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临床试验/NCT02918643
NCT02918643已完成不适用

Development and Evaluation of the Use of a Mobile Application as a Support at the Prescription of Appropriate Medications for Elderly

Federal University of Bahia0 个研究点目标入组 30 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
主要终点
Prescription frequency of potentially inappropriate medications for elderly after intervention

研究概览

简要总结

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.

详细描述

Step 1:

Initially, data of the drugs contained in Beers and STOPP criteria will be reviewed. The availability of medicines in the Brazilian market will be analyzed through the website of the National Health Surveillance Agency (ANVISA). Subsequently, drug data will be placed in a questionnaire to be sent to national experts in order to establish a consensus on the information presented. The questionnaire assessment will happen in two rounds. The first round consists of sending propositions based on information contained in the Beers criteria, STOPP 2012 and 2006 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. For the second round, the scores will be analyzed and the propositions in which there is no consensus will again be sent along with the comments of each specialist. In these cases, each specialist may review or maintain their position. It is worth noting that during the application of questionnaires rounds experts do not have access to the identification of their peers. In the second round, Statements with average scores above 4.0 will be considered consensus. The final information will be used for the mobile device application development.

Experts will be selected for convenience. Twelve professionals with experience in geriatrics will be invited via email to participate as experts in the validation of the Beers Criteria and STOPP. This call will include a summary of the project and general information about the Delphi Technique. After acceptance, they will receive a Term of Informed Consent Form (ICF) and an Authorization to Release Name as Specialist / Senior, which must be signed and returned.

The application will be developed for the Android platform, which is based on the Java programming language.

Step 2:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Application

Active Comparator

7 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

干预措施: Use of an application to for mobile devices like decision-making support for prescription drugs to elderly patients (Other)

Control

Sham Comparator

7 physicians will receive a tablet with internet access for consultation of the portal of evidence-based health

干预措施: Use of an application to for mobile devices like decision-making support for prescription drugs to elderly patients (Other)

结局指标

主要结局

Prescription frequency of potentially inappropriate medications for elderly after intervention

时间窗: Two months after the intervention

次要结局

未报告次要终点

研究者

发起方
Federal University of Bahia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Márcio Galvão Guimarães de Oliveira

Adjunct Professor

Federal University of Bahia

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