Clinical trial NCT02592928: Regional Implementation of Collaborative Lung Function Testing
Official title: Regional Implementation of Collaborative Lung Function Testing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Integrated Care
Telehealth
Health Care Rationing
Keywords: eHealth
Spirometry
Lung Function
Primary Care
Telehealth
Integrated Care
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Department of Health, Generalitat de Catalunya
name: Fundació TicSalut
name: Institut Catala de Salut
name: Fundació Eurecat
name: Universitat Politècnica de Catalunya
First posted: 2015-10-30
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The initial 6 months will include 3 healthcare sectors: Lleida (168k inhabitants, 21 Primary Care Centers), Vic (49k inhabitants, 11 PCC), and AISBE (540k inhabitants, 19 PCC) following a Plan-Do-Study-Act (PDSA) methodology. The first PDSA cycle (January - March 2016) including a total of 3 PCC, one in each healthcare sector, has as main purpose to ensure full functionality of the setting. The FS program will be progressively deployed to all PCC in the 3 sectors in a second 3-months PDSA cycle that will be completed by mid-2016. FS testing will be prescribed by general practitioner following standard criteria and it will be carried out by primary care nurses. The deployment in the entire region (7.5M inhabitants and 369 Primary Care centers) will be completed within 2016.

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.

Eligibility criteria: Inclusion Criteria:

* All patients included in the regular practice

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Primary Care Centers (PCC) and professionals involved in the territory using the Electronic Health Records (EHR)
timeFrame: Thought study completition in average of 18 months
measure: Number of professionals using Forced Spirometry included in the EHR (percentage per PCC)
timeFrame: Thought study completition in average of 18 months
measure: Change between inicial and end of the project (number of FS test included in the EHR)
timeFrame: Thought study completition in average of 18 months
Secondary outcomes:
measure: Forced Spirometry Parameters
timeFrame: Thought study completition in average of 18 months
measure: Grade of quality in relation of total Forced Spirometry
timeFrame: Thought study completition in average of 18 months
measure: Change from baseline in relations with ascertainment of COPD or Asthma diagnosis
timeFrame: Thought study completition in average of 18 months
measure: Number of participants per PCC
timeFrame: Through study completion, an average of 18 months
measure: Grade of satisfaction about new servicies
timeFrame: Through study completion, an average of 18 months
measure: Rating the degree of clinical impact to obtain the historical spirometry values of each patient.
timeFrame: Through study completion, an average of 18 months
measure: Number of avoided duplication tests using the EHR
timeFrame: Through study completion, an average of 18 months
measure: Cost-effectiveness (Rating usability and speed of data transfer)
timeFrame: Through study completion, an average of 18 months
measure: Cost-effectiveness (reducing the time of access to information and better display of the information)
timeFrame: Through study completion, an average of 18 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Felip Burgos
Study officials:
References:
citation: Cano I, Alonso A, Hernandez C, Burgos F, Barberan-Garcia A, Roldan J, Roca J. An adaptive case management system to support integrated care services: Lessons learned from the NEXES project. J Biomed Inform. 2015 Jun;55:11-22. doi: 10.1016/j.jbi.2015.02.011. Epub 2015 Mar 18.
citation: Burgos F, Melia U, Vallverdu M, Velickovski F, Lluch-Ariet M, Caminal P, Roca J. Clinical decision support system to enhance quality control of spirometry using information and communication technologies. JMIR Med Inform. 2014 Oct 21;2(2):e29. doi: 10.2196/medinform.3179.
citation: Melia U, Burgos F, Vallverdu M, Velickovski F, Lluch-Ariet M, Roca J, Caminal P. Algorithm for automatic forced spirometry quality assessment: technological developments. PLoS One. 2014 Dec 31;9(12):e116238. doi: 10.1371/journal.pone.0116238. eCollection 2014.
citation: Velickovski F, Ceccaroni L, Roca J, Burgos F, Galdiz JB, Marina N, Lluch-Ariet M. Clinical Decision Support Systems (CDSS) for preventive management of COPD patients. J Transl Med. 2014 Nov 28;12 Suppl 2(Suppl 2):S9. doi: 10.1186/1479-5876-12-S2-S9. Epub 2014 Nov 28.
citation: Llauger MA, Rosas A, Burgos F, Torrente E, Tresserras R, Escarrabill J; en nombre del grupo de trabajo de espirometria del Plan Director de las Enfermedades del Aparato Respiratorio (PDMAR). [Accesibility and use of spirometry in primary care centers in Catalonia]. Aten Primaria. 2014 Jun-Jul;46(6):298-306. doi: 10.1016/j.aprim.2013.12.012. Epub 2014 Apr 24. Spanish.
citation: Burgos F, Disdier C, de Santamaria EL, Galdiz B, Roger N, Rivera ML, Hervas R, Duran-Tauleria E, Garcia-Aymerich J, Roca J; e-Spir@p Group. Telemedicine enhances quality of forced spirometry in primary care. Eur Respir J. 2012 Jun;39(6):1313-8. doi: 10.1183/09031936.00168010. Epub 2011 Nov 10.
citation: Salas T, Rubies C, Gallego C, Munoz P, Burgos F, Escarrabill J. Technical requirements of spirometers in the strategy for guaranteeing the access to quality spirometry. Arch Bronconeumol. 2011 Sep;47(9):466-9. doi: 10.1016/j.arbres.2011.06.005. Epub 2011 Aug 6. English, Spanish.
citation: Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
citation: Vargas C, Burgos F, Cano I, Blanco I, Caminal P, Escarrabill J, Gallego C, Llauger MA, Miralles F, Solans O, Vallverdu M, Velickovski F, Roca J. Protocol for regional implementation of collaborative lung function testing. NPJ Prim Care Respir Med. 2016 Jun 2;26:16024. doi: 10.1038/npjpcrm.2016.24. No abstract available.