Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

Официальное название

Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening in Hospitals Serving Diverse Patients

Обзор

The purpose of this study is to implement an electronic consent education process for the retention and research use of residual dried bloodspots at four hospitals in Michigan and assess the impact of the new education, both on patients and hospital staff. The research team will recruit women who have just given birth to answer surveys about the Michigan BioTrust consent process. Surveys will be collected from participants in the hospital and again four weeks later. The research team will collect survey data from patient participants at each hospital prior to hospital staff implementation of the new education process and again after staff implementation.

Подробное описание

The research team will compare a prospective observational control group enrolled during pre-implementation data collection within a hospital (n=2,990) to the implemented consent process group enrolled at the same hospital after implementation (2,990). Implementation will consist of hospital staff providing patients with access to a website with detailed written descriptions and a video about the Michigan BioTrust. The current standard of care, that will be maintained in addition to the new website, involves providing the patient with a brochure and descriptive information from hospital staff about the Michigan BioTrust.

A research staff member will approach patients and ask if they are willing to answer some surveys about the BioTrust consent process. After agreeing to answer the surveys, the researcher will provide them with a direct link to the research survey. If the participant does not have a phone or tablet with them, the research team member will provide a tablet upon which they can answer the questions on the survey.

All participating women or men will complete a survey 1) in the day following the BioTrust Consent and 2) at roughly 4 weeks later by email, text or telephone.

Hospital employees involved in the implementation will also answer surveys about potential sustainability immediately after completing training and again after several months of implementation.

Вмешательства

• Поведенческое Educational Website and Video
  The website offers users the opportunity to choose to watch a 4-minute video or read relevant information about Newborn Screening and the Michigan BioTrust. If they choose to read, the website is designed to present information in an engaging manner, while providing optional voiceover. The video uses a mixture of live action shots and animation, all with voiceover. All materials are available in English, Spanish and Arabic.

Первичные конечные точки

• Consent and biobanking knowledge scores [Срок оценки: Administered immediately after the intervention and at 4 week follow-up]
• Decisional regret [Срок оценки: Administered at the 4-week follow-up]
• Decisional Conflict [Срок оценки: Administered immediately after the intervention and at 4 week follow-up]
• Consenting rates [Срок оценки: Obtained from the state 6 months after the end of data collection]
• Biobanking rates [Срок оценки: Obtained from the state 6 months after the end of data collection]

Критерии участия

Критерии включения

• Adult (> 18 years)
• English, Spanish or Arabic speaking
• Just gave birth and currently a patient in the Mother \& Baby Unit in the hospital

Критерии исключения

• Parents of infants who are born pre-term (< 37 weeks gestation)
• Parents of infants in the Neonatal Intensive Care Unit
• Parents of infants being put up for adoption or in situations where legal guardianship is unknown at the time of birth

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 2 центра

• University of Utah Hospital and Clinics — Salt Lake City
• University of Utah, Department of Obstetrics & Gynecology — Salt Lake City

Идентификаторы

NCT: NCT06192511 · 00153608

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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