Improving Informed Consent in Pediatric Endoscopy

NCT00899392 | Completed Results

• 1 other identifier: 2008-6-6053
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

Informed consent/assent in pediatric medicine is an accepted and important practice that has been rarely studied, tested for quality, or optimized for patient satisfaction. In the pursuit of enhancing and studying pediatric care, the investigators propose, as pediatric gastroenterologists, assessing the current state of parental and adolescent consent/assent in upper gastrointestinal endoscopy and offering a computer based education program to improve it. The investigators will look at outcomes that include anxiety, satisfaction, attainment of informed consent, and patient flow efficiency in a GI endoscopy suite.

Conditions

Informed Consent; Procedural State Anxiety; Subject's Satisfaction

Keywords

consent; Anxiety; Satisfaction; Efficiency; Questions; Attainment of Informed Consent (Consent-20); Procedural State Anxiety (STAI); Subject Satisfaction (mGHAA-9); Duration in Endoscopy Suite; Number of questions asked

Outcome Measures

Primary Outcomes (1)

• Attainment of Informed Consent as Measured by Consent Instrument (Consent-20)

  Units on a scale (score) as Measured by Consent 20 Instrument. 20 questions administered on a laptop computer and answered in private. Questions 1-5: qualitative questions about recalling procedure, risks, benefits, etc. (correct or incorrectly scored 0 or 2 points), Questions 6-20: yes or no responses, measuring delivery, voluntariness, and understanding. Each scored 0 or 2 points. Measures theoretical attainment of a minimum standard of informed consent. Worse value: Zero Best Value: 40

  Every 1-2 months

Secondary Outcomes (4)

• Subject (Parental) Satisfaction as Measured by Modified Group Health Association of America-9 Survey (mGHAA-9)

  Every 1-2 months

• Subject (Parental) State Anxiety as Measured by the Spielberger-State Trait Anxiety Inventory (s-STAI) (State Section)

  12-18 hours (Night before Endoscopy to Day of Endoscopy)

• Questions Asked by Subjects (Parents)

  Questions written by parents during the end of consent process (48-72 hours)

• GI Suite Flow Efficiency Measured in 15 Minute Increments

  At completion of study

Study Arms (2)

Electronic Assisted Consent

EXPERIMENTAL

Standard procedural consent performed by pediatric gastroenterologist plus assistance from computerized emmi module.

Other: Emmi Pediatric Upper Endoscopy Patient Education Module

Control Consent

NO INTERVENTION

Standard procedural consent as performed by pediatric gastroenterologists

Interventions

Emmi Pediatric Upper Endoscopy Patient Education Module OTHER

Emmi Pediatric Upper Endoscopy Patient Education Module as designed by EMMI SOLUTIONS, LLC

Also known as: Pediatric Upper Endoscopy Patient Education Module, Patient Education Module, Upper Endoscopy Patient Education Module, Endoscopy Patient Education Module

Electronic Assisted Consent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent of child undergoing 1st, elective, outpatient, sedated, upper endoscopy (EGD)
• Subject gives consent to participate
• Child of parent does not have a planned endoscopy intervention.

You may not qualify if:

• Does not speak or understand English
• Does not give consent to participate
• Does not complete consent instrument at a minimum during study

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Midwestern University: collaborator

Study Sites (1)

Chidren's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (5)

• Woodrow SR, Jenkins AP. How thorough is the process of informed consent prior to outpatient gastroscopy? A study of practice in a United Kingdom District Hospital. Digestion. 2006;73(2-3):189-97. doi: 10.1159/000094528. Epub 2006 Jul 11.

  PMID: 16837805 BACKGROUND

• Gros DF, Antony MM, Simms LJ, McCabe RE. Psychometric properties of the State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA): comparison to the State-Trait Anxiety Inventory (STAI). Psychol Assess. 2007 Dec;19(4):369-81. doi: 10.1037/1040-3590.19.4.369.

  PMID: 18085930 BACKGROUND

• Yacavone RF, Locke GR 3rd, Gostout CJ, Rockwood TH, Thieling S, Zinsmeister AR. Factors influencing patient satisfaction with GI endoscopy. Gastrointest Endosc. 2001 Jun;53(7):703-10. doi: 10.1067/mge.2001.115337.

  PMID: 11375575 BACKGROUND

• Standards of Practice Committee; Zuckerman MJ, Shen B, Harrison ME 3rd, Baron TH, Adler DG, Davila RE, Gan SI, Lichtenstein DR, Qureshi WA, Rajan E, Fanelli RD, Van Guilder T. Informed consent for GI endoscopy. Gastrointest Endosc. 2007 Aug;66(2):213-8. doi: 10.1016/j.gie.2007.02.029. No abstract available.

  PMID: 17643691 BACKGROUND

• Friedlander JA, Loeben GS, Finnegan PK, Puma AE, Zhang X, de Zoeten EF, Piccoli DA, Mamula P. A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy. J Med Ethics. 2011 Apr;37(4):194-200. doi: 10.1136/jme.2010.037622. Epub 2011 Jan 18.

  PMID: 21245476 DERIVED

Related Links

• The Study Web Site

MeSH Terms

Conditions

Anxiety Disorders; Personal Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Limitations and Caveats

Subjects of study did not all complete secondary outcome measures hence some pilot data was included in 2ndary outcome analysis, New instrument used attempting to validate. Largely female, educated cohort. \>60% college educated in both groups.

Results Point of Contact

• Title: Joel A Friedlander
• Organization: Children's Hospital of Philadelphia/OHSU/Doernbecher Children's Hospital

friedlan@ohsu.edu

503-494-1078

Study Officials

• Petar Mamula, M.D.

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Joel Friedlander, D.O., M.Be.

  Children's Hospital of Phildelphia

  PRINCIPAL INVESTIGATOR

• Greg Loeben, Ph.D.

  Midwestern University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2009
• First Posted: May 12, 2009
• Study Start: September 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: July 30, 2013
• Results First Posted: July 30, 2013

Record last verified: 2013-07

Locations

US (1)