Clinical trial NCT02718807: Rapid Prototyping Models for Patient Education
Official title: Use of 3-D Printed Models to Improve Patient Understanding During the Informed Consent Process: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Education
Keywords: Patient Care
Education
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-partum women and respective co-parents who are greater than 18 years of age and fluent in the English language.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in questionnaire score
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Participant Age
timeFrame: through study completion, an average of 1 year
measure: Participant Education Level
timeFrame: through study completion, an average of 1 year
measure: Participant Gender
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Milton S. Hershey Medical Center
name: James Mooney, MD
role: PRINCIPAL_INVESTIGATOR
References:
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