Effectiveness of a Virtual Intervention for Professionals to Improve Their Attitudes Towards Patient Empowerment. (eMPODERA)
Primary Purpose
Chronic Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Community of Practice
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Disease focused on measuring Patient empowerment, Patient involvement, Patient participation, Healthcare professional attitudes, Chronic diseases
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Intervention group
Arm Description
Group of healthcare professionals that NOT receive the intervention (community of practice)
Group of healthcare professionals that receive the intervention (community of practice)
Outcomes
Primary Outcome Measures
Change from Patient-Provider Orientation Scale (PPOS) at 12 months
PPOS is a questionnaire administrated to healthcare professionals
Secondary Outcome Measures
Change from Patient Activation Measure (PAM) at 12 months
PAM is validated questionnaire to measure patient activation (administrated to patients)
Full Information
NCT ID
NCT02757781
First Posted
April 25, 2016
Last Updated
May 10, 2016
Sponsor
Avedis Donabedian Research Institute
Collaborators
Servicio Canario de Salud, Gerencia de Atención Primaria, Madrid
1. Study Identification
Unique Protocol Identification Number
NCT02757781
Brief Title
Effectiveness of a Virtual Intervention for Professionals to Improve Their Attitudes Towards Patient Empowerment.
Acronym
eMPODERA
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
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avedis Donabedian Research Institute
Collaborators
Servicio Canario de Salud, Gerencia de Atención Primaria, Madrid
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Patient empowerment, Patient involvement, Patient participation, Healthcare professional attitudes, Chronic diseases
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
272 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Group of healthcare professionals that NOT receive the intervention (community of practice)
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Group of healthcare professionals that receive the intervention (community of practice)
Intervention Type
Behavioral
Intervention Name(s)
Community of Practice
Other Intervention Name(s)
educational intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Patient-Provider Orientation Scale (PPOS) at 12 months
Description
PPOS is a questionnaire administrated to healthcare professionals
Time Frame
At baseline and 12 months
Secondary Outcome Measure Information:
Title
Change from Patient Activation Measure (PAM) at 12 months
Description
PAM is validated questionnaire to measure patient activation (administrated to patients)
Time Frame
Baseline and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carola Orrego, PhD
Phone
34 932076608
Email
corrego@fadq.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carola Orrego, PhD
Organizational Affiliation
Avedis Donabedian Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lilisbeth Perestelo, PhD
Organizational Affiliation
Servicio de Evaluación del Servicio Canario de la Salud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana I Gonzalez, MD
Organizational Affiliation
Unidad de Apoyo Técnico de la Gerencia Asistencial de Atención Primaria de la Comunidad de Madrid
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos Bermejo, RN,Msc
Organizational Affiliation
Unidad de Apoyo Técnico de la Gerencia Asistencial de Atención Primaria de la Comunidad de Madrid
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is not plan to make individual participant data available
Citations:
PubMed Identifier
35606139
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. Erratum In: Ann Fam Med. 2022 Jul-Aug;20(4):357.
Results Reference
derived
PubMed Identifier
31221215
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.
Results Reference
derived
PubMed Identifier
29084597
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.
Results Reference
derived
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Effectiveness of a Virtual Intervention for Professionals to Improve Their Attitudes Towards Patient Empowerment.
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