Health LiteracyNCT06490406
Communication Practices to Develop the Health Literacy Competencies in Nursing Students
A study testing Multimodal intervention (communication and education simulations) for EG1 in people with Health Literacy and Competence, run by University of Cadiz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Literacy, Competence, Nursing Students
- What is being tested?
- Multimodal intervention (communication and education simulations) for EG1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Second-year nursing students at the University of Cadiz enrolled in the Interpersonal Communication Skills subject.
Who cannot join
- Absence in training.
- Does not consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Health Literacy, Competence, Nursing Students
- Being tested
- Multimodal intervention (communication and education simulations) for EG1
- Keywords
- Health Communication, Formative feedback, Health Literacy, Randomized Controlled Trial, Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal intervention (communication and education simulations) for EG1Behavioural
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".
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Jan 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a parallel group-randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pilar Bas-Sarmiento, Ph.D., Principal investigator, University of Cadiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490406
- Sponsor's protocol ID
- sol-201900138441-tra
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 31744702Abdolrahimi 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.
PubMed 29387487Sorensen 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.
PubMed 22276600Berkman 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.
PubMed 21768583Coleman 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.
PubMed 24093348Coleman 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.
PubMed 31294254Karuranga 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.
PubMed 31294270Helitzer 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.
PubMed 20219315Toronto 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.
PubMed 27893919Yin 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.
PubMed 26173523MacLean 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.
PubMed 27741440Zhang 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.
PubMed 36137289Toronto 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.
PubMed 26652801
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication Practices to Develop the Health Literacy Competencies in Nursing Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06490406
- Acronym / sponsor ID
- sol-201900138441-tra
- Conditions
- Health Literacy, Competence, Nursing Students
- Keywords
- Health Communication, Formative feedback, Health Literacy, Randomized Controlled Trial, Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a parallel group-randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 (EG1) | Experimental | Behavioral: Multimodal intervention (communication and education simulations) for EG1In 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). |
| 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) |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Second-year nursing students at the University of Cadiz enrolled in the Interpersonal Communication Skills subject.
Key exclusion criteria (2 listed)
- Absence in training.
- Does not consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal intervention (communication and education simulations) for EG1In 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". | Behavioural | Experimental Group 1 (EG1) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Background: PubMed 31744702Cusatis 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.
- Background: PubMed 29387487Abdolrahimi 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.
- Background: PubMed 22276600Sorensen 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.
- Background: PubMed 21768583Berkman 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.
- Background: PubMed 24093348Coleman 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.
- Background: PubMed 31294254Coleman 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.
- Background: PubMed 31294270Karuranga 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.
- Background: PubMed 20219315Helitzer 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.
- Background: PubMed 27893919Toronto 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.
- Background: PubMed 26173523Yin 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.
- Background: PubMed 27741440MacLean 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.
- Background: PubMed 36137289Zhang 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pilar Bas-Sarmiento, Ph.D. principal investigator
University of Cadiz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal intervention (communication and education simulations) for EG1 in people with Health Literacy and Competence, run by University of Cadiz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical relationship during the healthcare process (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06490406, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.