Pharmaceutical Care in Emergency Department

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Medication Adherence, Hypertension, Diabetes Mellitus

Intervention / Treatment
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* Other: Pharmaceutical care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmaceutical care<br>In the ED, immediately after discharge, participants randomized to the pharmaceutical care group will receive intervention coordinated by the study pharmacist. | Other: Pharmaceutical care<br>* 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.<br>|
| No Intervention: Usual care<br>In addition to counseling provided by a physician and by the nursing staff during their stay in the ED (usual care), patients randomized to the control group will receive the same printed material information on hypertension and/or diabetes medications and lifestyle interventions in order to keep patients masked. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence | Outcome of interest: High Adherence According to the Brief Medication Questionnaire and Morisky-Green Test | Two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Control |  | Two months | 
| Glycated hemoglobin (HbA1C) for diabetic patients |  | two months | 
| Quality of Life |  | Two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmaceutical care, Medication Adherence, Blood Pressure, Diabetes, Emergency