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
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Pulmonary Disease, Chronic Obstructive||Other: Pharmaceutical Care Program Other: Standard Care||Not Applicable|
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|
|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|
Experimental: Pharmaceutical care program
Other: Pharmaceutical Care Program
Intensive pharmaceutical care program, initiated in the emergency department, as described in its corresponding arm intervention description.
Other: Standard Care
Standard pharmaceutical care process, initiated at the hospital admission, as described in its corresponding arm intervention description.
- 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
- Mortality [ Time Frame: 6-month after inclusion ]Patients who died during the following 6 months 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
- 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.
- 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.