Clinical trial NCT01704560: Improving Measurement Of Parents' Understanding Of Research Permission
Official title: IMPROVING MEASUREMENT OF PARENTS' UNDERSTANDING OF RESEARCH PERMISSION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Improve Parent Understanding of Research Permission
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Well-informed potential subjects are presumably better able to make autonomous decisions about the risks and benefits of participating in a research study than those in possession of less information. In actuality, prior research into consent understanding suggests that longer forms offering exhaustive information may inhibit rather than promote understanding. Moreover, technical wording in tools used to measure parent understanding of research permission may also lead to inhibition of understanding. This study will test the hypothesis that, among parents of potential subjects for greater-than-minimal-risk research, two modified and simplified subset of questions from the Deaconess Informed Consent Comprehension Test (DICCT), one oral and open-ended and one written and multiple choice, will increase subject understanding of the nature and risks of the research. The study will enroll the parents of 40 potential neonatal research subjects with an interim analysis of data at 20 subjects. Subjects will review a sham research permission form and will be randomized 1:1 to complete one of the two modified comprehension tests in addition to the DICCT (gold-standard) test. Parents will be given an open-ended survey after the tests in order to qualitatively describe their opinions of each test. A subset of parents who have received the written form will also undergo a cognitive interview about the form. A similar subset will also be given an open-ended survey about a proposed permission form cover sheet. The primary outcome will be the correlation of scores between the DICCT and modified comprehension tests, following the sham informed consent process.


Eligibility criteria: Inclusion Criteria:

* Parents of potential subjects eligible for a NICHD Neonatal Research Network (NRN) interventional trial ("Hydrocortisone/Extubation") or greater-than-minimal risk observational trial ("PROP")
* Permission being sought for a qualifying study
* English speaking

Exclusion Criteria:

* Permission has not been previously sought for another qualifying study
* Illiteracy (unable to read simple forms)

Primary outcomes:
measure: DICCT Questionnaire
timeFrame: Within 2 weeks after being approached for participation.
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Women and Children's Hospital of Buffalo
state: New York
city: Rochester
country: United States
facility: Ann Marie Scorsone
state: New York
Study officials:
affiliation: University of Rochester
name: Carl T D'Angio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: D'Angio CT, Wang H, Hunn JE, Pryhuber GS, Chess PR, Lakshminrusimha S. Permission form synopses to improve parents' understanding of research: a randomized trial. J Perinatol. 2017 Jun;37(6):735-739. doi: 10.1038/jp.2017.26. Epub 2017 Mar 30.