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临床试验/NCT06476483
NCT06476483已完成不适用

Implementing the DIALOG Outcome Measure and a Solution-Focused Intervention (DIALOG+) in a Rehabilitation Psychiatric Inpatient Setting: A Mixed Methods Feasibility Study

University of Sheffield1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年10月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Feasibility outcomes- Reasons for drop out

研究概览

简要总结

This study aims to understand if implementing DIALOG+ in an inpatient psychiatric rehabilitation setting is feasible (can the intervention be implemented) and acceptable (how the intervention is perceived by staff and patient participants). If the intervention is proven to be feasible and acceptable a larger-scale study may take place. This study has been developed in response to the trust-wide implementation of DIALOG outcome measures. DIALOG+ offers additional solution-focused and person-centred follow-up questions to the DIALOG questions and links to multidisciplinary team (MDT) discussions. It is hoped that the conversations had during DIALOG+ meetings will support positive outcomes, and the learning gathered from this study will drive change and improvement for other people requiring psychiatric rehabilitation inpatient admissions in the future. DIALOG+ has been successfully implemented in community settings in the national health service (NHS) but has not been implemented in psychiatric rehabilitation inpatient settings. This study will aim to recruit patient and staff participants from NHS psychiatric rehabilitation inpatient wards. Patient participants who will be eligible to take part are those who can consent, are between the ages of 18-65, and can complete DIALOG and DIALOG+. To understand the feasibility of the intervention, descriptive statistics will be collected and to understand acceptability focus groups will take place and surveys will be collected. Quantitative data collection will take place over 5 months and will be split into 2 groups. Group one will be a comparison group where participants will act as an extended baseline group and biweekly DIALOG outcomes will be collected. Group 2 will be a Treatment group and participants will receive the DIALOG+ intervention intervention, DIALOG outcomes will be collected biweekly as part of the intervention. Finally, there will be a period to gather qualitative feedback from patient participants using surveys, and from staff participants using focus groups or semi-structured interviews.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18-65
  • Capacity to give informed consent as determined by the MDT and through following informed consent processes.
  • Admitted into the inpatient ward
  • Can complete DIALOG and DIALOG+

排除标准

  • No capacity to consent
  • Insufficient command of the English language

研究组 & 干预措施

DIALOG+

Active Comparator

This is the treatment group. The participants in this group have agreed to participate in DIALOG+ and will receive the intervention biweekly for 10 sessions (5 months). Pre and post-intervention DIALOG scores will be used in the analysis.

干预措施: DIALOG+ (Behavioral)

DIALOG

Other

This is the comparison group, they will complete the DIALOG measure biweekly for 5 months. DIALOG scores pre and post-intervention will be used in the analyses.

干预措施: DIALOG (Behavioral)

结局指标

主要结局

Feasibility outcomes- Reasons for drop out

时间窗: assessed at the end of the study (after 5 months)

Reasons for drop out will be assessed when by asking the participant after drop out.

Feasibility outcome- Number of eligible participants.

时间窗: assessed at the end of the study (after 5 months)

Eligible participants are those who meet the inclusion criteria, reported as a count of participants.

Feasibility outcome- Participation rate

时间窗: assessed at the end of the study (after 5 months)

The proportion of those who consented and agreed to engage in DIALOG and DIALOG+ out of the number of participants who engaged in the intervention after consenting. Reported as a percentage of participants.

Feasibility outcome- Recruitment rate/consent rate

时间窗: assessed at the end of the study (after 5 months)

The number of people who agreed and consented to participate in the study out of the total number of eligible participants approached. Reported as a percentage.

Feasibility outcome- Completion rate

时间窗: assessed at the end of the study (after 5 months)

The proportion of those who completed the intervention out of the number who consented and engaged in DIALOG and DIALOG+. Reported as a percentage of participants.

Feasibility outcome- Drop out rate

时间窗: assessed at the end of the study (after 5 months)

The number of participants who completed the intervention out of total number of patients enrolled. Reported as a percentage of participants.

Feasibility outcome- The willingness of clinicians to recruit participants

时间窗: assessed at the end of the study (after 5 months)

Number of staff members who attend DIALOG+ training and implement intervention out of the total number of staff offered to participate. Reported as a percentage.

Acceptability outcome- Cost

时间窗: assessed at the end of the study (after 5 months)

Analysing the cost and benefits of implementing the intervention (including staff training). Reported as a total amount or duration of time spent on training (minutes).

Number of staff participants who find DIALOG and DIALOG+ feasible and acceptable to implement in an inpatient rehabilitation setting. Assessed using thematic analysis of focus groups.

时间窗: assessed at the end of the study (after 5 months)

To assess the acceptability of the intervention a theoretical framework (Sekhon et al., 2017) was used. Feasibility objectives are defined by Bugge et al., 2013. Focus group transcripts will be subject to a qualitative thematic analysis. Analysis of focus groups will involve coding, organising coding into themes, reviewing themes, and generating a final thematic overview with in relation to the research question (Braun \& Clarke, 2006).

Feasibility outcome- Average number of DIALOG+ sessions

时间窗: assessed at the end of the study (5 months)

Reported as the average number of participants.

Feasibility outcomes- Follow up rate

时间窗: assessed at the end of the study (after 5 months)

The number of patients willing to engage in follow-up surveys related to the study out of the total number of participants enrolled in the study. Reported as a percentage of participants.

Number of patients who find it feasible and acceptable to implement DIALOG and DIALOG+ in an inpatient rehabilitation setting. Assessed using thematic analysis and average scores of patient surveys.

时间窗: assessed at the end of the study (after 5 months)

The questionnaires will be a mixture of open ended questions and Likert Scale questions based on questions asked by Matanov et al. (2021), 8 of the questions are scored on a Likert scale (1-5). The survey will be given to patients post-intervention. Questions on the scale have been specifically developed to assess feasibility and acceptability of DIALOG+. An average total score will be used in the analysis of Likert scale questions. Open-ended questionnaire responses will be subject to a qualitative thematic analysis. Analysis will involve coding, organising coding into themes, reviewing themes, and generating a final thematic overview in relation to the research question (Braun \& Clarke, 2006).

次要结局

  • DIALOG questionnaire(At the beginning of the study, then biweekly for a duration of 5 months with the final measure taken after 5 months)
  • Length of admission in months(assessed at the end of the study (5 months))
  • Demographic information(assessed at the end of the study (5 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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