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Regional Implementation of Collaborative Lung Function Testing (e-Spiro-HC3)

H

Hospital Clinic of Barcelona

Status

Unknown

Conditions

Integrated Care
Health Care Rationing
Telehealth

Treatments

Other: Inclusion of Spirometry into the Electronic Health Records

Study type

Observational

Funder types

Other

Identifiers

NCT02592928
2015-PDMAR

Details and patient eligibility

About

Background/Aims There is evidence indicating that deployment of forced spirometry (FS) testing in a collaborative scenario, encompassing respiratory specialists and community professionals, generates healthcare efficiencies. The study describes the roadmap for regional implementation of the FS program in Catalonia (ES), from January to December 2016.

Methods/Design Firstly, the FS program will be deployed in three healthcare sectors (514 k inhabitants), following Plan-Do-Study-Act iterative cycles, using the Model for Assessment of Telemedicine for evaluation purposes. Thereafter, regional deployment of the FS program (7.5M inhabitants) will be conducted. The third step considers: evaluation of transferability, preparation for data analytics and recommendations for long-term assessment of outcomes. Main components of the FS program are: i) Automatic quality testing; ii) Standardized data transfer to a shared electronic health record; iii) Elaboration of individual FS reports including historical results; and, iv) Clinical decision support systems providing access to the FS report, and to remote support upon request.

Discussion/Conclusions The project constitutes the first attempt to scale-up a collaborative scenario for FS testing that will open new avenues for longitudinal lung function assessment. Moreover, the setting shows high potential for transferability to different sites and to other diagnostic procedures.

Full description

The Forced Spirometry program emerges from a series of studies reporting on technological solutions for each of the main components indicating the potential of their articulated application aiming at covering unmet needs for collaborative FS testing. The studies were initiated within the EU project NEXES22;23 and specific parts of the overall setting have already been successfully evaluated in the Basque Country.

The setting & Study design The current protocol has been designed as part of the regional deployment of integrated care services in Catalonia. It consists of the two lines of activity ultimately aiming at: i) regional adoption of the FS program; and, ii) generalization of the approach to other areas, as well as to other testing procedures. The research was submitted and apoved by the Ethical Committee of the Hospital Clínic i Provincial de Barcelona.

Program deployment The initial 6 months will include three healthcare sectors: Lleida (168k inhabitants and 21 Primary Care centers), Vic (49k inhabitants and 11 PCC), and Atenció Integral en Salut Barcelona Esquerra (AISBE) (540k inhabitants and 19 PCC) following a Plan-Do-Study-Act (PDSA) methodology24. The first PDSA cycle (January - March 2016) including a total of three primary care centers, one in each healthcare sector, has as main purpose to ensure full functionality of the setting. Immediately thereafter, the FS program will be progressively deployed to all Primary Care centers in the three sectors in a second 3-months PDSA cycle that will be completed by mid-2016. Forced spirometry testing will be prescribed by the attending general practitioner following standard criteria and it will be carried out by primary care nurses.

The deployment of the program in the entire region (7.5M inhabitants and 369 Primary Care centers) will be completed with no discontinuation within 2016. It will follow identical PDSA methodology. The outcomes of the assessment carried out during each PDSA cycle will modulate the long-term assessment strategy of the FS program described below.

Enrollment

300 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients included in the regular practice

Exclusion criteria

  • Clinical an Medical exclusion criteria as the forced spirometry standards recommend.

Trial design

300 participants in 3 patient groups

Lleida Health Sector
Description:
Lleida (168k inhabitants and 21 Primary Care centers). Primary Care centers from this health sector Inclusion of the Forced Spirometry into the Electronic Health Records No interventions performed
Treatment:
Other: Inclusion of Spirometry into the Electronic Health Records
Vic Health Sector
Description:
Vic (49k inhabitants and 11 Primary Care Centers). Primary Care centers from this health sector Inclusion of the Forced Spirometry into the Electronic Health Records No interventions performed
Treatment:
Other: Inclusion of Spirometry into the Electronic Health Records
AISBE Health Sector
Description:
Atenció Integral en Salut Barcelona Esquerra (AISBE) (540k inhabitants and 19 Primary Care centers). Primary Care centers from this health sector Inclusion of the Forced Spirometry into the Electronic Health Records No interventions performed
Treatment:
Other: Inclusion of Spirometry into the Electronic Health Records

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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