The Effect of Immediate Feedback on Long-term Blood Pressure Measurement Skills: a Randomized Controlled Trial

August 1, 2017 updated by: Federal University of Juiz de Fora
The present study aims to investigate the effect of immediate feedback on long-term blood pressure measurement skills. This is a randomized controlled trial including first year students from a Brazilian medical school, which will be randomized in two groups: an intervention group (submitted to a training on blood pressure measurement skills and an immediate feedback) and a control group (submitted to a training on blood pressure measurement skills, but with no immediate feedback). Then, students will be assessed 3 months after the feedback in order to see whether there will be a difference between groups. Our hypothesis is that students submitted to immediate feedback would have better scores in the blood-pressure measurement skills after 3 months. A knowledge questionnaire as well as a standardized patient scenario will be used to assess students' knowledge and skills.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

There are several studies evaluating the role of feedback in medical education, showing promising outcomes. Although, immediate feedback is associated with better knowledge and skills in short-term, few studies have assessed whether immediate feedback could impact the maintenance of skills. The present study aims to investigate the effect of immediate feedback on long-term blood pressure measurement skills. This is a randomized controlled trial including first year students from a Brazilian medical school, which will be randomized in two groups: an intervention group (submitted to a training on blood pressure measurement skills and an immediate feedback after their encounter with an standardized patient - SP) and a control group (submitted to the same training on blood pressure measurement skills, but with no immediate feedback after the SP encounter).

Both groups will be trained to measure blood pressure in the same way, with a brief 4-hour theoretical-practical intervention. After the training, students will measure the blood pressure of a standardized patient and observers will evaluate them using a checklist.

Then, students will have no other exposure to the BP training for three months and they will be invited again to participate in another SP encounter. Differences on BP skills after 3 months between those exposed to immediate feedback and those not exposed to immediate feedback would be investigated.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36.010-560
        • Recruiting
        • Faculdade de Ciências Médicas e da Saúde de Juiz de Fora
        • Contact:
          • Margareth Alves Bastos e Castro, Student
          • Phone Number: +55 32998193700
          • Email: maghms@terra.com.br

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  • students officially registered in the first semester of the medical school and older than 18 years old.

Exclusion criteria:

  • those absent in any part of the blood pressure measurement training and those who not signed the consent term

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate feedback
Submitted to a training on blood pressure measurement skills and an immediate feedback after their encounter with an standardized patient - SP
Students will be trained to measure blood pressure in the same way, with a brief 4-hour theoretical-practical intervention. After the training, students will measure the blood pressure of a standardized patient and observers will evaluate them using a checklist. After that, students from the intervention group will receive an immediate feedback based on the previous literature. Briefly, feedback will be based on what was directly observed and will be phrased in non-judgmental language, following the Pendleton model.
No Intervention: Students with no immediate feedback
Submitted to a training on blood pressure measurement skills, but without an immediate feedback after their encounter with an standardized patient - SP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess blood-pressure measurement skills
Time Frame: 3 months
Blood pressure measurement skills checklist - following the criteria adopted by international (Eighth Joint National Committee) and the Brazilian guidelines (VII Brazilian Guidelines on Hipertension)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess blood-pressure measurement knowledge
Time Frame: 3 months
Blood pressure measurement knowledge test - following the criteria adopted by international (Eighth Joint National Committee) and the Brazilian guidelines (VII Brazilian Guidelines on Hipertension)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Giancarlo Lucchetti, MD, PhD, Federal University of Juiz de Fora

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2017

Primary Completion (Anticipated)

November 6, 2017

Study Completion (Anticipated)

February 28, 2018

Study Registration Dates

First Submitted

May 4, 2017

First Submitted That Met QC Criteria

May 5, 2017

First Posted (Actual)

May 8, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 1.712.520

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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