is, a printed manual of flowcharts taking doctors and nurses from symptoms to diagnoses to treatments, tests or referrals, with advice on how to make decisions along the way about diagnoses, tests, treatments and referrals. They are prompted to think of other diseases and health problems that might be undetected or neglected. The package also includes a method of training known as outreach education. First trainers are trained, then trainers train groups of doctors and nurses at their workplaces, showing them how to use the guidelines, and using their own patients and clinical problems as examples. This outreach training is repeated several times in short sessions. The investigators' research in Africa has shown that this approach can be effective, cost effective, feasible and sustainable. It has been rolled out throughout South Africa and other African countries. But it has have not yet been shown to be effective for diabetes and CVD. The investigators have also not tried or evaluate it in Latin American countries, which have different health systems, and have many more doctors providing primary health care. Now co-investigators in the Brazilian city of Florianopolis have decided to put this educational package in place throughout the city, and have agreed to do so as a randomised controlled trial. This will clearly show whether PACK Brazil is effective, cost effective and feasible under Brazilian conditions. The core of the research will be a randomised controlled trial. 48 primary care clinics in the city will be randomly chosen either 1) to get the whole package of patient management tool plus training, or 2) only to get the patient management tool (which is expected to will make little difference without training). The investigators will compare patients in these two groups of clinics to see the effects of the training. They will use the clinics' electronic medical records to identify about 32000 adults diagnosed with diabetes and CVD. After the training starts they will follow these patients up for a year, and assess whether they are being appropriately treated and tested. The primary endpoints will be 1. Number of participants in whom at least one of the following tests was recorded: body mass index, plasma glucose, serum cholesterol, electrocardiogram, and 2. in participants with a diagnosis of hypertension recorded previously, average systolic blood pressure recorded. Secondary endpoints will include frequency of tests, the number who have each type of test, diastolic blood pressure in participants with hypertension, serum glucose levels in participants with diabetes, prescription of indicated treatments and treatment intensification, health measures (hospital admissions and deaths), and indicators of diagnosis and treatment of comorbid conditions such as depression. Eligible patients will be identified and outcomes measured using electronic medical records.

• Study Type: Interventional
• Enrollment (Actual): 40577
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Santa Catarina
    • Florianopolis, Santa Catarina, Brazil, 88.040-400
      • Florianopolis City Health Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 35 years and over in July 2016
• Diagnosis of hypertension (ICD-10 code I10-I15), ischaemic heart disease (ICD-10 code I20-I25), heart failure (ICD-10 code I50), cerebrovascular disease (ICD-10 code I60-I69), or diabetes mellitus (ICD-10 code E10-E14) ever recorded since January 1st 2010, and attended a participating clinic for any reason during the first year of the trial

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Doctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) and outreach education training. First trainers will be trained, then trainers will train groups of doctors and nurses at their workplaces, showing them how to use the guidelines, and using their own patients and clinical problems as examples. This outreach training is repeated several times in short sessions	Behavioral: Outreach education training; Printed copies of the patient management tool (PMT) and outreach education training
Active Comparator: Control; Doctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) but will receive no outreach education training.	Behavioral: No outreach education training; Printed copies of the patient management tool (PMT) without outreach education training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular risk and diabetes testing	Number of participants in whom at least one of the following tests was recorded: body mass index, plasma glucose, glycated hemoglobin (HbA1c), serum cholesterol, electrocardiogram.	During the first year of the trial
Systolic blood pressure	In participants with a diagnosis of hypertension recorded previously, and with systolic blood pressure >140 mm Hg recorded during 12 months before start of follow up, average systolic blood pressure recorded	During the first year of the trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic blood pressure	Number of tests for cardiovascular and diabetes risk factors (body mass index, plasma or skin prick glucose, serum cholesterol, electrocardiogram, chest X ray) recorded for each participant	During the first year of the trial
Number of tests	Number of tests for cardiovascular and diabetes risk factors (body mass index, plasma or skin prick glucose, serum cholesterol, electrocardiogram, chest X ray) recorded for each participant	During the first year of the trial
BMI measured	Number of participants who had body mass index recorded at least once	During the first year of the trial
Cholesterol tested	Number of participants who had serum cholesterol recorded at least once	During the first year of the trial
ECG tested	Number of participants who had electrocardiogram recorded at least once	During the first year of the trial
Chest X ray tested	Number of participants who had chest X ray recorded at least once	During the first year of the trial
Glucose tested	Number of participants who had plasma glucose recorded at least once	During the first year of the trial
Simvastatin prescribed	Number of participants in whom simvastatin was prescribed for the first time	During the first year of the trial
Simvastatin dose changed	Number of participants in whom dose of simvastatin was changed	During the first year of the trial
Depression diagnosed	Number of participants in whom a diagnosis of depression (ICD-10 code F32-F34) was recorded for the first time	During the first year of the trial
Antidepressant diagnosed	Number of participants in whom antidepressant medication (tricyclic and related antidepressants, selective serotonin re-uptake inhibitors, and monoamine oxidase inhibitors) was prescribed for the first time	During the first year of the trial
Heart failure diagnosed	Number of participants in whom a diagnosis of heart failure (ICD-10 code I50) was recorded for the first time	During the first year of the trial
Ischemic heart disease diagnosed	Number of participants in whom a diagnosis of heart failure (ICD-10 code I50) was recorded for the first time	During the first year of the trial
Cerebrovascular disease diagnosed	Number of participants in whom a diagnosis of cerebrovascular disease (ICD-10 code I60-I69) was recorded for the first time	During the first year of the trial
Angina referral	Number of participants referred to a hospital or specialist with a diagnosis of angina pectoris (ICD code I20)	During the first year of the trial
Hospital admission for CVD	Number of participants admitted to hospital for ischemic heart disease, heart failure, hypertension, cerebrovascular disease or peripheral vascular disease (ICD code I73)	During the first year of the trial
All cause mortality	Number of participants who died	During the first year of the trial
Death from CVD	Number of participants who died and in whom ischemic heart disease, heart failure, hypertension, or cerebrovascular disease was recorded as an underlying cause of death	During the first year of the trial
Any hypertension controlled	In participants with an average systolic blood pressure greater than 140 mm Hg, or an average diastolic blood pressure greater than 90 mm Hg, recorded during 12 months before enrolment, the number of participants with systolic blood pressure 140 mm Hg or less and with diastolic blood pressure 90 mm Hg or less	During the first year of the trial
Severe hypertension controlled	In participants with an average systolic blood pressure greater than 150 mm Hg, or an average diastolic blood pressure greater than 100 mm Hg, recorded during 12 months before enrolment, the number of participants with systolic blood pressure 140 mm Hg or less and with diastolic blood pressure 90 mm Hg or less	During the first year of the trial
Number of glucose tests	In participants with a diagnosis of diabetes, number of times plasma glucose or glycated hemoglobin (HbA1c) recorded	During the first year of the trial
Glycated hemoglobin (HbA1c)	In participants with a diagnosis of diabetes, average glycated hemoglobin (HbA1c) level recorded	During the first year of the trial
Heart failure treatment	In participants with a diagnosis of heart failure, the number of new prescriptions for furosemide, hydrochlorothiazide, enalapril or carvedilol	During the first year of the trial
Increased hypertension treatment	In participants with a diagnosis of hypertension, the number of participants with a prescription for increased dose of hydrochlorothiazide, enalapril, amlodipine or propanalol	During the first year of the trial
Ischemic heart disease treatment	In participants with a diagnosis of ischemic heart disease, then number of participants with a new prescription of angiotensin converting enzyme inhibitor, isosorbide dinitrate, propanalol, enalapril or losartan	During the first year of the trial

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: University of Sao Paulo; University of East Anglia; University of Cape Town; Medical Research Council, South Africa; Federal University of Bahia; Santa Catarina Federal University
• Investigators: Principal Investigator: Max Bachmann, MBChB PhD, University of East Anglia; Principal Investigator: Eric Bateman, MBChB MD, University of Cape Town; Principal Investigator: Rafael Stelmach, MD PhD, University of Sao Paulo

Publications and helpful links

General Publications

• Bachmann MO, Bateman ED, Stelmach R, Cruz AA, Pacheco de Andrade M, Zonta R, Zepeda J, Natal S, Cornick R, Wattrus C, Anderson L, Lombard C, Fairall LR. Integrating primary care of chronic respiratory disease, cardiovascular disease and diabetes in Brazil: Practical Approach to Care Kit (PACK Brazil): study protocol for randomised controlled trials. J Thorac Dis. 2018 Jul;10(7):4667-4677. doi: 10.21037/jtd.2018.07.34.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): March 31, 2018
• Study Completion (Anticipated): March 31, 2019

Study Registration Dates

• First Submitted: June 6, 2016
• First Submitted That Met QC Criteria: June 9, 2016
• First Posted (Estimate): June 10, 2016

Study Record Updates

• Last Update Posted (Actual): April 30, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Diabetes Mellitus; Cerebrovascular Disorders
• Other Study ID Numbers: PACKBrazil2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No