What is the Impact of the Presence of a Support Person on Informed Consent

Completed

Conditions studied: Surgery, Knowledge, Attitudes, Practice, Prolapse, Vaginal, Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT03966469

Run by

Hartford Hospital

People needed

82

Starts

2019-05-17

Expected to finish

2020-02-25

Last updated by the study team

2020-04-07

Who can join

Age: 18 and older, up to 89. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States

Full record on ClinicalTrials.gov

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