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

Heart Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368548
• Other study ID #: IIBSP-PAF-2011-81
• Secondary ID: IIBSP-PAF-2011-8
• Status: Completed
• Phase: N/A
• First received: January 20, 2015
• Last updated: February 16, 2015
• Start date: January 2012
• Est. completion date: September 2013

Study information

• Verified date: February 2015
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Disease
• Heart Failure
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Pharmaceutical Care Program
Intensive pharmaceutical care program, initiated in the emergency department, as described in its corresponding arm intervention description.
• Standard Care
Standard pharmaceutical care process, initiated at the hospital admission, as described in its corresponding arm intervention description.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

References & Publications (5)

Baena MI, Fajardo PC, Pintor-Mármol A, Faus MJ, Marín R, Zarzuelo A, Martínez-Olmos J, Martínez-Martínez 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. — View Citation

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. — View Citation

Gillespie U, Alassaad A, Henrohn D, Garmo H, Hammarlund-Udenaes M, Toss H, Kettis-Lindblad A, Melhus H, Mörlin 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. — View Citation

Gorgas Torner MQ, Pàez Vives F, Camós Ramió J, de Puig Cabrera E, Jolonch Santasusagna P, Homs Peipoch E, Schoenenberger Arnaiz JA, Codina Jané C, Gómez-Arbonés J. [Integrated pharmaceutical care programme in patients with chronic diseases]. Farm Hosp. 2012 Jul-Aug;36(4):229-39. Epub 2011 Dec 3. Spanish. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Mortality	Patients who died during the following 6 months after inclusion	6-month after inclusion	No
Primary	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	No
Primary	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	No
Primary	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	No

External Links

•   Third Consensus of Granada on Drug Related Problems (DRP) and Negative