[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631854":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":27,"studyPopulation":17,"armGroups":28,"interventions":39,"overallOfficials":17,"centralContacts":45,"locations":17,"responsibleParty":51,"collaborators":55,"id":58,"slug":17,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":17,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":17,"enrollmentInfo":67,"targetDuration":17,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":82,"whyStopped":17,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":17},{"fullName":5,"class":6},"University of Manchester","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"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.",[14],{"measure":15,"description":16,"timeFrame":12},"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.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":23,"maskingDescription":17,"whoMasked":24},"DOUBLE",[25,26],"PARTICIPANT","INVESTIGATOR","Background and study aims\n\nPrevious 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.\n\nThis 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.\n\nImplementation 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.\n\nThis 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.\n\nThe aim of the study is to test the effectiveness of an implementation intention-based intervention for promoting safety-related behaviours among healthcare professionals.\n\nAims\n\nTo test the effectiveness of an implementation intention-based intervention for promoting the raising and responding to patient safety concerns among healthcare professionals.\n\nWho can participate?\n\nHealthcare professionals aged 18 and over currently working in health or social care settings, with a good understanding of written and spoken English.\n\nWhat does the study involve?\n\nParticipants 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:\n\n1. Intervention Group (Implementation Intention Planning Exercise)\n\n   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:\n\n   \"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\").\n2. Control Group (Passive Control) Participants in the control group will complete the same questionnaire but will not receive the intervention.\n\nAfter 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.\n\nWhat are the possible benefits and risks of participating?\n\nParticipants 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.\n\nWhere is the study run from?\n\nThe University of Manchester (UK)\n\nWho is funding the study?\n\nThe NIHR Greater Manchester Patient Safety Research Collaboration (GM PSRC), at The University of Manchester.\n\nWho is the main contact?\n\nProf Christopher J. Armitage - chris.armitage@manchester.ac.uk Dr Chris Keyworth - c.keyworth@leeds.ac.uk\n\nScientific title\n\nUsing IF-THEN plans to support healthcare professionals in raising and responding to patient safety concerns.\n\nStudy hypothesis\n\nParticipants 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.\n\nStudy design\n\nTwo-arm randomised controlled trial with repeated measures (baseline, 1-month, and 6-month follow-up)\n\nPrimary study design\n\nInterventional\n\nSecondary study design\n\nRandomised controlled trial\n\nTrial type\n\nBehavioural intervention \u002F Prevention\n\nPatient information sheet\n\nNot available in web format, please use contact details to request a participant information sheet.\n\nCondition\n\nImproved raising and responding to patient safety concerns in healthcare settings\n\nIntervention\n\nParticipants complete a series of questionnaires about their experiences and attitudes toward patient safety concerns. They are then randomly assigned to one of two conditions:\n\n1. Intervention Group:\n\n   Participants will form implementation intentions (\"if-then\" plans) related to raising and responding to patient safety concerns. They will be presented with the stem:\n\n   \"If I notice or feel concerned about a potential safety issue…\" and will link situations (\"if\") with responses (\"then\") using a structured online interface.\n2. Control Group:\n\nParticipants will complete the same baseline questionnaire but will not receive the intervention.\n\nAfter 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.\n\nIntervention type\n\nBehavioural\n\nPrimary outcome measure\n\nSelf-reported frequency of raising and responding to patient safety concerns at 1-month and 6-month follow-up.\n\nSecondary outcome measures\n\nCapability, opportunity and motivation (based on the COM-B model) measured at baseline, 1-month, and 6-month follow-up.\n\nData analysis plan\n\nRandomisation checks\n\nThe 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.\n\nThe 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.\n\nPlanned 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.",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"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.\n\nParticipants 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.",[34],"Behavioral: Implementation intention planning",{"label":36,"type":37,"description":38,"interventionNames":17},"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).",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":17},"BEHAVIORAL","Implementation intention planning","Implementation intention planning to promote patient safety concerns",[30],[46],{"name":47,"role":48,"phone":49,"phoneExt":17,"email":50},"Chris Keyworth","CONTACT","+44 (0) 161 306 6000","c.keyworth@leeds.ac.uk",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Dr Chris Keyworth","Associate Professor",[56],{"name":57,"class":6},"University of Leeds","100631854",false,"NCT07506096","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.","Inclusion Criteria:\n\nAged 18 years and over\n\n* Currently working as a healthcare professional in a health or social care setting\n* Good understanding of written and spoken English\n\nExclusion Criteria:\n\n* Aged under 18 years\n* Not currently working as a healthcare professional in a health or social care setting\n* Poor understanding of written and spoken English",true,"ALL","18 Years",{"count":68,"type":69},1000,"ESTIMATED","INTERVENTIONAL",[72],"NA","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.\n\nParticipants 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.",[75],"Patient Safety Concerns",[77,78,79,80,81],"patient safety","implementation intentions","behaviour change","safety concerns","randomised controlled trial","NOT_YET_RECRUITING","2026-04-20",{"date":85,"type":86},"2026-04-23","ACTUAL",{"date":88,"type":69},"2026-05-31",{"date":90,"type":69},"2026-12-31",{"name":5,"class":6}]