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Development and Validation of the Saint Paul's Endoscopy Comfort Scale (SPECS) for Colonoscopy and Upper Endoscopy

NCT ID: NCT02443480

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-05-31

Brief Summary

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The investigators created the St. Paul's Endoscopy Comfort Score (SPECS) which includes the frequency of verbal cues, body positioning and anxiety levels with descriptions for each of the variables. Our objective is to compare the SPECS, NAPCOMs, NPAT and GS amongst different observers and to determine any correlation with patient satisfaction.

Detailed Description

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Colonoscopy is used for the diagnosis and treatment of colonic lesions as well as screening and follow up of patients at risk of developing colorectal cancer. With the increasing demand for colonoscopies, the number of procedures performed in recent years has increased dramatically (Bjorkman \& Popp Jr., 2006). Given that performance of a high quality colonoscopy is dependent on the expertise and technical skills of the endoscopist, quantitative and reliable methods for measurement of the quality of colonoscopy are needed. Although other colonoscopy quality indicators, such as adenoma detection rate, have been studied comprehensively (Rex, et al., 2006), patient comfort as a measure of endoscopic quality performance has not been thoroughly assessed.

Conditions

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Patient Comfort

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age 19 years or older
* Outpatients referred to Saint Paul's Hospital for colonoscopy and upper endoscopy
* Capable of reading and understanding English

Exclusion Criteria

* Patients who undergo colonoscopy and upper endoscopy in the same appointment
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Robert Enns

Dr. Robert Enns

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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Bjorkman DJ, Popp JW Jr. Measuring the quality of endoscopy. Gastrointest Endosc. 2006 Apr;63(4 Suppl):S1-2. doi: 10.1016/j.gie.2006.02.022. No abstract available.

Reference Type BACKGROUND
PMID: 16564905 (View on PubMed)

Dyson JK, Mason JM, Rutter MD. Prior hysterectomy and discomfort during colonoscopy: a retrospective cohort analysis. Endoscopy. 2014 Jun;46(6):493-8. doi: 10.1055/s-0034-1365462. Epub 2014 Apr 30.

Reference Type BACKGROUND
PMID: 24788540 (View on PubMed)

Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91. doi: 10.1001/jama.289.22.2983.

Reference Type BACKGROUND
PMID: 12799407 (View on PubMed)

Gelinas C, Puntillo KA, Joffe AM, Barr J. A validated approach to evaluating psychometric properties of pain assessment tools for use in nonverbal critically ill adults. Semin Respir Crit Care Med. 2013 Apr;34(2):153-68. doi: 10.1055/s-0033-1342970. Epub 2013 May 28.

Reference Type BACKGROUND
PMID: 23716307 (View on PubMed)

Klein DG, Dumpe M, Katz E, Bena J. Pain assessment in the intensive care unit: development and psychometric testing of the nonverbal pain assessment tool. Heart Lung. 2010 Nov-Dec;39(6):521-8. doi: 10.1016/j.hrtlng.2010.05.053.

Reference Type BACKGROUND
PMID: 20888642 (View on PubMed)

Ko HH, Zhang H, Telford JJ, Enns R. Factors influencing patient satisfaction when undergoing endoscopic procedures. Gastrointest Endosc. 2009 Apr;69(4):883-91, quiz 891.e1. doi: 10.1016/j.gie.2008.06.024. Epub 2009 Jan 18.

Reference Type BACKGROUND
PMID: 19152911 (View on PubMed)

Kohli E, Ptak J, Smith R, Taylor E, Talbot EA, Kirkland KB. Variability in the Hawthorne effect with regard to hand hygiene performance in high- and low-performing inpatient care units. Infect Control Hosp Epidemiol. 2009 Mar;30(3):222-5. doi: 10.1086/595692.

Reference Type BACKGROUND
PMID: 19199530 (View on PubMed)

Leonard KL. Is patient satisfaction sensitive to changes in the quality of care? An exploitation of the Hawthorne effect. J Health Econ. 2008 Mar;27(2):444-59. doi: 10.1016/j.jhealeco.2007.07.004. Epub 2007 Nov 29.

Reference Type BACKGROUND
PMID: 18192043 (View on PubMed)

Munson GW, Van Norstrand MD, O'donnell JJ, Hammes NL, Francis DL. Intraprocedural evaluation of comfort for sedated outpatient upper endoscopy and colonoscopy: the La Crosse (WI) intra-endoscopy sedation comfort score. Gastroenterol Nurs. 2011 Jul-Aug;34(4):296-301. doi: 10.1097/SGA.0b013e3182248777.

Reference Type BACKGROUND
PMID: 21814063 (View on PubMed)

Rex DK, Petrini JL, Baron TH, Chak A, Cohen J, Deal SE, Hoffman B, Jacobson BC, Mergener K, Petersen BT, Safdi MA, Faigel DO, Pike IM. Quality indicators for colonoscopy. Gastrointest Endosc. 2006 Apr;63(4 Suppl):S16-28. doi: 10.1016/j.gie.2006.02.021. No abstract available.

Reference Type BACKGROUND
PMID: 16564908 (View on PubMed)

Rostom A, Ross ED, Dube C, Rutter MD, Lee T, Valori R, Bridges RJ, Pontifex D, Webbink V, Rees C, Brown C, Whetter DH, Kelsey SG, Hilsden RJ. Development and validation of a nurse-assessed patient comfort score for colonoscopy. Gastrointest Endosc. 2013 Feb;77(2):255-61. doi: 10.1016/j.gie.2012.10.003.

Reference Type BACKGROUND
PMID: 23317691 (View on PubMed)

Related Links

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https://www.rcpi.ie/news/publication/guidelines-for-the-implementation-of-a-national-quality-assurance-programme-in-gi-endoscopy/

Guidelines for the Implementation of a National Quality Assurance Programme in GI Endoscopy

Other Identifiers

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H14-01714

Identifier Type: -

Identifier Source: org_study_id