Impact of Clinical Pharmacist on Adverse Drug Events in Older Adults

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03156348
• Other study ID #: SA14ID0141
• Status: Recruiting
• Phase: N/A
• First received: May 10, 2017
• Last updated: May 15, 2017
• Start date: May 2, 2015
• Est. completion date: December 22, 2017

Study information

• Verified date: May 2017
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The intervention plan during hospitalization will consist of daily monitoring of pharmacological efficacy and safety, participating in clinical rounds and patient interviews. To review, assess the indications according to the conditions of each patient and evaluating possible interactions of clinical importance, dose adjustments, potentially inappropriate medication for older adult (OA), adverse effects and omissions of therapy. To make recommendations to the healthcare team regarding pharmacological therapy received during hospitalization and at discharge.

Patient-directed interventions will occur at discharge and post-discharge, focusing on clarifying management regimens, drug use motives, preventing drug-related problems, clarifying doubts and educating on pharmacotherapy, and enhancing adherence to treatment. The selection and recruitment of the patients will be made during the first 48 hours of their admission to the Internal Medicine Service (IMS), where they will be invited to participate and sign the informed consent.

In all groups, a physician, pharmacist, and occupational therapist, blind to treatment assignment, will collect sociodemographic, morbid, pharmacotherapeutic, and functional (Barthel Index and Lawton & Brody Scale), adherence (Morisky & Green Scale), delirium (Confusion Assessment Method, CAM), comorbidity (cumulative illness rating scale in Geriatrics (CIRS-G)), anticholinergic burden (Anticholinergic Burden Scale and Ars Risk Scale), potentially inappropriate medications (Beers Criteria and screening tool of older people's prescriptions & screening tool to alert to right treatment criteria (STOPP & START)) before, during hospitalization, at discharge and post-discharge. Also a follow up by telephone interviews at 30, 60 and 90 days after hospital discharge from the IMS.

Two trained and independent evaluators (geriatrician and clinical pharmacist), blind to treatment assignment, will evaluate the history of each case and by consensus will assign the presence of Adverse Drug Events (ADE), and classify them as preventable or not and according to severity. The Chi-squared or Fisher exact test will be used to test the hypothesis that clinical pharmacist intervention prevents at least 50% of ADE at 3 months post-discharge in OA compared to usual care in the IMS.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions

Intervention

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.

Locations

Country	Name	City	State
Chile	Hospital Clínico de la Universidad de Chile	Independencia	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

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