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

NCT07506096 | Not Yet Recruiting

• 1 other identifier: 2026-25455-46333
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Patient Safety Concerns

Keywords

patient safety; implementation intentions; behaviour change; safety concerns; randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  1 month, 6 months.

Study Arms (2)

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.

Behavioral: Implementation intention planning

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).

Interventions

Implementation intention planning BEHAVIORAL

Implementation intention planning to promote patient safety concerns

Intervention (volitional help sheet)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manchester: lead
• University of Leeds: collaborator

Related Publications (2)

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

  BACKGROUND

• 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 BACKGROUND

Central Study Contacts

Chris Keyworth

CONTACT

+44 (0) 161 306 6000; c.keyworth@leeds.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: May 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share