24-Hour Urine Study Procedures Manual 2014

24-Hour Urine Study Procedures Manual

January 2014

Table of Contents

Chapter 1

2 3

Introduction to the 24-Hour Urine Study.......................................................

1.1 Introduction ........................................................................................... 1.2 Background and Justification .............................................................. 1.3 Study Protocol .......................................................................................

1.3.1 MEC Recruitment ................................................................ 1.3.2 UMEC First Visit.................................................................. 1.3.3 Completion Questionnaire--UMEC Second

Visit ......................................................................................... 1.3.4 Second 24-Hour Urine Collection ..................................... 1.3.5 Processing 24 Hour Urine Specimens ............................... 1.3.6 Home Urine Collection ....................................................... 1.3.7 Scheduling Sample Persons (SPs) Using the

Field Followup Management System (FFMS).................. 1.3.8 24-Hour Urine Terminology...............................................

24-Hour Urine Recruitment..............................................................................

Field Followup Management System...............................................................

3.1 Logging onto the FFMS....................................................................... 3.2 Summary of FFMS Functions............................................................. 3.3 Viewing Appointments Using the Day Tab...................................... 3.4 Viewing Appointments Using the Week Tab ................................... 3.5 Viewing Appointments Using the Month Tab ................................. 3.6 Viewing and Printing the Appointment Schedule............................ 3.7 Scheduling Appointments for "Not Scheduled" SPs ...................... 3.8 Rescheduling Appointments for SPs Already on the

Schedule ..................................................................................................

3.8.1 OPTION #1: Use this Option if the SP's Current Appointment Date is Known ..............................

3.8.2 OPTION #2: Use this Option if the SP's Current Appointment Date is Not Known ......................

Page

1-1

1-1 1-1 1-1

1-2 1-2

1-3 1-3 1-4 1-4

1-4 1-5

2-1

3-1

3-2 3-3 3-4 3-5 3-6 3-8 3-14

3-21

3-22

3-26

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Contents (continued)

Chapter 4 5

3.9 Call History ............................................................................................

3.9.1 3.9.2.

OPTION #1: Rescheduling through Appointment Manager......................................................... OPTION #2: Rescheduling through Call History ....................................................................................

3.10 Contact Manager ? Viewing Addresses and Phone Numbers .................................................................................................

3.11 Making Reminder Calls ........................................................................ 3.12 Reminder Call Scripts ...........................................................................

24-Hour Urine Collection Kit...........................................................................

4.1 Items in the 24-Hour Collection Kit..................................................

4.1.1 Supplies Used While SP is at Home .................................. 4.1.2 Supplies Used While SP is Away from Home..................

4.2 SP Instruction Handouts .....................................................................

4.2.1 Starting and Ending Collection in UMEC ........................ 4.2.2 Starting and Ending Collection at Home.......................... 4.2.3 Preparing SP Instruction Handouts................................... 4.2.4 Types of Handouts ............................................................... 4.2.5 Using the Handouts ............................................................. 4.2.6 Starting Collection at UMEC and Ending at

Home ...................................................................................... 4.2.7 24 Hour Urine Talking Points ............................................ 4.2.8 Other SP Instructions ..........................................................

ISIS Application for 24-Hour Urine Study.....................................................

5.1 Picking Up First 24-Hour Urine Collection Kit (Phase 1)..............

5.1.1 Logging onto the 24-Hour Urine Compliance Application ............................................................................

5.1.2 SP Log Pickup List ............................................................... 5.1.3 Verify SP Return Appointment .......................................... 5.1.4 Begin Instructing SP.............................................................

Page

3-29

3-29

3-34

3-35 3-38 3-40

4-1

4-1

4-2 4-2

4-3

4-3 4-3 4-3 4-4 4-5

4-5 4-5 4-6

5-1

5-1

5-1 5-4 5-5 5-6

iv

Contents (continued)

Chapter 6

5.1.5 Receipt for Transportation Allowance .............................. 5.1.6 Printed Receipt for Transportation.................................... 5.1.7 24-Hour Urine Exam Status Screen...................................

5.2 Returning the First 24-Hour Urine Collection (Phase 2) ................

5.2.1 Completion Questionnaire .................................................. 5.2.2 Receipt for Collecting 24-Hour Urine ............................... 5.2.3 Thank You for Participating ............................................... 5.2.4 24-Hour Urine Exam Status Screen................................... 5.2.5 SPs Eligible for Second 24-Hour Urine

Collection ............................................................................... 5.2.6 Schedule SP Appointment to Pick Up Second

24-Hour Urine Kit................................................................

5.3 Picking Up Second 24-Hour Urine Collection Kit (Phase 3) .................................................................................................

5.3.1 Logging into the 24-Hour Urine Compliance Application ............................................................................

5.3.2 SP Log Pickup List ............................................................... 5.3.3 Verify the SP's Return Appointment................................. 5.3.4 Begin Instructing the SP ...................................................... 5.3.5 Receipt for Transportation Allowance .............................. 5.3.6 24-Hour Urine Exam Status Screen...................................

5.4 Returning Second 24-Hour Urine Collection (Phase 4)..................

5.4.1 Completion Questionnaire .................................................. 5.4.2 Receipt for Collecting 24-Hour Urine ............................... 5.4.3 Thank You for Participating ............................................... 5.5.4 24-Hour Urine Exam Status Screen...................................

Completion Questionnaire ................................................................................

6.1 Observation Questions ........................................................................ 6.2 Example of the Observational Questions ......................................... 6.3 Special Program Functions .................................................................. 6.4 Questions for SP to Determine Completeness of the

Sample.....................................................................................................

Page

5-7 5-8 5-10

5-11

5-11 5-11 5-14 5-15

5-16

5-17

5-18

5-18 5-19 5-19 5-19 5-19 5-19

5-20

5-20 5-21 5-21 5-21

6-1

6-1 6-5 6-6

6-10

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Contents (continued)

Chapter 7

8

6.5 Example of the 24-Hour Urine Completion Questionnaire ........................................................................................

6.6 Reasons Why the 24-Hour Urine Is Not Complete ........................ 6.7 Procedures for 24-Hour Urine In-Person Home Visit ...................

6.7.1 Receipt to Use for In-Person Home Visits (Exhibit 6-8) ..........................................................................

24-Hour Urine Petty Cash System ...................................................................

7.1 Remuneration Incentives for 24-Hour Urine ...................................

7.1.1 Remuneration ........................................................................ 7.1.2 Transportation....................................................................... 7.1.3 Child Care/Adult Care.........................................................

7.2 Obtaining Petty Cash from the Field Office.....................................

7.2.1 Large Advance....................................................................... 7.2.2 Small Advance.......................................................................

7.3 Handling of Petty Cash ........................................................................

7.3.1 Petty Cash Disbursement .................................................... 7.3.2 Petty Cash Storage................................................................ 7.3.3 Preparing Your Cash Box for the Day .............................. 7.3.4 Reconciliation of Cash Advances.......................................

7.4 End of Stand Petty Cash Reconciliation Procedure ........................

Home Urine Collection .....................................................................................

8.1 Background ............................................................................................ 8.2 Description of Examination Room.................................................... 8.3 Description of Equipment and Supplies ...........................................

8.3.1 Equipment ............................................................................. 8.3.2 Supplies ..................................................................................

Page

6-11 6-14 6-14

6-17

7-1

7-1

7-1 7-1 7-2

7-2

7-2 7-4

7-5

7-5 7-5 7-6 7-6

7-14

8-1

8-1 8-2 8-3

8-3 8-3

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Contents (continued)

Chapter 9

8.4 Start of Stand Procedures ....................................................................

8.4.1 Room Setup Procedures ...................................................... 8.4.2 Inventory Management........................................................

8.5 Inventory Management During the Stand......................................... 8.6 End of Stand Procedures ..................................................................... 8.7 Urine Collection Kit Storage ............................................................... 8.8 Protocol ..................................................................................................

8.8.1 Overview................................................................................ 8.8.2 Eligibility Criteria .................................................................. 8.8.3 Pre-Examination Procedures .............................................. 8.8.4 Recruiting the Participant to Accept the Home

Collection ............................................................................... 8.8.5 Examination Procedures ..................................................... 8.8.6 Packing the Urine Collection Kit for the SP to

Take Home ............................................................................ 8.8.7 Final Steps.............................................................................. 8.8.8 Coding Not Done Exams ...................................................

Processing 24-Hour Urine Specimens.............................................................

9.1 Logging onto 24-Hour Urine Processing .......................................... 9.2 24-Hour Urine Processing--Weighing Containers .........................

9.2.1 Tare Weight ........................................................................... 9.2.2 Adjusted Weight ................................................................... 9.2.3 Comment Codes ................................................................... 9.2.4 Multiple Urine Containers................................................... 9.2.5 Weigh Containers but Do Not Process

Conditions .............................................................................

9.3 Processing the 24-Hour Urine Samples.............................................

9.3.1 Special Procedure for Vessels 193 and 206 ? Use Eppendorf Pipette to Dispense 3mL ................................

9.3.2 Filling all Vessels................................................................... 9.3.3 Not Filling All Vessels ......................................................... 9.3.4 Container Verification..........................................................

Page

8-5

8-5 8-5

8-6 8-6 8-7 8-7

8-7 8-8 8-8

8-9 8-10

8-23 8-23 8-24

9-1

9-1 9-2

9-3 9-4 9-5 9-6

9-8

9-12

9-13 9-15 9-17 9-20

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Contents (continued)

Chapter 10 11

12 13

9.4 Laboratory Quality Control .................................................................

9.4.1 Start of Stand QC ................................................................. 9.4.2 Daily QC ................................................................................ 9.4.3 Weekly QC............................................................................. 9.4.4 End of Stand QC .................................................................. 9.4.5 QC Pop-Up Message ...........................................................

Printing Labels for 24-Hour Urine Vessels ....................................................

10.1 Introduction ........................................................................................... 10.2 Print Vessel Labels Using the Label Print Application ................... 10.3 Main Printing Screen ............................................................................ 10.4 Filter Options ........................................................................................ 10.5 Print Key ................................................................................................

10.5.1 Print Options: Modules to Print......................................... 10.5.2 Printing Individual Labels ...................................................

Shipping Procedures for 24-Hour Urine.........................................................

11.1 Create New Container Labels ............................................................. 11.2 Reprinting Container Labels from the Container Map

Screen ...................................................................................................... 11.3 Shipping Overview ............................................................................... 11.4 Assign Containers to Shippers ............................................................ 11.5 Create Shipping Manifests ................................................................... 11.6 Packing Procedure for the Shippers................................................... 11.7 Pack Medium Shipping Containers for Frozen Shipment .............. 11.8 Pack Small Shipping Containers for Frozen Shipment ................... 11.9 Label Shippers .......................................................................................

Inventory and Teardown Procedures ..............................................................

12.1 General Procedures .............................................................................. 12.2 End of Stand Inventory Procedures .................................................. 12.3 Mid-Stand Inventory Procedures........................................................

Interpreters ..........................................................................................................

Page

9-27

9-27 9-28 9-29 9-30 9-31

10-1

10-1 10-2 10-2 10-3 10-8

10-8 10-9

11-1

11-1

11-3 11-4 11-6 11-11 11-17 11-20 11-21 11-21

12-1

12-1 12-2 12-3

13-1

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Contents (continued)

Appendixes

A

Starting and Ending in the UMEC...................................................................

B

Starting and Ending at Home ...........................................................................

C

"What To Do" Urine Collection and Shipping Instructions

English and Spanish ...........................................................................................

D

Kit Labeling Instructions...................................................................................

E

Talking Points English and Spanish ................................................................

F

Inventory of Home Urine Collection Supplies ..............................................

Page A-1 B-1

C-1 D-1 E-1 F-1

Exhibits 2-1 2-2 2-3 2-4 2-5 2-6 2-7 2-8 2-9 2-10 2-11 2-12 2-13

24-hour urine icon .............................................................................................. 2-1 24-hour urine recruitment script ...................................................................... 2-2 Agreement schedule ........................................................................................... 2-2 Scheduling screen ............................................................................................... 2-3 Scheduling screen sections ................................................................................ 2-4 Family members.................................................................................................. 2-5 Preferred day ....................................................................................................... 2-5 Show all pickup times ........................................................................................ 2-6 No return appointment...................................................................................... 2-6 Return times ........................................................................................................ 2-7 Scheduling error .................................................................................................. 2-8 Not scheduled ..................................................................................................... 2-8 Warning to enter a reason ................................................................................. 2-9

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