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

Primary Purpose

Respiratory Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Integral Action Program for Respiration
Sponsored by
Instituto Nacional de Salud Publica, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Respiratory Disease focused on measuring Practical Approach to Lung Health, Respiratory diseases, Mexico

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Phase 1 without intervention

    Phase 2 with intervention

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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)
    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
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 20, 2017
    Last Updated
    July 26, 2017
    Sponsor
    Instituto Nacional de Salud Publica, Mexico
    Collaborators
    Instituto Nacional de Enfermedades Respiratorias
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03230968
    Brief Title
    Use of a Respiratory Care Model in Population Older Than 15 Years in Orizaba, Veracruz Mexico
    Official Title
    Reduction in Morbidity, Complications and Mortality Caused by Respiratory Diseases Using a Personalized Integral Model of Care.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (Actual)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto Nacional de Salud Publica, Mexico
    Collaborators
    Instituto Nacional de Enfermedades Respiratorias

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    The design was that of a prospective quasi-experimental pre-post study. A pre-survey and a follow-up survey were used.Investigators selected 4 health centers in the Sanitary Jurisdiction in Orizaba, Veracruz, two located in rural areas (Potrerillo and Tlilapan) and two located in urban areas (Río Blanco and Orizaba). The pre-survey (phase1) was conducted on all consenting individuals older than 15 years seeking health services in selected health centers. Before the physician consultation, researchers investigated sociodemographic, epidemiologic, clinical characteristics and reason for seeking health services. Immediately after consultation, researchers asked the patient his/her diagnoses. Investigators confirmed all diagnoses with treating physicians. If the patient had been diagnosed with respiratory disease, researchers collected information on prescribed treatment, and classified the type of respiratory disease and comorbidities based on the 10th International Classification of Diseases (ICD-10). Researchers conducted a home visit one month after the consultation to determine clinical evolution, occurrence of referral to a specialist, if the patient had obtained prescribed drugs at the health center or at a private drugstore and if the patients had been hospitalized. During September 2014 researchers 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 INER. The AIRE guidelines have been adapted from WHO "Practical Approach to Lung Health" and include management of asthma, acute respiratory infections (ARI, that comprises acute bronchitis and pneumonia), chronic obstructive pulmonary disease (COPD), infections of the upper respiratory airways, and preventive measures for smoking, tuberculosis and breathing disorders during sleep. The model was presented to the authorities of the participating health services and of the local hospital (Regional Hospital in Río Blanco (HRRB, its acronym in Spanish) as well as to health personnel involved in treatment of respiratory diseases, to promote their participation, counseling and support for the referral and counter-referral of patients. The implementation of the guidelines included: 1) availability of the guidelines for the management of respiratory diseases in primary care "AIRE", that were revised and modified based on the analysis of the first phase of the study. Physicians providing primary care in the health centers and at the local hospital revised the guidelines to ensure that language was understandable. 2) Distribution of educational materials to health personnel including printed and electronic versions of AIRE guidelines, algorithm for management of acute and severe respiratory disease, and operational and good clinical practices manuals; 3) Training at the INER of the pulmonologist of the local hospital on AIRE guidelines and certification in spirometry. 4) Development of two workshops for 97 physicians and nurses of the participating health centers on AIRE Guidelines, oximetry tests, spirometry, referral and counter-referral of patients and clinical cases with the participation of specialized physicians from the INER, HRRB and the Instituto Nacional de Salud Pública (INSP); 5) Creation of a respiratory health network between primary care facilities, hospital and public health offices. Researchers considered that patients participated in one of the two phases according to the period in which they sought health services. Researchers defined a patient with a respiratory disease as any patient who after consultation with a physician was diagnosed with a respiratory disease according to the ICD-10. The medical diagnosis was obtained from the patient and confirmed with the treating physician and classified according to ICD-10. Respiratory diseases were classified in the following categories: emphysema, asthma and bronchitis, allergic rhinitis, lung cancer, chronic bronchitis, COPD and TB. Researchers also used a second categorization as follows: viral infections, bacterial infections and chronic diseases following the national clinical practice guidelines . Comorbidities were classified in the following categories: diabetes, hypertension, HIV and heart disease. The reason for seeking medical attention was classified into 20 categories. Researchers defined timeliness in requesting of health services measuring the interval from the onset of symptoms to request of physician consultation both as a continuous variable and as a dichotomic variable using as cut off >3 days. Researchers obtained the physician prescription and classified prescribed drugs as antibiotics, corticosteroids, cough suppressants, expectorants, bronchodilators, analgesics and antihistamines. Researchers also grouped cough suppressants, expectorants, analgesics and antihistamines in one category. Researchers categorized age in 3 groups: 15 to 44 years, 45 to 59 years and >60 years. The variable "type of floor" was classified in two categories (hard floor/earth floor) according to the material of the floor. Smoking was categorized as whether the patient was a current smoker or not. Alcohol consumption was dichotomized in more or equal or less than 14 alcoholic drinks per week. Use of drugs was categorized as to whether the patient reported using drugs during the study period. Researchers considered a patient was exposed to dust or smoke if he/she had worked for more than a year in a place with dust, smoke or vapors. Researchers considered occupational exposure to asbestos if the patient had worked for more than a year in a place with asbestos. Biomass exposure was categorized as whether the patient was currently exposed or not. Researchers compared sociodemographic, epidemiologic and clinical characteristics of patients demanding physician consultation and of patients who were diagnosed with respiratory disease according to study period. In the bivariate analysis researchers used U of Mann Whitney test for continuous variables that didn't follow a normal distribution, chi-squared of Pearson test for dichotomous variables and binomial test for categorical variables. Researchers compared by bivariate analyses the following outcomes according to study phase: 1) Acquisition of prescribed drugs in the pharmacy of the health center; 2) Treatment based on guidelines; 3) Clinical outcome; 4) Referral to a specialist. Using multivariate unconditional logistic regression, we built three models to investigate the association between phase of the study and 1) Acquisition of prescribed drugs in the pharmacy of the health center; 2) Treatment based on guidelines; 3) Clinical outcome. Variables with p < 0.20 in the bivariate analysis and biological plausibility were included in multivariate models. Multivariate models were built considering patients as clusters given that each patient could have had more than one drug prescription. Researchers estimated the odds ratio (OR) and 95 per cent confidence intervals (95% CI), and identified the covariates that were independently associated with each outcome. All statistical analyses were performed using the statistical package STATA V13.3 (StataCorp LP).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Disease
    Keywords
    Practical Approach to Lung Health, Respiratory diseases, Mexico

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    649 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Phase 1 without intervention
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Phase 2 with intervention
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Integral Action Program for Respiration
    Primary Outcome Measure Information:
    Title
    Number of prescribed drugs acquired in the pharmacy of the health center as stated in the questionnaire
    Description
    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)
    Time Frame
    One month after physician consultation
    Title
    Accordance of prescribed treatment (based on questionnaire) with proposed guidelines
    Description
    For each respiratory disease patient we evaluated if he/she had received treatment in compliance to AIRE guidelines
    Time Frame
    One month after physician consultation
    Title
    Clinical outcome of each participant based on follow up questionnaire
    Description
    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.
    Time Frame
    One month after physician consultation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: None
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elizabeth Ferreira, MD
    Organizational Affiliation
    Instituto Nacional de Salud Pública
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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