Effectiveness of a virtual intervention for primary healthcare professionals aimed at improving attitudes towards the empowerment of patients with chronic diseases: study protocol for a cluster randomized controlled trial (e-MPODERA project)

Ana Isabel González-González, Carola Orrego, Lilisbeth Perestelo-Perez, Carlos Jesús Bermejo-Caja, Nuria Mora, Débora Koatz, Marta Ballester, Tasmania Del Pino, Jeannet Pérez-Ramos, Ana Toledo-Chavarri, Noemí Robles, Francisco Javier Pérez-Rivas, Ana Belén Ramírez-Puerta, Yolanda Canellas-Criado, Yolanda Del Rey-Granado, Marcos José Muñoz-Balsa, Beatriz Becerril-Rojas, David Rodríguez-Morales, Luis Sánchez-Perruca, José Ramón Vázquez, Armando Aguirre, Ana Isabel González-González, Carola Orrego, Lilisbeth Perestelo-Perez, Carlos Jesús Bermejo-Caja, Nuria Mora, Débora Koatz, Marta Ballester, Tasmania Del Pino, Jeannet Pérez-Ramos, Ana Toledo-Chavarri, Noemí Robles, Francisco Javier Pérez-Rivas, Ana Belén Ramírez-Puerta, Yolanda Canellas-Criado, Yolanda Del Rey-Granado, Marcos José Muñoz-Balsa, Beatriz Becerril-Rojas, David Rodríguez-Morales, Luis Sánchez-Perruca, José Ramón Vázquez, Armando Aguirre

Abstract

Background: Communities of practice are based on the idea that learning involves a group of people exchanging experiences and knowledge. The e-MPODERA project aims to assess the effectiveness of a virtual community of practice aimed at improving primary healthcare professional attitudes to the empowerment of patients with chronic diseases.

Methods: This paper describes the protocol for a cluster randomized controlled trial. We will randomly assign 18 primary-care practices per participating region of Spain (Catalonia, Madrid and Canary Islands) to a virtual community of practice or to usual training. The primary-care practice will be the randomization unit and the primary healthcare professional will be the unit of analysis. We will need a sample of 270 primary healthcare professionals (general practitioners and nurses) and 1382 patients. We will perform randomization after professionals and patients are selected. We will ask the intervention group to participate for 12 months in a virtual community of practice based on a web 2.0 platform. We will measure the primary outcome using the Patient-Provider Orientation Scale questionnaire administered at baseline and after 12 months. Secondary outcomes will be the sociodemographic characteristics of health professionals, sociodemographic and clinical characteristics of patients, the Patient Activation Measure questionnaire for patient activation and outcomes regarding use of the virtual community of practice. We will calculate a linear mixed-effects regression to estimate the effect of participating in the virtual community of practice.

Discussion: This cluster randomized controlled trial will show whether a virtual intervention for primary healthcare professionals improves attitudes to the empowerment of patients with chronic diseases.

Trial registration: ClicalTrials.gov, NCT02757781 . Registered on 25 April 2016. Protocol Version. PI15.01 22 January 2016.

Keywords: Empowerment; Healthcare professional attitudes; Primary healthcare; Virtual system.

Conflict of interest statement

Authors’ information

Not applicable.

Ethics approval and consent to participate

The trial will fulfil GCP standards and the principles of the latest version of the Helsinki Declaration (Brazil, 2013). The project has been approved by the Clinical Research Ethics Committee of Ramón y Cajal University Hospital in Madrid (ACTA 303), Nuestra Señora de Candelaria University Hospital in Santa Cruz de Tenerife (PI-18/16) and IDIAP Jordi Gol in Barcelona (C2748). In accordance with Spanish Law 15/1999 on personal data protection, confidentiality and anonymity will be guaranteed both in the execution phase of the trial and in presentations or publications derived from the trial. We will obtain informed consent from all participants in the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) study timeline
Fig. 2
Fig. 2
Randomization flowchart. *Patient-Practitioner Orientation Scale questionnaire **Patient Activation Measure questionnaire

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