Feasibility of a Digital Intervention for Patients Frequently Admitted to Psychiatric Acute Wards

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaukeland University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Muli-app

    Behavioral

    The Muli-app is designed after a traffic-light model, indicating different levels of severity of emotional distress and need for help. Green parts represent self-management measures that can be taken to try to regulate themselves (coping plan, write notes for their next appointment , and exercises to reduce emotional distress.) Yellow parts represent contact-based measures when the patient needs someone to talk to outside office hours, to de-escalate emotional distress and to avoid further crisis. This function connects study participants with mental health professionals at the local psychiatric hospital outside office hours (chat, phone or videocall). When the patient activates this function, the staff at the local hospital have 30 minutes to reply. The red part also activates contact with the local psychiatric hospital, but with a need of acute response, activating acute measures stated in the coping plan, such as access to an open bed in the municipality.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Muli-appOther 1 intervention

Trial outcomes

Primary outcomes

1

Acceptability of the digital mental health intervention for patients

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?

Time frame
From enrollment to the end of trial phase, 3 months.
2

Acceptability of the digital mental health intervention for healthcare providers

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?

Time frame
From enrollment to end of trial phase, 3 months
3

Perceived usefulness of the digital mental health intervention for patients

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?

Time frame
From enrollment to the end of trial phase, 3 months.
4

Perceived usefulness of the intervention for healthcare providers

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?

Time frame
From enrollment to the end of trial phase, 3 months.

Secondary outcomes

1

Number of contacts with health services

Number of readmissions and/or contacts with emergency services during the feasibility trial phase. Data source: interviews with patients.

Time frame
From enrollment to the end of trial, 3 months
2

Implementation feasibility of the digital intervention

Implementation feasibility is understood as the extent to which the digital intervnetion can be practically and successfully delivered in a real-world setting, considering technical, organizational, and contextual factors. Focus: Technical, organizational and contextual factors affecting the delivery and use of the app. Data Source: focus group interviews with healthcare workers (implementation staff) Research Questions: * What barriers or facilitators affect the implementation of the app? * Are there technical, organizational, or contextual challenges? * What adaptations are needed for successful implementation?

Time frame
From enrollment to the end of trial phase, 3 months.
3

Fidelity to protocol

Fidelity to protocol is understood as the degree to which the digital intervention is delivered and used as originally intended, according to the planned procedures, content, and timing. Focus: Whether the app is used as intended and what deviations occur. Data Source: Interviews (with patients) and focus-group interviews (with health care providers), and app-usage logs Research Questions: * Do users follow the intended use of the app? * What factors lead to deviations from the protocol? * How do these deviations affect the perceived value of the app?

Time frame
From enrollment to the end of trial phase, 3 months

Other outcomes

1

Exploration of unintended negative effects

Qualitative assessment of any adverse or unintended effects reported by participants during interviews or focus groups. Unintended effects could be: emotional distress, increased dependence or avoidance, misinterpretation or misuse, privacy and trust concerns. These will be monitored on a weekly basis through the Muli-service (treatment team).

Time frame
From enrollment to end of trial phase, 3 months

Sponsors and contacts

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Haukeland University Hospital

Lead sponsor

Western Norway University of Applied Sciences

Collaborator

This trial is not recruiting at the moment. You can still explore other options: