ReadmissionPPREINGRESOSNCT06604780
Reducing Early Readmission to an Acute Psychiatric Unit
A study testing Transitional discharge program in people with Readmission and Mental Health Disorder, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial summary
Early readmission to psychiatric units poses a significant challenge for both patients with mental health issues and healthcare institutions. It hampers patient progress and prognosis, and the professional approach taken during discharge can greatly influence the recovery process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Readmission, Mental Health Disorder, Hospitalizations Psychiatric
- What is being tested?
- Transitional discharge program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 836 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2023to 30 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All hospital admission episodes at MHHU during the 12 months following the implementation of the Discharge Transition Intervention Program will be considered.
- The experimental group, to which the Discharge Transition Intervention Program will be applied, will consist of users whose Community Mental Health Units (CMHU) are affiliated with the Regional Hospital of Málaga.
- Be of legal age.
- Speak spanish fluently.
- Have had recent admission to the MHHU of the Regional Hospital of Málaga and a score considered as "High Risk" on the Early Rehospitalization Risk Scale or have experienced an early rehospitalization.
- Belong to the Clinical Management Unit of Mental Health of the RUH of Málaga.
- Have sufficient cognitive capacity to understand the rules and contents of the group intervention.
Who cannot join
- Users belonging to other hospitals in the province will be excluded from the intervention program and will form part of the control group.
- Post-Discharge Group Psychotherapy Support Recovery has its own eligibility criteria:
- Individuals whose primary diagnosis is a Mental and Behavioral Disorder due to psychoactive substance use.
- Moderate or severe intellectual disability.
- Clinical Management Unit belonging to a hospital other than the RUH of Málaga.
- Lack of commitment to attending sessions or complying with group rules.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Vera Carbonell Aranda
Málaga, 29009
Vera Carbonell Aranda, 695992369, vera.caar@hotmail.com
José Guzmán Parra, Doctor, 951290307, jose.guzman.parra.sspa@juntadeandalucia.es
About this study
Official title: Implementation and Evaluation of a Transition to Discharge Program for the Reduction of Early Readmission in a Mental Health Inpatient Unit
Early readmission to psychiatric units poses a significant challenge for both patients with mental health issues and healthcare institutions. It hampers patient progress and prognosis, and the professional approach taken during discharge can greatly influence the recovery process. This paper proposes a multicomponent discharge transition intervention to mitigate the risk of early readmission to a Mental Health Hospitalization Unit (MHHU).
The intervention entails developing a measurement scale to assess patients' risk of early readmission, allowing for stratification into high, medium, and low-risk categories. Tailored intervention strategies will focus on ensuring adherence and continuity of care post-discharge, with a more comprehensive approach for high-risk patients. Additionally, a post-discharge psychotherapeutic group will be incorporated for high-risk cases to support recovery. The efficacy of the program will be analyzed by comparing the overall early readmission risk at the Regional Hospital of Malaga's MHHU with the previous year, using admission episodes from two other hospitals in the province as a control group where the intervention program is not implemented. The success of the post-discharge group psychotherapeutic intervention will be evaluated through pre-post assessments of recovery measures, functionality, subjective well-being, social support, and treatment satisfaction.
This proposal aims to address the issue of early readmission to psychiatric units by enhancing predictability and understanding of intervention strategies to reduce readmission rates.
Read the detailed description
The aim of this study is, firstly, to create a tool for assessing the risk of early readmission that allows for stratification of admitted patients according to their risk level, based on the analysis of clinical and sociodemographic variables. The second objective is to implement an intervention program tailored to each risk level, involving coordination among all involved mental health units and a specific intensive program for patients at higher risk.
The present study is a quasi-experimental cluster clinical trial aimed at assessing the efficacy of a multicomponent discharge transition program for the reduction of early readmissions in a MHHU. The development of this study consists of two distinct parts or elements:
To carry out the main objective, a quasi-experimental design with a control group will be used, and within the intervention, an early readmission risk assessment scale will be created to categorize patients into different risk levels.
In addition, a study will be conducted to assess the predictive value and validity of the early readmission risk rating scale and to study the risk factors for early readmission.
- Being tested
- Transitional discharge program
- Keywords
- early readmission, discharge interventions, psychyatric unit, continuity of care, psychotherapy group, recovery
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitional discharge programBehavioural
For patients classified in the low-risk group, general measures would be applied. For patients in the medium-risk group, reinforced measures would be implemented. Lastly, for patients considered to be in the high-risk group, intensive case management measures would be applied, and if they meet the inclusion criteria, they would be included in the Post-Discharge Group Psychotherapeutic Intervention.
- General measures
- Reinforcement measures
- Intensive measures
- Intensive case management measures
- Post-Discharge Psychotherapeutic Recovery Support Program: For application to patients at high risk of early readmission who meet the inclusion criteria. It consists of a multicomponent group psychotherapeutic intervention from a rehabilitative and recovery-oriented perspective. This intervention will be structured into 20 sessions, each lasting 90 minutes, held weekly in an open format.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention program is based on the Discharge Transition Model for the prevention of hospital readmission in Mental Health. This is a multicomponent program that initially involves the development of a scale to assess the risk of readmission for each patient, followed by its systematic application. This allows for stratification of patients according to their risk of early readmission and adaptation of the intervention to the needs of each risk level. The intervention includes elements aimed at promoting continuity of care after discharge, transitioning back to the community setting, as well as elements aimed at enhancing personal and emotional resources through psychotherapeutic approaches. Receives: Behavioral: Transitional discharge program |
| Control group I | No intervention | To assess the effectiveness of the Multicomponent Discharge Transition Program, users from Málaga East Axarquía Hospital and North Málaga Health Management Area will be employed as the control group. Participants in the control group will continue with their usual treatment. |
| Control group II | No intervention | Additionally, users from the Mental Health Management Unit of Regional Hospital of Málaga who were admitted the previous year and thus did not participate in the intervention program will also be used as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early readmission rate
Changes in the percentage of early readmissions over the total number of recorded admission episodes, considering early readmission as any admission episode that occurs within 30 days after hospital discharge.
Measured: Data will be collected over the 12 months following the implementation of the intervention program.
Secondary outcomes (5)
Recovery
Changes in measures of recovery, will be assessed through pre-post administration of the QPR-15-SP questionnaire.
Measured: Five months between pre and post evaluation
Functionality
Changes in measures of functionality, will be assessed through pre-post administration of the PSP questionnaire.
Measured: Five months between pre and post evaluation
Subjective well-being
Changes in measures of subjective well-being, will be assessed through pre-post administration of the Core-Om questionnaire.
Measured: Five months between pre and post evaluation
Satisfaction with treatment
Changes in measures of satisfaction with treatment, will be assessed through pre-post administration of the CAT questionnaire.
Measured: Five months between pre and post evaluation
Perceived social support
Changes in Perceived social support will be assessed through pre-post administration of the DUKE-UNK questionnaire.
Measured: Five months between pre and post evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start1 Jan 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for ReadmissionStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 836 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vera Carbonell Aranda, Bachelor, Principal investigator, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604780
- Sponsor's protocol ID
- PPREINGRESOTEMP
- Acronym
- PPREINGRESOS
- Status last verified
- Apr 2024
- First submitted
- 14 Aug 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tyler N, Wright N, Waring J. Interventions to improve discharge from acute adult mental health inpatient care to the community: systematic review and narrative synthesis. BMC Health Serv Res. 2019 Nov 25;19(1):883. doi: 10.1186/s12913-019-4658-0.
PubMed 31760955Donisi V, Tedeschi F, Salazzari D, Amaddeo F. Pre- and post-discharge factors influencing early readmission to acute psychiatric wards: implications for quality-of-care indicators in psychiatry. Gen Hosp Psychiatry. 2016 Mar-Apr;39:53-8. doi: 10.1016/j.genhosppsych.2015.10.009. Epub 2015 Nov 1.
PubMed 26804775Wobrock T, Weinmann S, Falkai P, Gaebel W. Quality assurance in psychiatry: quality indicators and guideline implementation. Eur Arch Psychiatry Clin Neurosci. 2009 Nov;259 Suppl 2(Suppl 2):S219-26. doi: 10.1007/s00406-009-0072-7.
PubMed 19876682Vigod SN, Kurdyak PA, Seitz D, Herrmann N, Fung K, Lin E, Perlman C, Taylor VH, Rochon PA, Gruneir A. READMIT: a clinical risk index to predict 30-day readmission after discharge from acute psychiatric units. J Psychiatr Res. 2015 Feb;61:205-13. doi: 10.1016/j.jpsychires.2014.12.003. Epub 2014 Dec 13.
PubMed 25537450Vigod SN, Kurdyak PA, Dennis CL, Leszcz T, Taylor VH, Blumberger DM, Seitz DP. Transitional interventions to reduce early psychiatric readmissions in adults: systematic review. Br J Psychiatry. 2013 Mar;202(3):187-94. doi: 10.1192/bjp.bp.112.115030.
PubMed 23457182Owusu E, Oluwasina F, Nkire N, Lawal MA, Agyapong VIO. Readmission of Patients to Acute Psychiatric Hospitals: Influential Factors and Interventions to Reduce Psychiatric Readmission Rates. Healthcare (Basel). 2022 Sep 19;10(9):1808. doi: 10.3390/healthcare10091808.
PubMed 36141418Hegedus A, Kozel B, Richter D, Behrens J. Effectiveness of Transitional Interventions in Improving Patient Outcomes and Service Use After Discharge From Psychiatric Inpatient Care: A Systematic Review and Meta-Analysis. Front Psychiatry. 2020 Jan 21;10:969. doi: 10.3389/fpsyt.2019.00969. eCollection 2019.
PubMed 32038320García-Herrera Pérez-Bryan JM, Hurtado Lara MM, Quemada González C, Nogueras Morillas EV, Bordallo Aragón A, Martí García C, et al. Guía de Práctica Clínica para el Tratamiento de la Psicosis y la Esquizofrenia. Manejo en Atención Primaria y en Salud Mental. [Internet]. Plan Integral de Salud Mental. Servicio Andaluz de Salud, editor. 2019 [cited 2024 Jan 29]. Available from: https://www.sspa.juntadeandalucia.es/servicioandaluzdesalud/sites/default/files/sincfiles/wsas-media-pdf_publicacion/2020/1gpc_psicosis_completa.pdf
Ministerio de Ciencia e Innovación. Guía de Práctica Clínica de intervenciones psicosociales en el trastorno mental grave [Internet]. 2009 [cited 2024 Jan 29]. Available from: https://portal.guiasalud.es/wp-content/uploads/2018/12/GPC_453_TMG_ICS_compl.pdf
Lam M, Li L, Anderson KK, Shariff SZ, Forchuk C. Evaluation of the transitional discharge model on use of psychiatric health services: An interrupted time series analysis. J Psychiatr Ment Health Nurs. 2020 Apr;27(2):172-184. doi: 10.1111/jpm.12562. Epub 2019 Sep 29.
PubMed 31529589Chris Evans JMCFMMBKAJCGM. CORE: Clinical Outcomes in Routine Evaluation. http://dx.doi.org/101080/jmh93247255. 2009 Jan;9(3):247-55.
Feixas i Viaplana G, Evans C, Trujillo A, Saúl Gutiérrez LÁ, Botella L, Corbella S, et al. La versión española del CORE-OM: Clinical Outcomes in Routine Evaluation - Outcome Measure. Revista de Psicoterapia. 2012;23(89):109-35.
Bellon Saameno JA, Delgado Sanchez A, Luna del Castillo JD, Lardelli Claret P. [Validity and reliability of the Duke-UNC-11 questionnaire of functional social support]. Aten Primaria. 1996 Sep 15;18(4):153-6, 158-63. Spanish.
PubMed 8962994Broadhead WE, Gehlbach SH, de Gruy FV, Kaplan BH. The Duke-UNC Functional Social Support Questionnaire. Measurement of social support in family medicine patients. Med Care. 1988 Jul;26(7):709-23. doi: 10.1097/00005650-198807000-00006.
PubMed 3393031Morosini PL, Magliano L, Brambilla L, Ugolini S, Pioli R. Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. Acta Psychiatr Scand. 2000 Apr;101(4):323-9.
PubMed 10782554
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of a Transition to Discharge Program for the Reduction of Early Readmission in a Mental Health Inpatient Unit
- ClinicalTrials.gov ID
- NCT06604780
- Acronym / sponsor ID
- PPREINGRESOS / PPREINGRESOTEMP
- Keywords
- early readmission, discharge interventions, psychyatric unit, continuity of care, psychotherapy group, recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 836 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 20 Sep 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.
Early readmission to psychiatric units poses a significant challenge for both patients with mental health issues and healthcare institutions. It hampers patient progress and prognosis, and the professional approach taken during discharge can greatly influence the recovery process. This paper proposes a multicomponent discharge transition intervention to mitigate the risk of early readmission to a Mental Health Hospitalization Unit (MHHU).
The intervention entails developing a measurement scale to assess patients' risk of early readmission, allowing for stratification into high, medium, and low-risk categories. Tailored intervention strategies will focus on ensuring adherence and continuity of care post-discharge, with a more comprehensive approach for high-risk patients. Additionally, a post-discharge psychotherapeutic group will be incorporated for high-risk cases to support recovery. The efficacy of the program will be analyzed by comparing the overall early readmission risk at the Regional Hospital of Malaga's MHHU with the previous year, using admission episodes from two other hospitals in the province as a control group where the intervention program is not implemented. The success of the post-discharge group psychotherapeutic intervention will be evaluated through pre-post assessments of recovery measures, functionality, subjective well-being, social support, and treatment satisfaction.
This proposal aims to address the issue of early readmission to psychiatric units by enhancing predictability and understanding of intervention strategies to reduce readmission rates.
Detailed description
The aim of this study is, firstly, to create a tool for assessing the risk of early readmission that allows for stratification of admitted patients according to their risk level, based on the analysis of clinical and sociodemographic variables. The second objective is to implement an intervention program tailored to each risk level, involving coordination among all involved mental health units and a specific intensive program for patients at higher risk.
The present study is a quasi-experimental cluster clinical trial aimed at assessing the efficacy of a multicomponent discharge transition program for the reduction of early readmissions in a MHHU. The development of this study consists of two distinct parts or elements:
To carry out the main objective, a quasi-experimental design with a control group will be used, and within the intervention, an early readmission risk assessment scale will be created to categorize patients into different risk levels.
In addition, a study will be conducted to assess the predictive value and validity of the early readmission risk rating scale and to study the risk factors for early readmission.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Transitional discharge programThe intervention program is based on the Discharge Transition Model for the prevention of hospital readmission in Mental Health. This is a multicomponent program that initially involves the development of a scale to assess the risk of readmission for each patient, followed by its systematic application. This allows for stratification of patients according to their risk of early readmission and adaptation of the intervention to the needs of each risk level. The intervention includes elements aimed at promoting continuity of care after discharge, transitioning back to the community setting, as well as elements aimed at enhancing personal and emotional resources through psychotherapeutic approaches. |
| Control group I | No intervention | –To assess the effectiveness of the Multicomponent Discharge Transition Program, users from Málaga East Axarquía Hospital and North Málaga Health Management Area will be employed as the control group. Participants in the control group will continue with their usual treatment. |
| Control group II | No intervention | –Additionally, users from the Mental Health Management Unit of Regional Hospital of Málaga who were admitted the previous year and thus did not participate in the intervention program will also be used as a control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All hospital admission episodes at MHHU during the 12 months following the implementation of the Discharge Transition Intervention Program will be considered.
- The experimental group, to which the Discharge Transition Intervention Program will be applied, will consist of users whose Community Mental Health Units (CMHU) are affiliated with the Regional Hospital of Málaga.
- Be of legal age.
- Speak spanish fluently.
- Have had recent admission to the MHHU of the Regional Hospital of Málaga and a score considered as "High Risk" on the Early Rehospitalization Risk Scale or have experienced an early rehospitalization.
Key exclusion criteria (6 listed)
- Users belonging to other hospitals in the province will be excluded from the intervention program and will form part of the control group.
- Individuals whose primary diagnosis is a Mental and Behavioral Disorder due to psychoactive substance use.
- Moderate or severe intellectual disability.
- Clinical Management Unit belonging to a hospital other than the RUH of Málaga.
- Lack of commitment to attending sessions or complying with group rules.
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 |
|---|---|---|
| Transitional discharge programFor patients classified in the low-risk group, general measures would be applied. For patients in the medium-risk group, reinforced measures would be implemented. Lastly, for patients considered to be in the high-risk group, intensive case management measures would be applied, and if they meet the inclusion criteria, they would be included in the Post-Discharge Group Psychotherapeutic Intervention. 1. General measures 2. Reinforcement measures 3. Intensive measures * Intensive case management measures * Post-Discharge Psychotherapeutic Recovery Support Program: For application to patients at high risk of early readmission who meet the inclusion criteria. It consists of a multicomponent group psychotherapeutic intervention from a rehabilitative and recovery-oriented perspective. This intervention will be structured into 20 sessions, each lasting 90 minutes, held weekly in an open format. | Behavioural | Intervention group |
Primary outcome
Early readmission rate
Time frame: Data will be collected over the 12 months following the implementation of the intervention program.
Changes in the percentage of early readmissions over the total number of recorded admission episodes, considering early readmission as any admission episode that occurs within 30 days after hospital discharge.
5 secondary outcomes
Recovery
Time frame: Five months between pre and post evaluation
Functionality
Time frame: Five months between pre and post evaluation
Subjective well-being
Time frame: Five months between pre and post evaluation
Satisfaction with treatment
Time frame: Five months between pre and post evaluation
Perceived social support
Time frame: Five months between pre and post evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Background: PubMed 31760955Tyler N, Wright N, Waring J. Interventions to improve discharge from acute adult mental health inpatient care to the community: systematic review and narrative synthesis. BMC Health Serv Res. 2019 Nov 25;19(1):883. doi: 10.1186/s12913-019-4658-0.
- Background: PubMed 26804775Donisi V, Tedeschi F, Salazzari D, Amaddeo F. Pre- and post-discharge factors influencing early readmission to acute psychiatric wards: implications for quality-of-care indicators in psychiatry. Gen Hosp Psychiatry. 2016 Mar-Apr;39:53-8. doi: 10.1016/j.genhosppsych.2015.10.009. Epub 2015 Nov 1.
- Background: PubMed 19876682Wobrock T, Weinmann S, Falkai P, Gaebel W. Quality assurance in psychiatry: quality indicators and guideline implementation. Eur Arch Psychiatry Clin Neurosci. 2009 Nov;259 Suppl 2(Suppl 2):S219-26. doi: 10.1007/s00406-009-0072-7.
- Background: PubMed 25537450Vigod SN, Kurdyak PA, Seitz D, Herrmann N, Fung K, Lin E, Perlman C, Taylor VH, Rochon PA, Gruneir A. READMIT: a clinical risk index to predict 30-day readmission after discharge from acute psychiatric units. J Psychiatr Res. 2015 Feb;61:205-13. doi: 10.1016/j.jpsychires.2014.12.003. Epub 2014 Dec 13.
- Background: PubMed 23457182Vigod SN, Kurdyak PA, Dennis CL, Leszcz T, Taylor VH, Blumberger DM, Seitz DP. Transitional interventions to reduce early psychiatric readmissions in adults: systematic review. Br J Psychiatry. 2013 Mar;202(3):187-94. doi: 10.1192/bjp.bp.112.115030.
- Background: PubMed 36141418Owusu E, Oluwasina F, Nkire N, Lawal MA, Agyapong VIO. Readmission of Patients to Acute Psychiatric Hospitals: Influential Factors and Interventions to Reduce Psychiatric Readmission Rates. Healthcare (Basel). 2022 Sep 19;10(9):1808. doi: 10.3390/healthcare10091808.
- Background: PubMed 32038320Hegedus A, Kozel B, Richter D, Behrens J. Effectiveness of Transitional Interventions in Improving Patient Outcomes and Service Use After Discharge From Psychiatric Inpatient Care: A Systematic Review and Meta-Analysis. Front Psychiatry. 2020 Jan 21;10:969. doi: 10.3389/fpsyt.2019.00969. eCollection 2019.
- BackgroundGarcía-Herrera Pérez-Bryan JM, Hurtado Lara MM, Quemada González C, Nogueras Morillas EV, Bordallo Aragón A, Martí García C, et al. Guía de Práctica Clínica para el Tratamiento de la Psicosis y la Esquizofrenia. Manejo en Atención Primaria y en Salud Mental. [Internet]. Plan Integral de Salud Mental. Servicio Andaluz de Salud, editor. 2019 [cited 2024 Jan 29]. Available from: https://www.sspa.juntadeandalucia.es/servicioandaluzdesalud/sites/default/files/sincfiles/wsas-media-pdf_publicacion/2020/1gpc_psicosis_completa.pdf
- BackgroundMinisterio de Ciencia e Innovación. Guía de Práctica Clínica de intervenciones psicosociales en el trastorno mental grave [Internet]. 2009 [cited 2024 Jan 29]. Available from: https://portal.guiasalud.es/wp-content/uploads/2018/12/GPC_453_TMG_ICS_compl.pdf
- Background: PubMed 31529589Lam M, Li L, Anderson KK, Shariff SZ, Forchuk C. Evaluation of the transitional discharge model on use of psychiatric health services: An interrupted time series analysis. J Psychiatr Ment Health Nurs. 2020 Apr;27(2):172-184. doi: 10.1111/jpm.12562. Epub 2019 Sep 29.
- BackgroundChris Evans JMCFMMBKAJCGM. CORE: Clinical Outcomes in Routine Evaluation. http://dx.doi.org/101080/jmh93247255. 2009 Jan;9(3):247-55.
- BackgroundFeixas i Viaplana G, Evans C, Trujillo A, Saúl Gutiérrez LÁ, Botella L, Corbella S, et al. La versión española del CORE-OM: Clinical Outcomes in Routine Evaluation - Outcome Measure. Revista de Psicoterapia. 2012;23(89):109-35.
- Individual participant dataSharing planned: No
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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.
Vera Carbonell Aranda, Bachelor principal investigator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitional discharge program in people with Readmission and Mental Health Disorder, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vera Carbonell Aranda, Bachelor (695992369, vera.caar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early readmission rate (time frame: Data will be collected over the 12 months following the implementation of the intervention program.). 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 NCT06604780, which also lists 24 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 20 Sep 2024.