Improving Informed Consent in Pediatric Endoscopy

Informed Consent Clinical Trial

Official title:

Improving Informed Consent and Assent in Pediatric Endoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00899392
• Other study ID #: 2008-6-6053
• Status: Completed
• Phase: N/A
• First received: May 8, 2009
• Last updated: July 24, 2013
• Start date: September 2008
• Est. completion date: March 2009

Study information

• Verified date: July 2013
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Two hundred first-time upper endoscopy patients from The Children's Hospital of Philadelphia will be prospectively selected for participation in the study. One hundred subjects will then be randomized to participate in either the standard consent arm or the electronic assisted informed consent (EAIC) arm. The electronic assisted informed consent web module is a professionally designed program by Emmi Solutions, LLC. Adolescents, if present and greater than 13 years of age, will undergo the program apart from their parent as a separate subgroup not included in the 100 randomized subjects. At time of endoscopy scheduling, the scheduler will ask the subjects if they would like to participate in the study. If interest is expressed the study coordinator or PI will contact the subject to explain the study and inform them of the study parameters. At time of phone contact, consent or assent via a verbal method will be performed. Once verbal consent is given by the subject or verbal assent by the adolescent subject they will follow the protocol. No incentives will be given to the subjects. Institutional Review Board (IRB) approval will be obtained.

Between 24 and 48 hours prior to endoscopy, the participant will have the option to access the web-based module outside the hospital or through a hospital-based kiosk. The web address used is http://www.pedsgiconsent.com. Just prior to starting the module, a five-minute electronic pre-intervention test will be given and its results recorded in an electronic database. This will gather demographic and pre-intervention state anxiety without personal identifying information. After the survey is complete, the educational module will be accessed. Upon completion, the subjects will print a confirmatory document of completion and a list of questions to hand to their physician at time of endoscopy. Hand written questions will also be permitted. Non-EAIC participants will perform a non-educational web program not related to gastroenterology and also have their endoscopy questions printed to give to their physician. The questions and confirmation sheet will also be presented to their physician at time of procedure. Participants will also have space to write further questions by hand on the form. The questions collected will be used to assess number and complexity of questions asked as influenced by the education program. The web module will record time duration taken for the program. After completing the program, the participants will report to the GI suite as previously scheduled. The procedure will occur without either the practitioner or nursing staff knowing in which arm of the study the participants are enrolled. After the questions are answered and formal GI endoscopy procedural consent is obtained, the question sheet will be deposited in a lock box in the endoscopy suite for review at a later time. Total time spent in the endoscopy suite will be recorded. Prior to the patient's endoscopy, but after formal consent is obtained, the participant will then take a ten minute electronic post-test to ascertain satisfaction (mGHAA-modified-Group Health Association of America Survey-9), change in state anxiety [s-STAI-(Spielberger-State Trait Anxiety Inventory (state section)], and change in understanding of consent parameters achieved. Satisfaction will be measured using the validated modified Group Health Association of America-9 Survey (mGHAA-9). It is a well-validated instrument used to measure patient satisfaction in adult endoscopy. Probing questions to evaluate the attainment of consent will be based on a modified survey taken from Woodrow's study titled, "How Thorough is the Process of Informed Consent Prior to Outpatient Gastroscopy?"(Consent-20)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Does not speak or understand English

• Does not give consent to participate

• Does not complete consent instrument at a minimum during study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Informed Consent
• Procedural State Anxiety
• Subject's Satisfaction

Intervention

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

Locations

Country	Name	City	State
United States	Chidren's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Midwestern University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Grös 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. — View Citation

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. — View Citation

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. Epub 2006 Jul 11. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Subject (Parental) Satisfaction as Measured by Modified Group Health Association of America-9 Survey (mGHAA-9)	Worse Value: 5 Best Value 45 Measures satisfaction on a scale per the mGHAA-9. 9 questions administered on a laptop in private.	Every 1-2 months	No
Secondary	Subject (Parental) State Anxiety as Measured by the Spielberger-State Trait Anxiety Inventory (s-STAI) (State Section)	s-STAI as a series of question administered by laptop computer in private. 20 questions answered on Likert 4 point scale that varies based on question type. Max score 80.	12-18 hours (Night before Endoscopy to Day of Endoscopy)	No
Secondary	Questions Asked by Subjects (Parents)	Number of questions written down by family and asked of clinician. Question sheet given to nurse in endoscopy suite and deposited in a box.	Questions written by parents during the end of consent process (48-72 hours)	No
Secondary	GI Suite Flow Efficiency Measured in 15 Minute Increments		At completion of study	No

External Links

•   The Study Web Site