Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06217315
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-22
First Post:
2024-01-02
Brief Title:
Endometriosis and Health Care System Utilization in British Columbia
Sponsor:
BC Womens Hospital Health Centre
Organization:
BC Womens Hospital Health Centre
Study Overview
Official Title:
Endometriosis and Health Care System Utilization in British Columbia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EndoCare
Brief Summary:
Purpose Background Endometriosis is a chronic inflammatory condition believed to affect 8-10 of reproductive-age women and an unmeasured number of gender-diverse people It is a common cause of pelvic pain and infertility is now known to be associated with other conditions such as heart disease and ovarian cancer and can have a devastating impact on a womans ability to function and achieve their full potential It has been shown that endometriosis and chronic pelvic pain are associated with considerable costs to the health-care system in Canada The in-patient hospital costs for chronic pelvic pain were estimated to be 25 millionyear and the total societal costs for endometriosis were estimated to be 18 billionyear
Standard therapies for endometriosis and pelvic pain include pain medications hormonal suppressive therapies and surgery There is a tertiary referral centre of excellence for endometriosis at BC Womens Hospital Centre for Pelvic Pain and Endometriosis which provides advanced surgical treatment of endometriosis and interdisciplinary care for patients with endometriosis who have developed other pain comorbidities eg due to central nervous system sensitization Central sensitization responds best to treatments targeted to the nervous system such as Interdisciplinary care includes pain education physiotherapy and mindfulness-based cognitive therapies One randomized trial has shown the benefit of an interdisciplinary approach compared to standard treatment for the management of chronic pelvic pain At our centre the investigators reported improvements in pain mental health quality-of-life and self-reported reduction in health care utilization after interdisciplinary care utilizing our ongoing prospective registry However a formal economic analysis of health care system utilization is required to quantify savings to the health care system with an interdisciplinary approach to endometriosis
Despite surgery being a common treatment of endometriosis there is variability in outcome and a gap is the lack of ability to predict outcomes after endometriosis surgery For example utilizing self-reported outcomes from our registry the investigators found that poorer outcome after endometriosis surgery was found in patients with evidence of pain comorbidities and central sensitization as surgery is not a direct treatment of these factors in preparation Moreover the investigators have a biobank and have been studying biomarkers in surgically excised endometriosis tissue that may predict outcomes after surgery These biomarkers include somatic cancer driver mutations and neuroinflammation The investigators have preliminary data that suggests that these biomarkers may predict rates of re-operation at the centre Beyond self-reported outcomes and re-operation at the centre there is a need to assess health care utilization and re-operation occurring throughout the province as additional outcomes that may be associated with our clinical and biomarker predictors
Finally the SARS-CoV-2 COVID-19 pandemic has had profound physical and mental health effects on populations worldwide However there exists limited empirical evidence focusing on the wellbeing of patients with endometriosis andor pelvic pain during the public health crisis Herein the investigators propose to compare a pre-pandemic cohort to a pandemic cohort of subjects with endometriosis andor chronic pelvic pain again in terms of health care system utilization
Therefore the overall purpose of this project is to assess health care utilization patterns of patients with endometriosis in British Columbia and to perform an economic analysis of interdisciplinary care evaluate clinical-biomarker predictors of surgical outcome and assess the impact of the covid pandemic This will be achieved by linking Population Data BC datasets to our ongoing prospective registry H16-00264 and prospective and retrospective biobanks H14-03040 H17-00329
Standard therapies for endometriosis and pelvic pain include pain medications hormonal suppressive therapies and surgery There is a tertiary referral centre of excellence for endometriosis at BC Womens Hospital Centre for Pelvic Pain and Endometriosis which provides advanced surgical treatment of endometriosis and interdisciplinary care for patients with endometriosis who have developed other pain comorbidities eg due to central nervous system sensitization Central sensitization responds best to treatments targeted to the nervous system such as Interdisciplinary care includes pain education physiotherapy and mindfulness-based cognitive therapies One randomized trial has shown the benefit of an interdisciplinary approach compared to standard treatment for the management of chronic pelvic pain At our centre the investigators reported improvements in pain mental health quality-of-life and self-reported reduction in health care utilization after interdisciplinary care utilizing our ongoing prospective registry However a formal economic analysis of health care system utilization is required to quantify savings to the health care system with an interdisciplinary approach to endometriosis
Despite surgery being a common treatment of endometriosis there is variability in outcome and a gap is the lack of ability to predict outcomes after endometriosis surgery For example utilizing self-reported outcomes from our registry the investigators found that poorer outcome after endometriosis surgery was found in patients with evidence of pain comorbidities and central sensitization as surgery is not a direct treatment of these factors in preparation Moreover the investigators have a biobank and have been studying biomarkers in surgically excised endometriosis tissue that may predict outcomes after surgery These biomarkers include somatic cancer driver mutations and neuroinflammation The investigators have preliminary data that suggests that these biomarkers may predict rates of re-operation at the centre Beyond self-reported outcomes and re-operation at the centre there is a need to assess health care utilization and re-operation occurring throughout the province as additional outcomes that may be associated with our clinical and biomarker predictors
Finally the SARS-CoV-2 COVID-19 pandemic has had profound physical and mental health effects on populations worldwide However there exists limited empirical evidence focusing on the wellbeing of patients with endometriosis andor pelvic pain during the public health crisis Herein the investigators propose to compare a pre-pandemic cohort to a pandemic cohort of subjects with endometriosis andor chronic pelvic pain again in terms of health care system utilization
Therefore the overall purpose of this project is to assess health care utilization patterns of patients with endometriosis in British Columbia and to perform an economic analysis of interdisciplinary care evaluate clinical-biomarker predictors of surgical outcome and assess the impact of the covid pandemic This will be achieved by linking Population Data BC datasets to our ongoing prospective registry H16-00264 and prospective and retrospective biobanks H14-03040 H17-00329
Detailed Description:
HYPOTHESIS Aim 1 The investigators hypothesize that health care costs for patients being cared for in our clinic will be higher in the three years preceding their time with us than the years following their discharge The investigators hypothesize that the overall cost of the interdisciplinary clinic including physiotherapist counsellor and nurse salaries and administrative support will be less than overall cost savings to the system from reduced utilization of health care resources after discharge
Aim 2 The investigators hypothesize that comorbidities associated with central nervous system sensitization and biomarkers including somatic mutations and local neurogenesisneuroinflammation are linked to persistent pain and disease recurrence after endometriosis surgery which results in increased risk of re-operation and health care utilization after surgery
Aim 3 The pandemic cohort will have increased health care system utilization and also poorer health system outcomes after care the centre
Aim 4 People with endometriosis utilizing different case definitions will experience higher health care use and worse pregnancy outcomes compared to people without endometriosis
Aim 2 The investigators hypothesize that comorbidities associated with central nervous system sensitization and biomarkers including somatic mutations and local neurogenesisneuroinflammation are linked to persistent pain and disease recurrence after endometriosis surgery which results in increased risk of re-operation and health care utilization after surgery
Aim 3 The pandemic cohort will have increased health care system utilization and also poorer health system outcomes after care the centre
Aim 4 People with endometriosis utilizing different case definitions will experience higher health care use and worse pregnancy outcomes compared to people without endometriosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-06565 | OTHER_GRANT | The Swedish Research Council | None |