Overview of the Study Protocol

Josephine Silvestre, MSN, RN

Associate, Regulatory Innovations

Transition to Practice Project Manager

April 27, 2011

Phase I Site Coordinator Meeting

Objectives of Protocol Overview

Review research outcomes

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 Outcomes

Patient safety and quality outcomes

Patient satisfaction

Self report of errors

New nurse job satisfaction

Knowledge

Perception of competence

Job stress

Nurse retention

Study Control

Additional Outcomes – Study Group

Efficacy of preceptor training module

Cost/benefit analysis

Feasibility of model implementation

Participant Selection

Inclusion Criteria New nurse enrollment begins July 1, 2011.

New graduate nurses hired as RNs within 30 days of this enrollment start date through September 30, 2011 are eligible

New graduate nurses who have passed the NCLEX-RN

Participant Selection

Inclusion Criteria (continued) Nurses who meet the hospital’s criteria for a

new graduate transition program

Nurses who have not worked a permanent position as an RN at another hospital prior to the current position

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 study

Nurses who previously worked a permanent position as an RN in a hospital before current employment (temporary positions at facilities other than hospitals are allowed)

Participant Selection

Preceptors Hospitals will 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

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 evaluation

At 9 months – complete 9-month survey

Study Procedures

Study New Nurse (continued): At 12 months – complete 12-month survey

and evaluation, take online Knowledge Assessment

Throughout study – meet weekly with preceptor

Study Procedures

Study Preceptor: Prior to new nurse enrollment – 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 weekly with new nurse

Study Procedures

Module Completion New nurses and preceptors will receive

20 continuing education contact hours for completion of modules

Study Procedures

Study Nurse Manager: Beginning of study – complete Demographic

survey

At 6 months – complete 6-month evaluation

Study Procedures

Study Institutions: Study hospital will use NCSBN TTP model

as only method of transition to practice throughout Phase I, December 2012

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 program

Cooperation with personnel, resources, etc.

Celebration!

Study Procedures – Focus Groups

Cohorts of new nurses, preceptors, and site coordinators from the study group will participate in focus groups

Objective: to obtain qualitative data on evaluation of transition program and modules

Schedule of Events – Study GroupPrior to

enrollment of New Nurses

Baseline (Within 1

month of Start Date)

6 months from Start

Date(-7 days/+21

days)

9 months from Start

Date(-7 days/+21

days)

12 months from Start

Date (-7 days/+21

days)Experimental 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 Institutions: Control hospital 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 hospital will have free access to modules for 1 year

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 Date

(-7 days/+21 days)

12 months from Start Date

(-7 days/+21 days)

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 Phase I – complete

Institutional Demographics & Outcomes survey

At 12 months – complete Institutional Demographics & Outcomes survey

End of Phase I – complete Institutional Demographics & Outcomes survey

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 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 approximately 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

Hospital 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