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Using a Mobile Application as a Support at the Prescription of Appropriate Medications for Elderly

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ClinicalTrials.gov Identifier: NCT02918643
Recruitment Status : Active, not recruiting
First Posted : September 29, 2016
Last Update Posted : September 30, 2016
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Apoio à Pesquisa do Estado da Bahia
Information provided by (Responsible Party):
Márcio Galvão Guimarães de Oliveira, Federal University of Bahia

Brief Summary:
Objective: To develop and evaluate the effectiveness of a mobile application to support decision making for prescription drugs to elderly patients. Method: Firstly, there will be a two-tier content validation of potentially inappropriate medicines (PIM) for the elderly based on Beers Criteria and STOPP. For the validation, a modified Delphi consensus technique will be applied. Twelve national experts will be invited. For each statement contained in the Beers criteria and STOPP a proposition will be prepared in order to allow each participant to issue an opinion on each of the propositions by assigning a value according to their agreement to the statement. Therefore, the Likert scale with established score of 1 to 5 (completely disagree - strongly agree) will be used. Statements with average scores above 4.0 will be considered consensus. All information regarding PIMs will be made available through an application for tablets. The information on risks and recommendations about the drugs will be available whenever the users enter the medicines name. The application will be developed for the Android platform, which is based on the Java programming language. To evaluate the use of this application 30 doctors working in basic health units and health units of the family in a municipality from Bahia will be asked to join the study. Upon acceptance, the proportion of PIMs' prescription by these professionals for a minimum period of two months will be analyzed. Later, 15 doctors will be randomized into the intervention group and will receive a tablet with the application installed. They will be trained to use it as well as to access to the Evidence Based Health Portal of the Ministry of Health. The control group of 15 other physicians will receive the tablet and will be trained to access the Evidence Based Health Portal. The study will be blind to the participants and to the main investigator. To continue, the information will be analyzed by sampling the PIMs' prescription in both groups. To access this information the prescriptions' duplicate original, filed in pharmacies, patient files or home visit will be required. The PIMs prescription ratios before and after the intervention will be compared.

Condition or disease Intervention/treatment Phase
Inappropriate Prescribing Other: Use of an application to for mobile devices like decision-making support for prescription drugs to elderly patients Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Development and Evaluation of the Use of a Mobile Application as a Support at the Prescription of Appropriate Medications for Elderly
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017

Arm Intervention/treatment
Active Comparator: Application
15 physicians will receive an application to tablet device with information about potentially inappropriate medications for elderly and access for consultation of the portal of evidence-based health
Other: Use of an application to for mobile devices like decision-making support for prescription drugs to elderly patients
Sham Comparator: Control
15 physicians will receive a tablet with internet access for consultation of the portal of evidence-based health
Other: Use of an application to for mobile devices like decision-making support for prescription drugs to elderly patients



Primary Outcome Measures :
  1. Prescription frequency of potentially inappropriate medications for elderly after intervention [ Time Frame: Two months after the intervention ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

-Doctors who meet elderly people in basic health units, family health units or primary care polyclinics.

Exclusion criteria:

-Doctors with residency in medicine-geriatrics or specialization recognized by the Brazilian Society of Geriatrics.