跳至主要内容
临床试验/NCT06998654
NCT06998654尚未招募不适用

Feasibility of a Digital Intervention for Patients Frequently Admitted to Psychiatric Acute Wards: the MULI App Study

Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年6月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25
试验地点
1
主要终点
Acceptability of the digital mental health intervention for patients

研究概览

简要总结

This qualitative feasibility study investigates a digital health app designed for patients who are frequently admitted to the psychiatric acute ward, to facilitate crisis support outside of office hours to avoid unnecessary readmissions, as well as self-harm. As this is a novel app to be implemented in an already existing service, key uncertainties regarding the intervention content and its delivery needs to be addressed before potentially conducting a full-scale trial, or, alternatively, to inform further intervention refinement. Such uncertainties are appropriate to explore in a feasibility study according to the Medical Research Council (MRC) framework for the development and evaluation of complex interventions.

There is a need to investigate whether the app is acceptable and useful to the patients using it, and to the healthcare providers who respond to it. There is also a need to know whether the healthcare providers responding to the app find the task manageable. The context in which the staff are to deliver the intervention, i.e. the in-bed ward, may be subject to different barriers, such as a staff shortage due to sick leave and heavy workload in the ward. Such barriers are essential to identify ahead of possible future trials in other contexts.

详细描述

The present study is a part of the larger Revolving Door Project, a collaborative service innovation project between a university hospital and two municipalities in Norway. The revolving door project aims to create a more sustainable service to prevent unnecessary hospital readmissions, reducing the strain repeated rehospitalisations can produce and also reducing financial costs. By collecting valuable insights from key stakeholders, critical points in the healthcare services have been identified and outlined in the "emergency loop". This loop illustrates how the current service solution can worsen the revolving door problem by failing to offer timely and adequate help and ultimately risking an escalation of the patient's difficulties. To address these issues, a new healthcare service has been developed to meet the needs of the stakeholders. The service is aimed at individuals who are repeatedly readmitted and discharged from the psychiatric acute ward, who have emotionally unstable traits (not necessarily diagnosis specific), where previously attempted measures have proven insufficient and where there is an insecurity in the help apparatus as to how to help the patient.

The Muli-service The muli-app is a part of a new service, called The Muli-service. This service comprises a collaborative multidisciplinary team (Muli-team), with representatives from municipal mental health services, local psychiatric hospital, psychiatric acute ward, and police. This team coordinates admissions and collaborates with individuals to improve communication and cooperation between services and patients. As such, the Muli-service isn't a new treatment but an intervention meant to complement and enhance existing treatment and mental health provision.

The collaborative part of the service is already established. In addition, the revolving door project has developed the Muli-app, which is the focus of the present feasibility study. A Person-Based Approach has been used to guide the development the app, where stakeholders have been consulted iteratively. The app was created based on stakeholders reported needs, to provide them with an alternative means to seek help outside of office hours, which is a typical time for emergency hospital admissions. The goal is to provide timely and adequate help and thus prevent further escalation of the situation. This aligns with recommendations in the European Psychiatric Association (EPA) guidance on the quality of mental health services.

The Muli-app At the point of download, the app consists of a few predefined sets of emotion regulation exercises and contact information for emergency services. Tailored content (i.e crisis plan and crisis measures) will be written in collaboration between patient and therapist/Muli-contact. Possible crisis measures for each individual patient will be discussed and agreed upon in the Muli-team in advance, ensuring that these measures are in fact feasible. The patient will be presented with the options, and from this the patient and therapist agree upon the most fitting crisis measures to be put into the app. This is communicated back to the Muli-team.

Patients admitted into the Muli-service will be informed of the app through their Muli-contact in the collaborative team and receive an invitation to participate in this study. Study participants who consent to participation will be set up with a user profile in the Muli app and receive a text message from the developers informing them of how to access the app on their own smartphones. The Muli-app will be available to download in app-stores but won't work unless an existing profile is connected to the patient. study participants will receive training from their Muli-contact on how to use the app.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •older than 18 years
  • •reside in one of the study municipalities
  • •admitted into the Muli service
  • •have had at least three admissions into the psychiatric acute ward in the last 12 months
  • •Inclusion criteria, healthcare workers:
  • •staff members at the local psychiatric hospital who respond to patient contacts made through the app

排除标准

  • •staff members at the local psychiatric hospital who rare not tasked with responding to patient contacts made through the app.

研究组 & 干预措施

Muli-app

Other

The feasibility study will be conduced using a concurrent mixed methods design, where quantitative and qualitative data are collected simultaneously.

The trial will be run in two neighbouring municipalities in Norway that are affiliated with the same university hospital. To allow for sufficient time to engage with the intervention, the two trial-phases will be run, each lasting 3 months. For patients, the intervention will be tested in real-life situations, wherever they lead their everyday lives. Qualitative data will be collected through individual interviews in the patients' preferred settings. App-usage data will be collected through the app-platform.

For staff, qualitative data will be collected through focus group interviews at the local psychiatric hospital tasked with responding when patients make contact through the app. Suitable meeting rooms will be provided to ensure privacy.

干预措施: Muli-app (Behavioral)

结局指标

主要结局

Acceptability of the digital mental health intervention for patients

时间窗: From enrollment to the end of trial phase, 3 months.

Acceptability refers to the degree to which patients feel that the digital health service is appropriate, comfortable, and aligned with their needs and values. Focus: How patients perceive the app in terms of relevance, usability, and emotional response. Data Source: Semi-structured interviews. Research Questions: * How do patients experience using the app? * What aspects of the app do they find helpful or frustrating? * Would they be willing to use it again?

Acceptability of the digital mental health intervention for healthcare providers

时间窗: From enrollment to end of trial phase, 3 months

Acceptability refers to the extent to which the digital intervention fits within clinical routines, professional standards, and ethical expectations. Focus: How healthcare workers perceive the app's fit with their workflow, values, and patient care. Data Source: Focus group interviews. Research Questions: * How do healthcare workers experience integrating the app into their practice? * What concerns or benefits do they identify? * Does the app align with their professional judgment and routines?

Perceived usefulness of the digital mental health intervention for patients

时间窗: From enrollment to the end of trial phase, 3 months.

Usefulness is understood as the degree to which the intervention helps users achieve their goals or solve a problem. Focus: Whether the app is seen as beneficial in supporting patient self-management. Data Source: Interviews with patients Research Questions: * In what ways do users feel the app supports their needs and goals? * Are there features they find particularly valuable or lacking?

Perceived usefulness of the intervention for healthcare providers

时间窗: From enrollment to the end of trial phase, 3 months.

Usefulness is understood as the extent to which the digital service contributes to improved care delivery, decision-making, or communication with patients. Focus: Whether the app is seen as beneficial in supporting clinical care. Data Source: Focusgroup interviews. Research Questions: * In what ways do users feel the app supports them in their clinical care? * Are there features they find particularly valuable or lacking?

次要结局

  • Number of contacts with health services(From enrollment to the end of trial, 3 months)
  • Implementation feasibility of the digital intervention(From enrollment to the end of trial phase, 3 months.)
  • Fidelity to protocol(From enrollment to the end of trial phase, 3 months)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mette Senneseth

Researcher

Haukeland University Hospital

研究点 (1)

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