Improving Measurement Of Parents' Understanding Of Research Permission

NCT ID: NCT01704560

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-30
• Study Completion Date: 2019-04-30

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.

Conditions

Improve Parent Understanding of Research Permission

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Coversheet to Informed Consent

Coversheet attached to Informed Consent.

Group Type: EXPERIMENTAL

Coversheet to Informed Consent

Intervention Type: OTHER

The intervention is a one page cover sheet to be affixed to the front of the standard permission form for the trial for which permission is being sought (attached to application). The form will identify the study as research and contain sections that include investigator contact information, the purpose of the study, a brief description of the study procedures, the alternatives, the voluntary nature, the risks, the potential benefits, a discussion of privacy and confidentiality, the costs and the payments. Each topic will also contain a reference to the page in the consent containing the full description of the topic. The form is designed to have a reading level no higher than 6th to 8th grade. Parents will also receive the full permission form, and all required signatures will still be collected on the permission form.

No Coversheet

Standard, full permission form, without the coversheet.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Coversheet to Informed Consent

The intervention is a one page cover sheet to be affixed to the front of the standard permission form for the trial for which permission is being sought (attached to application). The form will identify the study as research and contain sections that include investigator contact information, the purpose of the study, a brief description of the study procedures, the alternatives, the voluntary nature, the risks, the potential benefits, a discussion of privacy and confidentiality, the costs and the payments. Each topic will also contain a reference to the page in the consent containing the full description of the topic. The form is designed to have a reading level no higher than 6th to 8th grade. Parents will also receive the full permission form, and all required signatures will still be collected on the permission form.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Carl D'Angio

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carl T D'Angio, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Women and Children's Hospital of Buffalo

Buffalo, New York, United States

Ann Marie Scorsone

Rochester, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28358380 (View on PubMed)

Other Identifiers

39377

Identifier Type: -

Identifier Source: org_study_id