Pharmaceutical Care in Emergency Department

Hypertension Clinical Trial

— AMPaRAR  

Official title:

Effectiveness Pharmaceutical Care at Discharge in the Emergency Department: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01978925
• Other study ID #: AMPaRAR 01
• Status: Completed
• Phase: N/A
• First received: November 1, 2013
• Last updated: May 19, 2015
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: Hospital Moinhos de Vento
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of pharmaceutical care, compared to usual care, in patient discharge in an emergency department in patients with hypertension and/or diabetes mellitus type 2.

Description:

This is a randomized controlled, single-center study, with blinding of outcome assessors. A pilot study with ten patients was previously conducted in order to test study logistics and data collection instruments. Participants will be recruited from a public ED at Restinga district in Porto Alegre, southern Brazil.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Blood pressure inadequate control (systolic blood pressure = 160 or diastolic blood pressure = 100 mmHg) or

• Diabetes mellitus inadequate Control( = 200 mg/dL) or hypoglycemia moderate or severe

• Be referred to clinical care.

Exclusion Criteria:

• < 18 years

• Not resident of Porto Alegre

• Diabetes mellitus type I

• Unable to answer the questionnaire or to sign the informed consent form

• Hospital admission

• Death

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Emergencies
• Hypertension
• Medication Adherence

Intervention

Other:
• Pharmaceutical care
The clinical pharmacist will provide a structured 30-minute intervention for enhancing their medication adherence. The recommendations include: discussion on hypertension and/or diabetes, risk of complications, prescribed drug therapy, correct use of medications and proper dosage, possible adverse effects, route of administration, schedule of administration and correct storage. The pharmacist will also emphasize the importance of lifestyle modifications. Printed educational material, with information on hypertension and/ or diabetes medications, including suggested lifestyle interventions was prepared to assist in the intervention and will be handed to patients in the end of the session.

Locations

Country	Name	City	State
Brazil	Emergency Department - Hospital Moinhos de Vento	Porto Alegre	Rio Grande do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Moinhos de Vento	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fasting plasma glucose for diabetic patients		Two months	No
Primary	Medication Adherence	Outcome of interest: High Adherence According to the Brief Medication Questionnaire and Morisky-Green Test	Two months	No
Secondary	Blood Pressure Control		Two months	No
Secondary	Glycated hemoglobin (HbA1C) for diabetic patients		two months	No
Secondary	Quality of Life		Two months	No