Cultural CompetenceOHANANCT06944678
OHANA: Optimizing Cross-Cultural Care
An observational study of Cultural Competence, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Increasing globalisation and international migration have led to greater cultural diversity in Western societies, including healthcare settings. Hospitals and healthcare environments have become meeting places for individuals from different cultural backgrounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cultural Competence
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 10 Apr 2025to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: The study will be conducted by enrolling participants who adopt a cultural concordance system.
Who may be able to join
- All nurses or caregivers involved in the concordance system cultural will be included, with direct experience in caring for foreign patients
- All foreign patients admitted to hospital who speak a language other than the main language of the host country and who have been involved in the concordance system cultural will be included
Who cannot join
- All patients with severe cognitive conditions that prevent participation and nurses or caregivers who do not work closely with assigned patients will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168
Cristina Pistacchio, PI, +393382458373, cristina.pistacchio@policlinicogemelli.it
About this study
Official title: OHANA Project: Optimizing Health Care Through Alignment and Care Across Cultures
Increasing globalisation and international migration have led to greater cultural diversity in Western societies, including healthcare settings. Hospitals and healthcare environments have become meeting places for individuals from different cultural backgrounds.
This diversity presents significant opportunities for improving healthcare, but also introduces complex challenges related to communication, trust and mutual understanding between healthcare professionals and patients. In this context, the concept of culturally competent care, i.e. the ability of healthcare professionals to provide respectful and appropriate care to patients by taking into account their cultural beliefs, values and practices, emerges as a crucial approach to address the specific needs of patients from different cultures. The concept of cultural competence was first introduced by Cross, who defines it as a set of behaviours, attitudes and policies that, when integrated into an organisation or among professionals, enable them to operate effectively in intercultural contexts.
Read the detailed description
Although there is preliminary evidence on the benefits of cultural concordance, the literature is still scarce and fragmented. In particular, there is a lack of in-depth studies on the subjective experiences of the main actors involved. For healthcare professionals, cultural concordance could be a valuable resource, but also a source of additional stress or pressure, especially if perceived as a task requiring cultural or linguistic competence that is not always adequately supported. For patients, the experience of being cared for by a professional from the same culture might enhance a sense of trust and comfort, but also generate unrealistic expectations or influence perceptions of quality of care. Exploring the lived experiences of healthcare professionals and patients in a context of cultural concordance is essential to understanding perceived benefits, criticisms and areas for improvement. This multicentre study, coordinated by the Gemelli Hospital in Italy in collaboration with several Italian hospitals , aims to explore cultural concordance in a variety of healthcare settings, providing an in-depth understanding of the potentials and criticisms of cultural concordance in hospital settings
- Conditions
- Cultural Competence
What is being measured
The primary outcome is the main question the study is designed to answer.
Health workers' perceived utility of the cultural concordance system
Assessed through thematic content analysis of semi-structured interviews.
Measured: 12 months
Socio-demographic characteristics of health workers
Collected using a socio-demographic questionnaire.
Measured: 12 months
Secondary outcomes (5)
Patients' perceptions of the cultural sensitivity of care received
Assessed through thematic content analysis of semi-structured interviews.
Measured: 24 months
Socio-demographic characteristics of patients
Collected using a socio-demographic questionnaire.
Measured: 24 months
Barriers to implementation of the cultural concordance system
Assessed through thematic content analysis of semi-structured interviews with health workers.
Measured: 24 months
Facilitators to implementation of the cultural concordance system
Assessed through thematic content analysis of semi-structured interviews with health workers.
Measured: 24 months
Development of evidence-based recommendations to improve cultural concordance
Number and content of guidelines produced based on interview data.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start10 Apr 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cultural CompetenceStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristina Pistacchio, PI, Principal investigator, Fondazione Policlinico A. Gemelli IRCCS, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944678
- Sponsor's protocol ID
- Project OHANA - ID 7512
- Acronym
- OHANA
- Status last verified
- Sep 2026
- First submitted
- 4 Apr 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OHANA Project: Optimizing Health Care Through Alignment and Care Across Cultures
- ClinicalTrials.gov ID
- NCT06944678
- Acronym / sponsor ID
- OHANA / Project OHANA - ID 7512
- Conditions
- Cultural Competence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 25 Apr 2025 (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.
Increasing globalisation and international migration have led to greater cultural diversity in Western societies, including healthcare settings. Hospitals and healthcare environments have become meeting places for individuals from different cultural backgrounds.
This diversity presents significant opportunities for improving healthcare, but also introduces complex challenges related to communication, trust and mutual understanding between healthcare professionals and patients. In this context, the concept of culturally competent care, i.e. the ability of healthcare professionals to provide respectful and appropriate care to patients by taking into account their cultural beliefs, values and practices, emerges as a crucial approach to address the specific needs of patients from different cultures. The concept of cultural competence was first introduced by Cross, who defines it as a set of behaviours, attitudes and policies that, when integrated into an organisation or among professionals, enable them to operate effectively in intercultural contexts.
Detailed description
Although there is preliminary evidence on the benefits of cultural concordance, the literature is still scarce and fragmented. In particular, there is a lack of in-depth studies on the subjective experiences of the main actors involved. For healthcare professionals, cultural concordance could be a valuable resource, but also a source of additional stress or pressure, especially if perceived as a task requiring cultural or linguistic competence that is not always adequately supported. For patients, the experience of being cared for by a professional from the same culture might enhance a sense of trust and comfort, but also generate unrealistic expectations or influence perceptions of quality of care. Exploring the lived experiences of healthcare professionals and patients in a context of cultural concordance is essential to understanding perceived benefits, criticisms and areas for improvement. This multicentre study, coordinated by the Gemelli Hospital in Italy in collaboration with several Italian hospitals , aims to explore cultural concordance in a variety of healthcare settings, providing an in-depth understanding of the potentials and criticisms of cultural concordance in hospital settings
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted by enrolling participants who adopt a cultural concordance system.
Key inclusion criteria (2 listed)
- All nurses or caregivers involved in the concordance system cultural will be included, with direct experience in caring for foreign patients
- All foreign patients admitted to hospital who speak a language other than the main language of the host country and who have been involved in the concordance system cultural will be included
Key exclusion criteria (1 listed)
- All patients with severe cognitive conditions that prevent participation and nurses or caregivers who do not work closely with assigned patients will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health workers' perceived utility of the cultural concordance system
Time frame: 12 months
Assessed through thematic content analysis of semi-structured interviews.
Socio-demographic characteristics of health workers
Time frame: 12 months
Collected using a socio-demographic questionnaire.
5 secondary outcomes
Patients' perceptions of the cultural sensitivity of care received
Time frame: 24 months
Socio-demographic characteristics of patients
Time frame: 24 months
Barriers to implementation of the cultural concordance system
Time frame: 24 months
Facilitators to implementation of the cultural concordance system
Time frame: 24 months
Development of evidence-based recommendations to improve cultural concordance
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
Related trials for Cultural Competence
Recruiting
Effect of Cultural Competence Training on Nurses' Cultural Competence Levels and Patients' Perceptions of Culturally Competent Care
Cultural Competence Training in Nursing
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.
Cristina Pistacchio, PI principal investigator
Fondazione Policlinico A. Gemelli IRCCS, Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cultural Competence, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Pistacchio, PI (+393382458373, cristina.pistacchio@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health workers' perceived utility of the cultural concordance system (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.