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Completed

NCT Number: NCT02368548

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

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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Key information

Conditions

Heart Failure Cardiovascular Diseases Chronic Disease Disease Attributes Heart Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmaceutical Care Program

Other

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

Standard care

Other

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 23, 2015
Registry last updated
Feb 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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