[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599407":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":17,"centralContacts":24,"locations":17,"responsibleParty":30,"collaborators":34,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":41,"acronym":17,"eligibilityCriteria":42,"healthyVolunteers":43,"sex":44,"minAge":45,"maxAge":17,"enrollmentInfo":46,"targetDuration":17,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":61,"whyStopped":17,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":17},{"fullName":5,"class":6},"University of Manchester","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Implementation intention planning",{"label":15,"type":16,"description":17,"interventionNames":17},"Control","NO_INTERVENTION",null,[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":17},"BEHAVIORAL","Implementation intention planning","Implementation intention planning to promote patient safety concerns",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":17,"email":29},"Chris Keyworth","CONTACT","0","c.keyworth@leeds.ac.uk",{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Dr Chris Keyworth","Associate Professor",[35],{"name":36,"class":6},"University of Leeds","100599407","using-if-then-plans-to-support-patients-in-raising-safety-concerns-about-their-care-100599407",false,"NCT07084090","Using IF-THEN Plans to Support Patients in Raising Safety Concerns About Their Care","Inclusion Criteria:\n\nAged 18 and over Good verbal and written understanding of English\n\nExclusion Criteria:\n\nAged under 18 years of age Poor verbal and written understanding of English",true,"ALL","18 Years",{"count":47,"type":48},10000,"ESTIMATED","INTERVENTIONAL",[51],"NA","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.\n\nEach 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.",[54],"Patient Safety Concerns",[56,57,58,59,60],"Patient safety","implementation intentions","behaviour change","safety concerns","randomised controlled trial","NOT_YET_RECRUITING","2026-03-18",{"date":64,"type":65},"2026-03-19","ACTUAL",{"date":67,"type":48},"2026-03-20",{"date":69,"type":48},"2026-12-31",{"name":5,"class":6}]