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| ID | Type | Description | Link |
|---|---|---|---|
| IIBSP-PAF-2011-81 | Other Identifier | Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmaceutical care program | Experimental |
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| Standard Care | Other | Stages:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmaceutical Care Program | Other | Intensive pharmaceutical care program, initiated in the emergency department, as described in its corresponding arm intervention description. |
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| Measure | Description | Time Frame |
|---|---|---|
| Drug Related Problems (DRP) | 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 | Patients who died during the following 6 months after inclusion | 6-month after inclusion |
| Average length of the hospital stay | 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 | 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 | Average money spent per patient in Euros. | Participants will be followed for the duration of hospital stay, an expected average of 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24091839 | Background | Baena MI, Fajardo PC, Pintor-Marmol A, Faus MJ, Marin R, Zarzuelo A, Martinez-Olmos J, Martinez-Martinez F. Negative clinical outcomes of medication resulting in emergency department visits. Eur J Clin Pharmacol. 2014 Jan;70(1):79-87. doi: 10.1007/s00228-013-1562-0. Epub 2013 Oct 3. | |
| 22137609 | Background | Gorgas Torner MQ, Paez Vives F, Camos Ramio J, de Puig Cabrera E, Jolonch Santasusagna P, Homs Peipoch E, Schoenenberger Arnaiz JA, Codina Jane C, Gomez-Arbones J. [Integrated pharmaceutical care programme in patients with chronic diseases]. Farm Hosp. 2012 Jul-Aug;36(4):229-39. doi: 10.1016/j.farma.2011.06.015. Epub 2011 Dec 3. Spanish. |
| Label | URL |
|---|---|
| Third Consensus of Granada on Drug Related Problems (DRP) and Negative | View source |
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| Standard Care | Other | Standard pharmaceutical care process, initiated at the hospital admission, as described in its corresponding arm intervention description. |
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| 19433702 | Background | Gillespie U, Alassaad A, Henrohn D, Garmo H, Hammarlund-Udenaes M, Toss H, Kettis-Lindblad A, Melhus H, Morlin C. A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. Arch Intern Med. 2009 May 11;169(9):894-900. doi: 10.1001/archinternmed.2009.71. |
| 19388074 | Background | Koehler BE, Richter KM, Youngblood L, Cohen BA, Prengler ID, Cheng D, Masica AL. Reduction of 30-day postdischarge hospital readmission or emergency department (ED) visit rates in high-risk elderly medical patients through delivery of a targeted care bundle. J Hosp Med. 2009 Apr;4(4):211-8. doi: 10.1002/jhm.427. |
| 23695594 | Background | Castro I, Guardiola JM, Tuneu L, Sala ML, Faus MJ, Mangues MA. Drug-related visits to the emergency department in a Spanish university hospital. Int J Clin Pharm. 2013 Oct;35(5):727-35. doi: 10.1007/s11096-013-9795-7. Epub 2013 May 22. |
| 31157039 | Derived | Juanes A, Garin N, Mangues MA, Herrera S, Puig M, Faus MJ, Baena MI. Impact of a pharmaceutical care programme for patients with chronic disease initiated at the emergency department on drug-related negative outcomes: a randomised controlled trial. Eur J Hosp Pharm. 2018 Sep;25(5):274-280. doi: 10.1136/ejhpharm-2016-001055. Epub 2017 Feb 23. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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