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Trial registered on ANZCTR


Registration number
ACTRN12621000909820
Ethics application status
Approved
Date submitted
5/05/2021
Date registered
13/07/2021
Date last updated
13/07/2021
Date data sharing statement initially provided
13/07/2021
Date results information initially provided
13/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Virtual Clinics in Gynaecology - Can we shorten the wait?
Scientific title
Virtual Clinics in Gynaecology - Can we shorten the wait? A randomised control trial assessing the success of a novel clinic model to reduce time in the gynaecology clinic system for post-menopausal bleeding
Secondary ID [1] 304133 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-menopausal bleeding 321821 0
outpatient clinic access 321822 0
Condition category
Condition code
Reproductive Health and Childbirth 319555 319555 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: A virtual clinic model was established for those randomised to the intervention group. This model involved a streamlined assessment of the referral by the gynaecology fellow and use of the endometrial thickness (ET) threshold of 4mm to dichotomise those women who were at low and intermediate/high risk of endometrial cancer. Those with an endometrial thickness 4mm or less and without additional risk factors for endometrial cancer were mailed information (a study-specific letter) regarding vaginal atrophy, and usual management with topical oestrogen, along with contact details if any concerns. A follow-up phone call of 5-10minutes duration by the gynaecological fellow occurred at 3months; this included: assessment as to whether any repeat episodes of PMB had occurred, and whether any additional risk factors had developed. All those with an endometrial thickness >4mm had their referral assessed by the gynaecology fellow for contraindications to outpatient hysteroscopy. In the absence of contraindications, these women were phoned and had their condition explained, and the recommendation for a hysteroscopy. This was suggested as an outpatient procedure as first line. Those who accepted this model were booked directly to the outpatient hysteroscopy clinic for a same-day ‘see-and-sample’ appointment. This appointment involved a routine history-taking assessment by a gynaecologist (approximately 10minutes) followed by consent for procedure. The outpatient hysteroscopy was then performed, with subsequent endometrial biopsy (with pipelle) or Myosure(TM) intrauterine morcellation if a polyp was found. Awake outpatient hysteroscopies generally take 10-20minutes. Those who were unsuitable or who declined outpatient hysteroscopy, along with those randomised to the control group underwent routine care with outpatient clinic appointment and sampling as an inpatient at a later date as deemed appropriate.
Intervention code [1] 320471 0
Treatment: Other
Intervention code [2] 320827 0
Treatment: Drugs
Intervention code [3] 320828 0
Treatment: Surgery
Comparator / control treatment
Routine outpatient clinic which included a face-to-face appointment with a gynaecologist. At this appointment, the patient's history and imaging was reviewed. A clinical examination may or may not have occurred. In the majority of cases, the patient was advised of the need for hysteroscopy and the patient was consented for the procedure. These appointments typically take 20-40minutes depending on the complexity of the patient.
Control group
Active

Outcomes
Primary outcome [1] 327417 0
Time in the gynaecology clinic system, measured as the interval (days) between referral triage and date of discharge for definitive management or to the GP. This data was gained from reviewing the inpatient management system (iPM) to note particular dates that appointments/reviews/procedures occurred.
Timepoint [1] 327417 0
Discharge to GP, or transfer of unit for definitive management (eg hysterectomy by gynae-oncology)
Secondary outcome [1] 395064 0
Time from referral to diagnostic sampling. This data was gained from reviewing the inpatient management system (iPM) to note particular dates that appointments/reviews/procedures occurred, and marrying it to the clinical results system to assess when results were received and signed for.
Timepoint [1] 395064 0
Procedure for endometrial sampling
Secondary outcome [2] 395065 0
patient satisfaction as assessed by a study-specific questionnaire.
Timepoint [2] 395065 0
following discharge to GP, or transfer of unit for definitive management (eg hysterectomy by gynae-oncology)

Eligibility
Key inclusion criteria
1. Postmenopausal (by definition, cessation of menstrual periods (in the absence of hormonal suppression) for at least 12months (average age of menopause is 51-52yrs)
2. Referred from primary care with an episode (at least one) of postmenopausal vaginal bleeding
3. English-speaking
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. additional pathology or symptomatology (eg abdominal pain, pelvic mass, prolapse etc)
2. non-english speaking
3. non-consenting
4. incomplete referral

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (computerised sequence generation using Excel)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculations were based on the hypothesis that the virtual clinic model could reduce the time spent in the system by at least 21 days. To demonstrate this reduction with 80% power at the 5% significance level, 40 patients were required in each arm. Due to the anticipated impact of the study design that involved randomising to study group prior to consent, a decision was made to randomise 56 patients to each study arm.
Analyses were conducted using Stata/IC v16.1 (StataCorp, College Station, TX, USA). Characteristics for the analysis sample were examined using descriptive statistics. Pairwise comparisons were conducted to compare those in the analysis sample to those who were randomised but excluded using chi-square tests for categorical variables, independent sample t-tests for approximately Normally distributed continuous variables, and Wilcoxon rank-sum test for non-Normally distributed continuous variables. Log-rank tests were used to compare the equality of time-to-event functions across randomised groups for specific events within the clinical care pathway (defined a priori: total time spent in system, time from referral to first appointment, time from first appointment to procedure (if needed), time from referral to procedure, and time from referral to notification of results). For analyses were the time-to-event was also found to differ by the type of surgical procedure performed (none, IPH, or OPH), subgroup analyses using stratified log-rank test were conducted. A series of secondary outcomes were also examined. A series of exploratory univariable logistic regressions were conducted to identify characteristics associated with consenting to OPH procedures (of those who were clinically suitable). A series of independent chi-square tests were used to compare histology results across randomised groups (and to compare the presence of malignancy on histology between those included in the analysis sample and those who were excluded). Patient satisfaction data has been presented descriptively with Wilcoxon rank-sum tests conducted to compare satisfaction items across randomised groups and selected subgroups, and Spearman rank correlations to examine potential associations between overall satisfaction and selected study variables. Analysis was by intention to treat. A p-value of 0.05 was considered the threshold for statistical significance in all analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19291 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 33872 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 308511 0
Hospital
Name [1] 308511 0
Mercy Hospital for Women, Small Research Grant
Address [1] 308511 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country [1] 308511 0
Australia
Primary sponsor type
Hospital
Name
Mercy Hospital for Women
Address
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 309364 0
None
Name [1] 309364 0
Address [1] 309364 0
Country [1] 309364 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308469 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 308469 0
Administration Officer, Human Research Ethics Committee
c/- Mercy Hospital for Women
163 Studley Road Heidelberg, VIC. 3084
Ethics committee country [1] 308469 0
Australia
Date submitted for ethics approval [1] 308469 0
05/03/2018
Approval date [1] 308469 0
09/10/2018
Ethics approval number [1] 308469 0
2018-022

Summary
Brief summary
Currently at our institution (Mercy Hospital for Women), approximately 12 women are referred each week for postmenopausal bleeding, or 600 per annum. These women are then seen in the outpatient gynaecology department in any one of four clinics. Pelvic ultrasonography is used as a binary differentiator, as a risk predictor for endometrial cancer. If the endometrial thickness (lining of the womb) is below a certain level (4mm as per national and international guidelines), the risk of endometrial cancer is less than 1%, and thus endometrial sampling is not indicated, in the absence of recurrent episodes or high-risk features.

Unfortunately, the time from referral to our clinics, to the time of notification of the histological diagnosis (and thus options for definitive management) is usually 12 weeks at best. The effect of this delay is 2-fold; 1) we believe patients may experience anxiety and frustration at the delay to review and diagnosis, particularly when concerns regarding endometrial cancer have been raised, and 2) seeing women in the outpatient clinic with a normal endometrial thickness (<4mm) is unnecessary, when sampling is not required. We believe these women can be safely managed in the community by their local general practitioner.

We thus plan to randomise patients referred to the Endosurgery B unit to either routine care (with outpatient ‘in-person’ clinic review) or a ‘virtual clinic’ utilising telephone consultation with a gynaecologist after pelvic ultrasound results are known.

We suspect outcomes to indicate:
1. more efficient throughput of patients with postmenopausal bleeding
2. a change in patient satisfaction impacted by faster contact and review, and individual acceptance of the telephone clinic model
3. clinician satisfaction upon seeing improved efficiency in the management of this common problem
4. shorter outpatient clinic wait times
Trial website
N/A
Trial related presentations / publications
Public notes
This study has previously been presented as a Free Communication ‘Chairman’s Choice’ at AGES ASM, 2020: Mooney S, Gill G, Readman E. Virtual Clinics in Gynaecology: Can we shorten the wait? Assessing the success, feasibility and patient acceptance of Virtual (Telephone) Clinics for Postmenopausal Bleeding.

Contacts
Principal investigator
Name 110798 0
Dr Samantha Mooney
Address 110798 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 110798 0
Australia
Phone 110798 0
+61 3 84584022
Fax 110798 0
Email 110798 0
smooney@mercy.com.au
Contact person for public queries
Name 110799 0
Dr Samantha Mooney
Address 110799 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 110799 0
Australia
Phone 110799 0
+61 3 84584022
Fax 110799 0
Email 110799 0
smooney@mercy.com.au
Contact person for scientific queries
Name 110800 0
Dr Samantha Mooney
Address 110800 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 110800 0
Australia
Phone 110800 0
+61 3 84584022
Fax 110800 0
Email 110800 0
smooney@mercy.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary