Integrated Primary Care for Diabetes and Cardiovascular Disease (PACKBrazDCVD)

• ClinicalTrials.gov Identifier: NCT02795910
• Recruitment Status: Unknown
• First Posted: June 10, 2016
• Last Update Posted: April 30, 2018
• Sponsor: University of Sao Paulo General Hospital
• Collaborators: University of Sao Paulo; Santa Catarina Federal University; University of Cape Town; Federal University of Bahia; Medical Research Council, South Africa; University of East Anglia
• Information provided by (Responsible Party): University of Sao Paulo General Hospital

Tracking Information

• First Submitted Date: June 6, 2016
• First Posted Date: June 10, 2016
• Last Update Posted Date: April 30, 2018
• Actual Study Start Date: April 1, 2017
• Actual Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 26, 2018)

• Cardiovascular risk and diabetes testing [ Time Frame: During the first year of the trial ]
  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.
• Systolic blood pressure [ Time Frame: During the first year of the trial ]
  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

Original Primary Outcome Measures (submitted: June 9, 2016)

• Cardiovascular risk and diabetes testing [ Time Frame: During the first year of the trial ]
  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.
• Systolic blood pressure [ Time Frame: During the first year of the trial ]
  In participants with a diagnosis of hypertension recorded previously, average systolic blood pressure recorded

Current Secondary Outcome Measures (submitted: June 9, 2016)

• Diastolic blood pressure [ Time Frame: During the first year of the trial ]
  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
• Number of tests [ Time Frame: During the first year of the trial ]
  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
• BMI measured [ Time Frame: During the first year of the trial ]
  Number of participants who had body mass index recorded at least once
• Cholesterol tested [ Time Frame: During the first year of the trial ]
  Number of participants who had serum cholesterol recorded at least once
• ECG tested [ Time Frame: During the first year of the trial ]
  Number of participants who had electrocardiogram recorded at least once
• Chest X ray tested [ Time Frame: During the first year of the trial ]
  Number of participants who had chest X ray recorded at least once
• Glucose tested [ Time Frame: During the first year of the trial ]
  Number of participants who had plasma glucose recorded at least once
• Simvastatin prescribed [ Time Frame: During the first year of the trial ]
  Number of participants in whom simvastatin was prescribed for the first time
• Simvastatin dose changed [ Time Frame: During the first year of the trial ]
  Number of participants in whom dose of simvastatin was changed
• Depression diagnosed [ Time Frame: During the first year of the trial ]
  Number of participants in whom a diagnosis of depression (ICD-10 code F32-F34) was recorded for the first time
• Antidepressant diagnosed [ Time Frame: During the first year of the trial ]
  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
• Heart failure diagnosed [ Time Frame: During the first year of the trial ]
  Number of participants in whom a diagnosis of heart failure (ICD-10 code I50) was recorded for the first time
• Ischemic heart disease diagnosed [ Time Frame: During the first year of the trial ]
  Number of participants in whom a diagnosis of heart failure (ICD-10 code I50) was recorded for the first time
• Cerebrovascular disease diagnosed [ Time Frame: During the first year of the trial ]
  Number of participants in whom a diagnosis of cerebrovascular disease (ICD-10 code I60-I69) was recorded for the first time
• Angina referral [ Time Frame: During the first year of the trial ]
  Number of participants referred to a hospital or specialist with a diagnosis of angina pectoris (ICD code I20)
• Hospital admission for CVD [ Time Frame: During the first year of the trial ]
  Number of participants admitted to hospital for ischemic heart disease, heart failure, hypertension, cerebrovascular disease or peripheral vascular disease (ICD code I73)
• All cause mortality [ Time Frame: During the first year of the trial ]
  Number of participants who died
• Death from CVD [ Time Frame: During the first year of the trial ]
  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
• Any hypertension controlled [ Time Frame: During the first year of the trial ]
  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
• Severe hypertension controlled [ Time Frame: During the first year of the trial ]
  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
• Number of glucose tests [ Time Frame: During the first year of the trial ]
  In participants with a diagnosis of diabetes, number of times plasma glucose or glycated hemoglobin (HbA1c) recorded
• Glycated hemoglobin (HbA1c) [ Time Frame: During the first year of the trial ]
  In participants with a diagnosis of diabetes, average glycated hemoglobin (HbA1c) level recorded
• Heart failure treatment [ Time Frame: During the first year of the trial ]
  In participants with a diagnosis of heart failure, the number of new prescriptions for furosemide, hydrochlorothiazide, enalapril or carvedilol
• Increased hypertension treatment [ Time Frame: During the first year of the trial ]
  In participants with a diagnosis of hypertension, the number of participants with a prescription for increased dose of hydrochlorothiazide, enalapril, amlodipine or propanalol
• Ischemic heart disease treatment [ Time Frame: During the first year of the trial ]
  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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Integrated Primary Care for Diabetes and Cardiovascular Disease
• Official Title: Integrated Primary Care for Diabetes and Cardiovascular Disease in Less Developed Countries: Pragmatic Trial of the Practical Approach to Care Kit
• Brief Summary: 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.
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• Diabetes Mellitus
• Hypertension
• Heart Failure
• Ischemic Heart Disease
• Cerebrovascular Disease

Intervention

• Behavioral: Outreach education training
  Printed copies of the patient management tool (PMT) and outreach education training
• Behavioral: No outreach education training
  Printed copies of the patient management tool (PMT) without outreach education training

Study Arms

• 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
  Intervention: Behavioral: 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.
  Intervention: Behavioral: No outreach education training

• Publications *: Bachmann MO, Bateman ED, Stelmach R, Cruz ÁA, 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. Review.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: April 26, 2018): 40577
• Original Estimated Enrollment (submitted: June 9, 2016): 35000
• Estimated Study Completion Date: March 31, 2019
• Actual Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 35 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT02795910
• Other Study ID Numbers: PACKBrazil2
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University of Sao Paulo General Hospital
• Study Sponsor: University of Sao Paulo General Hospital

Collaborators

• University of Sao Paulo
• Santa Catarina Federal University
• University of Cape Town
• Federal University of Bahia
• Medical Research Council, South Africa
• University of East Anglia

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

• PRS Account: University of Sao Paulo General Hospital
• Verification Date: April 2018