Clinical trial NCT03206606: Evaluation of a Mobile Application to Facilitate the Interpretation of Spirometry by Family Physicians and Residents
Official title: Evaluation of a Mobile Application to Facilitate the Interpretation of the Spirometry Test by Family Physicians and Family Medicine Residents: Impact on Prescription and Interpretation of This Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Spirometry
Mobile Application
Keywords: COPD
Spirometry
Mobile application
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care physicians and residents in family medicine of 18 years old or more working in one of the 12 family medicine units in Quebec affiliated with Laval University.

Brief summary: Problematic: Spirometry is used to objectify the obstructive syndrome defining chronic obstructive pulmonary disease (COPD). However, this test remains underused in the primary care. The tools available for its interpretation are little used and the existence of several decision algorithms can create confusion during the diagnosis.

Principal objective: To evaluate the impact of a mobile application (SPIRO©) on medical practice (interpretation and prescription of spirometry) of family physicians and family medicine residents working in family medicine units (FMU) in Quebec affiliated with Laval University.

Secondary objective : To evaluate the usability of SPIRO© among family physicians and residents in family medicine working in FMU in Quebec affiliated with Laval University.

Methods: This is a pre-post clinical trial with control group. Participants (family MD and family medicine residents) will be recruited from the various FMU affiliated with Laval University. Participants working in the FMU in the experimental group will be able to use the SPIRO® mobile application to facilitate interpretation of the spirometry test results while participants in the control group will not have access to it during the study. The basic characteristics of the participants and various behavioral parameters based on the theory of planned behavior concerning the interpretation and prescription of spirometry test will be measured. Data from the control group will be collected before those in the experimental group at the time the application is not yet available, which will minimize contamination between groups. The data will be collected with questionnaires delivered in person to the participants before the intervention (T0 time) and then four months later (T1 time) during their team or research meeting. Participants will be recruited in eight of the 12 Quebec FMU affiliated with Laval University, who will be randomly assigned to two equal groups: control and experimental. The intervention will consist in sending the SPIRO© mobile application to participants in the experimental group who will use it for a period of four months.

Detailed description: Hypothesis : The investigators hypothesize that the use of the SPIRO© application will increase the skills and confidence of family physicians and family medicine residents in prescribing and interpreting spirometry compared to the control group.

The project will be conducted in the following six major steps: 1) Collection of socio-demographic and behavioral characteristics of participants using sections A, B, C and D of the NAPI questionnaire in the control group; 2) Intervention in the control group (they will continue their daily medical practice without being subject to any intervention by our research team), for a period of 4 months; 3) Measurement of behavioral changes in the control group using Sections B, C, D and E of the NAPI questionnaire 4 months after the start of the study; 4) Collection of socio-demographic and behavioral data from participants in the experimental group using sections A, B, C and D of the NAPI questionnaire; 5) E-mail distribution of the application and use of the application by participants in the experimental group for a period of four months, 6) Measurement of behavioral changes in the experimental group after the use of the application, Using sections B, C, D and E of the NAPI questionnaire as well as a questionnaire on the application SPIRO© (SPIRO questionnaire) which will evaluate the usability of this one.

The study has been approved by the research ethic board of the Health and Social Services Center of the old capital - attached to the Integrated Center for Health and Social Services of the National Capital.

Eligibility criteria: Inclusion Criteria:

* Participants need to be primary care physicians or residents in family medicine of 18 years old or more working in one of the 12 family medicine units in Quebec affiliated with Laval University.

Exclusion Criteria:

* Health professionals not practicing family medicine and residents of other specialties will not be eligible. Individuals who participated in the development of the " subjective Norms, Attitudes, Perceived behavioral control, Intentions (NAPI) " questionnaires (apparent validation) will be excluded.

Primary outcomes:
measure: Beliefs about capabilities - interpretation
timeFrame: six weeks
Secondary outcomes:
measure: Beliefs about consequences - prescription
timeFrame: six weeks
measure: Beliefs about consequences - interpretation
timeFrame: six weeks
measure: Beliefs about consequences - use of a mobile application
timeFrame: six weeks
measure: Moral norms - prescription
timeFrame: six weeks
measure: Moral norms - interpretation
timeFrame: six weeks
measure: Moral norms - use of a mobile application
timeFrame: six weeks
measure: Intentions - prescription
timeFrame: six weeks
measure: Intentions - interpretation
timeFrame: six weeks
measure: Intentions - use of a mobile application
timeFrame: six weeks
measure: Social influence - prescription
timeFrame: six weeks
measure: Social influence - interpretation
timeFrame: six weeks
measure: Social influence - use of a mobile application
timeFrame: six weeks
measure: Belief about capabilities - prescription
timeFrame: six weeks
measure: Belief about capabilities - use of a mobile application
timeFrame: six weeks
Other outcomes:
Locations:
city: Baie-Comeau
country: Canada
facility: UMF de Manicouagan
state: Quebec
city: Gaspé
country: Canada
facility: UMF de Gaspé
state: Quebec
city: Lac-Etchemin
country: Canada
facility: UMF des Etchemins
state: Quebec
city: Lévis
country: Canada
facility: UMF de Lévis
state: Quebec
city: Quebec City
country: Canada
facility: Unité de médecine familiale - GMF Maizerets
state: Quebec
city: Quebec City
country: Canada
facility: UMF Saint-François d'Assise
state: Quebec
city: Quebec City
country: Canada
facility: Unité de médecine familiale Laval
state: Quebec
city: Trois-Pistoles
country: Canada
facility: UMF de Trois-Pistoles
state: Quebec
Study officials:
affiliation: Heart and Lung Institute
name: Louis-Philippe Boulet, MD
role: PRINCIPAL_INVESTIGATOR
References: