NCT06490406

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 8, 2024

Completed
Last Updated

July 8, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 13, 2024

Last Update Submit

July 5, 2024

Conditions

Keywords

Health CommunicationFormative feedbackHealth LiteracyRandomized Controlled TrialSimulation

Outcome Measures

Primary Outcomes (1)

  • Clinical relationship during the healthcare process

    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

Study Arms (2)

Experimental Group 1 (EG1)

EXPERIMENTAL

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

Control Group / Experimental Group 2 (CG / EG2)

NO INTERVENTION

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)

Interventions

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".

Experimental Group 1 (EG1)

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing, University of Cadiz

Algeciras, Cadiz, 11207, Spain

Location

Related Publications (13)

  • Cusatis R, Holt JM, Williams J, Nukuna S, Asan O, Flynn KE, Neuner J, Moore J, Makoul G, Crotty BH. The impact of patient-generated contextual data on communication in clinical practice: A qualitative assessment of patient and clinician perspectives. Patient Educ Couns. 2020 Apr;103(4):734-740. doi: 10.1016/j.pec.2019.10.020. Epub 2019 Oct 30.

    PMID: 31744702BACKGROUND
  • Abdolrahimi M, Ghiyasvandian S, Zakerimoghadam M, Ebadi A. Antecedents and Consequences of Therapeutic Communication in Iranian Nursing Students: A Qualitative Research. Nurs Res Pract. 2017;2017:4823723. doi: 10.1155/2017/4823723. Epub 2017 Dec 13.

    PMID: 29387487BACKGROUND
  • Sorensen K, Van den Broucke S, Fullam J, Doyle G, Pelikan J, Slonska Z, Brand H; (HLS-EU) Consortium Health Literacy Project European. Health literacy and public health: a systematic review and integration of definitions and models. BMC Public Health. 2012 Jan 25;12:80. doi: 10.1186/1471-2458-12-80.

    PMID: 22276600BACKGROUND
  • Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011 Jul 19;155(2):97-107. doi: 10.7326/0003-4819-155-2-201107190-00005.

    PMID: 21768583BACKGROUND
  • Coleman CA, Hudson S, Maine LL. Health literacy practices and educational competencies for health professionals: a consensus study. J Health Commun. 2013;18 Suppl 1(Suppl 1):82-102. doi: 10.1080/10810730.2013.829538.

    PMID: 24093348BACKGROUND
  • Coleman C, Hudson S, Pederson B. Prioritized Health Literacy and Clear Communication Practices For Health Care Professionals. Health Lit Res Pract. 2017 Jul 10;1(3):e91-e99. doi: 10.3928/24748307-20170503-01. eCollection 2017 Jul.

    PMID: 31294254BACKGROUND
  • Karuranga S, Sorensen K, Coleman C, Mahmud AJ. Health Literacy Competencies for European Health Care Personnel. Health Lit Res Pract. 2017 Dec 11;1(4):e247-e256. doi: 10.3928/24748307-20171005-01. eCollection 2017 Oct.

    PMID: 31294270BACKGROUND
  • Helitzer DL, Lanoue M, Wilson B, de Hernandez BU, Warner T, Roter D. A randomized controlled trial of communication training with primary care providers to improve patient-centeredness and health risk communication. Patient Educ Couns. 2011 Jan;82(1):21-9. doi: 10.1016/j.pec.2010.01.021. Epub 2010 Mar 12.

    PMID: 20219315BACKGROUND
  • Toronto CE. Health Literacy Competencies for Registered Nurses: An e-Delphi Study. J Contin Educ Nurs. 2016 Dec 1;47(12):558-565. doi: 10.3928/00220124-20161115-09.

    PMID: 27893919BACKGROUND
  • Yin HS, Jay M, Maness L, Zabar S, Kalet A. Health Literacy: An Educationally Sensitive Patient Outcome. J Gen Intern Med. 2015 Sep;30(9):1363-8. doi: 10.1007/s11606-015-3329-z.

    PMID: 26173523BACKGROUND
  • MacLean S, Kelly M, Geddes F, Della P. Use of simulated patients to develop communication skills in nursing education: An integrative review. Nurse Educ Today. 2017 Jan;48:90-98. doi: 10.1016/j.nedt.2016.09.018. Epub 2016 Sep 28.

    PMID: 27741440BACKGROUND
  • Zhang H, Yoong SQ, Dong YH, Goh SH, Lim S, Chan YS, Wang W, Wu XV. Using a 3-Phase Peer Feedback to Enhance Nursing Students' Reflective Abilities, Clinical Competencies, Feedback Practices, and Sense of Empowerment. Nurse Educ. 2023 Jan-Feb 01;48(1):E11-E16. doi: 10.1097/NNE.0000000000001294. Epub 2022 Sep 21.

    PMID: 36137289BACKGROUND
  • Toronto CE, Weatherford B. Health Literacy Education in Health Professions Schools: An Integrative Review. J Nurs Educ. 2015 Dec;54(12):669-76. doi: 10.3928/01484834-20151110-02.

    PMID: 26652801BACKGROUND

Study Officials

  • Pilar Bas-Sarmiento, Ph.D.

    University of Cadiz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and the data analyst will be masked.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: This study is a parallel group-randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2024

First Posted

July 8, 2024

Study Start

January 1, 2020

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

July 8, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Data will become available when the results of the study will be published.
Access Criteria
Data will be published in supplementary material or they will available upon reasonable request to the corresponding author.

Locations