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

NCT02443480 | Completed

• 1 other identifier: H14-01714
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patient Comfort

Outcome Measures

Primary Outcomes (2)

• Inter-observer reliability

  To determine the inter-observer reliability for the SPECS amongst observers and the different comfort scores, NAPCOMS, GS and NPAT.

  15-30 minutes

• Correlation with patient's reported pain

  To determine the correlation of SPECS, NAPCOMS, GS and NPAT with post-procedure patient reported pain and satisfaction controlling for sedation.

  10-15 minutes

Eligibility Criteria

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

Study Population

Outpatients referred to Saint Paul's Hospital for colonoscopy and upper endoscopy

You may qualify if:

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

You may not qualify if:

• Patients who undergo colonoscopy and upper endoscopy in the same appointment

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Related Publications (11)

• 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.

  PMID: 16564905 BACKGROUND

• 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.

  PMID: 24788540 BACKGROUND

• 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.

  PMID: 12799407 BACKGROUND

• 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.

  PMID: 23716307 BACKGROUND

• 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.

  PMID: 20888642 BACKGROUND

• 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.

  PMID: 19152911 BACKGROUND

• 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.

  PMID: 19199530 BACKGROUND

• 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.

  PMID: 18192043 BACKGROUND

• 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.

  PMID: 21814063 BACKGROUND

• 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.

  PMID: 16564908 BACKGROUND

• 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.

  PMID: 23317691 BACKGROUND

Related Links

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Robert Enns

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 13, 2015
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: May 1, 2016
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

CA (1)