Patient Safety ConcernsNCT07506096
Using IF-THEN Plans to Support Healthcare Professionals in Raising Patient Safety Concerns
A study testing Implementation intention planning in people with Patient Safety Concerns, run by University of Manchester.
Trial 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… 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
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 31 May 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 years and over
- Currently working as a healthcare professional in a health or social care setting
- Good understanding of written and spoken English
Who cannot join
- 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
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
Official title: 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.
Read the 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:
- 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").
- 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:
- 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.
- 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.
- 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 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. Receives: 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). |
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 and responding to patient safety concerns at 1-month and 6-month follow-up.
Measured: 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.
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: 1 month, 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start31 May 2026 (estimated)
- Primary completion31 Dec 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
- 1,000 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
- NCT07506096
- Sponsor's protocol ID
- 2026-25455-46333
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gollwitzer, P. M. (1993). Goal achievement: The role of intentions. European review of social psychology, 4(1), 141-185.
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 32314500
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using IF-THEN Plans to Support Healthcare Professionals in Raising and Responding to Patient Safety Concerns.
- ClinicalTrials.gov ID
- NCT07506096
- Acronym / sponsor ID
- 2026-25455-46333
- 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
- 1,000 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- University of Leeds
- Study start
- 31 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Apr 2026 (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.
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.
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:
- 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").
- 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:
- 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.
- 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 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 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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: 1 month, 6 months.
Self-reported frequency of raising and responding to patient safety concerns at 1-month and 6-month follow-up.
1 secondary outcome
Capability, opportunity and motivation (based on the COM-B model) measured at baseline, 1-month, and 6-month follow-up.
Time frame: 1 month, 6 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 23 Apr 2026.
- BackgroundGollwitzer, P. M. (1993). Goal achievement: The role of intentions. European review of social psychology, 4(1), 141-185.
- Background: 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.
- Individual participant dataSharing planned: No
Related trials for Patient Safety Concerns
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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 3 inclusion and 3 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 23 Apr 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 (+44 (0) 161 306 6000, 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: 1 month, 6 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 NCT07506096, 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 23 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.