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

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

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