Plain English Summary
Background and study aims
The aim of this study is to assess the effectiveness of reminders in patients’ electronic medical records, to find out whether they improve control of chronic (long-term) diseases such as diabetes, high blood pressure and heart disease, and encourage preventive activity, such as influenza vaccination and smoking cessation.
Who can participate?
Family doctors and nurses of the primary care teams of the Catalan Health Institute
What does the study involve?
Participating primary care teams are randomly allocated into four groups. Three of the groups receive three different types of reminders in their patients’ medical records: either pop-up reminders, pop-up reminders and calendar icons, or pop-up reminders, calendar icons and configurability (users can select how the reminders are shown). The fourth group do not receive reminders.
What are the possible benefits and risks of participating?
The main benefit is to provide information targeted to improve patient care when they are visiting, regardless of the reason for the consultation. The risks are minor and are related to some stress for the availability of clinical information unrelated to the reason for patient consultation. This effect is however unimportant, considering that the information is relevant to the health of the patient.
Where is the study run from?
Catalan Health Institute (Spain)
When is the study starting and how long is it expected to run for?
February 2012 to January 2013
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Manuel Medina Peralta
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P11/62
Study information
Scientific title
Randomized clinical trial to evaluate the effectiveness of synchronous electronic clinical reminders for professionals of primary care
Acronym
Study hypothesis
Main hypothesis:
To provide synchronous electronic clinical reminders in patient records with a clinical situation to be improved, detection of a chronic disease or prevention activity. The electronic clinical reminders improves the clinical practice of professionals by reducing the number of clinical conditions likely to recall and improving its resolution.
Secondary hypothesis:
1. To add trademarks on the agenda of professionals to help prioritize those patients with a greater number of clinical situations which will further contribute to improving clinical practice.
2. To allow the auto-configurability of reminder system and trademarks on the agenda which will further contribute to improving clinical practice.
Ethics approval
Ethics Committee on Clinical Research of the Primary Care Research Institute (IDIAP) Jordi Gol. Barcelona, 25/11/2011, ref: P11/62
Study design
Non-blinded randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Clinical reminders for chronic diseases in primary care
Intervention
The 270 primary care teams are divided randomly into four groups adjusted by their previous results in a quality of care synthetic indicator (consists of 62 clinical sub-indicators)
The control group consists of professional from 135 teams dont receive intervention.
Professionals from the other three groups receive reminders in the computerized medical record, based on recommendations from clinical practice guidelines and linked to the patient. Reminder status is updated weekly for the duration of the intervention depending on the study subgroup in one of the following:
Subgroup 1: "Reminder in record": Professionals see reminders synchronously with the patient visit and they can directly access the module where the situation is resolved.
Subgroup 2: mark on the agenda: In addition to the intervention of subgroup 1, the professionals see a mark on the agenda by identifying those patients with reminders and the number of these, allowing a greater prioritization of patients to address.
Subgroup 3: auto-configure: In addition to the intervention of subgroup 2, professionals can configure reminders, focusing on those that most interest them, to keep in mind.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Resolved reminder
2. Time from onset to resolution reminder
Secondary outcome measures
1. Type of clinical situation that generates the reminder
2. Type of reminder
3. Characteristics of the team:
3.1. Socioeconomic level of population
3.2. Dispersion level of population alloted
3.3. Existence of post-graduate teaching in family medicine
3.4. Existence of undergraduate nursing teaching
4. Characteristics of professionals
4.1. Type of professional: physician or nurse
4.2. Age
4.3. Sex
4.4. Type of contract
Overall trial start date
01/02/2012
Overall trial end date
31/01/2013
Reason abandoned
Eligibility
Participant inclusion criteria
3,425 family physicians and 3,262 nurses caring for adult population of the 279 Primary Care Teams (PCT) managed by the Catalonian Health Institute.
Participant type
Health professional
Age group
Adult
Gender
Both
Target number of participants
3425 general practitioners and 3262 primary care nurses
Participant exclusion criteria
1. Professionals from seven primary care teams involved in another clinical trial related to the emergence of brands in the professional agenda
2. Professionals from two primary care teams that were in a process of reorganization to become four different teams, which made the process of randomization difficult
3. 150 professionals who have a much lower attendance schedule and a very low computerization of their consultations
Recruitment start date
01/02/2012
Recruitment end date
31/01/2013
Locations
Countries of recruitment
Spain
Trial participating centre
Gran Via de les Corts Catalanes, 587-589
Barcelona
08007
Spain
Sponsor information
Organisation
Primary Care Research Institute (IDIAP) Jordi Gol (Spain)
Sponsor details
Gran Via de les Corts Catalanes
587-589
Barcelona
08007
Spain
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27652078