- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02592928
Regional Implementation of Collaborative Lung Function Testing (e-Spiro-HC3)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08036
- Recruiting
- Felip Burgos
-
Contact:
- Felip Burgos, PhD, RN
- Phone Number: 34932275540
- Email: fburgos@ub.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients included in the regular practice
Exclusion Criteria:
- Clinical an Medical exclusion criteria as the forced spirometry standards recommend.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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 |
Inclusion of the Forced Spirometry into the Electronic Health Records
Other Names:
|
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 |
Inclusion of the Forced Spirometry into the Electronic Health Records
Other Names:
|
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 |
Inclusion of the Forced Spirometry into the Electronic Health Records
Other Names:
|
What is the study measuring?
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)
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.
|
Thought study completition in average of 18 months
|
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
|
Thought study completition in average of 18 months
|
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
|
Thought study completition in average of 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced Spirometry Parameters
Time Frame: Thought study completition in average of 18 months
|
- Measured in liters
|
Thought study completition in average of 18 months
|
Grade of quality in relation of total Forced Spirometry
Time Frame: Thought study completition in average of 18 months
|
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
Time Frame: Thought study completition in average of 18 months
|
|
Thought study completition in average of 18 months
|
Number of participants per PCC
Time Frame: Through study completion, an average of 18 months
|
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
Time Frame: Through study completion, an average of 18 months
|
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.
Time Frame: Through study completion, an average of 18 months
|
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
Time Frame: Through study completion, an average of 18 months
|
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)
Time Frame: Through study completion, an average of 18 months
|
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)
Time Frame: Through study completion, an average of 18 months
|
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
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2015-PDMAR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Integrated Care
-
Universitair Ziekenhuis BrusselUnknownIntegrated Care
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)CompletedStudy Focusing on Integrated Versus Non-integrated Psychiatric Care in | Opioid-dependent and Methadone Treated Patients With Other Psychiatric | DiagnosesUnited States
-
Göteborg UniversityVastra Gotaland Region; Sahlgrenska University Hospital, Sweden; Forte; Narhalsan...Not yet recruitingFrailty | Integrated Care | Dependence
-
Jordi Gol i Gurina FoundationInstitut Català de la Salut; Department of Health, Generalitat de CatalunyaUnknown
-
Jimma UniversityRecruitingKnowledge, Attitudes, Practice | Morbidity;Newborn | Breastfeeding, Exclusive | Complementary Feeding | Food Security | Integrated Community-based Intervention Package | Birth Preparedness and Complication Readiness Plan | Neonatal Care | Health Care Seeking Behavior | Delivery Care | Postnatal CareEthiopia
-
Hospital Clinic of BarcelonaInstitut de Recerca Biomèdica de Lleida; Badalona Serveis AssistencialsCompletedChronic Disease | Telemedicine | Integrated CareSpain
-
Technische Universität DresdenInstitute of Social Medicine and Health Systems Research, Medical Faculty... and other collaboratorsRecruitingCohort Study | Evaluation | Mental Health Care | Cross-sectoral Treatment | Flexible and Integrated Treatment | FIT64b | Child and Adolescent PsychiatryGermany
-
Mackay Memorial HospitalCompletedArtifacts | Integrated Advanced Information Management SystemsTaiwan
-
Ankara City Hospital BilkentRecruitingSedation | BIS | Integrated Pulmonary IndexTurkey
-
Fondation Ophtalmologique Adolphe de RothschildCompletedMRI Scans | Artifacts | Bone Anchored Devices | Osseo-Integrated ImplantsFrance
Clinical Trials on Inclusion of Spirometry into the Electronic Health Records
-
GlaxoSmithKlineCompleted
-
Kettering Health NetworkOhio UniversityCompletedKangaroo Care | Prenatal Education | Video | Skin-to-skinUnited States
-
Dufresne, Craig, MD, PCRecruitingFreeman-Sheldon Syndrome | Whistling Face Syndrome | Freeman-Sheldon Syndrome Variant | Sheldon-Hall Syndrome | Gordon Syndrome | Arthrogryposis Distal Type 3 | Arthrogryposis Distal Type 1 | Freeman-Burian SyndromeUnited States
-
Norwegian Institute of Public HealthUniversity of Oslo; Oslo University Hospital; Oslo MunicipalityActive, not recruitingHip Fractures | Fall Injury
-
Denver Health and Hospital AuthorityPatient-Centered Outcomes Research Institute; Mayo Clinic; Intermountain Health... and other collaboratorsNot yet recruitingPediatric Infectious Disease | Acute Otitis Media | Ear Infection
-
M.D. Anderson Cancer CenterCompletedBreast Carcinoma | Invasive Breast CarcinomaUnited States
-
Queen Mary University of LondonCompleted
-
Jaeb Center for Health ResearchRecruitingCystic FibrosisUnited States
-
Eli Lilly and CompanyCompletedDiabetes Mellitus, Type 2 | Acute Myocardial InfarctionCanada, Croatia, Czech Republic, Germany, Hungary, India, Israel, Lebanon, Poland, Romania, Russian Federation, Slovakia, Slovenia, South Africa, Spain, Turkey, United Kingdom
-
Mayo ClinicRecruitingIndolent Non-hodgkin Lymphoma | Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaUnited States