Structuring of Diabetes Care in Primary Health Care

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effectiveness of reorganization in Primary Health Care teams and individualized glycemic targets for type 2 diabetes.

Detailed Description
-----------------
The prevalence of diabetes is increasing in parallel with the obesity epidemic. Diabetes is, therefore, a costly disease for individuals and healthcare system, generating expenses in its management and its complications. Also, it has significant social cost related to reduction of productivity. This study will evaluate the effectiveness of a multimodal intervention for Primary Health Care (PHC) teams to increase the nurse clinical role and implement individualized glycemic targets and care plan for type 2 diabetes through a pragmatic cluster-randomized clinical trial, with 1:1 allocation of health units in Porto Alegre, Brazil. Two study arms will be evaluated: 1) intervention group: will receive a set of proposed actions (redistribution of diabetes care between nurses and physicians, use of the individualized glycemic target calculator and implementation of care recommendations); 2) control group: usual follow-up in PHC.

Official Title
-----------------
Structuring Diabetes Care in Primary Health Care With Individualized Goals and Multidisciplinary Integration: A Cluster-randomized Clinical Trial for

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: Redistribution of diabetes care between nurses and physicians
* Other: Individualized glycemic target
* Other: Minimum care recomendations
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Health care unit: Inclusion criteria Health unit has registered at least 50 users diagnosed with type 2 diabetes Exclusion criteria: Health units that do not have a doctor and a nurse available on the same shift or do not have at least one doctor and a nurse willing to participate in the study. Individuals: Inclusion criteria Individuals with type 2 diabetes for at least one year In person diabetes consultation in the last six months Exclusion criteria: Expected survival < one year

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Multimodal intervention in the primary care team that includes: redistribution of diabetes care between nurses and physicians, use of the individualized glycemic target calculator and implementation of minimum care recommendations | Other: Redistribution of diabetes care between nurses and physicians<br>* It will be proposed that nurses and physician share the clinical care of patients with type 2 diabetes, with complementing actions<br>Other: Individualized glycemic target<br>* Define the target of individualized glycemic treatment for patients with the support of a tool on the website, which will encourage the intensification and de-intensification of treatment when appropriate<br>Other: Minimum care recomendations<br>* It will be proposed to carry out the minimum necessary assessments that, annually, nurses and physicians must do to ensure the adequacy of quality indicators in the care of diabetes in the PHC<br>|
| Active Comparator: Control<br>Usual follow-up in Primary Health Care (no intervention in the teams) | Other: No intervention<br>* Primary care health teams will follow their rotine care of type 2 diabetes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who achieved individualized target HbA1c | Number of patients who achieved the individualized target HbA1c defined at baseline | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of clinical consultations carried out by nurses | Proportion of nursing consultations in relation to the total number of consultations (nurse and physician) | 12 months | 
| Foot evaluation | Total number of nursing consultations in which the feet were evaluated | 12 months |