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

NCT02918643 | Completed

• 1 other identifier: CNPq 444841/2014-8
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inappropriate Prescribing

Keywords

Elderly; Potentially Inappropriate Medications

Outcome Measures

Primary Outcomes (1)

• Prescription frequency of potentially inappropriate medications for elderly after intervention

  Two months after the intervention

Study Arms (2)

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

Other: Use of an application to for mobile devices like decision-making support for prescription drugs to elderly patients

Control

SHAM COMPARATOR

7 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

Interventions

Use of an application to for mobile devices like decision-making support for prescription drugs to elderly patients OTHER

Application; Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Bahia: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Apoio à Pesquisa do Estado da Bahia: collaborator

Related Publications (4)

• Dimitrow MS, Airaksinen MS, Kivela SL, Lyles A, Leikola SN. Comparison of prescribing criteria to evaluate the appropriateness of drug treatment in individuals aged 65 and older: a systematic review. J Am Geriatr Soc. 2011 Aug;59(8):1521-30. doi: 10.1111/j.1532-5415.2011.03497.x. Epub 2011 Jul 28.

  PMID: 21797829 BACKGROUND

• American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2012 Apr;60(4):616-31. doi: 10.1111/j.1532-5415.2012.03923.x. Epub 2012 Feb 29.

  PMID: 22376048 BACKGROUND

• Oliveira MG, Amorim WW, de Jesus SR, Rodrigues VA, Passos LC. Factors associated with potentially inappropriate medication use by the elderly in the Brazilian primary care setting. Int J Clin Pharm. 2012 Aug;34(4):626-32. doi: 10.1007/s11096-012-9656-9. Epub 2012 Jun 13.

  PMID: 22692715 BACKGROUND

• Amorim WW, Passos LC, Gama RS, Souza RM, Santos PM, Macedo JC, Queiroga HM, Nunes LG, Fraga LM, Oliveira BS, Graia LT, Oliveira MG. Using a mobile application to reduce potentially inappropriate prescribing for older Brazilian adults in primary care: a triple-blind randomised clinical trial. BMC Geriatr. 2024 Jan 8;24(1):35. doi: 10.1186/s12877-023-04645-z.

  PMID: 38191317 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 29, 2016
• Study Start: August 1, 2016
• Primary Completion: March 20, 2019
• Study Completion: March 20, 2019
• Last Updated: October 7, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share