Using IF-THEN Plans to Support Healthcare Professionals in Raising Patient Safety Concerns
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implementation intention planning.
- Who it may be relevant to
- Registry conditions: Patient Safety Concerns. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Using IF-THEN Plans to Support Healthcare Professionals in Raising and Responding to Patient Safety Concerns.
Overview
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.
Detailed description
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.
The aim of the study is to test the effectiveness of an implementation intention-based intervention for promoting safety-related behaviours among healthcare professionals.
Aims
To test the effectiveness of an implementation intention-based intervention for promoting the raising and responding to patient safety concerns among healthcare professionals.
Who can participate?
Healthcare professionals aged 18 and over currently working in health or social care settings, with a good understanding of written and spoken English.
What does the study involve?
Participants will complete an online questionnaire about their professional background, experiences of patient safety risks or incidents, and attitudes toward raising and responding to concerns. They will then be randomly assigned to one of two groups:
1. Intervention Group (Implementation Intention Planning Exercise)
Participants in this group will be asked to form implementation intentions ("if-then" plans) related to raising and responding to patient safety concerns. They will be presented with the stem:
"If I notice or feel concerned about a potential safety issue…" and provided with a set of options to help them link specific situations ("if") with appropriate responses ("then"). 2. Control Group (Passive Control) Participants in the control group will complete the same questionnaire but will not receive the intervention.
After completing the baseline questionnaire, participants will be invited to complete follow-up questionnaires at approximately one month and six months. These follow-up questionnaires will assess how often they have raised or acted on patient safety concerns since baseline.
What are the possible benefits and risks of participating?
Participants may benefit from increased awareness and confidence in raising and responding to patient safety concerns. The study is low risk, and participants can withdraw at any time before data anonymisation. All data will be collected and stored securely and anonymised before analysis.
Where is the study run from?
The University of Manchester (UK)
Who is funding the study?
The NIHR Greater Manchester Patient Safety Research Collaboration (GM PSRC), at The University of Manchester.
Who is the main contact?
Prof Christopher J. Armitage - chris.armitage@manchester.ac.uk Dr Chris Keyworth - c.keyworth@leeds.ac.uk
Scientific title
Using IF-THEN plans to support healthcare professionals in raising and responding to patient safety concerns.
Study hypothesis
Participants who complete a volitional help sheet ("if-then" plans) will report a higher frequency of raising and responding to patient safety concerns at follow-up compared to the control group.
Study design
Two-arm randomised controlled trial with repeated measures (baseline, 1-month, and 6-month follow-up)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial type
Behavioural intervention / Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Improved raising and responding to patient safety concerns in healthcare settings
Interventions
- Behavioral Implementation intention planning
Implementation intention planning to promote patient safety concerns
Primary outcome measures
- Raising safety concerns [Time frame: 1 month, 6 months.]
Secondary outcome measures (1)
- Capability, opportunity and motivation (based on the COM-B model) measured at baseline, 1-month, and 6-month follow-up. [Time frame: 1 month, 6 months.]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Gollwitzer, P. M. (1993). Goal achievement: The role of intentions. European review of social psychology, 4(1), 141-185.
- Keyworth C, Epton T, Goldthorpe J, Calam R, Armitage CJ. Acceptability, reliability, and validity of a brief measure of capabilities, opportunities, and motivations ("COM-B"). Br J Health Psychol. 2020 Sep;25(3):474-501. doi: 10.1111/bjhp.12417. Epub 2020 Apr 20. PMID 32314500
Identifiers
NCT: NCT07506096 · 2026-25455-46333