Presentation on theme: "Overview of the Study Protocol"— Presentation transcript:
1 Overview of the Study Protocol Josephine Silvestre, MSN, RNAssociate, Regulatory InnovationsTransition to Practice Project ManagerApril 27, 2011Phase I Site Coordinator Meeting
2 Objectives of Protocol Overview Review research outcomesDiscuss participant selectionReview study proceduresView study schedule of eventsDiscuss data collection and handlingReview IRB monitoring planDiscuss financial support for study sites
3 Research Outcomes Patient safety and quality outcomes Patient satisfactionSelf report of errorsNew nurse job satisfactionKnowledgePerception of competenceJob stressNurse retentionStudyControl
4 Additional Outcomes – Study Group Efficacy of preceptor training moduleCost/benefit analysisFeasibility of model implementation
5 Participant Selection Inclusion CriteriaNew nurse enrollment begins July 1, New graduate nurses hired as RNs within 30 days of this enrollment start date through September 30, 2011 are eligibleNew graduate nurses who have passed the NCLEX-RN
6 Participant Selection Inclusion Criteria (continued)Nurses who meet the hospital’s criteria for a new graduate transition programNurses who have not worked a permanent position as an RN at another hospital prior to the current position
7 Participant Selection Exclusion Criteria:Nurses employed as RNs by the hospital prior to June 1,2011 and after September 30, 2011 will be excluded from participation in the studyNurses who previously worked a permanent position as an RN in a hospital before current employment (temporary positions at facilities other than hospitals are allowed)
8 Participant Selection PreceptorsHospitals will identify preceptors who will participate in the study prior to enrollment period of new nurses
9 Orientation Separate process from transition to practice Includes introducing staff to philosophy, goals, policies & procedures, skills checks, etc.
10 Study Procedures Study New Nurse: Beginning of study – complete Demographic and Initial surveys, take online Knowledge Assessment, initiate online modules (should be completed within 3 months)At 6 months – complete 6-month survey and evaluationAt 9 months – complete 9-month survey
11 Study Procedures Study New Nurse (continued): At 12 months – complete 12-month survey and evaluation, take online Knowledge AssessmentThroughout study – meet weekly with preceptor
12 Study Procedures Study Preceptor: Prior to new nurse enrollment – complete preceptor training module, complete Demographic surveyAt 6 months – complete 6-month survey and evaluationAt 9 months – complete 9-month surveyAt 12 months – complete 12-month surveyThroughout study – meet weekly with new nurse
13 Study Procedures Module Completion New nurses and preceptors will receive 20 continuing education contact hours for completion of modules
14 Study Procedures Study Nurse Manager: Beginning of study – complete Demographic surveyAt 6 months – complete 6-month evaluation
15 Study Procedures Study Institutions: Study hospital will use NCSBN TTP model as only method of transition to practice throughout Phase I, December 2012Access to modules during work hours for new nurses and preceptorsInstitutional support
16 Study Procedures Institutional Support for One Year Support starts at the topOrganizational communication about the programCooperation with personnel, resources, etc.Celebration!
17 Study Procedures – Focus Groups Cohorts of new nurses, preceptors, and site coordinators from the study group will participate in focus groupsObjective: to obtain qualitative data on evaluation of transition program and modules
18 Schedule of Events – Study Group Prior to enrollment of New NursesBaseline (Within 1 month of Start Date)6 months from Start Date(-7 days/+21 days)9 months from Start Date12 months from Start DateExperimental Group:New NurseInitiate TTP ModulesXComplete Demographic SurveyComplete Knowledge AssessmentComplete Initial SurveyComplete 6- or 12-month EvaluationComplete 6-, 9-, or 12-month SurveyFocus group interviewPreceptorInitiate Preceptor Training ModuleComplete 6-month EvaluationNurse Manager
19 Study Procedures Control New Nurse: Beginning of study – complete Demographic and initial surveys, take online Knowledge AssessmentAt 6 months – complete 6-month survey and evaluationAt 9 months – complete 9-month surveyAt 12 months – complete 12-month survey and evaluation, take online Knowledge Assessment
20 Study Procedures Control Preceptor/Manager: Beginning of study – complete Demographic surveyAt 6 months – complete 6-month survey and evaluationAt 9 months – complete 9-month surveyAt 12 months – complete 12-month survey and evaluation
21 Study Procedures Control Institutions: Control hospital will use traditional method of onboarding new graduate nurses*** No new transition method/system should be initiated throughout duration of studyAt the end of the study, control hospital will have free access to modules for 1 year
22 Schedule of Events – Control Group Baseline (Within 1 month of Start Date)6 months from Start Date(-7 days/+21 days)9 months from Start Date12 months from Start DateControl Group:New NurseComplete Demographic SurveyXComplete Knowledge AssessmentComplete Initial SurveyComplete 6- or 12-month EvaluationComplete 6-, 9-, or 12-month SurveyPreceptor/Manager
23 Study Procedures Site Coordinator: Beginning of Phase I – complete Institutional Demographics & Outcomes surveyAt 12 months – complete Institutional Demographics & Outcomes surveyEnd of Phase I – complete Institutional Demographics & Outcomes survey
24 Schedule of Events – Both Groups Pre-Study (Prior to enrollment of New Nurses)12 months from Start Date(-7 days/+21 days)End of Phase I(-28 days/+56 days)Site CoordinatorSubmit institutional demographics and outcomes dataXFocus group interview
25 Duration of Study Participation New nurse and preceptor/manager will continue participation for approximately 12 months.
26 Duration of Study Participation Special circumstancesIf new nurse leaves, ask new nurse to complete outstanding surveys/evaluations.If preceptor/manager leaves, ask preceptor to complete outstanding surveys/evaluations and new nurse will be re-assigned to another preceptor.
27 Data Collection Web-based data collection system Surveys/evaluations Knowledge assessmentsHospital outcomes data
28 ConfidentialityParticipants will receive individual password-protected access to the websiteInformation collected from new nurses, preceptors, nurse managersOutcomes data entered by site coordinators will be kept confidential; data will be reported in aggregate
29 IRB Monitoring PlanIn order to protect the rights of all participants, the study will be submitted for IRB review/approval.Continuous IRB monitoring per each site’s IRB requirements
30 Financial Information At the end of the study phase, each study site will receive $2,000 for their participation