Clinical trial NCT02368548: Randomized Clinical Trial of a Pharmaceutical Care Program in Chronic Patients Users of an Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Pulmonary Disease, Chronic Obstructive
Keywords: Pharmaceutical care
Emergency Service
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Drug Related Problems (DRP)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
measure: Mortality
timeFrame: 6-month after inclusion
measure: Average length of the hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
measure: Readmissions
timeFrame: 6-month after inclusion
measure: Average cost of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
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.
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.
citation: 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.