Communication Practices to Develop the Health Literacy Competencies in Nursing Students

July 5, 2024 updated by: University of Cadiz

Communication Practices to Develop the Health Literacy Competencies in Nursing Students: A Randomized Controlled Trial

Communication is a key health literacy educational competency in the professional training of health providers. However, students often have difficulty in applying theoretical communication models to the reality of clinical practice. Multimodal interventions based on simulation models emerge as an essential element to overcome this gap. During the simulation training, students must be aware of their communication errors and the needs that patients share in a clinical interaction.

The aim is to evaluate the effectiveness of multimodal training, which incorporates a systematic feedback guide about the student's clinical interview simulation performance, as a training complement to classical education to improve health literacy competencies and clear communication practices in health sciences students.

A randomized controlled trial will be conducted on 82 second-year nursing students recruited from the University of Cadiz. The experimental and control groups will receive the same communication multimodal training except for the inclusion of feedback on key aspects of communication for health literacy, which the experimental groups only used. Students will be assessed through clinical interview simulations by external observers. Bivariate and inferential statistical analyses will be carried out.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

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

  • Spain
    • Cadiz
      • Algeciras, Cadiz, Spain, 11207
        • Faculty of Nursing, University of Cadiz

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Second-year nursing students at the University of Cadiz enrolled in the Interpersonal Communication Skills subject.

Exclusion Criteria:

  • Absence in training.
  • Does not consent to participate in the study.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group 1 (EG1)
In addition to the usual training in communication skills, a systematic and digitalized guide will be used that included the "health literacy practices" qualified by Coleman et al. [10] as a training complement and self-assessment of its performance. They will also receive feedback from independent observers (according to the systematic guide).
Behavioral: Multimodal intervention (communication and education simulations) for EG1
In summary, students in EG1 received the following multimodal intervention flow: 1) Health communication training, 2) Structured educational simulation using standardized patients (SPs), and 3) simulation feedback and self-assessment using a systematic guide that included the "health literacy practices".
No Intervention: Control Group / Experimental Group 2 (CG / EG2)

The CG will receive the usual training (consisting of two weekly meetings of two hours each with seven sessions whose main topics were social skills for clinical interviews: opening and closing of the clinical interviews, non-verbal communication, active listening, empathy, helping relationship, giving information about the nature of the disease and rationality of the therapeutic measures, health education, and negotiation). Furthermore, throughout the course, they will self-assess their performance using the opening video recording without systematic guidance and they will receive feedback about their communication practices during this first performance.

Thus, CG will receive the full intervention after being evaluated (post-test 1 assessment), becoming the delayed Experimental Group 2 (EG2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical relationship during the healthcare process
Time Frame: 5 months

Clinical relationship developed between a healthcare professional and a patient was measured through CICAA scale (pre-test, post-test 1, and post-test 2).

The CICAA scale is a measure instrument designed to assess the clinical relationship (CR) developed between a health professional and a patient. It can be used to evaluate global or partial aspects of CR, is based on an external evaluation through observation of the interaction and can be used for teaching purposes. For all 29 items (scored 0, 1, 2), the minimum score is 0, and the maximum score is 58. The higher the score, the better the communication skills in the consultation.
5 months

Collaborators and Investigators

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

Sponsor

University of Cadiz

Investigators

  • Principal Investigator: Pilar Bas-Sarmiento, Ph.D., University of Cadiz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2020

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

July 5, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • sol-201900138441-tra

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Data will become available when the results of the study will be published.

IPD Sharing Access Criteria

Data will be published in supplementary material or they will available upon reasonable request to the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

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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