Clinical trial NCT02757781: Effectiveness of a Virtual Intervention for Professionals to Improve Their Attitudes Towards Patient Empowerment.
Official title: Effectiveness of a Virtual Intervention (CoP) for Professionals to Improve Their Attitude Towards the Empowerment of Patients With Chronic Disease: Cluster Randomised Controlled Trial (eMPODERA Project)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Disease
Keywords: Patient empowerment
Patient involvement
Patient participation
Healthcare professional attitudes
Chronic diseases
Lead sponsor: Avedis Donabedian Research Institute
Sponsor class: OTHER
Collaborators: name: Servicio Canario de Salud
name: Gerencia de Atención Primaria, Madrid
First posted: 2016-05-02
Enrollment: 272
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The eMPODERA study aims to assess the effectiveness of a Community of Practice (CdP) virtual in improving attitudes of primary care professionals on the empowerment of patients with chronic diseases.

Detailed description: Main Objective: to assess the effectiveness of a Community of Practice (CdP) virtual in improving attitudes of health professionals in primary care on the empowerment of patients with chronic diseases.

Methodology:

Design: cluster randomised controlled.

Scope: primary care centers (PCC) belonging to the Regions of Catalonia, Madrid and Canary Islands.

Population: primary care health professionals (family doctors and nurses).

Sample size: 270 healthcare professionals and 1382 patients.

Randomization: Randomization unit: PCC; unit of analysis: primary care health professionals. 9 pairs of PCC by region will be randomly selected and randomly assigned to the intervention or control group. Randomization will be performed after the selection of professionals and patients.

Intervention: the intervention group will be offered participation for 12 months in a virtual CdP based on a web 2.0 platform. The control group will receive usual training.

Measurements: the primary outcome will be measured by Patient-Provider Orientation Scale (PPOS) questionnaire at baseline and 12 months. Secondary outcomes: sociodemographic of professionals; sociodemographic and clinical characteristics of patients; Patient Activation Measure (PAM) questionnaire for patient activation; outcomes regarding use of the CdP.

Analysis: A linear mixed-effects regression to estimate the effect of participating in the CdP will be estimated. Additionally, an analysis of how the CdP is functioning through techniques of social network analysis and control charts will be performed.

Eligibility criteria: Inclusion Criteria:

Clusters:

* Primary Care Centres (PCC) with Electronic Record system with more than 1 year of implementation
* PCC belongs to the Automonous Comunities of Canary Island, Catalonia and Madrid

Healthcare professionals:

* Acceptance to participate
* stable contract with the Primary care centre
* Physician or Nurses

Exclusion Criteria:

Clusters:

- Primary Care Centres where its directors do not accept to participate in the trial

Healthcare professionals:

* Students
* Medical and Nursing residents

Primary outcomes:
measure: Change from Patient-Provider Orientation Scale (PPOS) at 12 months
timeFrame: At baseline and 12 months
Secondary outcomes:
measure: Change from Patient Activation Measure (PAM) at 12 months
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Avedis Donabedian Research Institute
name: Carola Orrego, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Evaluación del Servicio Canario de la Salud
name: Lilisbeth Perestelo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unidad de Apoyo Técnico de la Gerencia Asistencial de Atención Primaria de la Comunidad de Madrid
name: Ana I Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unidad de Apoyo Técnico de la Gerencia Asistencial de Atención Primaria de la Comunidad de Madrid
name: Carlos Bermejo, RN,Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orrego C, Perestelo-Perez L, Gonzalez-Gonzalez AI, Ballester-Santiago M, Koatz D, Pacheco-Huergo V, Rivero-Santana A, Ramos-Garcia V, Fernandez NM, Torres-Castano A, Bermejo-Caja C. A Virtual Community of Practice to Improve Primary Health Care Professionals' Attitudes Toward Patient Empowerment (e-MPODERA): A Cluster Randomized Trial. Ann Fam Med. 2022 May-Jun;20(3):204-210. doi: 10.1370/afm.2799.
citation: Bermejo-Caja CJ, Koatz D, Orrego C, Perestelo-Perez L, Gonzalez-Gonzalez AI, Ballester M, Pacheco-Huergo V, Del Rey-Granado Y, Munoz-Balsa M, Ramirez-Puerta AB, Canellas-Criado Y, Perez-Rivas FJ, Toledo-Chavarri A, Martinez-Marcos M; e-MPODERA group. Acceptability and feasibility of a virtual community of practice to primary care professionals regarding patient empowerment: a qualitative pilot study. BMC Health Serv Res. 2019 Jun 20;19(1):403. doi: 10.1186/s12913-019-4185-z.
citation: Gonzalez-Gonzalez AI, Orrego C, Perestelo-Perez L, Bermejo-Caja CJ, Mora N, Koatz D, Ballester M, Del Pino T, Perez-Ramos J, Toledo-Chavarri A, Robles N, Perez-Rivas FJ, Ramirez-Puerta AB, Canellas-Criado Y, Del Rey-Granado Y, Munoz-Balsa MJ, Becerril-Rojas B, Rodriguez-Morales D, Sanchez-Perruca L, Vazquez JR, Aguirre A. 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). Trials. 2017 Oct 30;18(1):505. doi: 10.1186/s13063-017-2232-9.