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

February 16, 2015 updated by: Ana Juanes, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: Pharmaceutical Care Program
Intensive pharmaceutical care program, initiated in the emergency department, as described in its corresponding arm intervention description.
Other: 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.
Other: Standard Care
Standard pharmaceutical care process, initiated at the hospital admission, as described in its corresponding arm intervention description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug Related Problems (DRP)
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Patient health outcomes that are not consistent with the objectives of pharmacotherapy and are associated with the use or errors in the use of medicines
Participants will be followed for the duration of hospital stay, an expected average of 10 days
Mortality
Time Frame: 6-month after inclusion
Patients who died during the following 6 months after inclusion
6-month after inclusion
Average length of the hospital stay
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Duration of the stay (in hours) from the emergency episode until discharge from the hospital
Participants will be followed for the duration of hospital stay, an expected average of 10 days
Readmissions
Time Frame: 6-month after inclusion
Number of visits (emergency department/hospitalization) due to HF and/or COPD decompensation after the first episode (inclusion in the study), in the next 1180 days.
6-month after inclusion
Average cost of hospital stay
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Average money spent per patient in Euros.
Participants will be followed for the duration of hospital stay, an expected average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

February 16, 2015

First Posted (Estimate)

February 23, 2015

Study Record Updates

Last Update Posted (Estimate)

February 23, 2015

Last Update Submitted That Met QC Criteria

February 16, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-PAF-2011-81 (Other Identifier: Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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