overview of the study protocol
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Overview of the Study Protocol. Josephine Silvestre, MSN, RN Associate, Regulatory Innovations Transition to Practice Project Manager February 1, 2012 Phase II Site Coordinator Meeting. Objectives of Protocol Overview. Review research objectives Discuss participant selection - PowerPoint PPT PresentationTRANSCRIPT
Overview of the Study Protocol
Josephine Silvestre, MSN, RNAssociate, Regulatory Innovations
Transition to Practice Project Manager
February 1, 2012Phase II Site Coordinator Meeting
Objectives of Protocol Overview
Review research objectives Discuss participant selection Review study procedures View study schedule of events Discuss data collection and handling Review IRB monitoring plan Discuss financial support for study sites
Research Objectives
Primary Objective:
To evaluate the feasibility of model
implementation in non-hospital settings
Research ObjectivesSecondary Objectives: New nurse job satisfaction, knowledge, self report
of errors, job stress Perception of competence Nurse retention Patient satisfaction Patient safety and quality outcomes Efficacy of preceptor training module Cost/benefit analysis
Intervention Control
Participant Selection
Inclusion Criteria New nurse enrollment begins April 1, 2012. New
graduate RNs and LPNs who are employed within 30 days of this enrollment start date through October 31, 2012 are eligible
New graduate nurses who have passed the NCLEX-RN
Participant Selection
Inclusion Criteria (continued) Nurses who meet the organization’s criteria for a
new graduate transition program Nurses who have not worked a permanent
position as an RN or LPN at another facility prior to the current positionMust be employed and will maintain at least 0.5 FTEExpectation is that new nurse is considered
permanent staff
Participant Selection
Exclusion Criteria: Nurses employed as RNs or LPNs by the
organization prior to March 1,2012 and after October 31, 2012 will be excluded from participation in the study
Nurses who previously worked a permanent position as an RN or LPN before current positionAn RN who worked as an LPN prior to current RN
employment is eligible
Participant Selection
Preceptors Site coordinators will start to identify preceptors
who will participate in the study prior to enrollment period of new nurses
Orientation
Separate process from transition to practice
Includes introducing staff to philosophy, goals, policies & procedures, skills checks, etc.
Study Procedures
Intervention New Nurse: Beginning of study – complete Demographic and
Initial surveys, take online Knowledge Assessment, initiate online modules (ideally across first 3 months of employment)
At 6 months – complete 6-month survey and evaluation
At 9 months – complete 9-month survey
Study Procedures
Intervention New Nurse (continued): At 12 months – complete 12-month survey and
evaluation, take online Knowledge Assessment Throughout study – ideally meet with preceptor
at least weekly
Study ProceduresIntervention Preceptor: Prior to precepting new nurse – complete
preceptor training module, complete Demographic survey
At 6 months – complete 6-month survey and evaluation
At 9 months – complete 9-month survey At 12 months – complete 12-month survey Throughout study – meet at least weekly with
new nurse
Study Procedures
Module Completion New nurses and preceptors will receive 20
continuing education contact hours for completion of modules and preceptorship
Study Procedures
Intervention Nurse Manager: Beginning of study – complete Demographic
survey At 6 months – complete 6-month evaluation
Study Procedures
Intervention Sites: Intervention sites will use NCSBN TTP model as
only method of transition to practice throughout Phase II, October 2013
Allow access to modules during work hours for new nurses and preceptors
Institutional support
Study Procedures
Institutional Support for One Year Support starts at the top Organizational communication about the study Cooperation with personnel, resources, etc. Celebration!
Study Procedures – Focus Groups
Cohorts of new nurses, preceptors, and site coordinators from the intervention group will participate in focus groups at the end of the study
Objective: to obtain qualitative data on evaluation of transition program and modules
Schedule of Events – Intervention GroupPrior to
enrollment of New Nurses
Baseline (Within 1 month of
Start Date)
6 months from Start
Date
9 months from Start
Date
12 months
from Start Date
Intervention Group: New Nurse
Initiate TTP Modules X Complete Demographic Survey X Complete Knowledge Assessment X X Complete Initial Survey X Complete 6- or 12-month Evaluation X X Complete 6-, 9-, or 12-month Survey X X X Focus group interview X
Preceptor Initiate Preceptor Training Module X Complete Demographic Survey X Complete 6-month Evaluation X Complete 6-, 9-, or 12-month Survey X X X Focus group interview X
• Nurse Manager Complete Demographic Survey X Complete 6-month Evaluation X
Study Procedures
Control New Nurse: Beginning of study – complete Demographic
and initial surveys, take online Knowledge Assessment
At 6 months – complete 6-month survey and evaluation
At 9 months – complete 9-month survey At 12 months – complete 12-month survey and
evaluation, take online Knowledge Assessment
Study Procedures
Control Preceptor/Manager: Beginning of study – complete Demographic
survey At 6 months – complete 6-month survey and
evaluation At 9 months – complete 9-month survey At 12 months – complete 12-month survey and
evaluation
Study Procedures
Control Sites: Control sites will use traditional method of
onboarding new graduate nurses *** No new transition method/system should be
initiated throughout duration of study At the end of the study, control sites will have
free access to modules for 1 year
Schedule of Events – Control GroupBaseline (Within 1 month of
Start Date)
6 months from Start
Date
9 months from Start
Date
12 months from Start
Date
Control Group:
New Nurse
Complete Demographic Survey X
Complete Knowledge Assessment X X
Complete Initial Survey X
Complete 6- or 12-month Evaluation X X
Complete 6-, 9-, or 12-month Survey X X X
Preceptor/Manager
Complete Demographic Survey X
Complete 6- or 12-month Evaluation X X
Complete 6-, 9-, or 12-month Survey X X X
Study Procedures
Site Coordinator: Beginning of study – complete Institutional
Demographics & Outcomes survey At 12 months – complete Institutional
Demographics & Outcomes survey End of study – complete Institutional
Demographics & Outcomes survey
Schedule of Events – Both Groups
Pre-Study(-28 days/+84
days)
12 months from Start
Date
End of Phase II(-28 days/+84
days)
Site Coordinator
Submit institutional demographics and outcomes data
X X X
Focus group interview X
Duration of Study Participation
New nurse and preceptor/manager will continue participation for 12 months.
Duration of Study Participation
Special circumstances If 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.
Data Collection
Web-based data collection system
Surveys/evaluations Knowledge
assessments Organization
outcomes data
Confidentiality
Participants will receive individual password-protected access to the website
Information collected from new nurses, preceptors, nurse managers
Outcomes data entered by site coordinators will be kept confidential; data will be reported in aggregate
IRB Monitoring Plan
In 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
Financial Information
At the end of the study phase, each study site will receive $2,000 for their participation
Questions