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临床试验/NCT07506096
NCT07506096尚未招募不适用

Using IF-THEN Plans to Support Healthcare Professionals in Raising and Responding to Patient Safety Concerns.

University of Manchester0 个研究点目标入组 1,000 人开始时间: 2026年5月31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
入组人数
1,000
主要终点
Raising safety concerns

研究概览

简要总结

This study aims to test whether a brief behavioural intervention can help healthcare professionals raise and respond to patient safety concerns in their work. Healthcare professionals are often encouraged to speak up about safety risks, but barriers such as time pressure, uncertainty, and workplace culture can make this difficult.

Participants will complete an online questionnaire about their experiences of patient safety risks and how often they raise concerns. They will then be randomly assigned to one of two groups. One group will complete a short planning exercise ("if-then" plans) designed to help them act when they notice safety concerns, while the other group will not receive this exercise. Participants will be invited to complete follow-up questionnaires at approximately one month and six months to assess how often they have raised or responded to safety concerns since taking part.

详细描述

Background and study aims

Previous research has shown that while healthcare professionals are encouraged to raise and act on patient safety concerns, barriers such as time pressures, uncertainty, hierarchical dynamics, and concerns about negative consequences can limit whether concerns are raised or acted upon. These barriers may reduce opportunities to identify and address safety risks in clinical practice.

This study therefore aims to test whether a brief, theory-based intervention based on implementation intentions (Gollwitzer, 1993) can increase healthcare professionals' confidence and likelihood of raising and responding to patient safety concerns.

Implementation intentions, or "if-then" plans, are a well-established method for changing behaviour. They work by helping individuals identify critical situations ("if") and link them to specific responses ("then"), thereby automating helpful behaviours and overcoming barriers. This approach has been shown to be effective across a range of health and professional behaviours.

This study will examine whether forming "if-then" plans can help healthcare professionals overcome barriers to raising and responding to patient safety concerns. The intervention will be delivered via an online questionnaire, with follow-up assessments to examine changes in behaviour over time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Aged 18 years and over
  • Currently working as a healthcare professional in a health or social care setting
  • Good understanding of written and spoken English

排除标准

  • Aged under 18 years
  • Not currently working as a healthcare professional in a health or social care setting
  • Poor understanding of written and spoken English

研究组 & 干预措施

Intervention (volitional help sheet)

Experimental

Participants in this group will complete a brief behavioural planning exercise designed to support raising and responding to patient safety concerns. They will be asked to form implementation intentions ("if-then" plans) by linking situations in which they might notice or feel concerned about a potential safety issue with specific actions they could take in response.

Participants will be presented with a stem (e.g. "If I notice or feel concerned about a potential safety issue…") and a set of predefined response options, and will select and combine these to form one or more "if-then" plans using a structured online interface.

干预措施: Implementation intention planning (Behavioral)

Control

No Intervention

Participants in this group will complete the same baseline questionnaire as the intervention group, including questions about their professional background, experiences of patient safety risks or incidents, and attitudes toward raising and responding to concerns. They will not receive the planning exercise ("if-then" intervention).

结局指标

主要结局

Raising safety concerns

时间窗: 1 month, 6 months.

Self-reported frequency of raising and responding to patient safety concerns at 1-month and 6-month follow-up.

次要结局

  • Capability, opportunity and motivation (based on the COM-B model) measured at baseline, 1-month, and 6-month follow-up.(1 month, 6 months.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Chris Keyworth

Associate Professor

University of Manchester

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