Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening in Hospitals Serving Diverse Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,980
- 试验地点
- 2
- 主要终点
- Consent and biobanking knowledge scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (> 18 years)
- •English, Spanish or Arabic speaking
- •Just gave birth and currently a patient in the Mother & Baby Unit in the hospital
排除标准
- •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
研究组 & 干预措施
Standard of Care
Standard education provided about the Michigan BioTrust includes a brief verbal description from hospital staff and a brochure. Materials will be provided in English, Spanish, or Arabic.
Intervention
The intervention group will receive standard of care in addition to the opportunity to access a website with engaging information about the Michigan BioTrust and a 4-minute video. Materials will be provided in English, Spanish, or Arabic.
干预措施: Educational Website and Video (Behavioral)
结局指标
主要结局
Consent and biobanking knowledge scores
时间窗: Administered immediately after the intervention and at 4 week follow-up
Knowledge will be measured with with 23 questions specific to the setting of NIPS testing, and including the multidimensional measure of informed choice (MMIC). Scored will range from 0 (no knowledge) to 23 (extremely high knowledge)
Consenting rates
时间窗: Obtained from the state 6 months after the end of data collection
From the state the research team will obtain whole hospital consenting rates (people who make a decision, whether it's yes or no) for the 6-month time period before and after the Implementation
Biobanking rates
时间窗: Obtained from the state 6 months after the end of data collection
The research team will summarize the percentage who opt to participate in biobanking before and after implementation using state level data
Decisional regret
时间窗: Administered at the 4-week follow-up
The Residual Decisional Regret measure assesses a person's feelings of regret after making a decision. Scores range from 1 to 5 with lower scores indicating better outcomes
Decisional Conflict
时间窗: Administered immediately after the intervention and at 4 week follow-up
The Decisional Conflict survey will determine participant uncertainty in the decision process. DCS score ranges from 0 (no decisional conflict) to 100 (extremely high decisional conflict)
次要结局
未报告次要终点
研究者
Erin Rothwell
Professor
University of Utah