Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-01-01 @ 2:57 PM
Study NCT ID:
NCT03966469
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2019-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What is the Impact of the Presence of a Support Person on Informed Consent
Sponsor:
Hartford Hospital
Organization:
Study Overview
Official Title:
Informed Consent for Pelvic Reconstruction: Does Having a Support Person Matter
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Research Questions
The research questions to be answered as a part of this study are:
Does having a support person present at the pre-operative visit affect anxiety, satisfaction, preparedness and knowledge regarding their surgery? Does having a support person present impact utilization of clinic resources including preoperative phone calls, and postoperative phone calls?
Study Design and Methods This study will be a prospective cohort study. All women scheduled to undergo vaginal pelvic reconstructive surgery will be recruited from the Urogynecology clinics of the Hartford Hospital Medical Group at the time of their pre-operative appointment. Patients who qualify for inclusion and consent to participate will be enrolled in the study.
Participants will be assigned to one of two arms:
the "support person present" arm, or the "patient present only" arm.
Participants will answer questionnaires prior to their appointment with the physician, after the appointment, 2-3 days prior to surgery via telephone, and at their postoperative appointment.
Risks/Benefits to Patients This is a minimal-risk study. The only research element, and therefore introduction of potential risk(s) beyond standard-of-care treatment, comprises administration of several surveys and data collection.
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.
Research Questions
The research questions to be answered as a part of this study are:
Does having a support person present at the pre-operative visit affect anxiety, satisfaction, preparedness and knowledge regarding their surgery? Does having a support person present impact utilization of clinic resources including preoperative phone calls, and postoperative phone calls?
Study Design and Methods This study will be a prospective cohort study. All women scheduled to undergo vaginal pelvic reconstructive surgery will be recruited from the Urogynecology clinics of the Hartford Hospital Medical Group at the time of their pre-operative appointment. Patients who qualify for inclusion and consent to participate will be enrolled in the study.
Participants will be assigned to one of two arms:
the "support person present" arm, or the "patient present only" arm.
Participants will answer questionnaires prior to their appointment with the physician, after the appointment, 2-3 days prior to surgery via telephone, and at their postoperative appointment.
Risks/Benefits to Patients This is a minimal-risk study. The only research element, and therefore introduction of potential risk(s) beyond standard-of-care treatment, comprises administration of several surveys and data collection.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: