Impact of Clinical Pharmacist on Adverse Drug Events in Older Adults

• ClinicalTrials.gov Identifier: NCT03156348
• Recruitment Status: Unknown
• First Posted: May 17, 2017
• Last Update Posted: May 17, 2017
• Sponsor: University of Chile
• Information provided by (Responsible Party): Marcela Jirón Aliste, University of Chile

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Drug-Related Side Effects and Adverse Reactions	Other: Clinical Pharmacist Care	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 611 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: parallels groups: control arm will receive usual care, intervention arm will receive a Clinical Pharmacist Care
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Impact of Clinical Pharmacist on Post-discharge Prevention of Adverse Drug Events in Older Adults: Randomized Clinical Trial.
• Actual Study Start Date: May 2, 2015
• Estimated Primary Completion Date: September 22, 2017
• Estimated Study Completion Date: December 22, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervented; 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; 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.
No Intervention: Control; 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.

Outcome Measures

Primary Outcome Measures :

1. Incidence of Adverse Drug Events at 90 days post discharge [ Time Frame: 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.

Secondary Outcome Measures :

1. Adherence measured with Morisky & Green Scale [ Time Frame: 90 days post discharge ]
   test with 4 question to know adherence to treatment of the patient
2. Incidence of potentially inappropriate medication [ Time Frame: 90 days post discharge ]
   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.
3. Incidence of adverse drug reactions [ Time Frame: 90 days post discharge ]
   The analysis of the direct relationship between adverse reaction and drug use, will be determined by a multidisciplinary team following validated instruments.
4. Incidence of non-programmed/programmed consultations or hospitalizations after discharge from the hospital [ Time Frame: 90 days post discharge ]
5. Prevalence of Polypharmacy (5 or more drugs) [ Time Frame: 90 days post discharge ]
   polypharmacy is a risk factor for many clinical outcomes related with treatment failure or drug related problems
6. Prevalence of self medication in each group [ Time Frame: 90 days post discharge ]
   when patient take a drug without medical indications, it is considerate self medication.
7. Presence of clinically relevant drug interactions [ Time Frame: 90 days post discharge ]
   Clinical relevance will be discussed with a multidisciplinary group
8. Characterization of the interventions made by the clinical pharmacist to the health team [ Time Frame: 90 days post discharge ]

   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

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Chile

Hospital Clínico de la Universidad de Chile; Recruiting

Independencia, Santiago, Chile

Contact: Jorge Hasbun, Dr (56-2) 2978 80 00 comiteetica@hcuch.cl

Sponsors and Collaborators

University of Chile

Investigators

• Principal Investigator: Marcela Jirón, PhD; University of Chile

More Information

• Responsible Party: Marcela Jirón Aliste, associate proffesor, University of Chile
• ClinicalTrials.gov Identifier: NCT03156348
• Other Study ID Numbers: SA14ID0141
• First Posted: May 17, 2017
• Last Update Posted: May 17, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marcela Jirón Aliste, University of Chile:

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

Additional relevant MeSH terms:

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders