Integrated Caree-Spiro-HC3NCT02592928
Regional Implementation of Collaborative Lung Function Testing
An observational study of Integrated Care and Telehealth, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Integrated Care, Telehealth, Health Care Rationing
- What is being tested?
- Inclusion of Spirometry into the Electronic Health Records
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2019to 20 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- All patients included in the regular practice
Who cannot join
- Clinical an Medical exclusion criteria as the forced spirometry standards recommend.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Felip Burgos
Barcelona, 08036
Felip Burgos, PhD, RN, 34932275540, fburgos@ub.edu
About this study
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.
Read the 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.
- Conditions
- Integrated Care, Telehealth, Health Care Rationing
- Being tested
- Inclusion of Spirometry into the Electronic Health Records
- Keywords
- eHealth, Spirometry, Lung Function, Primary Care, Telehealth, Integrated Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclusion of Spirometry into the Electronic Health RecordsOther
Also called Follow up using Plan-Do-Study-Act (PDSA) methodology
Inclusion of the Forced Spirometry into the Electronic Health Records
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Inclusion of Spirometry into the Electronic Health Records |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Thought study completition in average of 18 months
Change between inicial and end of the project (number of FS test included in the EHR)
Measured: Thought study completition in average of 18 months
Secondary outcomes (9)
Forced Spirometry Parameters
- Measured in liters
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 18 months
Grade of satisfaction about new servicies
Grade of satisfaction about new servicies (0-10)
Measured: 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
Measured: 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
Measured: 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 .
Measured: 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).
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study start1 Mar 2019
- Primary completion20 Dec 2019 (estimated)
- Study completion20 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Integrated CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya, Fundació TicSalut, Institut Catala de Salut, Fundació Eurecat, Universitat Politècnica de Catalunya
- Responsible party
- Principal investigator, Felip Burgos, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592928
- Sponsor's protocol ID
- 2015-PDMAR
- Acronym
- e-Spiro-HC3
- Status last verified
- Mar 2019
- First submitted
- 15 Oct 2015
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25796455Burgos 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.
PubMed 25600957Melia 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.
PubMed 25551213Velickovski 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.
PubMed 25471545Llauger 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.
PubMed 24768654Burgos 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.
PubMed 22075488Salas 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.
PubMed 21821333Miller 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.
PubMed 16055882Vargas 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.
PubMed 27251304
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Implementation of Collaborative Lung Function Testing
- ClinicalTrials.gov ID
- NCT02592928
- Acronym / sponsor ID
- e-Spiro-HC3 / 2015-PDMAR
- Conditions
- Integrated Care, Telehealth, Health Care Rationing
- Keywords
- eHealth, Spirometry, Lung Function, Primary Care, Telehealth, Integrated Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya, Fundació TicSalut, Institut Catala de Salut, Fundació Eurecat, Universitat Politècnica de Catalunya
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 20 Dec 2019 (estimated)
- Study completion
- 20 Dec 2019 (estimated)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lleida Health Sector | – | Other: Inclusion of Spirometry into the Electronic Health RecordsLleida (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 |
| Vic Health Sector | – | Other: Inclusion of Spirometry into the Electronic Health RecordsVic (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 |
| AISBE Health Sector | – | Other: Inclusion of Spirometry into the Electronic Health RecordsAtenció 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients included in the regular practice
Key exclusion criteria (1 listed)
- Clinical an Medical exclusion criteria as the forced spirometry standards recommend.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inclusion of Spirometry into the Electronic Health RecordsAlso: Follow up using Plan-Do-Study-Act (PDSA) methodologyInclusion of the Forced Spirometry into the Electronic Health Records | Other | AISBE Health Sector, Lleida Health Sector, Vic Health Sector |
Primary outcome
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
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
9 secondary outcomes
Forced Spirometry Parameters
Time frame: 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
Change from baseline in relations with ascertainment of COPD or Asthma diagnosis
Time frame: Thought study completition in average of 18 months
Number of participants per PCC
Time frame: Through study completion, an average of 18 months
Grade of satisfaction about new servicies
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.
Time frame: 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
Cost-effectiveness (Rating usability and speed of data transfer)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Background: PubMed 25796455Cano 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.
- Background: PubMed 25600957Burgos 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.
- Background: PubMed 25551213Melia 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.
- Background: PubMed 25471545Velickovski 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.
- Background: PubMed 24768654Llauger 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.
- Background: PubMed 22075488Burgos 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.
- Background: PubMed 21821333Salas 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.
- Background: PubMed 16055882Miller 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.
- Background: PubMed 27251304Vargas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Integrated Care and Telehealth, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02592928, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.