Drug-Related Side Effects and Adverse Reactions Clinical Trial
Official title:
Impact of Clinical Pharmacist on Post-discharge Prevention of Adverse Drug Events in Older Adults: Randomized Clinical Trial.
Verified date | May 2017 |
Source | University of Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 611 |
Est. completion date | December 22, 2017 |
Est. primary completion date | September 22, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Chile | Hospital Clínico de la Universidad de Chile | Independencia | Santiago |
Lead Sponsor | Collaborator |
---|---|
University of Chile |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Adherence measured with Morisky & Green Scale | test with 4 question to know adherence to treatment of the patient | 90 days post discharge | |
Secondary | Incidence of potentially inappropriate medication | The evaluation of which drugs will be considered inappropriate will be performed according to the Beers criteria and STOPP & START criteria, both allow to evaluate if the indicated medicines are appropriate for the older adults. | 90 days post discharge | |
Secondary | Incidence of adverse drug reactions | The analysis of the direct relationship between adverse reaction and drug use, will be determined by a multidisciplinary team following validated instruments. | 90 days post discharge | |
Secondary | Incidence of non-programmed/programmed consultations or hospitalizations after discharge from the hospital | 90 days post discharge | ||
Secondary | Prevalence of Polypharmacy (5 or more drugs) | polypharmacy is a risk factor for many clinical outcomes related with treatment failure or drug related problems | 90 days post discharge | |
Secondary | Prevalence of self medication in each group | when patient take a drug without medical indications, it is considerate self medication. | 90 days post discharge | |
Secondary | Presence of clinically relevant drug interactions | Clinical relevance will be discussed with a multidisciplinary group | 90 days post discharge | |
Secondary | Characterization of the interventions made by the clinical pharmacist to the health team | Cinical phasrmacist interventions may be: Dose adjustments Change, addition or withdrawal of a drug change in treatment regimen or schedule Medication errors prevention Drug-drug Interactions prevention Patient or health team education. Actions to improve the clinical outcome of the patients. Interventions relevance will be discussed with a multidisciplinary group |
90 days post discharge |
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