Clinical Trial: Impact of Clinical Pharmacist on Adverse Drug Events in Older Adults

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Impact of Clinical Pharmacist on Post-discharge Prevention of Adverse Drug Events in Older Adults: Randomized Clinical Trial.

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.

Detailed Summary:

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.

Sponsor: University of Chile

Current Primary Outcome: Incidence of Adverse Drug Events at 90 days post discharge [ Time Frame: 90 days post discharge ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Adherence measured with Morisky & Green Scale [ Time Frame: 90 days post discharge ]
  test with 4 question to know adherence to treatment of the patient
• 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.
• 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.
• Incidence of non-programmed/programmed consultations or hospitalizations after discharge from the hospital [ Time Frame: 90 days post discharge ]
• 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
• 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.
• Presence of clinically relevant drug interactions [ Time Frame: 90 days post discharge ]
  Clinical relevance will be discussed with a multidisciplinary group
• 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

Original Secondary Outcome: Same as current

Information By: University of Chile

Dates:
Date Received: May 10, 2017
Date Started: May 2, 2015
Date Completion: December 22, 2017
Last Updated: May 15, 2017
Last Verified: May 2017