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