Integrated Primary Care for Diabetes and Cardiovascular Disease

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• University of Sao Paulo

  collaborator OTHER

• Santa Catarina Federal University

  collaborator OTHER

• University of Cape Town

  collaborator OTHER

• Federal University of Bahia

  collaborator OTHER

• Medical Research Council, South Africa

  collaborator OTHER

• University of East Anglia

  collaborator OTHER

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Max Bachmann, MBChB PhD · University of East Anglia

• Eric Bateman, MBChB MD · University of Cape Town

• Rafael Stelmach, MD PhD · University of Sao Paulo

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-01

Primary Completion

2018-03-31

Completion

2019-03-31

Countries

• Brazil

Study Locations