Informed Consent for Pelvic Reconstruction: Does Having a Support Person Matter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Change in Anxiety
研究概览
简要总结
In practice, the Investigators recommend that patients bring a family member or close friend to their pre-operative appointment to help with patient anxiety, comprehension, and informed decision-making. However, there is limited literature to support this recommendation. The investigators are exploring if having a support person present during this consent process impacts anxiety, satisfaction, knowledge, and preparedness for surgery.
详细描述
Introduction:
In practice, the investigators recommend that patients bring a family member or close friend to their pre-operative appointment to help with patient anxiety, comprehension, and informed decision-making. However, there is limited literature to support this recommendation. The investigators hypothesize that having a family member or close friend present will decrease patient anxiety and improve patient satisfaction and recall regarding the risks/benefits/ alternatives of surgery.
Study Objectives The primary objective is to assess the impact of having a support person present during the patient's preoperative visit on patient anxiety regarding informed consent for surgery. The secondary objective is to assess the impact of a support person on patient satisfaction, self-assessment of understanding, knowledge, time spent with patient, and pre- and post-operative phone calls.
Hypotheses HO: For women with a support person present during their preoperative visit, there is no difference in the patient-reported anxiety regarding informed consent for surgery compared with women without a support person present.
HA: For women with a support person present during their preoperative visit, there is a difference in the patient-reported anxiety regarding informed consent for surgery compared with women without a support person present.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo a 23-hr observation or inpatient surgery for pelvic organ prolapse
- •Able to understand English
- •Able/willing to sign the informed consent document
排除标准
- •Surgery canceled
- •Inability to provide consent
- •Resident of a long-term care facility or utilization of a home health service
- •Scheduled for outpatient surgery
- •non-English speaking
- •unable/unwilling to sign informed consent document
结局指标
主要结局
Change in Anxiety
时间窗: Immediately prior to the preoperative visit with the physician and immediately after the preoperative appointment.
We will measure anxiety with the Spielberger State-Trait Anxiety Inventory (STAI-6) questionnaire. Score ranges from 20 to 80 with higher values indicating higher anxiety.
次要结局
- Patient satisfaction immediately after the preoperative appointment: the Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD) questionnaire(Patient satisfaction measured immediately after the preoperative appointment prior to leaving the clinic.)
- Patient satisfaction prior to surgery: the Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD) questionnaire(Patient satisfaction measured via telephone 2-3 days prior to surgery.)
- Preparedness at the preoperative appointment(Immediately after the preoperative appointment, the preparedness questionnaire will be provided)
- Preparedness 2-3 days prior to surgery(2-3 days prior to scheduled surgery, participants will be called and a preparedness questionnaire asked.)
- Knowledge after the preoperative appointment(Immediately after the the preoperative appointment involving informed consent.)
- Knowledge 2-3 days prior to surgery(2-3 days prior to surgery, participants will receive a phone call where we will ask questions regarding knowledge (complete the knowledge questionnaire))
- Phone calls.(From time of enrollment up to the participants 3-5 week postoperative appointment.)
- Postoperative satisfaction: questionnaire(At the 3-5 week postoperative appointment.)
- Impression of improvement at postoperative appointment(At the 3-5 week postoperative appointment, patients will be provided the PGI-I questionnaire)
- Anxiety prior to surgery(2-3 days prior to surgery)
研究者
Elisabeth Sappenfield
Principle Investigator
Hartford Hospital