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Pharmaceutical Care in Emergency Department (AMPaRAR)

Primary Purpose

Medication Adherence, Hypertension, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pharmaceutical care
Sponsored by
Hospital Moinhos de Vento
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medication Adherence focused on measuring Pharmaceutical care, Medication Adherence, Blood Pressure, Diabetes, Emergency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emergency Department - Hospital Moinhos de Vento

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pharmaceutical care

Usual care

Arm Description

In the ED, immediately after discharge, participants randomized to the pharmaceutical care group will receive intervention coordinated by the study pharmacist.

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.

Outcomes

Primary Outcome Measures

Medication Adherence
Outcome of interest: High Adherence According to the Brief Medication Questionnaire and Morisky-Green Test

Secondary Outcome Measures

Blood Pressure Control
Glycated hemoglobin (HbA1C) for diabetic patients
Quality of Life

Full Information

First Posted
November 1, 2013
Last Updated
May 19, 2015
Sponsor
Hospital Moinhos de Vento
Collaborators
Ministry of Health, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT01978925
Brief Title
Pharmaceutical Care in Emergency Department
Acronym
AMPaRAR
Official Title
Effectiveness Pharmaceutical Care at Discharge in the Emergency Department: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Moinhos de Vento
Collaborators
Ministry of Health, Brazil

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Hypertension, Diabetes Mellitus
Keywords
Pharmaceutical care, Medication Adherence, Blood Pressure, Diabetes, Emergency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
380 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pharmaceutical care
Arm Type
Experimental
Arm Description
In the ED, immediately after discharge, participants randomized to the pharmaceutical care group will receive intervention coordinated by the study pharmacist.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pharmaceutical care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication Adherence
Description
Outcome of interest: High Adherence According to the Brief Medication Questionnaire and Morisky-Green Test
Time Frame
Two months
Secondary Outcome Measure Information:
Title
Blood Pressure Control
Time Frame
Two months
Title
Glycated hemoglobin (HbA1C) for diabetic patients
Time Frame
two months
Title
Quality of Life
Time Frame
Two months
Other Pre-specified Outcome Measures:
Title
Fasting plasma glucose for diabetic patients
Time Frame
Two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo A Ribeiro, PhD
Organizational Affiliation
Hospital Moinhos de Vento
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Department - Hospital Moinhos de Vento
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
900350-001
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25888343
Citation
Kuhmmer R, Lima KM, Ribeiro RA, Hammes LS, Bastos GA, Cotta de Souza MC, Polanczyk CA, Soares Rollin GA, Caon S, Guterres CM, Araujo Leite LE, Delabary TS, Falavigna M. Effectiveness of pharmaceutical care at discharge in the emergency department: study protocol of a randomized controlled trial. Trials. 2015 Feb 25;16:60. doi: 10.1186/s13063-015-0579-3.
Results Reference
derived

Learn more about this trial

Pharmaceutical Care in Emergency Department

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