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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Heart Failure, Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Other: Pharmaceutical Care Program
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmaceutical care program<br>Initiated in the Emergency Department (ED): Review of home medication and medication reconciliation based on Primary Care data Patient interview. Assessment of the patient's knowledge on the pharmacological treatment Development of the pharmacological history and registration in the medical record Adequacy of drug therapy. Identification of Drug Related Problems including reconciliation errors (DRP) and communication to medical team Pharmacotherapy monitoring Treatment validation and medication reconciliation at discharge During the hospitalization (if admission from the ED): Treatment review and medication reconciliation Pharmacokinetics monitoring Retrospective validation of prescriptions and assessment of drugs appropriateness. DRP identification and communication to medical team Pharmacotherapy monitoring Validation and medication reconciliation at discharge Patient education at discharge | Other: Pharmaceutical Care Program<br>* Intensive pharmaceutical care program, initiated in the emergency department, as described in its corresponding arm intervention description.<br>|
| Other: Standard Care<br>Stages: 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. During the hospitalization (if admission from the ED): Pharmacokinetics monitoring Retrospective validation of prescriptions and assessment of drugs appropriateness. | Other: Standard Care<br>* Standard pharmaceutical care process, initiated at the hospital admission, as described in its corresponding arm intervention description.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmaceutical care, Emergency Service