Regional Implementation of Collaborative Lung Function Testing

NCT02592928 | Unknown

• 1 other identifier: 2015-PDMAR
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Integrated Care; Telehealth; Health Care Rationing

Keywords

eHealth; Spirometry; Lung Function; Primary Care; Telehealth; Integrated Care

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Forced Spirometry Parameters

  Thought study completition in average of 18 months

• Grade of quality in relation of total Forced Spirometry

  Thought study completition in average of 18 months

• Change from baseline in relations with ascertainment of COPD or Asthma diagnosis

  Thought study completition in average of 18 months

• Number of participants per PCC

  Through study completion, an average of 18 months

• Grade of satisfaction about new servicies

  Through study completion, an average of 18 months

Study Arms (3)

Lleida Health Sector

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

Vic Health Sector

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

AISBE Health Sector

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

Interventions

Inclusion of Spirometry into the Electronic Health Records OTHER

Inclusion of the Forced Spirometry into the Electronic Health Records

Also known as: Follow up using Plan-Do-Study-Act (PDSA) methodology

AISBE Health Sector; Lleida Health Sector; Vic Health Sector

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All patients included in the regular practice

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Department of Health, Generalitat de Catalunya: collaborator
• Fundació TicSalut: collaborator
• Institut Catala de Salut: collaborator
• Fundació Eurecat: collaborator
• Universitat Politècnica de Catalunya: collaborator

Study Sites (1)

Felip Burgos

Barcelona, 08036, Spain

RECRUITING

Related Publications (9)

• 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.

  PMID: 25796455 BACKGROUND

• 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.

  PMID: 25600957 BACKGROUND

• 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.

  PMID: 25551213 BACKGROUND

• 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.

  PMID: 25471545 BACKGROUND

• 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.

  PMID: 24768654 BACKGROUND

• 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.

  PMID: 22075488 BACKGROUND

• 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.

  PMID: 21821333 BACKGROUND

• 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.

  PMID: 16055882 BACKGROUND

• 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.

  PMID: 27251304 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RN

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 30, 2015
• Study Start: March 1, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: March 4, 2019

Record last verified: 2019-03

Locations

ES (1)