Regional Implementation of Collaborative Lung Function Testing
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Change between inicial and end of the project (number of FS test included in the EHR)
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients included in the regular practice
Exclusion Criteria
- •Clinical an Medical exclusion criteria as the forced spirometry standards recommend.
Outcomes
Primary Outcomes
Change between inicial and end of the project (number of FS test included in the EHR)
Time Frame: Thought study completition in average of 18 months
Number of Primary Care Centers (PCC) and professionals involved in the territory using the Electronic Health Records (EHR)
Time Frame: Thought study completition in average of 18 months
Number of PCC exporting both the raw spirometric data, including all FS curves, and the FS report to the shared electronic health record at a regional level.
Number of professionals using Forced Spirometry included in the EHR (percentage per PCC)
Time Frame: Thought study completition in average of 18 months
Number of professionals with accessi of the FS testing report, irrespective of the healthcare provider and health level wherein testing was performed
Secondary Outcomes
- Grade of satisfaction about new servicies(Through study completion, an average of 18 months)
- Rating the degree of clinical impact to obtain the historical spirometry values of each patient.(Through study completion, an average of 18 months)
- Grade of quality in relation of total Forced Spirometry(Thought study completition in average of 18 months)
- Number of participants per PCC(Through study completion, an average of 18 months)
- Change from baseline in relations with ascertainment of COPD or Asthma diagnosis(Thought study completition in average of 18 months)
- Cost-effectiveness (Rating usability and speed of data transfer)(Through study completion, an average of 18 months)
- Forced Spirometry Parameters(Thought study completition in average of 18 months)
- Number of avoided duplication tests using the EHR(Through study completion, an average of 18 months)
- Cost-effectiveness (reducing the time of access to information and better display of the information)(Through study completion, an average of 18 months)
Investigators
Felip Burgos
PhD, RN
Hospital Clinic of Barcelona