Patient Safety ConcernsNCT07084090
Using IF-THEN Plans to Support Patients in Raising Safety Concerns About Their Care
A study testing Implementation intention planning in people with Patient Safety Concerns, run by University of Manchester.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Safety Concerns
- What is being tested?
- Implementation intention planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 and over Good verbal and written understanding of English
Who cannot join
- Aged under 18 years of age Poor verbal and written understanding of English
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
Background and study aims Previous research has demonstrated that while patients are often encouraged to raise concerns about the safety of their care, many feel uncertain about how and when to do so. This uncertainty can stem from a lack of confidence, fear of repercussions, or simply not knowing the appropriate channels. This study therefore aims to test whether a brief, theory-based intervention based on implementation intentions (Gollwitzer, 1993) can increase patients' confidence and likelihood of raising safety concerns in healthcare settings.
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 in changing a wide range of behaviours, including smoking cessation, reducing alcohol consumption, increasing physical activity, and reducing self-harm.
This study will examine whether forming "if-then" plans can help patients overcome barriers to raising safety concerns. The intervention will be delivered via an online questionnaire to a representative sample of adults in the United Kingdom, with follow-up after 12 months to assess changes in behaviour.
The aim of the study is to test the effectiveness of an implementation intention-based intervention for promoting the raising of safety concerns by patients in healthcare settings.
Aims To test the effectiveness of an implementation intention-based intervention for promoting the raising of safety concerns by patients in healthcare settings.
Who can participate? Adults aged 18 and over with good verbal and written understanding of English. Participants will be recruited from YouGov's existing panel of UK residents.
What does the study involve?
Participants will complete an online questionnaire about their experiences and attitudes toward raising safety concerns in healthcare. They will then be randomly assigned to one of two groups:
- Intervention Group (Volitional Help Sheet with Implementation Intentions): 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.
- Control Group (Passive Control):
The (passive) control condition includes the same questionnaire as the experimental group, however participants are not presented with the intervention.
After 12 months, all participants will be invited to complete a follow-up questionnaire assessing how often they have raised safety concerns in healthcare settings.
What are the possible benefits and risks of participating? Participants may benefit by gaining confidence in raising concerns about their care. The study is low risk, and participants can withdraw at any time before data anonymisation. All data will be collected and stored securely by YouGov and anonymised before being shared with the research team.
Where is the study run from? The University of Manchester (United Kingdom) When is the study starting and how long is it expected to run for? July 2025 to May 2026 Who is funding the study? The NIHR Greater Manchester Patient Safety Research Collaboration (Greater Manchester Patient Safety Research Collaboration), 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
- Conditions
- Patient Safety Concerns
- Being tested
- Implementation intention planning
- Keywords
- Patient safety, implementation intentions, behaviour change, safety concerns, randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation intention planningBehavioural
Implementation intention planning to promote patient safety concerns
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Implementation intention planning |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raising safety concerns
Self-reported frequency of raising safety concerns at 12-month follow-up
Measured: 12 months
Secondary outcomes (1)
Capability, opportunity and motivation (based on COM-B model)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start20 Mar 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patient Safety ConcernsStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds
- Responsible party
- Principal investigator, Dr Chris Keyworth, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084090
- Sponsor's protocol ID
- 2025-22683-41374
- Other IDs
- 2025
- Status last verified
- Dec 2025
- First submitted
- 16 Jul 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32314500Gollwitzer, P. M. (1993). Goal achievement: The role of intentions. European review of social psychology, 4(1), 141-185.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using IF-THEN Plans to Support Patients in Raising Safety Concerns About Their Care
- ClinicalTrials.gov ID
- NCT07084090
- Acronym / sponsor ID
- 2025-22683-41374
- Conditions
- Patient Safety Concerns
- Keywords
- Patient safety, implementation intentions, behaviour change, safety concerns, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- University of Leeds
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and study aims Previous research has demonstrated that while patients are often encouraged to raise concerns about the safety of their care, many feel uncertain about how and when to do so. This uncertainty can stem from a lack of confidence, fear of repercussions, or simply not knowing the appropriate channels. This study therefore aims to test whether a brief, theory-based intervention based on implementation intentions (Gollwitzer, 1993) can increase patients' confidence and likelihood of raising safety concerns in healthcare settings.
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 in changing a wide range of behaviours, including smoking cessation, reducing alcohol consumption, increasing physical activity, and reducing self-harm.
This study will examine whether forming "if-then" plans can help patients overcome barriers to raising safety concerns. The intervention will be delivered via an online questionnaire to a representative sample of adults in the United Kingdom, with follow-up after 12 months to assess changes in behaviour.
The aim of the study is to test the effectiveness of an implementation intention-based intervention for promoting the raising of safety concerns by patients in healthcare settings.
Aims To test the effectiveness of an implementation intention-based intervention for promoting the raising of safety concerns by patients in healthcare settings.
Who can participate? Adults aged 18 and over with good verbal and written understanding of English. Participants will be recruited from YouGov's existing panel of UK residents.
What does the study involve?
Participants will complete an online questionnaire about their experiences and attitudes toward raising safety concerns in healthcare. They will then be randomly assigned to one of two groups:
- Intervention Group (Volitional Help Sheet with Implementation Intentions): 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.
- Control Group (Passive Control):
The (passive) control condition includes the same questionnaire as the experimental group, however participants are not presented with the intervention.
After 12 months, all participants will be invited to complete a follow-up questionnaire assessing how often they have raised safety concerns in healthcare settings.
What are the possible benefits and risks of participating? Participants may benefit by gaining confidence in raising concerns about their care. The study is low risk, and participants can withdraw at any time before data anonymisation. All data will be collected and stored securely by YouGov and anonymised before being shared with the research team.
Where is the study run from? The University of Manchester (United Kingdom) When is the study starting and how long is it expected to run for? July 2025 to May 2026 Who is funding the study? The NIHR Greater Manchester Patient Safety Research Collaboration (Greater Manchester Patient Safety Research Collaboration), 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (volitional help sheet) | Experimental | Behavioral: Implementation intention planningParticipants 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. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18 and over Good verbal and written understanding of English
Key exclusion criteria (1 listed)
- Aged under 18 years of age Poor verbal and written understanding of English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation intention planningImplementation intention planning to promote patient safety concerns | Behavioural | Intervention (volitional help sheet) |
Primary outcome
Raising safety concerns
Time frame: 12 months
Self-reported frequency of raising safety concerns at 12-month follow-up
1 secondary outcome
Capability, opportunity and motivation (based on COM-B model)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Results publication: PubMed 32314500Keyworth 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.
- Results publicationGollwitzer, P. M. (1993). Goal achievement: The role of intentions. European review of social psychology, 4(1), 141-185.
- Individual participant dataSharing planned: No
Related trials for Patient Safety Concerns
Not yet recruiting
Using IF-THEN Plans to Support Healthcare Professionals in Raising Patient Safety Concerns
Patient Safety Concerns
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation intention planning in people with Patient Safety Concerns, run by University of Manchester.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris Keyworth (0, c.keyworth@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Raising safety concerns (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07084090, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.