Patient Centered Care in Diabetes in Ecuador

Study Overview
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Brief Summary
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Introduction: According to World Health Organization data, it is estimated that more than 422 million people have diabetes. In Ecuador, diabetes is the second cause of death, only after ischemic heart disease, and is the first chronic non-communicable disease. The complexity of the pathology, its difficult management and the patient's commitment and involvement in their own care has led health systems to seek mechanisms to activate patients. Currently, tools have been developed, Patient Reported Experience Measures (PREM) and Patient Reported Outcome Measures (PROM), which seek to reduce this gap between patient and health system. Objectives: To develop and validate PREM and PROM tools for diabetes in the Ecuadorian context. To achieve better clinical results and greater patient satisfaction with the system, thus adding value to the care process of patients with diabetes. Method: This is a study with two components. The first component will focus on the design and validation of PREM and PROM tools in Ecuador. A second component, consisting of a prospective cohort study for the corresponding implementation of the questionnaires obtained and their validation. Expected results: It is expected to involve patients in the care process, thus establishing a framework for achieving better clinical outcomes and greater patient satisfaction with the system.

Detailed Description
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Diabetes is considered a worldwide health problem. Its prevalence is increasing every year despite efforts by health systems in different countries to reduce its impact. Most studies have focused on prevention and the effectiveness of drug treatment and diabetes education. However, in order to achieve greater adherence to therapy we must incorporate one more measure, the activation of patients suffering from this condition. This activation is based, above all, on the perception of self-efficacy, life experience in the face of the disease, confidence that adequate care is being received, and the positive assessment that a better result is being achieved. To achieve this, health systems are committed to redesigning the care process to achieve better short and long term results through the inclusion of patients in the assessment of how the care process is developed (through the patient experience measures) and the results of the care provided (through the outcome measures from the patients' perspective). This approach is being addressed worldwide and is being carried out in various pathologies, such as diabetes and cardiovascular disease, Chronic Obstructive Pulmonary Disease, asthma, etc. Although the Ecuadorian Health System has undergone a transformation since 2008 with the new constitution and the existing political reform, it has not yet achieved all of its objectives. Despite the significant increase in the number of medical consultations, this is not sufficient as it has not been possible to reflect a real impact on the population. Currently, health systems are aware that it is no longer enough to obtain clinical and administrative data to obtain better clinical results and increase the health of a population, but that they are turning their attention particularly to incorporating the perspective and experience of patients when evaluating the incorporation of changes in the care process. This new focus on patient-centered care is forcing health systems to incorporate new measures to assess the patient's experience through PREMs (Patient Reported Experience Measures) and the results of this care from the patient's perspective through PROMs (Patient Reported Outcome Measure). Thus, at the international level, this type of tool is being developed more and more, and is even being considered in consensus at the international level, a task headed by the International Consortium of Health Outcomes Measures. In this way, through the development and elaboration, from the perspectives of patients and professionals in the field, tools will be obtained that will allow for adding value to the health care provided by the Ministry of Public Health of Ecuador, expanding the indicators that monitor quality, incorporating patient-centered care and consequently improving clinical results through patient activation and satisfaction. This is a mixed-methods study. A first component that will focus on the design and validation in Ecuador of PREM and PROM tools through a qualitative study. And a second component, consisting of a prospective cohort study for the implementation of the questionnaires obtained during the first phase that will allow the validation of instruments.

Official Title
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Patient Centered Care in Diabetes in Ecuador: Mixed-methods Study.

Conditions
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Patient Satisfaction, Patient Engagement, Patient Empowerment, Health Literacy, Patient Experience

Intervention / Treatment
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* Other: EPD Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons with diabetes Users of the Health National System From rural and urban areas of Ecuador Exclusion Criteria: History of ischemic vascular events. (myocardial infarction and stroke) People with neurological or psychiatric pathology that prevents the understanding of the questions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 - Qualitative phase<br>4 focus groups and 6 semi-structured interviews. | |
| Group 2 - Quantitative phase<br>Pilot study of the tools developed from phase 1. | Other: EPD Questionnaire<br>* A 44 items questionnaire (4 point likert scale) was distributed. Included dimensions where: experience with your physician, provision of care, barriers, outcomes of care, symptoms, patient engagement, health literacy and patient empowerment.<br>* Other names: Experience questionnaire of the Person with Diabetes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcome | Experience questionnaire of the Person with Diabetes | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Reported Measures, Chronic Diseases, Diabetes, Ecuador, Patient Experience, Quality of care