Reducing Early Readmission to an Acute Psychiatric Unit (PPREINGRESOS)

September 18, 2024 updated by: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

836

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Málaga, Spain, 29009
        • Recruiting
        • Vera Carbonell Aranda
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jesús Herrera Imbroda, Doctor
        • Principal Investigator:
          • José Guzmán Parra, Doctor
        • Principal Investigator:
          • Vera Carbonell Aranda, Bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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.
Behavioral: Transitional discharge program

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.

  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.
No Intervention: Control group I
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.
No Intervention: Control group II
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Data will be collected over the 12 months following the implementation of the intervention program.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery
Time Frame: Five months between pre and post evaluation
Changes in measures of recovery, will be assessed through pre-post administration of the QPR-15-SP questionnaire.
Five months between pre and post evaluation
Functionality
Time Frame: Five months between pre and post evaluation
Changes in measures of functionality, will be assessed through pre-post administration of the PSP questionnaire.
Five months between pre and post evaluation
Subjective well-being
Time Frame: Five months between pre and post evaluation
Changes in measures of subjective well-being, will be assessed through pre-post administration of the Core-Om questionnaire.
Five months between pre and post evaluation
Satisfaction with treatment
Time Frame: Five months between pre and post evaluation
Changes in measures of satisfaction with treatment, will be assessed through pre-post administration of the CAT questionnaire.
Five months between pre and post evaluation
Perceived social support
Time Frame: Five months between pre and post evaluation
Changes in Perceived social support will be assessed through pre-post administration of the DUKE-UNK questionnaire.
Five months between pre and post evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Investigators

  • Principal Investigator: Vera Carbonell Aranda, Bachelor, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

March 30, 2024

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 20, 2024

Study Record Updates

Last Update Posted (Actual)

September 20, 2024

Last Update Submitted That Met QC Criteria

September 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPREINGRESOTEMP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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