Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03156348
Other study ID # SA14ID0141
Secondary ID
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03258151 - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
Recruiting NCT05202964 - Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections (OTABIO)
Completed NCT04597593 - Association Between Genetic Variant Scores and DOACs (DARES2)
Recruiting NCT05096338 - Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Prostate Cancer
Recruiting NCT05078190 - Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Breast Cancer
Completed NCT02457039 - Acupuncture Prevents Chemobrain in Breast Cancer Patients N/A
Completed NCT02779530 - CYP4A11 and CYP4F2 Gene Variants as Makers of Cardiovascular Adverse Events of Non-steroidal Anti-inflammatory Drugs Phase 4
Recruiting NCT03051880 - Preventive Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors N/A
Recruiting NCT03047863 - Therapeutic Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors N/A
Completed NCT02482025 - The Secure Messaging for Medication Reconciliation Tool (SMMRT) Trial N/A
Not yet recruiting NCT03147157 - The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen After Liver Transplantation N/A
Recruiting NCT03501108 - Discontinuation of Long-term Medications in Older People Entering Nursing Home Care N/A
Recruiting NCT06427317 - Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment
Completed NCT03227653 - Neuropsychiatric Side Effects of Efavirenz in Children Living With HIV
Completed NCT03177174 - Different Chemotherapy Protocols Combined With Intensity Modulated Radiation Therapy in Patients With Locally Advanced Nasopharyngeal Carcinoma N/A
Recruiting NCT04077281 - Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly In Transitions N/A
Not yet recruiting NCT05247814 - Individual Risk Profiles for Adverse Drug Reactions in Geriatric Patients
Recruiting NCT03938597 - Investigation of Serious Adverse Events Following Vaccination Against Yellow Fever: Emphasis on Genetic Basis and Biological Markers
Recruiting NCT06291688 - Applying Mobile Healthcare Education to Improve Cutaneous Self-care Capability N/A
Active, not recruiting NCT02119078 - Acute Care for Elders (ACE) Program at OHSU Hospital N/A