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

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ClinicalTrials.gov Identifier: NCT02368548
Recruitment Status : Completed
First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Ana Juanes, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Pulmonary Disease, Chronic Obstructive Other: Pharmaceutical Care Program Other: Standard Care Not Applicable

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : January 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : September 2013

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.

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.




Primary Outcome Measures :
  1. 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

  2. Mortality [ Time Frame: 6-month after inclusion ]
    Patients who died during the following 6 months after inclusion

  3. 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

  4. 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.

  5. 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Additional Information:
Publications:
Responsible Party: Ana Juanes, Pharmacist, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02368548     History of Changes
Other Study ID Numbers: IIBSP-PAF-2011-81
IIBSP-PAF-2011-81 ( Other Identifier: Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau )
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: February 23, 2015
Last Verified: February 2015

Keywords provided by Ana Juanes, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Pharmaceutical care
Emergency Service

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive