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临床试验/NCT02636790
NCT02636790Unknown1 期

Is Prioritization of the Sinus Surgical Waitlist Required?

University of British Columbia2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年9月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
20
试验地点
2
主要终点
Questionnaire relating to demographics.

研究概览

简要总结

The sinus surgical wait list in British Columbia continues to grow. The current wait list is beyond what is acceptable by the province's standard; however, this is not likely to improve given the budget constraints of the health care system. The outcome of having patients to wait longer than medically reasonable for surgery, not only affects the patients' quality of life but presents financial difficulties, both directly to the patient, the healthcare system and the economy as a whole. Therefore, the investigators need to determine which patients need to be prioritized for surgery. The investigators will follow two groups of patients - one group from Stanford University who get surgery always before 8 weeks and compare them to patients on the VGH wait list which is often more than one year.

详细描述

Introduction Five percent of Canadians suffer from Chronic Rhinosinusitis (CRS) based on a national survey.1 CRS sufferers have debilitating facial pain, nasal congestion, nasal discharge and poor sense of smell. Relative to other chronic diseases, the quality of life of patients suffering with CRS is comparable to diseases such as congestive heart failure, chronic obstructive pulmonary disease, angina and back pain.3 Currently, CRS patients in Vancouver, British Columbia wait just over a year for surgery. British Columbia's (BC) health care policy recommends that CRS patients waiting for surgery be done in twelve weeks. It is well recognized that patients who wait longer than medically reasonable for surgery result in an excess costs, both directly to the patient, the healthcare system and the economy as a whole.5 Unfortunately, no studies done in Canada have illustrated the direct and indirect costs associated with CRS annually.

Patients' waiting time for elective sinus surgery in BC has come under public scrutiny in recent years. As a result, policy-makers are keen to address this waitlist issue.4 The government has identified sinus surgery as an elective day procedure that requires the Patient Focused Fund (PFF) to increase volume and address its disproportionately large waitlist. This likely has resulted in savings to VCH patients and the BC Health Ministry that would not have occurred had the PFF not been initiated. However, policy-makers must explore other innovate ways to supplement the PFF to provide further savings to VCH patients and the BC health care system.

An approach that has been adopted by other specialities such as orthopaedics, ophthalmology, and radiology is the use of a validated tool to prioritize waitlists.6-8 There are no validated tools published for prioritizing sinus surgery waitlists. The Canadian Institutes of Health Research provided funding to establish the Western Canada Waiting List Project (WCWL) to "improve the fairness of the health care system so that Canadians' access to appropriate and effective medical services is prioritized on the basis of need and potential benefit."9 Despite the work done by the WCWL being limited to five clinical areas (cataract surgery; general surgery procedures; hip and knee replacement; magnetic resonance imaging (MRI) scanning, and children's mental health), the methodology utilized in establishing their prioritization tool can be used to establish one for the sinus surgery waitlist;10 The impact of chronic diseases, including CRS, varies among patients11; therefore, prioritizing patients based on clinical measurements and cost-effectiveness from an individual and healthcare system perspective would be a novel approach to addressing waitlists for sinus surgery. Currently, VCH CRS patients are treated on a first come, first served basis. Despite this being the most transparent way of ordering the waitlist, the investigators feel VCH CRS patients need a waitlist system that promotes wellness and ensures care that focuses on quality - this can be achieved with a prioritized waitlist based on quality of life improvement and decreased healthcare expenditure.

Prior to establishing a validated tool for the prioritization of sinus surgery waitlists, one must first determine if VCH patients and the BC health care system would benefit from prioritized surgery. Providing a solution to this question requires moderate amount of resources and would take several of years to complete. The investigators propose a feasibility study coupled with an economic evaluation to determine if the disproportionately long wait list faced by CRS patients can be optimized and thus improve patient outcomes.

Current State of Knowledge Researchers must determine if CRS patients and the BC health care system would benefit from a prioritized waitlist for sinus surgery. It is accepted that sinus surgery compared to medical therapy improves the quality of life of CRS patients.12-14 However, to determine whether VCH CRS patients would benefit from a prioritized waitlist, the investigators must answer the following questions. If patients were to have surgery sooner: 1) how does their quality of life change with time compared to those on the waitlist? 2) do they experience a reduction in out of pocket costs?; 3) does the healthcare system experience a decrease in healthcare expenditure? and 4) is there are a subgroup of patients who would particularly benefit more than others from early surgical intervention? Providing this information is vital in determining if a prioritized waitlist would be beneficial for sinus surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients diagnosed with CRS based on 2 major symptoms (congestion, facial pain, nasal obstruction, nasal discharge, decreased sense of smell) and evidence of sino-nasal inflammation on CT scan and nasal endoscopy. Symptoms must also be present for >12 weeks.

排除标准

  • •History of or requiring surgery for a sino-nasal tumour

研究组 & 干预措施

Surgery wait time (< 8 weeks)

Active Comparator

Outcomes of patients with sinus surgery of less than 8 weeks.

干预措施: Surgery wait time (Procedure)

Surgery wait time (> 1 year)

Active Comparator

Outcomes of patients with sinus surgery of more than 1 year.

干预措施: Surgery wait time (Procedure)

结局指标

主要结局

Questionnaire relating to demographics.

时间窗: 30 min to complete questionnaire (once)

Patient demographic information to be completed once after surgery to determine if there is a distinct group of chronic Rhinosinusitis patients who would benefit from early surgical intervention.

Change relating to personal costs over 1 year following surgery.

时间窗: 30 min to complete questionnaire, every two months for 1 year (post-surgery).

Personal costs related to surgical wait times.

Change to the quality of life over 1 year following surgery based on the WPAI-SHP questionnaire.

时间窗: 10 min to complete questionnaire, every two months for 1 year (post-surgery).

The questionnaire WPAI-SHP relates to quality of life after surgery. The Work Productivity and Activity - Specific Health Problem (WPAI:SHP) is a validated instrument to evaluate impairment of daily activities and work productivity associated with a specific health problem (Chronic Rhinosinusitis).

Change to the quality of life over 1 year following surgery based on the SNOT-22 questionnaire.

时间窗: 10 min to complete questionnaire, every two months for 1 year (post-surgery).

The questionnaire SNOT-22 relates to quality of life after surgery. SNOT-22 is a disease-specific health-related quality of life instrument in CRS patients.

Change to the quality of life over 1 year following surgery based on the EQ5-D questionnaire.

时间窗: 10 min to complete questionnaire, every two months for 1 year (post-surgery).

The questionnaire EQ5-D relates to quality of life after surgery. The EQ-5D has 5 questions addressing: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arif Janjua

Principal Investigator

University of British Columbia

研究点 (2)

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