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Regional Implementation of Collaborative Lung Function Testing (e-Spiro-HC3)

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ClinicalTrials.gov Identifier: NCT02592928
Recruitment Status : Recruiting
First Posted : October 30, 2015
Last Update Posted : March 4, 2019
Sponsor:
Collaborators:
Department of Health, Generalitat de Catalunya
Fundació TicSalut
Institut Catala de Salut
Eurecat
Universitat Politècnica de Catalunya
Information provided by (Responsible Party):
Felip Burgos, Hospital Clinic of Barcelona

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.


Condition or disease Intervention/treatment
Integrated Care Telehealth Health Care Rationing Other: Inclusion of Spirometry into the Electronic Health Records

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.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Regional Implementation of Collaborative Lung Function Testing
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 20, 2019

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

Other: Inclusion of Spirometry into the Electronic Health Records
Inclusion of the Forced Spirometry into the Electronic Health Records
Other Name: Follow up using Plan-Do-Study-Act (PDSA) methodology

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
Inclusion of the Forced Spirometry into the Electronic Health Records
Other Name: Follow up using Plan-Do-Study-Act (PDSA) methodology

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
Inclusion of the Forced Spirometry into the Electronic Health Records
Other Name: Follow up using Plan-Do-Study-Act (PDSA) methodology




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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 ]

Secondary Outcome Measures :
  1. Forced Spirometry Parameters [ Time Frame: Thought study completition in average of 18 months ]
    - Measured in liters

  2. 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

  3. Change from baseline in relations with ascertainment of COPD or Asthma diagnosis [ Time Frame: Thought study completition in average of 18 months ]
    • 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

  4. 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


  5. Grade of satisfaction about new servicies [ Time Frame: Through study completion, an average of 18 months ]
    Grade of satisfaction about new servicies (0-10)

  6. 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

  7. 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

  8. 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 .

  9. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • All patients included in the regular practice

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592928


Locations
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Spain
Felip Burgos Recruiting
Barcelona, Spain, 08036
Contact: Felip Burgos, PhD, RN    34932275540    fburgos@ub.edu   
Sponsors and Collaborators
Hospital Clinic of Barcelona
Department of Health, Generalitat de Catalunya
Fundació TicSalut
Institut Catala de Salut
Eurecat
Universitat Politècnica de Catalunya

Publications:

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Responsible Party: Felip Burgos, PhD, RN, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02592928     History of Changes
Other Study ID Numbers: 2015-PDMAR
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019

Keywords provided by Felip Burgos, Hospital Clinic of Barcelona:
eHealth
Spirometry
Lung Function
Primary Care
Telehealth
Integrated Care