跳至主要内容
临床试验/NCT07084090
NCT07084090尚未招募不适用

Using IF-THEN Plans to Support Patients in Raising Safety Concerns About Their Care

University of Manchester0 个研究点目标入组 10,000 人开始时间: 2026年3月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
10,000
主要终点
Raising safety concerns

研究概览

简要总结

The aim of the present research is to test the effectiveness of an implementation intention-based intervention for promoting the raising of safety concerns by patients in healthcare settings.

Each participant will be randomly allocated to one of two conditions: (1) a control condition, and (2) an intervention condition, in which participants form multiple implementation intentions (i.e. "if-then" plans) using a structured online interface. The main outcome measure will be the frequency with which participants report raising safety concerns in healthcare settings over a 12-month follow-up period.

详细描述

Background and study aims Previous research has demonstrated that while patients are often encouraged to raise concerns about the safety of their care, many feel uncertain about how and when to do so. This uncertainty can stem from a lack of confidence, fear of repercussions, or simply not knowing the appropriate channels. This study therefore aims to test whether a brief, theory-based intervention based on implementation intentions (Gollwitzer, 1993) can increase patients' confidence and likelihood of raising safety concerns in healthcare settings.

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 in changing a wide range of behaviours, including smoking cessation, reducing alcohol consumption, increasing physical activity, and reducing self-harm.

This study will examine whether forming "if-then" plans can help patients overcome barriers to raising safety concerns. The intervention will be delivered via an online questionnaire to a representative sample of adults in the United Kingdom, with follow-up after 12 months to assess changes in behaviour.

The aim of the study is to test the effectiveness of an implementation intention-based intervention for promoting the raising of safety concerns by patients in healthcare settings.

Aims To test the effectiveness of an implementation intention-based intervention for promoting the raising of safety concerns by patients in healthcare settings.

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 and over Good verbal and written understanding of English

排除标准

  • Aged under 18 years of age Poor verbal and written understanding of English

研究组 & 干预措施

Intervention (volitional help sheet)

Experimental

Participants in this group will be asked to form implementation intentions-also known as "if-then" plans-specifically related to raising safety concerns. They will be presented with the stem: "If I am tempted not to raise concerns about my health care…" and provided with 10 evidence-based options to complete as many "if-then" plans as they wish. These options have been informed by behavioural science literature and have been shown to be effective in changing behaviours such as smoking cessation, reducing alcohol consumption, increasing physical activity, and reducing self-harm. Participants will link specific situations (the "if") with appropriate responses (the "then") using a structured online interface.

干预措施: Implementation intention planning (Behavioral)

Control

No Intervention

结局指标

主要结局

Raising safety concerns

时间窗: 12 months

Self-reported frequency of raising safety concerns at 12-month follow-up

次要结局

  • Capability, opportunity and motivation (based on COM-B model)(12 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

相似试验

Using IF-THEN Plans to Support Patients in Raising... | 临床试验