Impact of Clinical Pharmacist on Adverse Drug Events in Older Adults

NCT03156348 | Unknown DMC

• 1 other identifier: SA14ID0141
• Study Type: interventional
• Target: 611
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pharmaceutical intervention; Older adult; Internal medicine; Adverse drug event

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Drug Events at 90 days post discharge

  Two trained and independent evaluators (geriatrician and clinical pharmacist), blind to treatment allocation, will evaluate the history of each case and by consensus will assign the presence of ADE, and classify them as preventable or not preventable and according to severity.

  90 days post discharge

Secondary Outcomes (8)

• Adherence measured with Morisky & Green Scale

  90 days post discharge

• Incidence of potentially inappropriate medication

  90 days post discharge

• Incidence of adverse drug reactions

  90 days post discharge

• Incidence of non-programmed/programmed consultations or hospitalizations after discharge from the hospital

  90 days post discharge

• Prevalence of Polypharmacy (5 or more drugs)

  90 days post discharge

Study Arms (2)

Intervented

EXPERIMENTAL

The intervention group will receive in addition to the usual care, it will receive the Clinical Pharmacist Care during hospitalization, discharge and during 2 months post-discharge, through a home visit at 30 ± 5 days post-discharge and a telephone call at 60 ± 5 days.

Other: Clinical Pharmacist Care

Control

NO INTERVENTION

The control group will receive hospital care and discharge from a clinical team previously trained in geriatric clinical pharmacology, which includes epicrisis, indications that the physician deems pertinent to the discharge and prescriptions if necessary and a medical control at 15 days post-discharge. Information will be collected that allows the characterization: * Sociodemographic * Morbid * Pharmaco-therapeutic * Functionality before (baseline), during and after hospitalization A physician, a pharmacist and an occupational therapist, blind to the treatment assignment, will collect the records using a specially designed record. Post-discharge evaluations will be conducted through telephone interviews at 30, 60 and 90 days after hospital discharge.

Interventions

Clinical Pharmacist Care OTHER

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.

Intervented

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients attended by the staff of internists of the internal medicine service of the Clinical Hospital of the University of Chile for acute condition or decompensation of chronic pathology.
• Patients with an estimated survival of more than 6 months.
• Patients who are on pharmacological therapy.
• Patients who have a contact person or responsible caregiver, willing to comply with the scheduled care plan.
• Patients who have a contact telephone number

You may not qualify if:

• Patients without cognitive autonomy in which it is not possible to establish contact with the caregiver.
• Any other condition that in the judgment of the research team affects the quality of the collection of the information.

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Hospital Clínico de la Universidad de Chile

Independencia, Santiago Metropolitan, Chile

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Marcela Jirón, PhD

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate proffesor

Model Details: parallels groups: control arm will receive usual care, intervention arm will receive a Clinical Pharmacist Care

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 17, 2017
• Study Start: May 2, 2015
• Primary Completion: September 22, 2017
• Study Completion: December 22, 2017
• Last Updated: May 17, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)