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Impact of Clinical Pharmacist on Adverse Drug Events in Older Adults

NCT03156348 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 611

Last updated 2017-05-17

No results posted yet for this study

Summary

Adverse drug events (ADE) are one of the major problems affecting quality of care and achievement of therapeutic goals in older adults (OA), increasing re-admissions, hospital stays, resource use, and problems on patient safety. The present study aim is to determine the impact of the clinical pharmacist interventions on the prevention of ADE in OA at 3 months post-discharge compared to usual care.

A randomized clinical trial of two parallel groups 1: 1 (control and intervention) plus a historical control group will be carried out at the Internal Medicine Service (IMS) of the teaching Hospital at the University of Chile. The sample will be of 611 patients (242 per each parallel group and 127 of the historical control group) of 60 years or older, admitted to the IMS for acute pathology or decompensation of chronic pathology, with survival over 6 months, who is under pharmacological therapy and have a caretaker or responsible contact person at discharge.

The historical control group will receive usual care and the parallel control group will also receive training on pharmacogeriatrics. The intervention group will receive the care of a clinical pharmacist during hospitalization, at discharge and post-discharge, through a home visit at 30 days post-discharge and a telephone call at 60 days post discharge.

Conditions

  • Drug-Related Side Effects and Adverse Reactions

Interventions

OTHER

Clinical Pharmacist Care

During hospitalization and at discharge a clinical pharmacist (CP) will monitor daily pharmacological safety and efficacy of the medication to asses and make appropriate recommendations. CP will explain the use reasons of each of the drugs. At 30 days post-discharge, the CP will review the updated clinical record of patient and conduct a home visit to enhance and ask about adherence, self-medication, medication use at that time and possible results of laboratory tests performed and clarify doubts regarding the use of current medications. The same activities will be made at 60 days by telephonic way, to reinforce the recommendations.

Sponsors & Collaborators

  • University of Chile

    lead OTHER

Principal Investigators

  • Marcela Jirón, PhD · University of Chile

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-02
Primary Completion
2017-09-22
Completion
2017-12-22

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03156348 on ClinicalTrials.gov