Pharmaceutical Care in Emergency Department

NCT ID: NCT01978925

Last Updated: 2015-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-12-31

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.

Conditions

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Medication Adherence Hypertension Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Pharmaceutical care

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

Group Type EXPERIMENTAL

Pharmaceutical care

Intervention Type OTHER

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.

Usual care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Brazil

OTHER_GOV

Sponsor Role collaborator

Hospital Moinhos de Vento

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rodrigo A Ribeiro, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Moinhos de Vento

Locations

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Emergency Department - Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 25888343 (View on PubMed)

Other Identifiers

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AMPaRAR 01

Identifier Type: -

Identifier Source: org_study_id

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