Nurse-Patient RelationsNarratUNNCT05528523
The Relationship Competences Guiding Tool
A study testing Writing a clinical narrative in people with Nurse-Patient Relations and Professional Role, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
Aim: The aims of this study are: (1) to present the development, content validation and implementation study of the Relationship Competences Guiding Tool (RCGT); (2) to show some examples of how each of the items of the guide may be reflected on clinical narratives written by nurses, and justify its corresponding… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nurse-Patient Relations, Professional Role, Narration
- What is being tested?
- Writing a clinical narrative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2019to 1 Feb 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- nurses who agreed to participate and signed informed consent.
- nurses from different hospitals and clinical departments/services, such as general hospital wards, intensive care units, outpatient services, and other departments (i.e., perioperative, elder care, and haemodialysis, emergency, etc).
Who cannot join
- . other health professionals different from nurses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Competences Guiding Tool: A Development, Content Validation and Implementation Study
Aim: The aims of this study are: (1) to present the development, content validation and implementation study of the Relationship Competences Guiding Tool (RCGT); (2) to show some examples of how each of the items of the guide may be reflected on clinical narratives written by nurses, and justify its corresponding scores after the evaluation; (3) to present how the language and content of the narratives are interpreted with this guide and to describe an exemplar; (4) to present barriers and facilitators of its application.
Background: From a person-centred care approach, the fostering of authentic relationships with patients is key for therapeutic benefits. Therefore, it is essential to help nurses to establish meaningful relationships with patients and help them to achieve these abilities. In this line, clinical narratives can be used as a way to promote reflective practice and professional competences development between nurses. A guide to evaluate the knowledge, skills, attitudes and values necessary for developing authentic encounters with patients reflected by nurses on clinical narratives was developed and implemented.
Read more
Design: Design and evaluation of the RCGT, and evaluation of its implementation Methods: This study was conducted in three major steps. Step one entailed the conceptualization. Step two included the generation of items and content validation. Then, in step three, the tool was used to independently evaluate 25 narratives by two researchers, in order to identify and exemplify the attributes of the nurse patient relationship defined on the guide and identify barriers and facilitators. One of the narratives was linguistically analysed in the light of the guide, in order to provide a comprehensive view of the interpretative strategies deployed by evaluators.
Results: The RCGT helped to identify nursing professional competences reflected in clinical narratives. The tool guided in the process of assigning scores to the corresponding items. The use of the tool helped to identify some barriers and facilitators before and during the narrative evaluation process.
Conclusions: A clear, relevant, conceptually and linguistically adequate guide for assessing clinical narratives was obtained. The RCGT can be applied to accurately interpret how nurses reflect professional competences in a clinical narrative as a preliminary step to design a measurement tool.
Read the detailed description
This study is the first to present a valid guide for interpreting the essential aspects (respect, intentional presence and knowing the person) of the nurse-person relationship using clinical narratives. This is therefore an innovative tool to facilitate the nurses' work in caring patients and families, ensuring the success of a person-centred care for the target population. Moreover, this study describes the rigorous process that has been carried out both for the content validation of the RCGT, as well as for its application by two researchers independently with different backgrounds and perspectives.
- Conditions
- Nurse-Patient Relations, Professional Role, Narration
- Being tested
- Writing a clinical narrative
- Keywords
- Patient centred care, Clinical narrative, Guide
- Medical subject headings
- Narration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Writing a clinical narrativeOther
The participants had to write a clinical narrative regarding a significant encounter with a patient.
| Study group | Role | What they receive |
|---|---|---|
| Writing a clinical narrative | Other | The participants had to write a clinical narrative regarding a significant encounter with a patient. Receives: Other: Writing a clinical narrative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Professional competence 1: respect
The knowledge, skills, attitudes and values necessary for developing respect towards the patient. The Relationship Competences Guiding Tool was used to evaluate this competence.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start1 Sep 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nurse-Patient RelationsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Choperena, Clinica Universidad de Navarra, Universidad de Navarra
- Investigators
- Ana Choperena, PhD, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528523
- Sponsor's protocol ID
- 2020.002
- Acronym
- NarratUN
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share the clinical narratives. We will use the conclusions of the study for educational purposes.
Publications
Choperena A, Oroviogoicoechea C, Zaragoza Salcedo A, Olza Moreno I, Jones D. Nursing narratives and reflective practice: A theoretical review. J Adv Nurs. 2019 Aug;75(8):1637-1647. doi: 10.1111/jan.13955. Epub 2019 Feb 27.
PubMed 30666703Choperena A, Pardavila-Belio MI, Errasti-Ibarrondo B, Oroviogoicoechea C, Zaragoza-Salcedo A, Goni-Viguria R, Martin-Perez S, Llacer T, La Rosa-Salas V. Implementation and evaluation of a training programme to promote the development of professional competences in nursing: A pilot study. Nurse Educ Today. 2020 Apr;87:104360. doi: 10.1016/j.nedt.2020.104360. Epub 2020 Jan 29.
PubMed 32135456
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Competences Guiding Tool: A Development, Content Validation and Implementation Study
- ClinicalTrials.gov ID
- NCT05528523
- Acronym / sponsor ID
- NarratUN / 2020.002
- Conditions
- Nurse-Patient Relations, Professional Role, Narration
- Keywords
- Patient centred care, Clinical narrative, Guide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 6 Sep 2022 (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.
Aim: The aims of this study are: (1) to present the development, content validation and implementation study of the Relationship Competences Guiding Tool (RCGT); (2) to show some examples of how each of the items of the guide may be reflected on clinical narratives written by nurses, and justify its corresponding scores after the evaluation; (3) to present how the language and content of the narratives are interpreted with this guide and to describe an exemplar; (4) to present barriers and facilitators of its application.
Background: From a person-centred care approach, the fostering of authentic relationships with patients is key for therapeutic benefits. Therefore, it is essential to help nurses to establish meaningful relationships with patients and help them to achieve these abilities. In this line, clinical narratives can be used as a way to promote reflective practice and professional competences development between nurses. A guide to evaluate the knowledge, skills, attitudes and values necessary for developing authentic encounters with patients reflected by nurses on clinical narratives was developed and implemented.
Design: Design and evaluation of the RCGT, and evaluation of its implementation Methods: This study was conducted in three major steps. Step one entailed the conceptualization. Step two included the generation of items and content validation. Then, in step three, the tool was used to independently evaluate 25 narratives by two researchers, in order to identify and exemplify the attributes of the nurse patient relationship defined on the guide and identify barriers and facilitators. One of the narratives was linguistically analysed in the light of the guide, in order to provide a comprehensive view of the interpretative strategies deployed by evaluators.
Results: The RCGT helped to identify nursing professional competences reflected in clinical narratives. The tool guided in the process of assigning scores to the corresponding items. The use of the tool helped to identify some barriers and facilitators before and during the narrative evaluation process.
Conclusions: A clear, relevant, conceptually and linguistically adequate guide for assessing clinical narratives was obtained. The RCGT can be applied to accurately interpret how nurses reflect professional competences in a clinical narrative as a preliminary step to design a measurement tool.
Detailed description
This study is the first to present a valid guide for interpreting the essential aspects (respect, intentional presence and knowing the person) of the nurse-person relationship using clinical narratives. This is therefore an innovative tool to facilitate the nurses' work in caring patients and families, ensuring the success of a person-centred care for the target population. Moreover, this study describes the rigorous process that has been carried out both for the content validation of the RCGT, as well as for its application by two researchers independently with different backgrounds and perspectives.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Writing a clinical narrative | Other | Other: Writing a clinical narrativeThe participants had to write a clinical narrative regarding a significant encounter with a patient. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- nurses who agreed to participate and signed informed consent.
- nurses from different hospitals and clinical departments/services, such as general hospital wards, intensive care units, outpatient services, and other departments (i.e., perioperative, elder care, and haemodialysis, emergency, etc).
Key exclusion criteria (1 listed)
- . other health professionals different from nurses.
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 |
|---|---|---|
| Writing a clinical narrativeThe participants had to write a clinical narrative regarding a significant encounter with a patient. | Other | Writing a clinical narrative |
Primary outcome
Professional competence 1: respect
Time frame: One month
The knowledge, skills, attitudes and values necessary for developing respect towards the patient. The Relationship Competences Guiding Tool was used to evaluate this competence.
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 6 Sep 2022.
- Background: PubMed 30666703Choperena A, Oroviogoicoechea C, Zaragoza Salcedo A, Olza Moreno I, Jones D. Nursing narratives and reflective practice: A theoretical review. J Adv Nurs. 2019 Aug;75(8):1637-1647. doi: 10.1111/jan.13955. Epub 2019 Feb 27.
- Background: PubMed 32135456Choperena A, Pardavila-Belio MI, Errasti-Ibarrondo B, Oroviogoicoechea C, Zaragoza-Salcedo A, Goni-Viguria R, Martin-Perez S, Llacer T, La Rosa-Salas V. Implementation and evaluation of a training programme to promote the development of professional competences in nursing: A pilot study. Nurse Educ Today. 2020 Apr;87:104360. doi: 10.1016/j.nedt.2020.104360. Epub 2020 Jan 29.
- Individual participant dataSharing planned: No. We will not share the clinical narratives. We will use the conclusions of the study for educational purposes.
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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.
Ana Choperena, PhD principal investigator
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Writing a clinical narrative in people with Nurse-Patient Relations and Professional Role, run by Clinica Universidad de Navarra, Universidad de Navarra 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 2 inclusion and 1 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 6 Sep 2022. 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?
Professional competence 1: respect (time frame: One month). 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 NCT05528523, which also lists 2 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 6 Sep 2022.