NCT02368548

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Jan 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
Last Updated

February 23, 2015

Status Verified

February 1, 2015

Enrollment Period

1.1 years

First QC Date

January 20, 2015

Last Update Submit

February 16, 2015

Conditions

Heart FailurePulmonary Disease, Chronic Obstructive

Keywords

Pharmaceutical careEmergency Service

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

Pharmaceutical care program

EXPERIMENTAL

1. Initiated in the Emergency Department (ED): 1. Review of home medication and medication reconciliation based on Primary Care data 2. Patient interview. Assessment of the patient's knowledge on the pharmacological treatment 3. Development of the pharmacological history and registration in the medical record 4. Adequacy of drug therapy. Identification of Drug Related Problems including reconciliation errors (DRP) and communication to medical team 5. Pharmacotherapy monitoring 6. Treatment validation and medication reconciliation at discharge 2. During the hospitalization (if admission from the ED): 1. Treatment review and medication reconciliation 2. Pharmacokinetics monitoring 3. Retrospective validation of prescriptions and assessment of drugs appropriateness. DRP identification and communication to medical team 4. Pharmacotherapy monitoring 5. Validation and medication reconciliation at discharge 6. Patient education at discharge

Other: Pharmaceutical Care Program

Standard Care

OTHER

Stages: 1. Pharmaceutical care program in the episode at the Emergency Department: a. There was no monitoring of the patient by the pharmacist. Retrospective validation of the prescriptions was not performed. 2. During the hospitalization (if admission from the ED): 1. Pharmacokinetics monitoring 2. Retrospective validation of prescriptions and assessment of drugs appropriateness.

Other: Standard Care

Interventions

Pharmaceutical Care ProgramOTHER

Intensive pharmaceutical care program, initiated in the emergency department, as described in its corresponding arm intervention description.

Pharmaceutical care program
Standard CareOTHER

Standard pharmaceutical care process, initiated at the hospital admission, as described in its corresponding arm intervention description.

Standard Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Suffering from dementia, severe mental disorders and living in nursing homes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 24091839BACKGROUND

  • 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.

    PMID: 22137609BACKGROUND

  • 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.

    PMID: 19433702BACKGROUND

  • 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.

    PMID: 19388074BACKGROUND

  • 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.

    PMID: 23695594BACKGROUND

  • 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.

    PMID: 31157039DERIVED

Related Links

MeSH Terms

Conditions

Heart FailurePulmonary Disease, Chronic Obstructive

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmacist

Study Record Dates

First Submitted

January 20, 2015

First Posted

February 23, 2015

Study Start

January 1, 2012

Primary Completion

February 1, 2013

Study Completion

September 1, 2013

Last Updated

February 23, 2015

Record last verified: 2015-02