Early Versus Late Surgical Wait Times

NCT02636790 | Unknown Early Phase 1

• 1 other identifier: H15-02020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Rhinosinusitis

Outcome Measures

Primary Outcomes (5)

• Questionnaire relating to demographics.

  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.

  30 min to complete questionnaire (once)

• Change relating to personal costs over 1 year following surgery.

  Personal costs related to surgical wait times.

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

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

  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).

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

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

  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.

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

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

  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.

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

Study Arms (2)

Surgery wait time (< 8 weeks)

ACTIVE COMPARATOR

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

Procedure: Surgery wait time

Surgery wait time (> 1 year)

ACTIVE COMPARATOR

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

Procedure: Surgery wait time

Interventions

Surgery wait time PROCEDURE

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.

Surgery wait time (< 8 weeks); Surgery wait time (> 1 year)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (2)

UBC - Department of Surgery Division of Otolaryngology - Head and Neck Surgery

Vancouver, British Columbia, V5Z 1M9, Canada

Location

UBC

Vancouver, British Columbia, V6H 0A5, Canada

Location

Related Publications (19)

• Chen Y, Dales R, Lin M. The epidemiology of chronic rhinosinusitis in Canadians. Laryngoscope. 2003 Jul;113(7):1199-205. doi: 10.1097/00005537-200307000-00016.

  PMID: 12838019 BACKGROUND

• Cherry DK, Woodwell DA. National Ambulatory Medical Care Survey: 2000 summary. Adv Data. 2002 Jun 5;(328):1-32.

  PMID: 12661586 BACKGROUND

• Gliklich RE, Metson R. The health impact of chronic sinusitis in patients seeking otolaryngologic care. Otolaryngol Head Neck Surg. 1995 Jul;113(1):104-9. doi: 10.1016/S0194-59989570152-4.

  PMID: 7603703 BACKGROUND

• Mickleburgh, R. (2013, January 18). Ministers says BC wait lists too long. The Globe and Mail, Health Care, http://m.theglobeandmail.com/news/british-columbia/minister-says-bc-wait-lists-too-long/article7508904/?service=mobile (accessed on January 30, 2013).

  BACKGROUND

• The economic cost of wait times in Canada. Retrieved from www.cma.ca/multimedia/CMA/Content.../EconomicReport.pdf (accessed on February 2, 2013).

  BACKGROUND

• Conner-Spady BL, Sanmugasunderam S, Courtright P, Mildon D, McGurran JJ, Noseworthy TW; Steering Committee of the Western Canada Waiting List Project. The prioritization of patients on waiting lists for cataract surgery: validation of the Western Canada waiting list project cataract priority criteria tool. Ophthalmic Epidemiol. 2005 Apr;12(2):81-90. doi: 10.1080/09286580590932770.

  PMID: 16019691 BACKGROUND

• Conner-Spady B, Estey A, Arnett G, Ness K, McGurran J, Bear R, Noseworthy T; Steering Committee of the Western Canada Waiting List Project. Prioritization of patients on waiting lists for hip and knee replacement: validation of a priority criteria tool. Int J Technol Assess Health Care. 2004 Fall;20(4):509-15. doi: 10.1017/s0266462304001436.

  PMID: 15609803 BACKGROUND

• Hadorn DC; Steering Committee of the Western Canada Waiting List Project. Developing priority criteria for magnetic resonance imaging: results from the Western Canada Waiting List Project. Can Assoc Radiol J. 2002 Oct;53(4):210-8.

  PMID: 12391927 BACKGROUND

• Noseworthy TW, McGurran JJ, Hadorn DC; Steering Committee of the Western Canada Waiting List Project. Waiting for scheduled services in Canada: development of priority-setting scoring systems. J Eval Clin Pract. 2003 Feb;9(1):23-31. doi: 10.1046/j.1365-2753.2003.00377.x.

  PMID: 12558699 BACKGROUND

• Ben-Shlomo Y, Kuh D. A life course approach to chronic disease epidemiology: conceptual models, empirical challenges and interdisciplinary perspectives. Int J Epidemiol. 2002 Apr;31(2):285-93. No abstract available.

  PMID: 11980781 BACKGROUND

• Western Canada Waiting List Investigators .(2013). Retrieved on February 2, 2013 from http://www.wcwl.ca/.

  BACKGROUND

• Damm M, Quante G, Jungehuelsing M, Stennert E. Impact of functional endoscopic sinus surgery on symptoms and quality of life in chronic rhinosinusitis. Laryngoscope. 2002 Feb;112(2):310-5. doi: 10.1097/00005537-200202000-00020.

  PMID: 11889389 BACKGROUND

• Smith TL, Kern R, Palmer JN, Schlosser R, Chandra RK, Chiu AG, Conley D, Mace JC, Fu RF, Stankiewicz J. Medical therapy vs surgery for chronic rhinosinusitis: a prospective, multi-institutional study with 1-year follow-up. Int Forum Allergy Rhinol. 2013 Jan;3(1):4-9. doi: 10.1002/alr.21065. Epub 2012 Jun 26.

  PMID: 22736422 BACKGROUND

• Smith TL, Mendolia-Loffredo S, Loehrl TA, Sparapani R, Laud PW, Nattinger AB. Predictive factors and outcomes in endoscopic sinus surgery for chronic rhinosinusitis. Laryngoscope. 2005 Dec;115(12):2199-205. doi: 10.1097/01.mlg.0000182825.82910.80.

  PMID: 16369166 BACKGROUND

• Bhattacharyya N, Orlandi RR, Grebner J, Martinson M. Cost burden of chronic rhinosinusitis: a claims-based study. Otolaryngol Head Neck Surg. 2011 Mar;144(3):440-5. doi: 10.1177/0194599810391852. Epub 2011 Feb 3.

  PMID: 21493210 BACKGROUND

• Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.

  PMID: 19793277 BACKGROUND

• EuroQoL Group. EQ-5D. [Online] [Cited: January 30, 2013.] http://www.euroqol.org/.

  BACKGROUND

• Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.

  PMID: 11124729 BACKGROUND

• Diggle, P.J., Heagerty, P., Liang K-Y. and Zeger, S.L. (2002). Analysis of Longitudinal Data (second edition). Oxford: Oxford University Press.

  BACKGROUND

MeSH Terms

Conditions

Rhinosinusitis

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Arif Janjua, MD

  UBC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Thamboo, MD

CONTACT

650-308-6376; andrew.thamboo@gmail.com

Javier Ospina, MD

CONTACT

604-715-8276; jospinadiaz@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 22, 2015
• Study Start: September 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: May 8, 2018

Record last verified: 2018-05

Locations

CA (2)