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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Pharmaceutical care program

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

Group Type EXPERIMENTAL

Pharmaceutical Care Program

Intervention Type OTHER

Intensive pharmaceutical care program, initiated in the emergency department, as described in its corresponding arm intervention description.

Standard Care

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.

Group Type OTHER

Standard Care

Intervention Type OTHER

Standard pharmaceutical care process, initiated at the hospital admission, as described in its corresponding arm intervention description.

Interventions

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Pharmaceutical Care Program

Intensive pharmaceutical care program, initiated in the emergency department, as described in its corresponding arm intervention description.

Intervention Type OTHER

Standard Care

Standard pharmaceutical care process, initiated at the hospital admission, as described in its corresponding arm intervention description.

Intervention Type OTHER

Eligibility Criteria

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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.