Clinical trial NCT06604780: Reducing Early Readmission to an Acute Psychiatric Unit
Official title: Implementation and Evaluation of a Transition to Discharge Program for the Reduction of Early Readmission in a Mental Health Inpatient Unit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Readmission
Mental Health Disorder
Hospitalizations Psychiatric
Keywords: early readmission
discharge interventions
psychyatric unit
continuity of care
psychotherapy group
recovery
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 836
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

• 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:

Inclusion criteria:

* 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.

Exclusion 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.

Primary outcomes:
measure: Early readmission rate
timeFrame: Data will be collected over the 12 months following the implementation of the intervention program.
Secondary outcomes:
measure: Recovery
timeFrame: Five months between pre and post evaluation
measure: Functionality
timeFrame: Five months between pre and post evaluation
measure: Subjective well-being
timeFrame: Five months between pre and post evaluation
measure: Satisfaction with treatment
timeFrame: Five months between pre and post evaluation
measure: Perceived social support
timeFrame: Five months between pre and post evaluation
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Vera Carbonell Aranda
Study officials:
affiliation: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
name: Vera Carbonell Aranda, Bachelor
role: PRINCIPAL_INVESTIGATOR
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