Regional Implementation of Collaborative Lung Function Testing

Study Overview
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Brief Summary
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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
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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.

Official Title
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Regional Implementation of Collaborative Lung Function Testing

Conditions
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Integrated Care, Telehealth, Health Care Rationing

Intervention / Treatment
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* Other: Inclusion of Spirometry into the Electronic Health Records


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients included in the regular practice Exclusion Criteria: Clinical an Medical exclusion criteria as the forced spirometry standards recommend.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lleida Health Sector<br>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 | Other: Inclusion of Spirometry into the Electronic Health Records<br>* Inclusion of the Forced Spirometry into the Electronic Health Records<br>* Other names: Follow up using Plan-Do-Study-Act (PDSA) methodology;|
| Vic Health Sector<br>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 | Other: Inclusion of Spirometry into the Electronic Health Records<br>* Inclusion of the Forced Spirometry into the Electronic Health Records<br>* Other names: Follow up using Plan-Do-Study-Act (PDSA) methodology;|
| AISBE Health Sector<br>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 | Other: Inclusion of Spirometry into the Electronic Health Records<br>* Inclusion of the Forced Spirometry into the Electronic Health Records<br>* Other names: Follow up using Plan-Do-Study-Act (PDSA) methodology;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Primary Care Centers (PCC) and professionals involved in the territory using the Electronic Health Records (EHR) | 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. | Thought study completition in average of 18 months | 
| Number of professionals using Forced Spirometry included in the EHR (percentage per PCC) | Number of professionals with accessi of the FS testing report, irrespective of the healthcare provider and health level wherein testing was performed | Thought study completition in average of 18 months | 
| Change between inicial and end of the project (number of FS test included in the EHR) |  | Thought study completition in average of 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Spirometry Parameters | - Measured in liters | Thought study completition in average of 18 months | 
| Grade of quality in relation of total Forced Spirometry | Percentage of patients with FS grade of quality (A-B-C-D-F) in relation of total FS | Thought study completition in average of 18 months | 
| Change from baseline in relations with ascertainment of COPD or Asthma diagnosis | Percentage of patients with FEV1/FVC ratio < 0.7 and without diagnosis of Asthma and COPD Percentage of patients with FEV1/FVC ratio > 0.7 and with diagnosis Asthma and COPD Percentage of patients with restrictive pattern and FEV1/FVC ratio < 0.7 | Thought study completition in average of 18 months | 
| Number of participants per PCC | Long-term benefits from data analytics of longitudinal information Assessments using unique measurements | Through study completion, an average of 18 months | 
| Grade of satisfaction about new servicies | Grade of satisfaction about new servicies (0-10) | Through study completion, an average of 18 months | 
| Rating the degree of clinical impact to obtain the historical spirometry values of each patient. | Rating the degree of clinical impact to obtain the historical spirometry values of each patient. Grade 0 -10 | Through study completion, an average of 18 months | 
| Number of avoided duplication tests using the EHR | Number of avoided duplication tests using the EHR. measured as % of the total FS | Through study completion, an average of 18 months | 
| Cost-effectiveness (Rating usability and speed of data transfer) | Rating usability and speed of data transfer in minutes . | Through study completion, an average of 18 months | 
| Cost-effectiveness (reducing the time of access to information and better display of the information) | Questionnaire about reducing the time of access to information and better display of the information (measured in minutes). | Through study completion, an average of 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eHealth, Spirometry, Lung Function, Primary Care, Telehealth, Integrated Care