Evaluation of a "Fast Track" Respiratory Therapy Clinic for Patients With Suspected Severe Sleep-Disordered Breathing
Phase: NA
Conditions: Sleep Disordered Breathing
Sponsor: University of Calgary

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Fast Track Protocol v5.4 
Updated January 25, 2017 
Evaluation of a “Fast Track” Respiratory Therapy Clinic for Patients with Suspected Severe Sleep-
Disordered Breathing 
STUDY PROTOCOL 
NCT#: 02191085 
Document Date: January 25, 2017 
 
 
 

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Fast Track Protocol v5.4 
Updated January 25, 2017 
FAST TRACK PROTOCOL 
RECRUITING PROCESS 
TRIAGING PROCESS 
Triage team will screen all referrals to identify all suspected sleep disordered breathing (SDB) 
patients with one of the following criteria: 
• 
“Urgent” categorized referral. If patient is deemed urgent based on ESS alone, the Fast Track 
clinic supervisor will review with the project’s lead sleep physician (LSP) to determine 
whether assessment for study eligibility is appropriate 
• 
No previous treatment of sleep apnea (i.e. CPAP, BPAP, dental appliance, upper airway 
surgery) 
• 
Adjusted neck circumference (ANC) >= 43 from the referral questionnaire. ANC = Neck 
circumference in cm + 3 cm (history of snoring) + 3 cm (history of witnessed apnea) + 4 cm 
(Hypertension) 
• 
A level 3 home sleep apnea test (HSAT) result with one of the following: 
o Respiratory disturbance index (RDI) > 30 events/hour  
o Mean nocturnal oxygen saturation < 85%  
o Suspected hypoventilation, defined by an RDI > 15 events/hour AND partial 
pressure of carbon dioxide > 45 mmHg on arterial blood gas (within 6 months prior 
to referral). 
 
The triaging team will give the triaged referrals to the booking clerk to schedule ambulatory sleep 
tests for each patient. All triaged HSAT appointments will be marked in green in the scheduling 
system. The research associate (RA) will check the scheduling system (daily) and/or with the 
booking clerk to obtain date and times of HSAT appointments. The RA cannot see referrals or any 
patient information at this point until the sleep centre’s general research consent form  is 
signed. 
 
Possible scenarios 
Action 
Patient has one or more 
concerns that may 
compromise enrollment 
(i.e. Patients with 
significant cognitive 
impairment) 
The triaging team will notify the LSP to review the patient’s chart 
and determine if patient should be approached for the study. 
 
The triaging team will notify the RA if the patient is deemed 
ineligible on this basis and the RA will manually tally the number 
and reasons for ineligibility.  
Patients referred with 
unexplained hypoxemia 
who are on oxygen 
The triaging team will notify the LSP to determine if patient meets 
triaging criteria. (e.g. suspected severe SDB vs. other 
cardiopulmonary disease requiring oxygen and a suspicion of sleep 
disorder) 
 

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Fast Track Protocol v5.4 
Updated January 25, 2017 
The LSP will also determine if the patient requires an additional 
HSAT without oxygen. If so, the LSP will provide a note in the chart 
and the booking clerk will book the patient.  
Out of town patients 
The triaging team will accept out-of-house HSAT tests provided that 
the tests are completed with a Remmers recorder. The LSP will 
review the patient’s chart and test to authorize the inclusion of 
these patients/tests before the patients are contacted. 
 
CONSENTING PROCESS 
Upon arrival to the ambulatory sleep test appointment, the patient will be given the opportunity to 
sign the general research consent form by the HSAT administration team. Once patient has 
completed the HSAT training process and has signed the green form, HSAT clerk will say the 
following to the patient:  
 
“Based on your profile, you may be eligible to participate in a study. [Name] is a research 
associate and he/she is available in the waiting area to tell you what this study is about. 
Your participation is appreciated but not mandatory.”  
 
If the patient agrees, the RA will greet the patient and explain and obtain a written informed 
consent for the Fast Track study.  
Upon consenting, the RA will prepare a hard-copy of the “Fast Track Summary Sheet” (see Appendix 
1). All data will also be entered into an Excel sheet. All hard-copies of the “Fast Track Summary 
Sheet” and the Excel sheet will be stored at W21C. 
Possible scenarios 
Action 
Patient does not sign the 
general research consent 
form 
The RA will have no access to patient chart/data and will manually 
tally the number of non-consenting individuals manually. The RA 
will notify the Fast Track clinic supervisor of patient 
(anonymously). 
 
The LSP will review all charts with the Fast Track clinic supervisor 
to determine if the assessment will be done with the ACP Fast Track 
clinic (non-study) or by a sleep physician.   
Patient consent to general 
research but not to the 
study.  
The RA will ask why patient does not want to participate in the 
study and will tally the number and reason of non-consenting 
patients. The RA will notify the Fast Track clinic supervisor of 
patient. 
 
The LSP will review all charts with the Fast Track clinic supervisor 
to determine if the assessment will be done with the ACP Fast Track 
clinic (non-study) or by a sleep physician.   
Patient cannot stay after 
HSAT training to complete 
the consenting process 
 
The RA will provide the following options to the patient:  
1) Explain and obtain a verbal consent over the phone, 
followed by a written consent at the baseline visit 
(regardless of eligibility), 

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Fast Track Protocol v5.4 
Updated January 25, 2017 
2) Explain and obtain written consent when patient returns 
the HSAT machine, 
3) Give the consent form to the patient to read/sign at home 
and return when patient returns the machine. 
 
If patient refuses all options, patient is opted out of the study. The 
RA will notify the Fast Track clinic supervisor of patient and tally 
the number and reason of non-consenting patients. 
 
The LSP will review all charts with the Fast Track clinic supervisor 
to determine if the assessment will be done with the ACP Fast Track 
clinic (non-study) or by a sleep physician.   
Patient expresses difficulty 
in availability 
The RA will let patients know that the questionnaire portion of the 
study could be mailed/emailed to the patient and HSAT could be 
completed via homecare company.  
 
If patient still expresses difficulty, the RA will check if the patient 
would rather opt out of the study. 
Patient requires more time 
to understand and read 
through the consent form. 
The patient will be given a consent form to take home and return 
after completing the ambulatory sleep test. If a consent form is not 
returned within 24 hours, the RA will call to follow-up with the 
patient. 
Patients who are eligible 
based on previous HSAT 
results 
 
The Fast Track clinic supervisor will contact the patients via phone 
to obtain verbal consent for general research. If patient provides 
verbal consent, the Fast Track clinic supervisor will introduce the 
study and inform that an RA will be contact the patient. The RA will 
call the patient for a verbal consent for the study. If patient provides 
a verbal consent, a written consent will be obtained during the 
patient’s baseline visit regardless of eligibility. 
 
Note: Unlike standard referral procedures, the ambulatory sleep test and provider 
appointment will not be scheduled simultaneously, since the assignment of provider and 
subsequent appointment availability will depend on the study arm to which the patient is 
randomized. 
 
ELIGIBILITY  
Eligibility criteria include: 
• 
Written consent signed by the patient, 
• 
Patient is over 18 years old,  
• 
Patient did not have previous treatment of SDB, 
• 
HSAT results must show one of the following: 
o RDI > 30 events/hour on an ambulatory sleep test 
o Mean nocturnal oxygen saturation < 85%  
o Suspected hypoventilation, defined by an RDI > 15 events/hour AND partial 
pressure of carbon dioxide > 45 mmHg on arterial blood gas. 

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Fast Track Protocol v5.4 
Updated January 25, 2017 
Exclusion criteria include: 
• 
Primary health insurance provided by a province other than Alberta 
• 
No previous treatment of sleep apnea (i.e. CPAP, BAP, dental appliance, upper airway 
surgery) 
 
The RA will make a copy of HSAT results to include with the “Fast Track Summary Sheet” for each 
consented patient. The RA will notify The LSP to review HSAT results for all patients regardless of 
eligibility within a week. If patient is eligible, the RA will notify patients of eligibility and to expect 
a call from the sleep centre clerks within 5 – 10 business days. 
If patient is not eligible, the RA will give the patient’s chart to The Fast Track clinic supervisor. The 
LSP will review all charts with The Fast Track clinic supervisor to determine if the assessment will 
be done with the ACP Fast Track clinic (non-study) or by a sleep physician.   
Possible scenarios 
Action 
Patient has multiple HSAT 
results 
The most recent HSAT results from the clinic’s scheduled HSAT will 
be used to determine eligibility. 
Patient no longer wants to 
participate in the study or 
is not eligible 
The RA will attempt to identify the reason why patient does not 
want to participate in the study. The RA will remove the patient 
from the study and manually tally the number and reason the 
patient exited the study.  
 
Patient without a baseline visit will not be counted as part of the 
study. The RA will notify the Fast Track clinic supervisor of patient. 
Patient provided verbal 
consent but is not eligible 
Patient will still need to provide a written consent. The RA will 
approach the patient when patient is booked to review HSAT 
results. 
 
RANDOMIZATION 
Eligible patients will be randomly assigned by the RA to either to the Fast Track arm (intervention 
group) or to the standard treatment arm (control group) using the randomization website 
(www.randomization.com).   
 
For patients assigned to the “Fast Track” arm, the Fast Track clinic supervisor will schedule an 
appointment for the patient with an ACP. For patients assigned to the standard treatment arm, the 
booking clerk will schedule an appointment for the patient with a sleep physician. Patients will be 
asked to arrive 15 - 20 minutes prior to the appointment to complete study questionnaires. The 
booking clerks will notify the RA of the initial appointment date and time. 
STUDY PROCEDURE 
BASELINE VISIT & TREATMENT PLAN 

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Fast Track Protocol v5.4 
Updated January 25, 2017 
When patient arrives, the RA will ask the patients to complete the following questionnaires (ESS, 
Short SAQLI without treatment section, and HUI). The study will require an ESS at the time of the 
baseline visit, even though there may be multiple ESS questionnaires in the patient’s chart. 
If required, the sleep physician will order a polysomnography (PSG). The RA will check that the PSG 
is ordered as “urgent”. The following will be collected: PSG date, AHI, mean oxygen saturation and 
percentage of time under 90%.  
 
The RA will access the CPAP database to retrieve the patient’s treatment type. The RA will retrieve 
the patient’s treatment start date for the following treatments by: 
• 
CPAP/BAP – retrieving and calling the homecare company OR CPAP database, 
• 
Oxygen only – looking at the patient’s chart for the date when the patient was contacted 
about the PSG results (if the patient is previously on oxygen) OR determining when the 
patient started on oxygen, 
• 
Dental appliance – calling the dentist, 
• 
Weight loss – looking in the patient’s chart for the date treatment options were offered 
 
 
Possible scenarios 
Action 
Patient cancels or does not 
show to the appointment 
The RA will note the original appointment date and the rescheduled 
date. 
Patient does not show for 
3 or more appointments 
Patient is discharged from the CPAP clinic and the study. 
Patient stops their initial 
treatment 
The RA will note new treatment. 3-month and 1-year appointments 
will still be based on the original treatment date. 
Multiple patients need to 
meet the RA at the same 
time (recruitment, clinical 
visits) 
Possible options: 
1) Ask an another RA to assist in one of the appointments 
2) Ask The Fast Track clinic supervisor to obtain clinical study 
data at visit  
Patients with only a verbal 
consent to the study 
The RA will review the study with the patient and obtain a written 
consent to the patient regardless if the patient is eligible or not.  
 
If the patient revokes their verbal consent, the RA will remove 
patient from the study, identify the reason why the patient does not 
want to participate in the study. Because the patient has not yet had 
an initial appointment with a physician or an ACP, the patient will 
not be counted as part of the 150 patients recruited.  
 
The RA will notify the Fast Track clinic supervisor of patient. 
Patient delays their 
treatment  
If the patient delays their treatment due to insurance purposes, 
treatment start date will be the date they start their treatment. 
 
If the patient delays their treatment due to other medical reasons, 
the treatment start date will be the date that treatment was offered. 
Three-month and one year follow-up data will be collected as per 
usual procedures. 

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Fast Track Protocol v5.4 
Updated January 25, 2017 
Patient has had multiple 
PSGs after the indicated 
treatment start date 
The RA will pull the file and review with the LSP as the treatment 
start date may need to be modified. 
Patient does not have 
sleep disordered breathing 
after further testing (e.g., 
PSG) 
The treatment start date will be the date of the diagnostic test. 
Three-month and one year follow-up data will be collected as per 
usual procedures. 
 
 
3-MONTH & 1-YEAR FOLLOW-UP (± 2 WEEKS) 
 
3-Month Appointment Date and Time 
The RA will create a list (weekly) of patients who have completed their initial appointment for the 
booking clerk. The booking clerk will review the scheduling system to book and/or confirm 
patient’s 3-month appointment. Upon receiving the appointment date, the RA will complete a HSAT 
requisition for the booking clerk to book patient for a HSAT (in-house or with the patient’s CPAP 
company – if ordering a HSAT from the home care provider, state on cover letter to send the raw 
data to FMC Sleep Centre) on the day of the follow-up appointment or whenever is most convenient 
for the patient. HSAT test is to be completed with a Remmers recorder. Note: if the patient is on O2, 
request the HSAT done on room air or without O2. If the HSAT is completed on O2 note make a note 
that it was completed on O2 on the patients chart.  
 
1-Year Appointment Date and Time 
The RA will create a list (every 3 months) of patients who have completed their 3-month follow-up 
appointment for the booking clerk. The booking clerk will create a tracking task in the scheduling 
system to book the appointment several months before the 1-year target date. When the 
appointment is book, booking clerk will notify RA of appointment date and time. Upon receiving the 
appointment date, RA will complete a HSAT requisition for the booking clerk to book patient for a 
HSAT (in-house or with the patient’s CPAP company) on the day of the follow-up appointment or 
whenever is most convenient for the patient. HSAT test is to be completed with a Remmers 
recorder.  
 
The RA will attempt to call all three month and one year patients who do not have a follow up 
appointment booked through the Sleep Centre to coordinate the best date and time to complete the 
questionnaires.  
 
If the patient does not have a follow-up appointment booked at the Sleep Centre. We will use the 
date that the patient returns their questionnaire as the final appointment date; however, the 
research associate should note that it is the follow-up date not the final appointment date.  
 
At Time of Appointment 
The RA will give the patient a questionnaire package (ESS, Short SAQLI including treatment section, 
HUI, VSQ-9) at the time of visit. The ESS, Short SAQLI including treatment section and the HUI 
surveys are to be completed before the patient enters the clinical appointment. The VSQ9 survey is 

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Fast Track Protocol v5.4 
Updated January 25, 2017 
to be completed after the patient completes their clinical appointment. Download data will be 
obtained by the Fast Track clinic supervisor or by the therapist. The patient will not be 
compensated for parking if the follow-up visit is part of the patient’s clinical care. 
 
If there are any information missing from the Fast Track Summary sheet (i.e. Triaging criteria, co-
morbidities or medication), the RA will retrieve them from the chart or from the CPAP database 
before/during the time of visit. 
 
Possible scenarios 
Action 
Patient has a follow-up 
appointment booked 
outside of the 3-month 
or 1-year period  
The RA will book a follow-up appointment outside of the CPAP clinic 
with the patient and provide a reminder phone call a week before the 
appointment. The RA will also book a HSAT as per normal procedure.  
 
At the appointment, the RA will: 
1. Ask patient to complete the questionnaire package 
2. Ask The Fast Track clinic supervisor or the home-care 
company to retrieve CPAP data from the patient’s machine 
3. Give the patient a pre-paid parking voucher.  
Patient cannot come in 
for a follow-up 
appointment. 
The RA will book a HSAT via home-care company.  
 
The RA will email, fax, OR book a phone appointment with the patient 
to complete the questionnaire package. The date that the patient 
returns their questionnaire will be considered the final appointment 
date (3-month and 1-year); however, the RA should note that it is the 
follow-up date not the final appointment date. 
 
The RA will phone the home-care company to retrieve CPAP data 
from the patient’s machine.  
HSAT cannot be booked 
on the same day as the 3 
month or 1 year follow-
up appointment. 
The booking clerk will book a HSAT closest date to the follow-up 
appointment. The RA will give the patient a pre-paid parking voucher 
if the test was not ordered as part of the patient’s clinical care. 
Patient randomized in 
the “Fast Track” 
treatment arm requests 
to be seen by a 
physician. 
 
The RA will confirm that participant still wishes to participate in the 
study. If so, then the patient will remain in the assigned study arm (as 
per the modified intention to treat design), and physician visits will 
be tracked as per study outcomes.  
 
If the participant requests to withdraw from the study and withdraws 
from having their health utilization data collected, then no further 
research data will be collected. The patient will be informed that we 
will not collect questionnaires, additional clinical and HC 
utilization/cost data. Data up to the point of withdrawal is accessible 
to the research team. Everything else will be the same in terms of 
clinical care (i.e. dropping out of the Fast Track arm doesn’t 
necessarily mean that all subsequent visits are with a physician, but 
rather that the patient goes back into standard care – physician-led 
but with heavy ACP involvement) 

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Fast Track Protocol v5.4 
Updated January 25, 2017 
Patient is without a 
three-month or 12-
month clinical follow-up, 
or has follow-up 
appointments that are 
not at 3 or 12 months 
The RA will either call patient to come in for a follow-up to complete 
the follow-up data collection. If participant cannot meet with the RA, 
a questionnaire package will be mailed for the participant to 
complete. The date that the patient returns their questionnaire as the 
final appointment date; however, the research associate should note 
that it is the follow-up date not the final appointment date; however, 
the RA should note that it is the follow-up date not the final 
appointment date.   Download data will be obtained through the 
participants PAP provider.  
 
The RA will give the patient a pre-paid parking voucher for all 
appointments that are outside of standard clinical visits 
Patient is discharged by 
the clinic  
The RA will approach the patient to continue the study.  
Patient withdraws from 
the study after being 
discharged by the 
ACP/Provider  
The RA will ask permission to collect their data on healthcare 
utilization and visits to the sleep centre.  
 
If participant declines, the RA will cease ongoing data collection. Data 
collected up to the point of participant withdrawal will be retained. 
Cannot contact patient 
(i.e. called once a week 
for a month) 
The RA will send a participation letter to the patient requesting that 
they contact the RA to coordinate a time to complete the 
questionnaires and HSATs. If the RA does not hear from the patient, 
they will be considered lost to follow-up. 
Patient does not bring 
their PAP machine to the 
appointment 
The patient will be called to bring the machine in to be downloaded 
by a therapist. If they are unable to make it in to the FMC Sleep 
Centre, a download compliance form will be faxed to the provider 
requesting the needed information be sent to the FMC Sleep Centre 
addressed to the booking clerk. The RA will provide the booking clerk 
with a list of all requested downloads and HSATs which she will flag 
and provide to the RA. 

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Fast Track Protocol v5.4 
Updated January 25, 2017 
DATA COLLECTION  
SUMMARY SHEET 
 
 
Data to collect 
Data source 
Photocopy, handwritten 
or original copy 
Recruitment  Study consent 
From patient during HSAT appointment 
Original copy 
Triage Criteria (Level 3 HSAT or 
ANC) 
Level 3 HSAT – patient’s chart, if any.  
ANC – Patient Questionnaire.  
Handwritten 
 
HSAT – RDI, Mean O2 saturation, 
mean O2 saturation, time under 90% 
HSAT Summary page, day after patient completes 
HSAT.  
Photocopy 
Partial pressure of CO2 on ABG 
Netcare – will need to ask a person with access to 
Netcare (The Fast Track clinic supervisor or Carly) 
Photocopy 
HSAT Date 
Chart 
Handwritten 
Baseline 
Visit 
Initial baseline visit date 
Sleep clinic’s CIS system. 
Handwritten 
 
 
Actual baseline visit date 
ESS 
At baseline visit.  
 
Original 
Health Utilities Index 
Short SAQLI (without treatment 
section) 
Current medications 
Patient’s chart: 1) Patient info sheet (yellow) when 
patient comes in for the HSAT, 2) Physician’s initial 
visit letter 3) Patient’s self-filled questionnaire, 4) 
Administrative data from AHS 
Handwritten 
Comorbidities 
PSG date (if applicable) 
Sleep clinic’s CIS system. 
Handwritten 
PSG  - AHI, mean O2 saturation, time 
under 90% 
Patient’s chart - PSG report  
Handwritten 
Treatment start date 
CPAP database, homecare company (CPAP/BAP), 
patient’s chart (Oxygen), dentist (dental appliance)  
Handwritten 
Treatment type 
CPAP database 
Handwritten 
 

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Fast Track Protocol v5.4 
Updated January 25, 2017 
 
Data to collect 
Data source 
Photocopy, handwritten 
or original copy 
3-Month/1-
Year Follow-
up 
Initial 3-month/1-year visit date 
Sleep clinic’s CIS system. 
Handwritten 
Actual 3-month/1-year visit date 
ESS 
At 3-month and 1-year visit.  
 
Original copy 
Health Utilities Index 
Short SAQLI (with treatment section) 
Positive airway pressure adherence 
(1 month directly prior to the 
appointment) & date 
At 3-month and 1-year visit OR via home-care 
company 
Photocopy 
1-Year only 
Healthcare utilization - cumulative 
sum of outpatient physician visits, 
hospitalizations and length of stay, 
and urgent care/emergency room 
visits 
DIMR Database 
Electronic copy 
Healthcare utilization – additional 
physician consultation time 
Patient’s chart: Written communication between 
ACPs and physicians are recorded on a yellow sheet.  
Photocopy 
Healthcare costs – costs for sleep 
physician and ACP visit, diagnostic 
sleep testing costs for HSAT and PSG 
Taken from the Alberta Health Schedule of Medical 
Benefits, Health Sciences Association of Alberta 
(HSAA) Collective Agreement and the FMC sleep 
Sleep Centre Medical Director 
Electronic copy 
Healthcare costs – CPAP therapy 
costs 
Current market pricing through respiratory 
homecare providers 
Electronic copy 
Healthcare costs – hospitalization 
costs 
DIMR and AHS Finance department 
Electronic copy 
Healthcare costs – costs for 
ambulatory visits 
Canadian Institute for Health Information (CIHI) 
and DIMR 
Electronic copy 
*Note: All handwritten, photocopied and original information will be transcribed to electronic format by RA and all data will be 
stored at the W21C. 

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Fast Track Protocol v5.4 
Updated January 25, 2017 
APPENDIX 1 
“Fast Track” Summary Sheet 
 
Study consent:  £ Yes 
 
£ No 
 
Triage Criteria:  £ Level 3 HSAT 
 £ ANC = NC_______, HBP__, HSnore __, 
HApnea___ 
 
Referral Date: _________________________ 
 
Eligibility process  
£ Patient >= 18 years old 
£ Patient does not have a previous treatment 
of SDB 
 
One of the following: 
£ RDI >= 30 events/hr 
£ Mean nocturnal O2 saturation <= 85% 
£ RDI >= 15 events/hr AND partial pressure of 
CO2 >=45 mmHg on ABG 
 
Eligible:  
£ Yes:        £ACP     £Resp  
 
£ No 
 
Baseline visit date: _________________________ 
£ ESS 
£ Health Utilities Index 
£ SAQLI 
£ Current medications (if any) 
£ Comorbidities 
 
PSG: 
£ Yes, date_______________________ 
 
£ No 
Current Medications (list): 
 
 
 
Comorbidities (list): 
£ High Blood Pressure 
£ Asthma 
£ Diabetes 
£ Depression 
£ Angia/Heart Attack 
£ COPD/Emphysema 
£ Kidney Disease 
£ Psychiatric Disease 
£ Heart Failure 
£ Other Lung Disease 
£ Dialysis 
£ Fibromyalgia 
£ Heart Disease 
£ Stroke 
£ Atrial Fibrillation/ 
Arrhythmia 
 
 
 
ID#: _______________________ 
 
Treatment date: _________________________ 
 
Initial 3mth Appointment Date: ________________________ 
 
Actual 3mth Appointment Date: ________________________ 
Checklist: 
£ ESS 
£ Health Utilities Index 
£ SAQLI 
£ Positive airway pressure adherence  
          (1 month) 
£ Ambulatory sleep test 
£ CAHPS-GC 
 
Questionnaire Mailing Dates: 
£ Yes. Mail date_______________________ 
 
     Receive date___________________ 
 
£ No 
  
Initial 1 yr Appointment Date: ________________________ 
 
Actual 1 yr Appointment Date: ________________________ 
Checklist: 
£ ESS 
£ Health Utilities Index 
£ SAQLI 
£ Positive airway pressure adherence  
          (1 month) 
£ Ambulatory sleep test 
£ CAHPS-GC 
£ Healthcare utilization 
 
Questionnaire Mailing Dates: 
£ Yes. Mail date_______________________ 
 
     Receive date___________________ 
 
£ No