Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000427875
Ethics application status
Approved
Date submitted
7/02/2021
Date registered
16/04/2021
Date last updated
6/07/2024
Date data sharing statement initially provided
16/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Telehealth Voice Assessment by Speech Language Pathologists during a global pandemic using principles of a Primary contact Model.
Scientific title
Telehealth Assessment of patients with voice and laryngeal symptoms by Speech Language Pathologists during a global pandemic using principles of a Primary contact Model.
Secondary ID [1] 303375 0
None
Universal Trial Number (UTN)
Trial acronym
SLPPC-T
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Voice disorders 320647 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318499 318499 0 0
Speech therapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will be asked to complete a pre assessment written case history information questionnaire, patient reported outcome measures (Voice Handicap Index-10, Reflux Symptom Index, Newcastle Laryngeal Hypersensitivity Questionnaire) and a quality of life instrument (AQoL-6D). Blank copies of these forms will be sent to patients by email 2 weeks in advance of their appointment. Participants will be asked to return completed pre-assessment forms using an electronic secure file transfer service (KiteWorks) 2-3 days prior to their telehealth appointment. Participants without access to email can complete and return the pre-assessment forms by post. The anticipated duration to complete the pre-assessment questionnaires is 30 minutes.

The telehealth voice assessment with a Speech Language Pathologist (SLP) will consist of multiple parts designed to collect information relevant to the patients presenting vocal symptoms including: socio-demographic information; personal and family medical history; key symptoms; onset and variability of symptoms; red-flag signs or symptoms for laryngeal malignancy; clinical voice assessment data for auditory-perceptual and acoustic analysis. These assessments make up the usual care voice assessment protocol during a in-person voice assessment. The duration of the telehealth assessment will be 45 minutes including 15 minutes for the collection of case history information, 20 minutes for the clinical voice assessment and 10 minutes for education.

The participant will be guided by the SLP to record a standardised voice sample using their home computer/tablet/smart phone for auditory-perceptual and acoustic analysis. The audio file can be sent securely to the clinician for analysis using an electronic secure file transfer service (KiteWorks).

The SLP will then triage the patient for an in-person laryngoscopy assessment which will include diagnosis from an Ear, Nose and throat medical officer. Priority for diagnostic laryngoscopy will be categorised as emergent time sensitive, urgent or routine. This appointment will take approximately 20-30 minutes.

Participants will be observed from the telehealth assessment session until the in-person out-patient laryngoscopy assessment The overall duration of observation for each participant will depend on the urgency of laryngoscopy determined by the telehealth assessment, this is anticipated to take between 2 and 8 weeks from enrolment.

Participants who decline or are unable to participate in the telehealth assessment for any reason (e.g. access to telehealth equipment, patient preference, language/communication barriers) will be offered a face to face clinic appointment. These participants will still be invited to take part in the study and if they consent their data will be used for a sub-analysis.

If participants choose not to enroll in this study, or if they do not meet the study eligibility criteria, they will be offered the same assessment pathway in accordance with the usual care for this service.
Intervention code [1] 319684 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326453 0
Presenting vocal/laryngeal symptoms as reported to the speech pathologist through a pre-assessment written case history questionnaire and during the speech pathology telehealth assessment (SLPPC-T). The pre-assessment case history questionnaire is non-validated and has been designed specifically for this study. The questions are based on information usually explored through a typical speech pathology initial assessment for people with vocal symptoms.
Timepoint [1] 326453 0
At telehealth assessment (SLPPC-T).
Primary outcome [2] 326752 0
Medical, surgical and medication history as reported to the speech pathologist through a pre-assessment written case history questionnaire and during the speech pathology telehealth assessment (SLPPC-T).
Timepoint [2] 326752 0
At telehealth assessment (SLPPC-T).
Primary outcome [3] 327056 0
Voice aerodynamic measures of maximum phonation time (MPT), in seconds collected during the SLPPC-T measured using a stop watch.
Timepoint [3] 327056 0
At telehealth assessment (SLPPC-T).
Secondary outcome [1] 391532 0
Voice aerodynamic measures of S/Z ratio, time difference between a participants maximum sustained 's' and 'z' sounds, collected during the SLPPC-T and measured using a stop watch.
(Primary outcome measure)
Timepoint [1] 391532 0
At telehealth assessment (SLPPC-T).
Secondary outcome [2] 391533 0
Overall perceived severity of vocal/laryngeal dysfunction measured by the speech pathologist using the Consensus Auditory Perceptual Assessment of Voice scale (CAPE-V) from the participants voice recording made during the SLPPC-T.
The score is obtained using a visual analogue scale ranging from 0 (normal) to 100 (severe).
(Primary outcome measure)
Timepoint [2] 391533 0
At telehealth assessment (SLPPC-T).
Secondary outcome [3] 391534 0
Perceived degree of roughness in the participants voice disorder measured by the speech pathologist using the Consensus Auditory Perceptual Assessment of Voice scale (CAPE-V) from the participants voice recording made during the SLPPC-T.
The score is obtained using a visual analogue scale ranging from 0 (normal) to 100 (severe).
(Primary outcome measure)
Timepoint [3] 391534 0
At telehealth assessment (SLPPC-T).
Secondary outcome [4] 392568 0
Perceived degree of breathiness in the participants voice disorder measured by the speech pathologist using the Consensus Auditory Perceptual Assessment of Voice scale (CAPE-V) from the participants voice recording made during the SLPPC-T.
The score is obtained using a visual analogue scale ranging from 0 (normal) to 100 (severe).
(Primary outcome measure)
Timepoint [4] 392568 0
At telehealth assessment (SLPPC-T).
Secondary outcome [5] 392569 0
Perceived degree of strain in the participants voice disorder measured by the speech pathologist using the Consensus Auditory Perceptual Assessment of Voice scale (CAPE-V) from the participants voice recording made during the SLPPC-T.
The score is obtained using a visual analogue scale ranging from 0 (normal) to 100 (severe).
(Primary outcome measure)
Timepoint [5] 392569 0
At telehealth assessment (SLPPC-T).
Secondary outcome [6] 392570 0
Acoustic measure of noise to harmonic ratio of the voice during connected speech measured from the participants voice recording of reading a phonetically balanced passage 'the rainbow passage', created during the SLPPC-T and analysed using PRAAT acoustic software.
(Primary outcome measure)
Timepoint [6] 392570 0
At telehealth assessment (SLPPC-T).
Secondary outcome [7] 392571 0
Acoustic measure of mean speaking fundamental frequency (pitch) of the voice during connected speech measured from the participants voice recording of reading a phonetically balanced passage 'the rainbow passage', created during the SLPPC-T and analysed using PRAAT acoustic software.
(Primary outcome measure)
Timepoint [7] 392571 0
At telehealth assessment (SLPPC-T).
Secondary outcome [8] 392572 0
Acoustic measure of mean fundamental frequency (pitch) of the voice during sustained vowel measured from the participants voice recording, created during the SLPPC-T and analysed using PRAAT acoustic software.
(Primary outcome measure)
Timepoint [8] 392572 0
At telehealth assessment (SLPPC-T).
Secondary outcome [9] 392573 0
Acoustic measure of smoothed cepstral peak prominence (CPPs) of the voice during connected speech measured from the participants voice recording of reading a phonetically balanced passage 'the rainbow passage', created during the SLPPC-T and analysed using PRAAT acoustic software.
(Primary outcome measure)
Timepoint [9] 392573 0
At telehealth assessment (SLPPC-T).
Secondary outcome [10] 392574 0
Acoustic measure of smoothed cepstral peak prominence (CPPs) of the voice during sustained vowel measured from the participants voice recording, created during the SLPPC-T and analysed using PRAAT acoustic software.
(Primary outcome measure)
Timepoint [10] 392574 0
At telehealth assessment (SLPPC-T).
Secondary outcome [11] 392575 0
The participants self-reported Handicap of their presenting vocal symptoms, measured using a calculated overall score of the Voice Handicap Index-10 (VHI-10), a validated questionnaire.
(Primary outcome measure)
Timepoint [11] 392575 0
At telehealth assessment (SLPPC-T).
Secondary outcome [12] 392576 0
The participants self-reported symptoms of laryngo pharyngeal reflux, measured using a calculated overall score of the Voice Handicap Index-10 (VHI-10), a validated questionnaire.
(Primary outcome measure)
Timepoint [12] 392576 0
At telehealth assessment (SLPPC-T).
Secondary outcome [13] 392577 0
The participants self-reported symptoms of laryngeal hypersensitivity, measured using a calculated overall score of the Newcastle Laryngeal Hypersensitivity questionnaire (LHQ), a validated questionnaire,
(Primary outcome measure)
Timepoint [13] 392577 0
At telehealth assessment (SLPPC-T).
Secondary outcome [14] 392578 0
Degree of concordance on diagnosis of functional neurological (psychogenic) voice disorder assessed by SLPPC-T and assessed by flexible laryngoscopy. (reference comparator).
Timepoint [14] 392578 0
At telehealth assessment (SLPPC-T).
At in-person laryngoscopy.
Secondary outcome [15] 393647 0
Degree of concordance on diagnosis of muscle tension voice disorder with suspected/visible laryngeal pathology assessed by SLPPC-T and assessed by flexible laryngoscopy. (reference comparator).
Timepoint [15] 393647 0
At telehealth assessment (SLPPC-T).
At in-person laryngoscopy.
Secondary outcome [16] 393648 0
Degree of concordance on diagnosis of muscle tension voice disorder without suspected/visible laryngeal pathology assessed by SLPPC-T and assessed by flexible laryngoscopy. (reference comparator).
Timepoint [16] 393648 0
At telehealth assessment (SLPPC-T).
At in-person laryngoscopy.
Secondary outcome [17] 393649 0
Degree of concordance on diagnosis of organic voice disorder assessed by SLPPC-T and assessed by flexible laryngoscopy. (reference comparator).
Timepoint [17] 393649 0
At telehealth assessment (SLPPC-T).
At in-person laryngoscopy.
Secondary outcome [18] 393650 0
Healthcare costs to the patient measured using a trial specific patient experience questionnaire and Assessment of Quality of Life-6D (AQOL-6D).
Timepoint [18] 393650 0
At telehealth assessment (SLPPC-T).
At in-person laryngoscopy.
Secondary outcome [19] 393651 0
Healthcare costs to the health service (staff and equipment costs) measured through an audit hospital financial records.
Timepoint [19] 393651 0
At telehealth assessment (SLPPC-T).
At in-person laryngoscopy.
Secondary outcome [20] 393652 0
Patient views on the SLPPC-T measured using a trial specific patient experience questionnaire.
Timepoint [20] 393652 0
At in-person laryngoscopy.
Secondary outcome [21] 393653 0
Staff views on the SLPPC-T measured using a trial specific patient experience questionnaire.
Timepoint [21] 393653 0
One month after completion of the participant data collection.

Eligibility
Key inclusion criteria
New patients referred for initial ENT evaluation who are triaged by the ENT Surgical team as category 2 (complex care, assess <90 days) or 3 (non-urgent, delayed assessment unlikely to lead to deterioration or a need for more complex care, assess <365 days) on the ENT waitlist, in accordance with the Queensland Health Clinical Prioritisation Criteria (CPC), and then referred to the SLPPC service.
- Adults aged over 18.
- Referral symptoms of episodes of hoarseness or altered voice in patients with no risk factors for malignancy identified on written referral.
- Patients who can provide informed consent and complete a telehealth case history and assessment in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients whose referrals are triaged by ENT as Category-1 based on written referral information, as defined by the Queensland Health Clinical Prioritisation Criteria.
- Any significant medical comorbidities identified on written referral (i.e., previous head and neck cancer, previous laryngeal surgery, neuromuscular disease affecting the larynx).

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive analysis (number, percentages, means and standard deviations) to describe patient demographics, number of patients triaged to each of the laryngoscopy groups, and diagnostic classification before and after laryngoscopy.

Logistic regression analysis to examine the association of various signs, symptoms, and voice assessment measures from the SLPPC-T assessment and diagnosis from laryngoscopy assessment.

Statistical measures of agreement (weighted Kappa statistic) to examine concordance between disorder classification after SLPPC-T assessment and disorder classification after laryngoscopy.

Quantitative and qualitative survey data analysis will be used to report the results of the patient experience measures and stakeholder satisfaction surveys.

Cost and health outcomes will be measured by obtaining staffing and equipment costs through the hospital data analytics team, AQol-6D questionnaire and patient experience surveys, analysed through quantitative and qualitative analysis of survey data.

All statistical analysis will be performed using STATA v16.

A power calculation was completed to consider a model examining the relationship between signs, symptoms and voice measures and diagnostic group membership. This has been based on studies in the literature that have examined characteristics of a general voice disordered population. Based on this data, with a = 0.05 and power of 90%, 150 participants were identified as the minimum appropriate sample size for the logistic regression analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/05/2021
Actual
30/07/2021
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
150
Accrual to date
92
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18586 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 32959 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 307787 0
Hospital
Name [1] 307787 0
Gold Coast Hospital and Health Service
Country [1] 307787 0
Australia
Funding source category [2] 307788 0
Government body
Name [2] 307788 0
Allied Health Professions’ Office of Queensland (AHPOQ) Health Practitioner Research Scheme (HPRS) grant.
Country [2] 307788 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast Hospital and Health Service
Address
Gold Coast University Hospital,
1 Hospital Boulevard,
Southport,
Queensland 4215
Country
Australia
Secondary sponsor category [1] 308497 0
None
Name [1] 308497 0
Address [1] 308497 0
Country [1] 308497 0
Other collaborator category [1] 281642 0
University
Name [1] 281642 0
The University of Sydney
Address [1] 281642 0
Susan Wakil Health Building D18
Western Avenue,
University of Sydney,
Camperdown,
New South Wales 2006
Country [1] 281642 0
Australia
Other collaborator category [2] 281643 0
University
Name [2] 281643 0
Griffith University
Address [2] 281643 0
Parklands Drive,
Southport,
Queensland 4215
Country [2] 281643 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307804 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 307804 0
Ethics committee country [1] 307804 0
Australia
Date submitted for ethics approval [1] 307804 0
22/07/2020
Approval date [1] 307804 0
28/10/2020
Ethics approval number [1] 307804 0
HREC/2020/QGC/62832

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108558 0
Mr Christopher Payten
Address 108558 0
Department of Speech Pathology,
Gold Coast University Hospital
Level 3, D-Block,
1 Hospital Boulevard,
Southport,
Queensland 4215,
Country 108558 0
Australia
Phone 108558 0
+61 7 5687 3418
Fax 108558 0
+61 7 5687 7891
Email 108558 0
[email protected]
Contact person for public queries
Name 108559 0
Christopher Payten
Address 108559 0
Department of Speech Pathology,
Gold Coast University Hospital
Level 3, D-Block,
1 Hospital Boulevard,
Southport,
Queensland 4215,
Country 108559 0
Australia
Phone 108559 0
+61 7 5687 3418
Fax 108559 0
+61 7 5687 7891
Email 108559 0
[email protected]
Contact person for scientific queries
Name 108560 0
Christopher Payten
Address 108560 0
Department of Speech Pathology,
Gold Coast University Hospital
Level 3, D-Block,
1 Hospital Boulevard,
Southport,
Queensland 4215,
Country 108560 0
Australia
Phone 108560 0
+61 7 5687 3418
Fax 108560 0
+61 7 5687 7891
Email 108560 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only.
When will data be available (start and end dates)?
immediately following publication and for five years after publication.
Available to whom?
case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
only to achieve the aims in the approved proposal.
How or where can data be obtained?
access subject to approvals by Principal Investigator on Tel +61 7 5687 3418, [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10466Study protocolPayten CL, Nguyen DD, Novakovic D, et alTelehealth voice assessment by speech language pathologists during a global pandemic using principles of a primary contact model: an observational cohort study protocolBMJ Open 2022;12:e052518. doi: 10.1136/bmjopen-2021-052518  [email protected]
10467Informed consent form  [email protected]
10468Ethical approval  [email protected]



Results publications and other study-related documents

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