STITCH Trauma Telephone Randomisation Service STITCH ...research.ncl.ac.uk/trauma.STITCH/Information...

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Introduction The purpose of the STITCH Trial Randomisation Service is to allocate a treatment to participants in the STITCH Trial. The Randomisation Service system is telephone based. As you use the system you will be required to respond to it in one of two ways - dialling numbers on your telephone keypad, or speaking a response into the telephone handset. To make it easier for you, the image below will clearly indicate if you will need to interact with the telephone randomisation service. Use your telephone keypad to enter data Speak into the telephone when prompted Randomisation Telephone No. + 44 (0) 1224 273 661 Your Trial ID Code This will be a 4 digit code provided by the STITCH(Trauma) Office Any problems? STITCH Trial Office (general inquiries) E-mail: [email protected] Tel: + 44 (0) 191 222 5764 Dan Barnett (programmer) E-mail: [email protected] Tel: + 44 (0) 1224 438 186 STITCH Trauma Telephone Randomisation Service User Guide

Transcript of STITCH Trauma Telephone Randomisation Service STITCH ...research.ncl.ac.uk/trauma.STITCH/Information...

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STITCH Trauma User Guide

Introduction

The purpose of the STITCH Trial Randomisation Service is to

allocate a treatment to participants in the STITCH Trial.

The Randomisation Service system is telephone based. As

you use the system you will be required to respond to it in one

of two ways - dialling numbers on your telephone keypad, or

speaking a response into the telephone handset.

To make it easier for you, the image below will clearly indicate

if you will need to interact with the telephone randomisation

service.

Use your telephone keypad to enter data

Speak into the telephone when prompted

Randomisation Telephone No.

+ 44 (0) 1224 273 661

Your Trial ID Code

This will be a 4 digit code provided by the STITCH(Trauma)

Office

Any problems?

STITCH Trial Office (general inquiries)

E-mail: [email protected]

Tel: + 44 (0) 191 222 5764

Dan Barnett (programmer)

E-mail: [email protected]

Tel: + 44 (0) 1224 438 186

STITCH Trauma Telephone Randomisation Service

User Guide

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STITCH Trauma User Guide

Tel: +44 (0) 1224 273 661 Part 1 – Entering the Centre number

Prompt

Welcome to the Aberdeen Trials Service. Please enter your Centre Number or trial id code then press the * key.

Your response

You should respond with the 4-digit code given to you by the STITCH Trauma Study co-ordinator. For example, 1111*

Prompt

This is the STITCH Trauma trial. Your trial centre is …...

Your response

Part 2 – Name of neurosurgeon

Prompt

Please speak the name of the consultant neurosurgeon after the tone, then press the star key

Your response

You should respond by speaking into the handset after the tone. For example, John Smith *

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

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STITCH Trauma User Guide

Part 3 – Patient's name

Prompt

Please speak the patient's name after the tone, then press the star key

Your response

You should respond by speaking into the handset after the tone. For example, Michael Smith *

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

Part 4 – Date of Birth

Prompt

Please enter the patients date of birth as 8 digits in the form day-day month-month year-year-year-year.

Your response

You should respond by dialling the date of birth as 8 digits. For example, the date 18th February 1974 would be 18021974

Prompt

The date you entered was … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

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STITCH Trauma User Guide

Part 5 – Gender

Prompt

Please supply the gender of the patient. Enter 1 for Male or 2 for Female.

Your response

You should respond by dialling 1 or 2. For example, 1

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

Part 6 - Consent

Prompt

Has consent been obtained? Enter 1 for yes, 2 for yes (via proxy) or 3 for no.

Your response

You should respond by dialling 1 or 2. For example, 1

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

If consent has not been obtained, the call will terminate.

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STITCH Trauma User Guide

Part 7 - Date of injury

Prompt

Please enter the date of injury as 8 digits in the form day-day month-month year-year-year-year.

Your response

You should respond by dialling the date of injury as 8 digits. For example, the date 18th March 2009 would be 18032009

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

Part 8 - Time of injury

Prompt

Please enter the time of injury as 4 digits in the form hour-hour-minute-minute. The first two digits for the hour, the second two digits for the minutes.

Your response

You should respond by dialling the time of injury as 4 digits. For example, the date 1:45pm would be 1345 1pm = 1300, 2pm=1400, 3pm=1500, 4pm=1600, 5pm=1700, 6pm=1800, 7pm = 1900, 8pm=2000, 9pm=2100, 10pm=2200, 11pm=2300, 12am=0000

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

If the time since injury is >= 48 hours, the call will terminate.

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STITCH Trauma User Guide

Part 9 - Glasgow Coma Score - Best eye response

Prompt

Please enter the Glasgow coma score best eye response

Your response

You should respond by dialling 1, 2, 3 or 4. For example, 4

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

Part 10 - Glasgow Coma Score - Best verbal response

Prompt

Please enter the Glasgow coma score best verbal response

Your response

You should respond by dialling 1, 2, 3, 4 or 5. For example, 2

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

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STITCH Trauma User Guide

Part 11 - Glasgow Coma Score - Best motor response

Prompt

Please enter the Glasgow coma score best motor response

Your response

You should respond by dialling 1, 2, 3, 4, 5 or 6. For example, 6

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

Part 12 - Pupil response

Prompt

Please supply the pupil reaction. Enter 1 for both reactive, 2 for one reactive, 3 for both unreactive (<4mm) or 4 for both unreactive (>=4mm).

Your response

You should respond by dialling 1, 2, 3 or 4. For example, 4

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

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Part 13 - CT Scan - Location of the largest haemorrhage?

Prompt

Where is the largest haemorrhage located? Enter 1 for frontal, 2 for temporal, 3 for parietal or 4 for occipital.

Your response

You should respond by dialling 1, 2, 3 or 4. For example, 3

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

Part 14 - CT Scan - Maximum length of largest haematoma

Prompt

Please enter the maximum length of the largest haematoma in millimetres, then press the star(*) key

Your response

You should respond by dialling length in millimetres. For example, 30*

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

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Part 15 - CT Scan - Width of largest haematoma (at 90 degrees)

Prompt

Please enter the width of the largest haematoma in millimetres, then press the star(*) key

Your response

You should respond by dialling width in millimetres. For example, 30*

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

Part 16 - CT Scan - Height of largest haematoma

Prompt

Please enter the height of the largest haematoma in millimetres, then press the star(*) key

Your response

You should respond by dialling height in millimetres. For example, 30*

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

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Part 17 - CT Scan - Second haemorrhage

Prompt

Is a second haemorrhage present? Enter 1 for yes or 2 for no.

Your response

You should respond by dialling 1 or 2. For example, 2

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

If yes, continue, otherwise skip to Step 22

Part 18 - CT Scan - Location of the second haemorrhage?

Prompt

Where is the second haemorrhage located? Enter 1 for frontal, 2 for temporal, 3 for parietal or 4 for occipital.

Your response

You should respond by dialling 1, 2, 3 or 4. For example, 3

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

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Part 19 - CT Scan - Maximum length of second haematoma

Prompt

Please enter the maximum length of the second haematoma in millimetres, then press the star(*) key

Your response

You should respond by dialling length in millimetres. For example, 15*

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

Part 20 - CT Scan - Width of second haematoma (at 90 degrees)

Prompt

Please enter the width of the second haematoma in millimetres, then press the star(*) key

Your response

You should respond by dialling width in millimetres. For example, 5*

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

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Part 21 - CT Scan - Height of second haematoma

Prompt

Please enter the height of the second haematoma in millimetres, then press the star(*) key

Your response

You should respond by dialling height in millimetres. For example, 5*

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

Part 22 - Other inclusion and exclusion criteria

Prompt

Are all other inclusion and exclusion criteria fulfilled? Enter 1 for yes or 2 for no.

Your response

You should respond by dialling 1 or 2. For example, 1

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

Note: If the inclusion and exclusion criteria have not been fulfilled, the call will terminate.

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STITCH Trauma User Guide

Important: Your randomisation will not be saved until you confirm the Randomisation number.

Part 23 - Allocated treatment

Prompt

The allocated treatment is Early surgery / Initial Conservative Treatment. Please confirm the allocated treatment as Early surgery / Initial Conservative Treatment by dialling 1 for Early Surgery or 2 for Initial Conservative Treatment.

Your response

You should respond by the allocated treatment For example, 1

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

Part 24 - Randomisation number

Prompt

The randomisation number is XXX. Please confirm the randomisation number by dialling it on the telephone keypad after the tone.

Your response

You should respond by dialling the randomisation number. For example, 123

Prompt

You said … Press 1 to continue or 2 to modify.

Your response

Respond by dialling 1 or 2 on the telephone keypad

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STITCH Trauma User Guide

Part 25 - End of call

Prompt

Thank you for calling the STITCH Trauma Randomisation Service. Please hang up now.

Your response

Please hang up the phone.