Patient EducationNCT02718807

Rapid Prototyping Models for Patient Education

An observational study of Patient Education, run by Milton S. Hershey Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Pre-made rapid prototyping models will be used to increase patient education versus current methodologies. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Patient Education
What is being tested?: RP model explanation and questionnaire
How many people: 20 participants
Where: No sites listed yet
Study dates: May 2016to Jan 2017
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Study population: Post-partum women and respective co-parents who are greater than 18 years of age and fluent in the English language.

Who may be able to join

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

Who cannot join

any pregnancy related issues
fetal loss
NICU stay > 6 hours
Emergent cesarean section
Post-partum hemorrhage
Hysterectomy

Show all 10Show fewer

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

About this study

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

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

Read the detailed 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.

Conditions: Patient Education
Being tested: RP model explanation and questionnaire
Keywords: Patient Care, Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02718807
Study group	Role	What they receive
Post-partum Women		Post-partum women following an atraumatic pregnancy. Receives: Other: RP model explanation and questionnaire
Co-Parents		Co-parents to post-partum women following an atraumatic pregnancy. Receives: Other: RP model explanation and questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in questionnaire score
Measured: through study completion, an average of 1 year

Secondary outcomes (3)

Participant Age
Measured: through study completion, an average of 1 year
Participant Education Level
Measured: through study completion, an average of 1 year
Participant Gender
Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2016Jan 2017

First posted24 Mar 2016 (estimated)
Study startMay 2016
Primary completionDec 2016
Study completionJan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Patient EducationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02718807
Sponsor's protocol ID: 3980
Status last verified: Jan 2022
First submitted: 9 Mar 2016
Last updated: 11 Feb 2022
Results posted: No
Data monitoring committee: No
Individual data sharing: No: Data will not be shared with participants

Publications

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;2013(7):CD009445. doi: 10.1002/14651858.CD009445.pub2.
PubMed 23832767
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.
PubMed 24041712
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.
PubMed 23641760
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.
PubMed 20581164
Mankovich NJ, Cheeseman AM, Stoker NG. The display of three-dimensional anatomy with stereolithographic models. J Digit Imaging. 1990 Aug;3(3):200-3. doi: 10.1007/BF03167610.
PubMed 2085555
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. doi: 10.2176/nmc.48.582.
PubMed 19106500
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.
PubMed 23688608
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. doi: 10.1097/01.mat.0000217962.98619.ab.
PubMed 16760727
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.
PubMed 24288392
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.
PubMed 24202430
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. doi: 10.1159/000077796.
PubMed 15162002
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. No abstract available.
PubMed 23697530

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of 3-D Printed Models to Improve Patient Understanding During the Informed Consent Process: A Pilot Study
ClinicalTrials.gov ID: NCT02718807
Acronym / sponsor ID: 3980
Conditions: Patient Education
Keywords: Patient Care, Education
Study type: Observational
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Milton S. Hershey Medical CenterUniversity, hospital or other
Study start: May 2016
Primary completion: Dec 2016 (actual)
Study completion: Jan 2017 (actual)
First posted: 24 Mar 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Post-partum Women	–	Other: RP model explanation and questionnairePost-partum women following an atraumatic pregnancy.
Co-Parents	–	Other: RP model explanation and questionnaireCo-parents to post-partum women following an atraumatic pregnancy.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Post-partum women and respective co-parents who are greater than 18 years of age and fluent in the English language.

Key inclusion criteria (8 listed)

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

Key exclusion criteria (10 listed)

any pregnancy related issues
fetal loss
NICU stay > 6 hours
Emergent cesarean section
Post-partum hemorrhage

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RP model explanation and questionnaireRapid prototyping models of anatomy will be used to demonstrate an anatomic and medical condition and participants will grade the experience on a questionnaire.	Other	Co-Parents, Post-partum Women

Primary outcome

Difference in questionnaire score
Time frame: through study completion, an average of 1 year

3 secondary outcomes

Participant Age
Time frame: through study completion, an average of 1 year
Participant Education Level
Time frame: through study completion, an average of 1 year
Participant Gender
Time frame: through study completion, an average of 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
Background: PubMed 23832767Kinnersley 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;2013(7):CD009445. doi: 10.1002/14651858.CD009445.pub2.
Background: PubMed 24041712Farrell 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.
Background: PubMed 23641760Challoner 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.
Background: PubMed 20581164Gonzalez-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.
Background: PubMed 2085555Mankovich NJ, Cheeseman AM, Stoker NG. The display of three-dimensional anatomy with stereolithographic models. J Digit Imaging. 1990 Aug;3(3):200-3. doi: 10.1007/BF03167610.
Background: PubMed 19106500Mori 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. doi: 10.2176/nmc.48.582.
Background: PubMed 23688608Miller 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.
Background: PubMed 16760727Noecker 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. doi: 10.1097/01.mat.0000217962.98619.ab.
Background: PubMed 24288392Schubert 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.
Background: PubMed 24202430Starosolski 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.
Background: PubMed 15162002Suzuki 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. doi: 10.1159/000077796.
Background: PubMed 23697530Zopf 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. No abstract available.
Individual participant dataSharing planned: No. Data will not be shared with participants

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James Mooney, MD principal investigator

Milton S. Hershey Medical Center

Questions about this trial

What is this clinical trial studying?

An observational study of Patient Education, run by Milton S. Hershey Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in questionnaire score (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02718807, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.