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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patient Safety Concerns
• Intervention / Treatment: Behavioral: Implementation intention planning

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

Intervention

Participants complete a series of questionnaires about their experiences and attitudes toward patient safety concerns. They are then randomly assigned to one of two conditions:

1. Intervention Group:

   Participants will 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 will link situations ("if") with responses ("then") using a structured online interface.

2. Control Group:

Participants will complete the same baseline questionnaire but will not receive the intervention.

After completing the baseline questionnaire, all participants will be invited to complete follow-up questionnaires at approximately one month and six months. These follow-up questionnaires will assess changes in behaviour and will not include the intervention component.

Intervention type

Behavioural

Primary outcome measure

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

Secondary outcome measures

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

Data analysis plan

Randomisation checks

The investigators will run tests on all outcome and demographic variables to determine if there are any baseline differences in any of these between conditions: chi square will be used for categorical variables and ANOVA for continuous variables.

The effect of the intervention on frequency of raising and responding to patient safety concerns will be tested using a mixed-measures ANCOVA, with condition (intervention vs control) as the between-participants factor and time (baseline, 1-month, and 6-month follow-up) as the within-participants factor.

Planned contrasts will be used to examine between-group differences at 1-month and 6-month follow-up, and changes over time within each condition. Age, gender, professional role, and main work setting will be included as covariates in the analyses.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chris Keyworth; Phone Number: +44 (0) 161 306 6000; Email: c.keyworth@leeds.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (volitional help sheet); 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.	Behavioral: Implementation intention planning; Implementation intention planning to promote patient safety concerns
No Intervention: Control; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Raising safety concerns	Self-reported frequency of raising and responding to patient safety concerns at 1-month and 6-month follow-up.	1 month, 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capability, opportunity and motivation (based on the COM-B model) measured at baseline, 1-month, and 6-month follow-up.	Measured using the Capability, Opportunity, Motivation questionnaire. Each of the items (0-10 scale) will be analysed separately as these each measure a separate construct. Higher scores indicate higher agreement with statements.	1 month, 6 months.

Collaborators and Investigators

• Sponsor: University of Manchester
• Collaborators: University of Leeds

Publications and helpful links

General Publications

• 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.
• Gollwitzer, P. M. (1993). Goal achievement: The role of intentions. European review of social psychology, 4(1), 141-185.

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: randomised controlled trial; patient safety; implementation intentions; behaviour change; safety concerns
• Other Study ID Numbers: 2026-25455-46333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No