None listed
Conditions
Brief summary
Fifty-one percent of our current Australian population were born with ovaries and 6 million are now aged 40 or over; ie. at or approaching perimenopause and menopause, but very few clinicians have actually received training or education regarding menopause and its care. This study to aims to determine if the simple intervention proposed (combining education, reinforcement and telehealth) is a feasible approach to raise menopausal-awareness & training of your average primary care clinician (& patients too). This is especially important in rural/remote areas where telehealth follow-up may be significantly easier and patients are unlikely to have the option, and/or much longer wait times, to see menopause-specialist GPs who tend to be metropolitan-based.
Interventions
Total study duration is approximately 18 months (3 month preparation, 6 months recruitment, 9 month intervention period for clinicians/patients, and 3 month final analysis & report,
Interventions for consenting participating clinicians:
- a 5-minute set of demographic questions plus question on whether there are any specific outcomes or positive impacts they are hoping to achieve as a result of study participation;
- a 5-minute set of VITAL registry-aligned questions including a) current age,
Total study duration is approximately 18 months (3 month preparation, 6 months recruitment, 9 month intervention period for clinicians/patients, and 3 month final analysis & report, Interventions for consenting participating clinicians: - a 5-minute set of demographic questions plus question on whether there are any specific outcomes or positive impacts they are hoping to achieve as a result of study participation; - a 5-minute set of VITAL registry-aligned questions including a) current age, b) if they were born with ovaries, c) ethnicity, d) their opinion on the level of knowledge for i) themselves, ii) the commuinity, iii) the workplace, and iv) the healthcare system, e) their sources of information about menopause, and voluntary question f) whether they have any additional interests in menopause beyond pure clinical practice; - a 5-minute set of peri-/menopausal knowledge and confidence questions; - approximately 3 months of standard practice conduct (control) Approximately 3 months after initial clinician study consent: - 4hr online Peri-/Menopause Foundations course, composed of 8 online education modules covering hormone biology, symptoms & course, diagnosis & possible treatments, with evidence-based information, videos and questions to self-test learnings included. - a 5-minute review of three established internationally validated peri-/menopause questionnaires (Greene's Menopause Rating Scale, Meno-D, MenoQOL), plus study-specific patient peri-/menopause information resource brochure - a 5-minute repeat set of peri-/menopausal knowledge and confidence questions, For 9 months of intervention with participating clinicians implementing decision-support tools: - a 10-15-minute set of peri-/menopause questionnaires (Greene's Menopause Rating Scale & Meno-D) for all relevant patients with the MenQOL added for eligible & consenting patients - a 20-minute telehealth 3 month follow-up for ~5 eligible patients per participating clinician, including repeat implementation of questionnaires and request for patient feedback on study by clinician. - a 10-minute repeat set of peri-/menopausal knowledge and comfort questions, plus opportunity for clinicians to provide feedback on individual intervention components plus general study feedback at the end of the study after 9 months of intervention. - reference to additional established ongoing peri-/menopause education resources (menoECHO). - ongoing clinician participant support & monitoring of study adherence by Bespoke Clinical Research, via fortnightly email communications during 1st month of each of control and intervention phases, review of study-specific data collected and participant-specific time windows, and additional contacts via multimedia (eg phone/virtual) as required, plus monthly study status updates throughout. For relevant patients of participating clinicians during study participation: - a 10-minute set of peri-/menopausal symptom questions via two established internationally validated questionnaires (Greene’s Menopause Rating Scale & Meno-D) For eligible (symptomatic) consenting patients of participating clinicians: - a 5-minute established internationally validated quality of life questionnaire in relation to peri-/menopause (MenQOL), - a 5-minute set of demographic and medical history questions, - a study-specific brochure to take home referencing established peri-/menopause information resources of different formats that offer varying communication styles to suit individual preferences (aural, written, virtual, in-person, questionnaire, app etcetera). For this feasibility study they include: Dear Menopause podcast, Healthy Hormones community forum, Menopause & Peri-Menopause Australia private Facebook group, Balance app, VITAL Peri-/Menopause research platform & registry, Sheela health advocacy, WellFemme webpage & online lifestyle program, Don't Sweat It insta posts/videos and in-person retreats, & Metluma additional menopause resource list. - patient study adherence will be monitored by Bespoke Clinical Research in conjunction with their participating (treating) clinician, via review of study-specific data collected and participant-specific time windows, plus monthly study status updates. - a 5-30-minute entry into the VITAL peri-/menopause at their convenience, and - a 20-minute telehealth follow-up 3 months later including questionnaire repeat (symptoms and quality of life) and opportunity to offer study feedback.
Sponsors
Bespoke Clinical Research
Study design
Allocation
Non-randomised trial
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Clinicians: • Qualified and registered for clinical practice in Australia, e.g. Australian Health Practitioner Regulation Agency (AHPRA) minimum of 5 years of practice • Practice-based with general practice • Willing to comply with all study procedures, whether self-assessments, patient evaluations via validated questionnaires, provision of study-specific menopause information resource brochure, or 3-month telehealth follow-up intervention. • English-speaking • Appropriate access .to technology for Healthy Hormones education and telehealth Follow-Up • Intention to continue Australian clinical general practice at least 0.6FTE throughout study duration • Agreement with the Practice to undertake the study Patients: • Willing and able to consent • Willing and able to comply with relevant study procedures including answer/completion of validated study questionnaires, receipt of study-specific menopause information resource brochure, and 3 month telehealth follow-up intervention. • English-speaking • Appropriate access to technology for telehealth Follow-Up • Intention to remain living in Australia throughout study duration
Exclusion criteria
Not meeting inclusion criteria Less than 18 yrs old Not capable of providing informed consent.
Outcome results
None listed