Use of a Respiratory Care Model in Population Older Than 15 Years in Orizaba, Veracruz Mexico

NCT03230968 | Completed

• 2 other identifiers: CI:1026SALUD-2010-01-140645
• Study Type: interventional
• Target: 649
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background. Mexico is lacking guidelines that provide an integral approach for the prevention and control of respiratory diseases in adults. The World Health Organization (WHO) proposed a "Practical Approach to Lung Health" (PAL) using generic guidelines to be used in primary health care settings for diagnosis and treatment of respiratory diseases. These guidelines were adapted to the Mexican context as AIRE campaign by the Instituto Nacional de Enfermedades Respiratorias, Mexico. Objective. To evaluate the feasibility and effectiveness of implementing a model of care for respiratory diseases in adults based on AIRE guidelines,. Materials and methods. Prospective quasi-experimental pre-post study. During 03-08/2013 (phase 1), investigators recruited consenting subjects older than 15 years of age seeking medical care in primary care centers in Orizaba, Veracruz. Researchers investigated sociodemographic, epidemiological and clinical information before consultation. On patients who had been diagnosed with respiratory disease by a physician, researchers investigated prescribed treatment on leaving the physician´s office. A month later conducted a home visit to investigate clinical outcome. During 09/2014 we trained doctors from the participating health centers in "AIRE" guidelines. From 10/2014 to 03/2015 (phase 2) researchers again surveyed all consenting subjects older than 15 years of age who received health services in the same health centers following the same procedures as in phase 1.

Conditions

Respiratory Disease

Keywords

Practical Approach to Lung Health; Respiratory diseases; Mexico

Outcome Measures

Primary Outcomes (3)

• Number of prescribed drugs acquired in the pharmacy of the health center as stated in the questionnaire

  The variable was categorized in: health center (all the prescribed medication was obtained from the pharmacy in the health center), and other pharmacy and/or health center (all or a part of prescribed medication was obtained in private establishments)

  One month after physician consultation

• Accordance of prescribed treatment (based on questionnaire) with proposed guidelines

  For each respiratory disease patient we evaluated if he/she had received treatment in compliance to AIRE guidelines

  One month after physician consultation

• Clinical outcome of each participant based on follow up questionnaire

  Clinical outcome was classified as follows: cure (disappearance of signs and symptoms and patient described as "healthy"), improvement (improvement of signs and symptoms), drop out (the patient stopped taking prescribed medications despite continuing signs and symptoms), still on treatment or death.

  One month after physician consultation

Study Arms (2)

Phase 1 without intervention

NO INTERVENTION

In selected heath centers we interviewed all consenting patients older than 15 years. Before the physician consultation, we investigated sociodemographic, epidemiologic, clinical characteristics and reason for seeking health services. Immediately after consultation, we asked the patient his/her diagnoses. We confirmed all diagnoses with treating physicians. If the patient had been diagnosed with respiratory disease, we collected information on prescribed treatment, and classified the type of respiratory disease and comorbidities based on the 10th International Classification of Diseases (ICD-10). Patients were given follow up one month later.

Phase 2 with intervention

ACTIVE COMPARATOR

We trained health personnel from the participating health centers on implementation of the proposed model based on the AIRE guidelines previously approved by the AIRE committee of the National Institute for Respiratory Diseases. The AIRE guidelines have been adapted from WHO "Practical Approach to Lung Health". Once the model was in action we interviewed all consenting patients older than 15 years as in phase 1.

Behavioral: Integral Action Program for Respiration

Interventions

Integral Action Program for Respiration BEHAVIORAL

Phase 2 with intervention

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• People older than 15 years of age that go to one of the health clinics seeking medical attention for any cause.
• Residency in the study site.

You may not qualify if:

• None

Sponsors & Collaborators

• Instituto Nacional de Salud Publica, Mexico: lead
• Instituto Nacional de Enfermedades Respiratorias: collaborator

MeSH Terms

Conditions

Respiration Disorders; Respiratory Tract Diseases

Interventions

Respiration

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Elizabeth Ferreira, MD

  Instituto Nacional de Salud Pública

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Epidemiologist

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 27, 2017
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 28, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share