Classification of Protocol Complexity and Staffing Needs for MCRU

Final Report

Submitted To:

Ms. Cyndi BowerAdministrative Managing Director, MICHR Research Innovation/Clinical Research Support

GroupClinical Manager, Michigan Clinical Research Unit

1500 E. Medical Center DriveAnn Arbor, MI 48109

Ms. Amanda SilvaCentral Lean Coach, UMHS Michigan Quality System

2101 Commonwealth BoulevardAnn Arbor, MI 48105

Ms. Cindy PriddyCentral Lean Coach, UMHS Michigan Quality System

2101 Commonwealth BoulevardAnn Arbor, MI 48105

Dr. Mark Van OyenProfessor, Industrial and Operations Engineering

1205 Beal Ave.Ann Arbor, MI 48109

Submitted By:

Sanjeev Muralidharan, Hyeon Kyun Nho, Christine Rockwell, Ashwin VargheseIOE 481 Team 11, University of Michigan

Date Submitted: April 22, 2014

Table of Contents

Executive Summary.........................................................................................................................1Introduction......................................................................................................................................4Background......................................................................................................................................4

Key Issues....................................................................................................................................5Goals and Objectives...................................................................................................................5Project Scope...............................................................................................................................5

Methods...........................................................................................................................................6Data Collection and Analysis......................................................................................................6

Performed a Literature Search.................................................................................................6Evaluated the Nursing Student’s Draft Tool...........................................................................6Observed Tasks........................................................................................................................6Conducted Interviews..............................................................................................................6Surveyed Clinical Staff............................................................................................................6Took Data at Huddle Meetings................................................................................................7Attended Huddle Meetings......................................................................................................7Attended Protocol Initiation Meetings.....................................................................................7

Updating the Draft Tool...............................................................................................................7Performing Pilot Runs.................................................................................................................8

Findings...........................................................................................................................................8Learning about the Current State.................................................................................................8

MCRU needs a unique tool to classify protocol complexity...................................................8Outside factors can influence a protocol visit..........................................................................9Clinical staff feel understaffed and busiest in the morning.....................................................9Daily staff scheduling process has a low value-add time percentage....................................11MCRU has a finite list of procedures that can be performed................................................11Protocol initiation process exists to familiarize MCRU with study team needs...................11

Evaluating the Draft Tool..........................................................................................................12Performing Pilot Runs...............................................................................................................12

Conclusions....................................................................................................................................13MCRU Experiences Higher Demand in Mornings....................................................................13Updated Tool More Accurate than Draft Tool..........................................................................13

Recommendations..........................................................................................................................13Use Scores Proactively..............................................................................................................13Reference Time Component of Tool Output.............................................................................14Encourage Uniform Visit Labeling across Protocol Initiation and Visit Scheduling Stages....14

Expected Impact............................................................................................................................14References......................................................................................................................................15Appendix A: Draft Protocol Complexity Tool (Microsoft Excel version)....................................16Appendix B: Clinical Staff Survey................................................................................................17Appendix C: Huddle Meeting Tally Sheet....................................................................................19Appendix D: Updated Protocol Complexity Tool.........................................................................20Appendix E: Current State Value Stream Map..............................................................................22Appendix F: List of Procedures Performed by MCRU.................................................................23Appendix G: Clinical Staff Survey Results...................................................................................24

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Appendix H: Clinical Nurse Specialist Interview.........................................................................28Appendix I: Evaluating Draft Tool................................................................................................29Appendix J: Updated Tool Pilot Run.............................................................................................30

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List of Figures and Tables

Figure E-1. Understaffed survey question results............................................................................2

Figure 1. Understaffed survey question results …………………………………………...………9Figure 2. Busiest time of day survey question results...................................................................10

Table 1. Huddle Meeting Tally Sheet Results...............................................................................10Table 2. Huddle Meeting Tally Sheet Results, removing days with zero tallies...........................11Table 3. Pilot Run Results for Understaffed Days........................................................................12

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Executive Summary

The Michigan Clinical Research Unit (MCRU) is currently finding difficulty in predicting the number and specialties of clinical staff needed to support protocol visits on a daily basis due to high variability in protocol complexity. MCRU believes that they have adequate clinical staff overall; however, it is difficult to predict necessary daily staffing levels due to the variety of protocol requirements. Therefore, MCRU needs a consistent mechanism to evaluate the complexity of any protocol and the corresponding staffing requirements for protocol-specific visits. This mechanism would allow MCRU to better predict staffing for a given day and plan to provide the best possible service to study teams and participants.

The Administrative Managing Director of MICHR Research Innovation/Clinical Research Support Group would like to know how to improve staffing predictability. In 2010, a nursing student developed a draft protocol complexity tool that provides a complexity score and the types of clinical staff needed for a protocol, but the tool was not validated. The Administrative Managing Director asked an IOE 481 student team from the University of Michigan to evaluate and update the draft protocol complexity tool to predict the number and type of clinical staff needed on a day-to-day basis. MCRU would like to use the updated tool at their protocol initiation meetings, which are used to set up a new protocol or restart an outdated protocol.

Methods and Findings

To determine how to evaluate and update the draft protocol complexity tool, the team completed a data collection plan with ten methods.

Performed a Literature SearchThe team conducted a literature search to analyze similar studies and draw inferences about their relevance to this project. The team learned that MCRU is unique from other facilities in that each protocol visit can have a different participant care and staffing requirements.

Evaluated the Nursing Student’s Draft ToolThe team evaluated the draft protocol complexity tool based on daily staffing schedules for February 20 and 21, 2014. From the evaluation, the team found that the complex and simple tasks were often assigned the same number of points. As a result, protocol visits different in complexity called for the same number of registered nurses (RN) or medical assistants (MA).

Observed TasksThe team observed the Nursing Supervisor create the daily schedule to understand how staff scheduling works. The team learned that the initial process of schedule creation is short; however a lot of time is required for reviewing and finalizing the schedule. The team also observed clinical staff to determine how the workload varies. The team observed that staff was busiest in the morning (8 a.m. – 12 p.m.).

Conducted InterviewsThe team interviewed the Clinical Nurse Specialist at MCRU to understand her role in the protocol process.  The team interviewed three RNs to determine how much time RNs need to

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perform every task on the comprehensive list of MCRU services.

Surveyed Clinical StaffThe team created a survey for the clinical staff at MCRU to quantify observations on complexity of procedures and the clinical staff’s view of daily workload requirements. The results show that all clinical staff surveyed felt understaffed (Figure E-1).

Figure E-1. Understaffed survey question results(Source: MCRU Survey, Data Collection: February 27, 2014 – March 7, 2014, Sample Size: 7)

Took Data at Huddle MeetingsThe team prepared a tally sheet for the clinical staff to discuss a number of issues each afternoon huddle meeting. The results show that an average of 17.78% of huddle meeting attendees felt understaffed, with a minimum of 0% and a maximum of 100%.

Attended Huddle MeetingsThe MCRU staff holds two huddle meetings every day to look through the schedule and determine if the workload is appropriate. The team attended huddle meetings to understand what happens during the meetings.

Attended Protocol Initiation MeetingsThe team attended three protocol initiation meetings because the updated protocol complexity tool will eventually be used before and during these meetings. These meetings confirmed that the updated tool will be helpful in assessing staff needs.

Updated the Draft ToolThe team updated the draft protocol complexity tool several times. The updated tool includes the findings from interviewing the RNs and surveying the clinical staff. The team updated the draft tool by utilizing Microsoft Excel. The user can check the necessary tasks performed, input number of times a procedure is performed, and input time required for a procedure. The updated

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tool provides a complexity score based on the information the user inputs into the tool. The updated tool provides total staff time necessary and breaks this time down into RN and MA time.

Performed Pilot RunsThe team performed pilot runs and found the updated tool’s scoring is accurate. The tool details the amount of time required for the protocol, split into RN and MA time. The tool also gives a complexity score to the protocol and states if an RN is required for the visit.

Conclusions

The team drew two conclusions due to the findings from evaluating and updating the draft protocol complexity tool.

MCRU Experiences Higher Demand in MorningsThe survey results show clinical staff feel busiest in the mornings (from 8 a.m. – 12 p.m.). The team also observed staff was busier in the morning than in the afternoon. However, the huddle meeting results indicate the average % of staff who felt understaffed was 17.78. This result may be due to the fact that the huddle meeting data was collected in the afternoon when staff were not as busy, and therefore did not feel understaffed when answering that question.

Updated Tool More Accurate than Draft ToolThrough the pilot runs, the team found that the updated tool is more accurate in predicting staffing needs than the draft tool. The draft tool did not include many of the procedures that MCRU performs. The draft tool also assigned the same score to procedures that were different in complexity. The updated tool eliminates these two problems by providing a comprehensive list of updated services and more accurately quantifying the different complexities of procedures.

Recommendations

Based on the findings from evaluating and updating the draft protocol complexity tool, the team presents the following recommendations:

Use Scores ProactivelyThe team recommends MCRU use scores generated by the tool to proactively match workload to staff available. This approach will improve staff utilization and reduce idle time and over time.

Reference Time Component of Tool OutputIn addition, the team recommends that the time component of the output be used to help determine the duration of the participant appointment. By allocating adequate time for visits, MCRU can provide a higher quality of service to participants through reduced wait time before the visit and idle time during the visit.

Encourage uniform visit labeling across protocol initiation stage and visit scheduling stageThe team recommends MCRU encourage study teams to use uniform visit labeling across the protocol initiation and visit scheduling stages. Consistent visit labeling will be useful to tool’s user, because visit numbers will be consistent in the tool’s output and daily staffing schedule.

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Introduction

The Michigan Clinical Research Unit (MCRU) is the clinical research component of the Michigan Institute for Clinical and Health Research (MICHR) and has the infrastructure to support human clinical research. MCRU offers space, personnel, and specialized equipment to study teams who perform human clinical trial studies involving outpatient and extended stay procedures. The logistics needed to support each study is called a protocol.

MCRU is currently finding difficulty in predicting the number and specialties of staff needed to support protocol visits on a daily basis due to high variability in protocol complexity. MCRU believes that they have adequate clinical staff overall; however, it is difficult to predict necessary daily staffing levels due to the variety of protocol requirements. Therefore, MCRU needs a consistent mechanism to evaluate the complexity of any protocol and the corresponding staffing requirements associated with protocol-specific visits. This mechanism would allow MCRU to better predict staffing for a given day and plan to provide the best possible service to study teams and participants.

The Administrative Managing Director of MICHR Research Innovation/Clinical Research Support Group would like to know how to improve staffing predictability. In 2010, a nursing student developed a draft protocol complexity tool that provides a complexity score and the types of clinical staff needed for a protocol, but the tool was not validated. The Administrative Managing Director asked an IOE 481 student team from the University of Michigan to evaluate and update the draft protocol complexity tool. This report describes the project and is organized as follows: background, key issues, methods, findings, conclusions, recommendations, and expected impact.

Background

MCRU is currently supporting approximately 300 study teams who are conducting about 80 active protocols in a given month. Active protocols are those that are presently being supported by MCRU and seeing at least one participant. MCRU can operate on a 24/7 basis when necessary; however, the majority of protocols take place between 8 am and 8 pm. The protocols vary from one another in their complexities. A protocol can be as simple as one blood draw, and others can be as complex as a three-night study. The day-to-day staffing needs vary with the types of protocols scheduled.

MCRU does not have a standardized method to schedule daily staffing or a quantifiable measure to help predict the best daily staffing schedules. Currently, the MCRU Nursing Supervisor relies on her experience and protocol knowledge to match staff with protocols. In addition, MCRU has two daily huddle meetings (at 7:55 am and 3:15 pm every day) and relies on anecdotal evidence reported by staff at these meetings to determine the effectiveness of staffing schedules.

MCRU management expresses the experience of ‘peak and trough’ demand for their services. According to the MCRU management, on certain days, it appears that the staff is being overworked while on other days they appear to be underutilized. Due to the high variability in protocol complexity and the reported ‘peak and trough’ demand, MCRU finds it difficult to

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efficiently match their available human resources, which includes five full time registered nurses (RN), a part time RN, a full time medical assistant (MA), and a part time MA, to the protocols. MCRU has not yet faced serious problems with the current scheduling method; however, they want to quantify daily staffing needs in a standardized way to improve staffing predictability. Potential consequences of not being able to predict staffing needed for protocols include deviations in protocols (i.e. time sensitivity). Improving staffing predictability will also help MCRU to plan for any future demand growth.

A nursing student previously developed a draft protocol complexity tool for MCRU to estimate the protocol staffing needs by assigning a complexity score to each of the protocols. The complexity score in the draft tool is calculated by assigning and summing scores for specific procedures of each protocol. This complexity score indicates a protocol visit’s complexity and types and numbers of clinical staff needed. The draft tool was not validated, and it was left unused for four years.

MCRU asked the student team to evaluate and update the draft protocol complexity tool to predict the number and type of staff needed on a day-to-day basis. MCRU would like to use the tool at their protocol initiation meetings, which are used to set up a new protocol or restart an outdated protocol.

A nursing student previously developed a draft tool for MCRU to estimate (the protocol staffing needs by assigning a complexity score to each of the protocols. The complexity score in the draft tool is calculated by assigning and summing scores for specific procedures of each protocol. This complexity score indicates a protocol visit’s complexity and types and numbers of clinical staff needed. The tool was not validated, and it was left unused for four years. MCRU would like the student team to update and expand the draft tool to be able to predict the number and type of staff needed on a day-to-day basis. MCRU would like to use the tool at their protocol initiation meetings, which are used to set up a new protocol or restart an outdated protocol.

Key Issues

MCRU needed this project due to the following key issues: Staff feel frustrated due to lack of predictability in staffing needs for protocol visits. Clinical staff experiences overutilization and underutilization due to different protocol

complexities and intensiveness of effort required. Integrity of a study team’s data could be compromised due to time sensitivity issues,

resulting from inappropriate allocation of clinical staff.

Goals and Objectives

The primary goal of this project was to evaluate and update the draft protocol complexity tool. To achieve this goal, the student team addressed the following objectives:

Standardize clinical staff-to-visit assignment Reduce errors in RN assignment

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Project Scope

This project included the MCRU facility within the Cardiovascular Center (CVC) and the day-to-day staff scheduling of RNs and MAs. Protocols were analyzed by visits, and only outpatient visits, which comprise 90% of MCRU’s business, were included.

The protocols requiring extended stays were not included in this project. However, MCRU plans to incorporate all types of protocol visits into the tool later in the future. This project did not involve protocols in offsite MCRU locations that are outside of the CVC building or the MCRU 2U mobile unit. It did not include monthly staff, participant visit, or equipment scheduling.Methods

To evaluate and update the draft protocol complexity tool, the team completed ten methods to collect and analyze the data. The following section discusses the data collection and analysis.

Data Collection and Analysis

To determine how to evaluate and update the draft protocol complexity tool and assign a complexity score to protocol visits, the team developed a data collection plan. The plan included performing a literature search, evaluating the draft tool, observing tasks, conducting interviews, surveying clinical staff, taking data at huddle meetings, attending huddle meetings, attending protocol initiation meetings, updating the draft tool, and performing pilot runs.

Performed a Literature SearchThe team conducted a literature search to analyze similar studies and draw inferences about their relevance to this project. The team looked at previous project final reports from IOE 481.  

Evaluated the Nursing Student’s Draft ToolThe team evaluated the draft protocol complexity tool based on daily staffing schedules for February 20 and 21, 2014. The team transferred the draft tool information from the paper version of the draft tool into Microsoft Excel (Appendix A).

Every protocol has guidelines, created by MCRU staff, and a time and events table, created by the study team. The team reviewed visits that were 8 a.m. – 8 p.m. each day and reviewed protocol visit guidelines and time and events tables to see what procedures each protocol visit required. The team used the guidelines and time and events table for a protocol to assign a score to each visit using the draft tool.

Observed TasksThe team observed the Nursing Supervisor create the daily schedule on January 28, 2014 to understand the daily staff scheduling process. The team observed MCRU clinical staff for 30 hours to better understand daily operations. The team observed the staff on different days and during different times of the day to determine how the workload of the staff varies.

Conducted InterviewsThe team interviewed the Clinical Nurse Specialist at MCRU on February 12, 2014 to

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understand her role and responsibilities during the protocol initiation process. The team interviewed three RNs on February 25, 2014 and asked how much time RNs needed to perform every task on the comprehensive list of services. The team interviewed RNs because RNs are trained to perform all procedures that a protocol could require, whereas an MA is trained to perform only a subset of the procedures.

Surveyed Clinical StaffThe team created a survey for the clinical staff at MCRU (Appendix B) to quantify observations made by the team. Five RNs and two MAs completed the survey. Questions on the survey aimed to assess how busy staff were during the day and if they felt understaffed. The questions also aimed to assess complexity of the procedures performed by clinical staff and the impact of charting in MiChart on workflow.

The team compiled the survey results in Microsoft Excel to analyze the responses and to determine which responses were most common.

Took Data at Huddle MeetingsThe MCRU staff holds two huddle meetings, at approximately 7:55 am and 3:15 pm every day to look through the schedule and determine if the workload is appropriate. The team prepared a tally sheet (Appendix C) for the clinical staff to discuss at each afternoon huddle meeting. The leader of the afternoon huddle meeting facilitated discussion of the four categories on the tally sheet and recorded data: number of protocol deviations, number of staff who felt overworked during the day, number of specimens whose integrity was not maintained, and the number of time sensitivity issues. The clinical staff collected this data for 10 to 30 protocols each day February 10, 2014 – March 31, 2014.

Attended Huddle MeetingsThe team attended five morning huddles and one afternoon huddle to observe problems that may arise in scheduling.

Attended Protocol Initiation MeetingsThe team attended three protocol initiation meetings on February 5 and 10, and March 17, 2014. During these meetings, the protocol study team coordinates with all relevant MCRU representatives to get approval on the logistics of the study. The team attended these meetings because the updated protocol complexity tool will eventually be used before and during these meetings to assess the complexity of protocol visits.

Updating the Draft Tool

The team updated the draft protocol complexity tool several times. The final version of the updated tool is in Appendix D.

The team first updated the tool by adding procedures MCRU performs that were not on the draft tool based on observations and interviews. The team also used input from interviewing the RNs and surveying the clinical staff for procedure times and complexities, respectively.

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The team updated the draft tool by creating a Microsoft Excel file. The file has three tabs: Instructions, Tool, and Output. The user of the tool will select all the procedures involved in a particular visit on the Tool tab.

The tool calculates required visit time and assigns a complexity score for a particular protocol visit. Initially, required staff time for a particular procedure was calculated using the maximum time reported by the RNs during the interview. The maximum time was used to provide an upper bound on time. The team met with the Nursing Supervisor and based on her input changed any procedure times that she stated were too long by making the corresponding updates to the tool. The sum of the procedure times is the total time required for the visit. The tool gives the total time required for the visit, and breaks this number into three times: time required by an RN, time required by an MA and time during which the participant will be utilizing MCRU space.

The complexity of a procedure (1 to 5) was assigned based on the survey results of how complex the staff perceived a procedure to be. To determine the complexity of each procedure, the team analyzed the clinical staff survey results. Procedures reported as ‘Basic’ were given a complexity of 1, ‘Moderate’ a complexity of 3, and ‘Complex’ a complexity of 5. Procedures reported as both ‘Basic’ and ‘Moderate’ were given a complexity of 2 and similarly, procedures ranked both ‘Moderate’ and ‘Complex’ were given a complexity of 4.

The tool adds the complexity score of the procedures in a visit and put an ‘R’ or an ‘M’ at the beginning of this score. An ‘R’ indicates that an RN is required to perform the at least one procedure involved in the visit and an ‘M’ indicates that an MA can perform all the procedures in the visit. This component of the complexity score is intended to reduce errors in RN assignment.

The team added a button called ‘Save score information’ which saves the score and time outputs to the Output tab. All the protocol visits the user uses the tool to score are stored in the Output tab, allowing for a concise view of the time and complexity required for every visit.

Performing Pilot Runs

The team validated the updated protocol complexity tool by performing pilot runs. After each pilot run, the team updated the tool based on the pilot run results and feedback from both the Administrative Director and Nursing Supervisor.

The team performed two pilot runs on protocols on the February 20 and 21 schedules, the same days that the team used to evaluate the draft protocol complexity tool. The team compared the output of the both tools.

The team performed an additional two pilot runs using the protocols scheduled on two days where all staff reported feeling understaffed on the huddle meeting tally sheet to see how well the output compared with the staff schedule. The team performed these pilot runs using the staff schedules for February 10 and March 6.

Findings

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The team obtained results based on the evaluating and updating the draft tool from the methods outlined above. These findings are stated in the following sections.

Learning about the Current State

The team had six findings about the current state of clinical staffing at MCRU.

MCRU needs a unique tool to classify protocol complexityBased on the literature search, the team determined that many of the projects conducted by past IOE 481 teams were related to optimizing the use of a scarce resource, such as a physician or a patient room. In most of these cases, the handling procedure is similar for each patient. As a research unit, MCRU is unique in that each protocol visit can have different participant care and staffing requirements. This information indicated that the team should modify the draft protocol complexity tool to specifically the procedures performed at MCRU. In addition, protocol visit procedures had high variability, meaning MCRU may need to take additional iterations of evaluating and updating the draft tool after the team completes this project.

Outside factors can influence a protocol visitBased on a previous IOE 481 project, the team learned about outside factors that affect MCRU staffing. MCRU depends on the Investigational Drug Service (IDS) to produce investigational drugs for certain protocol visits [1]. If IDS does not produce the drug on time, this delay affects the length of time the participant needs to remain at MCRU and can negatively impact clinical staff and participant interaction due to long participant wait times as well as specimen integrity. Extra factors, such as timeliness of drug production, need to be kept in mind when trying to improve staffing predictability.

Clinical staff feel understaffed and busiest in the morningBased on surveys, observations, and tally sheets, the team found the clinical staff feel understaffed and busiest in the morning.

The results from the clinical staff survey show that all clinical staff feel understaffed (Figure 1).

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Figure 1. Understaffed survey question results(Source: MCRU Survey, Data Collection: February 27, 2014 – March 7, 2014, Sample Size: 7)

The survey findings show that the clinical staff feel most busy from 8 a.m. – 12 p.m. (Figure 2).

Figure 2. Busiest time of day survey question results(Source: MCRU Survey, Data Collection: February 27, 2014 – March 7, 2014, Sample Size: 7)

Based on staff observations, the team noticed that on average, the majority of the protocols were often scheduled in the morning, and that staff was not as busy in the afternoons and evenings. These observations were consistent with the survey findings.

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The results from the tally sheets are shown below in Table 1. The huddle meeting results showed 17.78% of MCRU staff felt understaffed on average.

Table 1. Huddle Meeting Tally Sheet Results(Source: Huddle Meeting Tally Sheet, Data Collection: Feb 10, 2014 – March 31, 2014, Sample Size: 36 days)

Number of deviations in

protocol today

Number of staff who feel as though MCRU was understaffed today

(%)

Number of specimens whose integrity was not maintained today

Number of time sensitivity

issues todayAverage 0.67 17.78 1.03 1.31Std. Dev. 0.99 34.17 1.92 1.55

Min. 0.00 0.00 0.00 0.00Max. 4.00 100.00 8.00 6.00

Table 2 shows the results, omitting the days when zero tallies were recorded. For each of the four categories listed in Table 2, the number of days where at least one tally was recorded is 15, 10, 15, and 24 days, respectively.

Table 2. Huddle Meeting Tally Sheet Results, removing days with zero tallies(Source: Huddle Meeting Tally Sheet, Data Collection: Feb 10, 2014 – March 31, 2014, Sample Size: 15, 10, 15, and 24 days, respectively)

Number of deviations in protocol today

Number of staff who feel as though MCRU was understaffed today (%)

Number of specimens whose integrity was not maintained today

Number of time sensitivity issues today

Average 1.60 64.00 2.47 1.96Std. Dev. 0.91 35.42 2.33 1.52Min. 1.00 20.00 1.00 1.00Max. 4.00 100.00 8.00 6.00

The Administrative Director noted differences in prompts, even though the four categories remained the same, depending on which staff member led the huddle meeting data collection on a particular day.

MCRU plans to continue taking data at their huddle meetings, as a result of this project, for quality control purposes. MCRU plans on asking similar questions about protocol deviations, understaffed feelings, specimen integrity, and time sensitivity issues.

Daily staff scheduling process has a low value-add time percentageThe team observed the Nursing Supervisor create the daily schedule. This initial step takes approximately 20 minutes. By observing this process, the team learned the steps required to

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create the daily staffing schedule. Based on these observations, the team created a Value Stream Map of the daily scheduling process at MCRU (Appendix E) to visualize the overall process. The value add time percentage is 3.57% because, of the 7 hour lead time, only 15 minutes of the process is value add time.

MCRU has a finite list of procedures that can be performedFrom the draft protocol complexity tool and conversations with the clinical staff at MCRU, the team formed a comprehensive list of services that an RN and/or MA can perform at MCRU (Appendix F).

The survey shows how the nurses rank the complexity of each task and gives information on how long the nurses spend entering participant information into the University of Michigan Health System (UMHS) charting system, MiChart (Appendix G). Charting is a part of every visit and is not considered separately in the updated tool.

Protocol initiation process exists to familiarize MCRU with study team needsThrough attending the protocol initiation meetings, the team learned how new protocols are started and how revised protocols are restarted. UMHS and MCRU management and staff from finance, clinical staff education, pharmacy, staffing, and the study team discuss questions about what MCRU needs to do for the protocol. The team learned that complexities of the protocol visits can require a lot of discussion, and predicting staffing for these visits is challenging. One factor that makes predicting staffing challenging is specimen retrieval because most protocol visits need specimens to be taken in the morning, sometimes even outside of normal MCRU working hours (8 a.m. – 8 p.m.). Hence, the updated tool will prove useful.

From the interview with the Clinical Nurse Specialist (Appendix H), the team learned that she gains background knowledge of the study and determines questions that need to be asked at the protocol initiation meetings. After the protocol initiation meeting, the Clinical Nurse Specialist provides guidelines to educate the clinical staff on procedures required by the protocol. This interview helped the team understand the current process of what happens before and after protocol initiation meetings.

Evaluating the Draft Tool

The team evaluated the draft tool by using it to assign complexity scores based on 30 protocol visits. From the evaluation, the team found that the draft protocol complexity tool often assigned the same number of points for complex and simple tasks. As a result, protocol visits different in complexity called for the same number of staff. Additionally, the draft tool always assigned at least one RN to a protocol visit. However, not all protocol visits require an RN and can be handled by an MA.

As an example of how the draft tool evaluated protocols, the output for Protocol 2488’s baseline visit is shown in Appendix I. The tool stated the visit is moderate, as it has been given a complexity score of 5 points and calls for 1 RN and 1 MA to be assigned for it.

Performing Pilot Runs

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Based on the pilot runs, the team found that the scoring using the updated protocol complexity tool was robust and accurate. As an example of how the tool functions, the baseline visit of protocol 2488 is shown in Appendix J. The tool details the amount of time required for the protocol, split into RN, MA and space time. The tool also gives a complexity score to the protocol and states that an RN is required for the visit.

The tool also provided an insight as to why staff might have felt understaffed on the days they said so. The pilot run results indicate that the time allocated to a number of procedures was too little for certain visits, thus causing the staff to feel overworked. Table 3 presents the results from the two pilot runs performed on schedules when the clinical staff reported feeling understaffed.

Table 3. Pilot Run Results for Understaffed Days(Source: Performing Pilot Runs, Data Collection: April 7 – 9, 2014, Sample Size: 36 days)

ScheduleScheduled visit duration <= pilot run output of required staff time

Total number of visits completed

Percentage of times visit duration <= pilot run

output required staff time2/10/201

4 3 14 21.43

3/6/2014 7 23 30.43

Additionally, when performing pilot runs, the team noticed that there is a lack of uniformity in protocol visit labeling when comparing the visit number (or name) in the protocol’s time and events table and the visit number (or name) in the staff schedule.

Conclusions  

The team drew two conclusions due to the findings from evaluating and updating the draft protocol complexity tool. MCRU may be understaffed in the mornings and the updated tool performs better than the draft tool.

MCRU Experiences Higher Demand in Mornings

The survey results show MCRU staff feel busiest in the mornings (from 8 a.m. – 12 p.m.). The team also observed staff was busier in the morning than in the afternoon.

Based on the survey results (Appendix G), all staff reported they are understaffed due to too many protocols scheduled each day, too many protocols that require an RN, not enough clinical staff members that work at MCRU, and too complex of protocols for the clinical staff. However, the huddle meeting results indicated that on average 17.78% of staff felt understaffed. For 26 out of the 36 days (72% of the time), zero people present at the huddle meeting reported feeling understaffed. This result may be due to the fact that the huddle meeting data was collected in the afternoon when staff were not as busy, and therefore did not feel understaffed when answering that question.

Updated Tool More Accurate than Draft Tool

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Through the pilot runs, the team found that the updated tool predicts staffing needs more accurately than the draft tool. The draft tool only states how many staff are required for a visit, while the updated tool provides the time needed for each type of staff, as shown in the findings.

Additionally, the draft tool did not include many of the procedures that MCRU performs. The draft tool also assigned the same score to procedures that were different in complexity. The updated tool eliminates these two problems by providing a comprehensive list of updated services and more accurately quantifying the different complexities of procedures. In conclusion, the updated tool significantly improves the results of the old tool.

Recommendations

Based on the findings from evaluating and updating the draft protocol complexity tool, the team presents the following recommendations.

Use Scores Proactively

The team recommends the scores generated by the tool be used proactively to match workload to the staff available. This approach is in contrast to the current approach where, at times, the staff is asked last minute to work extra hours to cover all of the visits that day. When the working hours are predictable, the clinical staff is much more likely to be satisfied on the job. This approach will improve staff utilization and predictability, as idle time and over time are reduced.Reference Time Component of Tool Output

In addition, the team recommends that the time component of the output be used to help determine the duration of the participant appointment. The staff time component will in most cases be shorter than the length of the visit because it is solely clinical staff time required by the visit. The space time component of the tool can be referenced to better plan for visit duration. By allocating adequate time for visits, MCRU can provide a higher quality of service to participants through reduced wait time before the visit and idle time during the visit.

Encourage Uniform Visit Labeling across Protocol Initiation and Visit Scheduling Stages

The team recommends MCRU encourage study teams to use uniform and consistent visit labeling across the protocol initiation stage and visit scheduling stage. Consistent visit labeling will be most helpful to tool’s user, because the visit numbers will be consistent in both the tool’s output and the daily staffing schedule. In general, uniform labeling will decrease confusion for both the study team and MCRU staff.

Expected Impact

The team collected data from meetings, interviews, and observations to refine the time and complexity requirements for each protocol task. The draft tool was evaluated and updated to provide a score for each of these requirements. Through the updated tool, a combined rating can be generated for a protocol visit. The tool will result in:

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A quantifiable and consistent method to evaluate time and complexity for protocols Better scheduling efficiency to prevent overutilization or underutilization of staff Improved employee satisfaction Increased quality of services to participants through better use of resources

For a given day with a pre-scheduled set of protocol visits, the overall task time and complexity can be factored into building optimal staff assignments. Nurses in the unit will be able to quantitatively understand the reasoning behind the day’s staffing assignments. Additionally, when scheduling new protocols, the Nursing Supervisor can evaluate the visit’s score and time needed to ensure that there is enough nursing capacity before adding the visit to that day’s schedule.

In addition to the updated tool, MCRU will continue to track metrics at the daily huddle meetings, based on the team’s method of taking data at huddle meetings. MCRU will record this information for quality control within the unit.

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References

[1] L. Baker, A. Chang, and A. Pollock. "Final Report on Project to Assess Comprehensive Pharmacy Services for Michigan Clinical Research Unit (MCRU).” Practicum in Hospital Systems: Ann Arbor, Michigan. Report. 16 Dec. 2010.

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Appendix A: Draft Protocol Complexity Tool (Microsoft Excel version)

Score Your Score Score Your Score Protocol #:1 Admission > 30 mins Length of Study Type of Care (basic moderate, complex):1 Assessment > 30 mins 1 0-3 hrs1 Set - Up > 20 mins 1 4-10 hrs * Shaded boxes = Tasks can be performed by MA1 Teaching > 30 mins 2 11-15 hrs * If more than 3 shaded boxes selected, add MA to scheduled staff1 Discharge > 20 mins 3 > 15 hrs (overnight)1 Emotional Care > 20 mins 1 Normal Healthy Participants1 EKG/ECG 2 Disease Specific Participants < 7 pts Basic Care staff 1 RN, 1 MA

Monitoring/Vital Signs 1 Pediatric Participants 7-19 pts Moderate staff 2 RN, 1 MA2 Q < 15 mins 1 Isolation Precautions 20-25 pts Moderate staff 3 RN, 1-2 MA2 Q 30 mins > 25 pts Complex staff 4 RN, 1-2 MA1 Q hr1 Q > 1 hr Score Your Score1 Timed Walks 1 IV Placement Points1 Questionnaires 2 Multiple IV Placements Staff needed

2 Placement of PICC/Cath/PortInvasive Procedure Assist

Score Your Score 1 0-30 min1 Single Blood Draw 2 > 30 mins

PK/PD, Multiple Blood Draws 1 Single Agent Infusion1 1-5 draws 2 Multiple Agent Infusions2 5-10 draws 1 Conscious Sedation3 10-20 draws4 > 20 draws

Specimen Collection EKG/ECG Electrocardiogram1 urine sample OGTT Oral glucose tolerance test1 nose/throat swab PICC Peripherally inserted central catheter1 Pregnancy Test PK/PD Pharmacokinetic/Pharmacodynamic1 OGTT (oral glucose tolerance test)

Abbreviations

Points

Total

General Information

Phlebotomy

Basic Care Research

Interventions

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Appendix B: Clinical Staff Survey

1. What is your role? (select one)

2. In general, do you feel understaffed? (select as many that apply)

No, in general, I do not feel understaffed.Yes, there are too many protocols scheduled each day.Yes, the protocols are unevenly distributed throughout the day.Yes, there are too many protocols that require an RN.Yes, there are not enough clinical staff members that work at MCRU.Yes, the protocols are too complex for the amount of clinical staff.

3. On average, what time of day do you feel most busy? (select as many that apply)

8-10 am9-11 am10-12 pm11-1 pm12-2 pm1-3 pm2-4 pm3-5 pm4-6 pm5-7 pm6-8 pm

4. What % of time are you busy during the average work day?

5. We are trying to better understand MCRU procedures. Rate the complexity (basic, moderate, complex) of each of the following procedures. If you have never performed a task, select “I have never performed this task.”

Basic Moderate Complex I have never performed this

taskEKG/ECGPhysical AssessmentTimed WalksVital SignsBlood DrawsPregnancy Urine TestUrine SampleEndoscopyLumbar punctureInfusionInjection

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Oral drug(cont.)

Liver biopsyMuscle/fat biopsySkin biopsyConscious sedationOral Glucose Tolerance TestPelvic examPlacement of catheterPort accessIV insertionMixed meal test

6. How many times on the average day does charting in Mi Chart disrupt your normal workflow, if any? (Enter a number)

7. How much time (in minutes) on the average day do you chart in Mi Chart?

8. Enter any additional comments. (optional)

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Appendix C: Huddle Meeting Tally Sheet

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Appendix D: Updated Protocol Complexity Tool

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(cont.)

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Appendix E: Current State Value Stream Map

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Appendix F: List of Procedures Performed by MCRU

MCRU Service Estimated Time (minutes)RN 1 RN 2 RN 3 Average

Basic ServicesEKG/ECG 15 15 15 15Physical Assessment 60 45-60 60 57.5Timed Walks 10-15 15 15 15Vital Signs 2-3 5 10 5.8

Specimen CollectionBlood 5 15 5-15 10Pregnancy Urine/Blood Test 2 2 5 3Stool - - 5 5Urine - - 5 5

ProceduresEndoscopy 60 60-120 60 70Lumbar Puncture 45 45 30 40

Drug AdministrationInfusion (Including IV set up) depends depends depends -Injection 30 45 30-45 37.5Oral - 30 15-30 26.3SC injection - - - -

BiopsyLiver 30 120 120 90Muscle/Fat 30 45 15 30Skin 30-45 45 45-60 45

OtherConscious Sedation - 90 120 105Oral Glucose Tolerance Test 150 150 150 150Pelvic Exam 30 30 30 30Placement of Catheter 30 30 30 30Port Access - - 30 30IV Insertion - - 15 15Mixed Meal Test - - 210 210

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Appendix G: Clinical Staff Survey Results

Figure G-1. (Source: MCRU Survey, Data Collection: February 27, 2014 – March 7, 2014, Sample Size: 7)

Figure G-2.(Source: MCRU Survey, Data Collection: February 27, 2014 – March 7, 2014, Sample Size: 7)

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Figure G-3.(Source: MCRU Survey, Data Collection: February 27, 2014 – March 7, 2014, Sample Size: 7)

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Table G-1.(Source: MCRU Survey, Data Collection: February 27, 2014 – March 7, 2014, Sample Size: 7)Procedure Basic Moderate Complex I have never performed this taskEKG/ECG 0 7 0 0Physical Assessment 0 0 5 2Timed Walks 4 1 0 2Vital Signs 7 0 0 0Blood Draws 1 6 0 0Pregnancy Urine Test 7 0 0 0Urine Sample 5 2 0 0Endoscopy 0 2 2 3Lumbar puncture 1 4 1 2Infusion 0 0 5 2Injection 0 5 0 2Oral drug 0 4 1 2Liver biopsy 0 0 5 2Muscle/fat biopsy 0 5 0 2Skin biopsy 0 4 1 2Conscious sedation 0 0 4 3

Oral Glucose Tolerance Test 1 6 0 0Pelvic exam 5 1 0 1Placement of catheter 0 5 0 2Port access 0 4 1 2IV insertion 0 7 0 0Mixed meal test 0 6 1 0

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Figure G-4.(Source: MCRU Survey, Data Collection: February 27, 2014 – March 7, 2014, Sample Size: 7)

Figure G-5.(Source: MCRU Survey, Data Collection: February 27, 2014 – March 7, 2014, Sample Size: 7)

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Appendix H: Clinical Nurse Specialist Interview

IOE 481 Clinical Nurse Specialist Interview 2/12/14, 10:30-11 am

Q1. What tasks are you specifically responsible for to prepare for a protocol initiation meeting?

Answer:-First step: MCRU initiation email-Review all information about study on eResearch-Determine what MCRU is responsible for-Gain background knowledge about study-Determine what questions need to be asked-Look at the time and events table: what MCRU is doing on unit (or if mobile)-Checklist of discussion points

Q2. What tasks are you responsible for after a protocol initiation meeting?

Answer:-Take everything from meeting-Provide guidelines to staff and nurses-2-week period to review-Every clinical staff member needs to sign off on the protocol-Expectations are high for staff-2 other nurses can help Chris with writing up materials if workload is too high

Q3. Do you feel that it is burdensome trying to remember what goes on in all of the protocols? How do you keep track of everything?

Answer:-Impossible to keep track of everything; too much information-Using reference tools and guidelines – very valuable-Sometimes protocols seem more complex on paper than in real life

Q4. In your opinion, if a score were to be assigned to each visit in a protocol, is that something that could be done during a protocol initiation meeting? Or do you think it should be done by MCRU or by the study team prior to a protocol initiation meeting?

Answer:-Might be too tedious to perform at protocol initiation meeting

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Appendix I: Evaluating Draft Tool

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Appendix J: Updated Tool Pilot Run

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