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

NCT07084090 | Not Yet Recruiting

• 1 other identifier: 2025-22683-41374
• Study Type: interventional
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

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 safety concerns at 12-month follow-up

  12 months

Secondary Outcomes (1)

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

  12 months

Study Arms (2)

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.

Behavioral: Implementation intention planning

Control

NO 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 and over Good verbal and written understanding of English

You may not qualify if:

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

Sponsors & Collaborators

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

Related Publications (2)

• 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 RESULT

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

  RESULT

Central Study Contacts

Chris Keyworth

CONTACT

0; 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: July 16, 2025
• First Posted: July 24, 2025
• Study Start: March 20, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share