Randomized Clinical Trial of a Pharmaceutical Care Program in Chronic Patients Users of an Emergency Department

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive; Heart Failure

Treatments: Other: Pharmaceutical Care Program; Other: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02368548

IIBSP-PAF-2011-81 (Other Identifier)

Details and patient eligibility

About

The study aims to assess the clinical and economic impact of a pharmaceutical care program initiated in the Emergency Department versus conventional follow-up of patients with decompensated heart failure/COPD.

Full description

Clinical trial aimed to assess the impact of a pharmaceutical care program initiated in the Emergency Department vs standard care in patients with heart failure and/or COPD, conducted at the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain) between Jan12-Feb13.

The researchers hypothesize that a systematic, standardized pharmaceutical care program may be related to a lower frequency of drug related problems (DRP). Moreover, the investigators also hypothesize that 6-month mortality, the average length of the hospital stay, and its related cost may also be decreased.

This study was approved by the Hospital de la Santa Creu i Sant Pau Ethics Committee. Written informed consent will be obtained from the participants .

The study will include 100 patients who fulfill all the inclusion criteria, described in the Eligibility Section.

Enrollment: 100 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 65 years and over
• Admission in the Emergency Department for a period equal to or higher than 12 hours;
• Number of home medication equal to or higher than four;
• Diagnose in the Emergency Department episode: decompensated heart failure and/or decompensated COPD.

Exclusion criteria

• Suffering from dementia, severe mental disorders and living in nursing homes.

Trial design

100 participants in 2 patient groups

Pharmaceutical care program

Experimental group

Description:

1. Initiated in the Emergency Department (ED): 1. Review of home medication and medication reconciliation based on Primary Care data 2. Patient interview. Assessment of the patient's knowledge on the pharmacological treatment 3. Development of the pharmacological history and registration in the medical record 4. Adequacy of drug therapy. Identification of Drug Related Problems including reconciliation errors (DRP) and communication to medical team 5. Pharmacotherapy monitoring 6. Treatment validation and medication reconciliation at discharge 2. During the hospitalization (if admission from the ED): 1. Treatment review and medication reconciliation 2. Pharmacokinetics monitoring 3. Retrospective validation of prescriptions and assessment of drugs appropriateness. DRP identification and communication to medical team 4. Pharmacotherapy monitoring 5. Validation and medication reconciliation at discharge 6. Patient education at discharge

Treatment:

Other: Pharmaceutical Care Program

Standard Care

Other group

Description:

Stages: 1. Pharmaceutical care program in the episode at the Emergency Department: a. There was no monitoring of the patient by the pharmacist. Retrospective validation of the prescriptions was not performed. 2. During the hospitalization (if admission from the ED): 1. Pharmacokinetics monitoring 2. Retrospective validation of prescriptions and assessment of drugs appropriateness.

Treatment:

Other: Standard Care