Heart Failure, Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Pharmaceutical care, Emergency Service
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.
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.
Interventions
Intensive pharmaceutical care program, initiated in the emergency department, as described in its corresponding arm intervention description.
OTHERStandard Care
Standard pharmaceutical care process, initiated at the hospital admission, as described in its corresponding arm intervention description.
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug Related Problems (DRP) | 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 | 6-month after inclusion | Patients who died during the following 6 months after inclusion |
| Average length of the hospital stay | 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 | 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 | Participants will be followed for the duration of hospital stay, an expected average of 10 days | Average money spent per patient in Euros. |
Outcome results
None listed