Rapid Prototyping Models for Patient Education

Patient Education Clinical Trial

Official title:

Use of 3-D Printed Models to Improve Patient Understanding During the Informed Consent Process: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02718807
• Other study ID #: 3980
• Status: Completed
• Start date: May 2016
• Est. completion date: January 2017

Study information

• Verified date: January 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pre-made rapid prototyping models will be used to increase patient education versus current methodologies.

Description:

Post-partum women and their co-parent will have a medical condition explained to them first verbally, followed by a questionnaire, and then with the use of anatomical models created by rapid prototyping, followed by a questionnaire. The two questionnaires will then be compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mother
• Post-partum
• Atraumatic delivery of healthy, live infant at HMC
• Age > 18 Co-parent
• Co-parent
• Atraumatic delivery of healthy, live infant at HMC
• Age > 18

Exclusion Criteria:

• any pregnancy related issues
• fetal loss
• NICU stay > 6 hours
• Emergent cesarean section
• Post-partum hemorrhage
• Hysterectomy
• Any other condition requiring unplanned, medical intervention during labor and delivery
• Prior fetal loss or anomaly
• Inability to read or write English
• those who do not consent

Related Conditions & MeSH terms

• Patient Education

Intervention

Other:
• RP model explanation and questionnaire
Rapid prototyping models of anatomy will be used to demonstrate an anatomic and medical condition and participants will grade the experience on a questionnaire.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

References & Publications (12)

Challoner A, Erolin C. Creating pathology models from MRI data: a comparison of virtual 3D modelling and rapid prototyping techniques. J Vis Commun Med. 2013 Jun;36(1-2):11-9. doi: 10.3109/17453054.2013.790011. — View Citation

Farrell EH, Whistance RN, Phillips K, Morgan B, Savage K, Lewis V, Kelly M, Blazeby JM, Kinnersley P, Edwards A. Systematic review and meta-analysis of audio-visual information aids for informed consent for invasive healthcare procedures in clinical practice. Patient Educ Couns. 2014 Jan;94(1):20-32. doi: 10.1016/j.pec.2013.08.019. Epub 2013 Aug 30. Review. — View Citation

Gonzalez-Cota A, Kruger GH, Raghavan P, Reynolds PI. Computational modeling and prototyping of a pediatric airway management instrument. Anesth Analg. 2010 Sep;111(3):649-52. doi: 10.1213/ANE.0b013e3181e5ea7c. Epub 2010 Jun 25. — View Citation

Kinnersley P, Phillips K, Savage K, Kelly MJ, Farrell E, Morgan B, Whistance R, Lewis V, Mann MK, Stephens BL, Blazeby J, Elwyn G, Edwards AG. Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. Cochrane Database Syst Rev. 2013 Jul 6;(7):CD009445. doi: 10.1002/14651858.CD009445.pub2. Review. — View Citation

Mankovich NJ, Cheeseman AM, Stoker NG. The display of three-dimensional anatomy with stereolithographic models. J Digit Imaging. 1990 Aug;3(3):200-3. — View Citation

Miller SF, Sanz-Guerrero J, Dodde RE, Johnson DD, Bhawuk A, Gurm HS, Shih AJ. A pulsatile blood vessel system for a femoral arterial access clinical simulation model. Med Eng Phys. 2013 Oct;35(10):1518-24. doi: 10.1016/j.medengphy.2013.04.010. Epub 2013 May 18. — View Citation

Mori K, Yamamoto T, Oyama K, Ueno H, Nakao Y, Honma K. Modified three-dimensional skull base model with artificial dura mater, cranial nerves, and venous sinuses for training in skull base surgery: technical note. Neurol Med Chir (Tokyo). 2008 Dec;48(12):582-7; discussion 587-8. — View Citation

Noecker AM, Chen JF, Zhou Q, White RD, Kopcak MW, Arruda MJ, Duncan BW. Development of patient-specific three-dimensional pediatric cardiac models. ASAIO J. 2006 May-Jun;52(3):349-53. — View Citation

Schubert C, van Langeveld MC, Donoso LA. Innovations in 3D printing: a 3D overview from optics to organs. Br J Ophthalmol. 2014 Feb;98(2):159-61. doi: 10.1136/bjophthalmol-2013-304446. Epub 2013 Nov 28. Review. — View Citation

Starosolski ZA, Kan JH, Rosenfeld SD, Krishnamurthy R, Annapragada A. Application of 3-D printing (rapid prototyping) for creating physical models of pediatric orthopedic disorders. Pediatr Radiol. 2014 Feb;44(2):216-21. doi: 10.1007/s00247-013-2788-9. Epub 2013 Nov 8. — View Citation

Suzuki M, Ogawa Y, Hagiwara A, Yamaguchi H, Ono H. Rapidly prototyped temporal bone model for otological education. ORL J Otorhinolaryngol Relat Spec. 2004;66(2):62-4. — View Citation

Zopf DA, Hollister SJ, Nelson ME, Ohye RG, Green GE. Bioresorbable airway splint created with a three-dimensional printer. N Engl J Med. 2013 May 23;368(21):2043-5. doi: 10.1056/NEJMc1206319. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in questionnaire score		through study completion, an average of 1 year
Secondary	Participant Age		through study completion, an average of 1 year
Secondary	Participant Education Level		through study completion, an average of 1 year
Secondary	Participant Gender		through study completion, an average of 1 year