Mental DisordersPAACINCT06879093
Adaptation Plan for Culturally Competent Care (PAACI) in the Acute Psychiatric Unit.
An observational study of Mental Disorders and Cultural Competency, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
This observational study aims to design, implement, and evaluate the Adaptation Plan for Culturally Competent Care (PAACI) in the Acute Psychiatric Unit of Parc de Salut Mar, Barcelona. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders, Cultural Competency, Psychiatric Hospitalization
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2023to 31 Dec 2025
- How long will I take part?
- 12 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: this study focuses on immigrant patients admitted to the acute psychiatric unit at hospital del mar. participants will be individuals aged 18 or older who experience acute mental health crises requiring hospitalization. the study will analyze clinical outcomes before and after the implementation of the paaci program, which aims to improve culturally competent psychiatric care.
Who may be able to join
- immigrant patients admitted to the acute psychiatric unit
- age 18 or older
- hospitalization during the study period (12 months post-paaci implementation)
Who cannot join
- patients with severe cognitive impairment preventing informed consent
- individuals with acute medical conditions requiring transfer to another service
- refusal to participate or withdraw consent
Trial locations and contacts
1 site in 1 country.
About this study
This observational study aims to design, implement, and evaluate the Adaptation Plan for Culturally Competent Care (PAACI) in the Acute Psychiatric Unit of Parc de Salut Mar, Barcelona. The study focuses on improving healthcare quality for immigrant patients by reducing cultural and linguistic barriers in psychiatric care.
The PAACI program includes educational materials in multiple languages, enhanced collaboration with social services, training for healthcare professionals in cultural competence, and the use of interpretation devices. Key outcomes include reducing mechanical restraints, improving patient adherence to treatment, decreasing hospital readmissions, and increasing outpatient care engagement.
The study will analyze data from immigrant patients admitted to the Acute Psychiatric Unit one year before and after the implementation of PAACI, using various clinical and patient satisfaction indicators. This initiative aims to promote equal and equitable healthcare for diverse populations, potentially serving as a model for other mental health units.
Read the detailed description
This study evaluates the implementation of the Adaptation Plan for Culturally Competent Care (PAACI) in an Acute Psychiatric Unit. The project aims to improve psychiatric care for immigrant patients by addressing cultural and linguistic barriers.
The study follows an observational design, comparing key clinical outcomes before and after the PAACI implementation. It includes measures such as staff training in cultural competence, improved coordination with social and healthcare services, and the introduction of multilingual patient education materials.
The primary focus is on enhancing healthcare equity, reducing the use of mechanical restraints, improving patient adherence to outpatient care, and decreasing hospital readmissions. Findings from this study may inform future adaptations of culturally competent care models in psychiatric settings.
- Keywords
- Cultural Competence, Mental Health Equity, Psychiatric Care, Immigrant Health, Acute Psychiatric Unit, Cross-Cultural Psychiatry, Health Disparities
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Immigrant patients in acute psychiatric unit | This cohort includes immigrant patients admitted to the Acute Psychiatric Unit at Parc de Salut Mar. The study will analyze key clinical indicators before and after the implementation of the Adaptation plan for culturally competent care (PAACI) to assess its impact on patient outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in mechanical restraints
this measure evaluates the impact of the paaci program on the total number of mechanical restraints used in immigrant patients admitted to the acute psychiatric unit. data will be compared before and after program implementation.
Measured: 12 months after paaci implementation
Secondary outcomes (4)
Hospital Readmission Rate Among Immigrant Patients
Comparison of the number of readmissions within 30 days post-discharge among immigrant patients before and after PAACI implementation.
Measured: 12 months after paaci implementation
Length of Hospital Stay for Immigrant Patients
Evaluation of the average length of hospitalization for immigrant patients before and after PAACI implementation.
Measured: 12 months after PAACI implementation
Patient adherence to outpatient mental health services
Assessment of the percentage of discharged immigrant patients who attend their first outpatient follow-up appointment after hospitalization.
Measured: 12 months after PAACI implementation
patient and staff satisfaction levels
comparison of patient and staff satisfaction levels with psychiatric care before and after paaci implementation, using validated survey tools.
Measured: 12 months after paaci implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Trabsa, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879093
- Sponsor's protocol ID
- 2021/10025
- Acronym
- PAACI
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to confidentiality considerations and ethical regulations. The study focuses on evaluating a healthcare intervention rather than collecting individualized clinical data for external research purposes. all collected data will be analyzed in aggregate form to ensure participant privacy and compliance with data protection laws.
Publications
Elwell-Sutton TM, Jiang CQ, Zhang WS, Cheng KK, Lam TH, Leung GM, Schooling CM. Inequality and inequity in access to health care and treatment for chronic conditions in China: the Guangzhou Biobank Cohort Study. Health Policy Plan. 2013 Aug;28(5):467-79. doi: 10.1093/heapol/czs077. Epub 2012 Sep 16.
PubMed 22987824Pereira ME, Alvaro Estramiana JL, Schweiger Gallo I. Essentialism and the expression of social stereotypes: a comparative study of Spain, Brasil and England. Span J Psychol. 2010 Nov;13(2):808-17. doi: 10.1017/s1138741600002468.
PubMed 20977029Dein S. ABC of mental health. Mental health in a multiethnic society. BMJ. 1997 Aug 23;315(7106):473-6. doi: 10.1136/bmj.315.7106.473. No abstract available.
PubMed 9284670Bhui K, Warfa N, Edonya P, McKenzie K, Bhugra D. Cultural competence in mental health care: a review of model evaluations. BMC Health Serv Res. 2007 Jan 31;7:15. doi: 10.1186/1472-6963-7-15.
PubMed 17266765Betancourt TS, Newnham EA, Birman D, Lee R, Ellis BH, Layne CM. Comparing Trauma Exposure, Mental Health Needs, and Service Utilization Across Clinical Samples of Refugee, Immigrant, and U.S.-Origin Children. J Trauma Stress. 2017 Jun;30(3):209-218. doi: 10.1002/jts.22186. Epub 2017 Jun 6.
PubMed 28585740
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation Plan for Culturally Competent Care (PAACI) in the Acute Psychiatric Unit.
- ClinicalTrials.gov ID
- NCT06879093
- Acronym / sponsor ID
- PAACI / 2021/10025
- Keywords
- Cultural Competence, Mental Health Equity, Psychiatric Care, Immigrant Health, Acute Psychiatric Unit, Cross-Cultural Psychiatry, Health Disparities
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Mar 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.
This observational study aims to design, implement, and evaluate the Adaptation Plan for Culturally Competent Care (PAACI) in the Acute Psychiatric Unit of Parc de Salut Mar, Barcelona. The study focuses on improving healthcare quality for immigrant patients by reducing cultural and linguistic barriers in psychiatric care.
The PAACI program includes educational materials in multiple languages, enhanced collaboration with social services, training for healthcare professionals in cultural competence, and the use of interpretation devices. Key outcomes include reducing mechanical restraints, improving patient adherence to treatment, decreasing hospital readmissions, and increasing outpatient care engagement.
The study will analyze data from immigrant patients admitted to the Acute Psychiatric Unit one year before and after the implementation of PAACI, using various clinical and patient satisfaction indicators. This initiative aims to promote equal and equitable healthcare for diverse populations, potentially serving as a model for other mental health units.
Detailed description
This study evaluates the implementation of the Adaptation Plan for Culturally Competent Care (PAACI) in an Acute Psychiatric Unit. The project aims to improve psychiatric care for immigrant patients by addressing cultural and linguistic barriers.
The study follows an observational design, comparing key clinical outcomes before and after the PAACI implementation. It includes measures such as staff training in cultural competence, improved coordination with social and healthcare services, and the introduction of multilingual patient education materials.
The primary focus is on enhancing healthcare equity, reducing the use of mechanical restraints, improving patient adherence to outpatient care, and decreasing hospital readmissions. Findings from this study may inform future adaptations of culturally competent care models in psychiatric settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immigrant patients in acute psychiatric unit | – | –This cohort includes immigrant patients admitted to the Acute Psychiatric Unit at Parc de Salut Mar. The study will analyze key clinical indicators before and after the implementation of the Adaptation plan for culturally competent care (PAACI) to assess its impact on patient outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- this study focuses on immigrant patients admitted to the acute psychiatric unit at hospital del mar. participants will be individuals aged 18 or older who experience acute mental health crises requiring hospitalization. the study will analyze clinical outcomes before and after the implementation of the paaci program, which aims to improve culturally competent psychiatric care.
Key inclusion criteria (3 listed)
- immigrant patients admitted to the acute psychiatric unit
- age 18 or older
- hospitalization during the study period (12 months post-paaci implementation)
Key exclusion criteria (3 listed)
- patients with severe cognitive impairment preventing informed consent
- individuals with acute medical conditions requiring transfer to another service
- refusal to participate or withdraw consent
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
reduction in mechanical restraints
Time frame: 12 months after paaci implementation
this measure evaluates the impact of the paaci program on the total number of mechanical restraints used in immigrant patients admitted to the acute psychiatric unit. data will be compared before and after program implementation.
4 secondary outcomes
Hospital Readmission Rate Among Immigrant Patients
Time frame: 12 months after paaci implementation
Length of Hospital Stay for Immigrant Patients
Time frame: 12 months after PAACI implementation
Patient adherence to outpatient mental health services
Time frame: 12 months after PAACI implementation
patient and staff satisfaction levels
Time frame: 12 months after paaci implementation
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 17 Mar 2025.
- Background: PubMed 22987824Elwell-Sutton TM, Jiang CQ, Zhang WS, Cheng KK, Lam TH, Leung GM, Schooling CM. Inequality and inequity in access to health care and treatment for chronic conditions in China: the Guangzhou Biobank Cohort Study. Health Policy Plan. 2013 Aug;28(5):467-79. doi: 10.1093/heapol/czs077. Epub 2012 Sep 16.
- Background: PubMed 20977029Pereira ME, Alvaro Estramiana JL, Schweiger Gallo I. Essentialism and the expression of social stereotypes: a comparative study of Spain, Brasil and England. Span J Psychol. 2010 Nov;13(2):808-17. doi: 10.1017/s1138741600002468.
- Background: PubMed 9284670Dein S. ABC of mental health. Mental health in a multiethnic society. BMJ. 1997 Aug 23;315(7106):473-6. doi: 10.1136/bmj.315.7106.473. No abstract available.
- Background: PubMed 17266765Bhui K, Warfa N, Edonya P, McKenzie K, Bhugra D. Cultural competence in mental health care: a review of model evaluations. BMC Health Serv Res. 2007 Jan 31;7:15. doi: 10.1186/1472-6963-7-15.
- Background: PubMed 28585740Betancourt TS, Newnham EA, Birman D, Lee R, Ellis BH, Layne CM. Comparing Trauma Exposure, Mental Health Needs, and Service Utilization Across Clinical Samples of Refugee, Immigrant, and U.S.-Origin Children. J Trauma Stress. 2017 Jun;30(3):209-218. doi: 10.1002/jts.22186. Epub 2017 Jun 6.
- Individual participant dataSharing planned: No. IPD will not be shared due to confidentiality considerations and ethical regulations. The study focuses on evaluating a healthcare intervention rather than collecting individualized clinical data for external research purposes. all collected data will be analyzed in aggregate form to ensure participant privacy and compliance with data protection laws.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mental Disorders and Cultural Competency, run by Parc de Salut Mar 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2025. 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?
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?
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?
reduction in mechanical restraints (time frame: 12 months after paaci implementation). 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 NCT06879093, which also lists 5 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 17 Mar 2025.