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

NCT03966469 | Completed

• 1 other identifier: HHC-2018-0251
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Knowledge, Attitudes, Practice; Prolapse, Vaginal; Urinary Incontinence

Keywords

informed consent; support person

Outcome Measures

Primary Outcomes (1)

• Change in Anxiety

  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.

  Immediately prior to the preoperative visit with the physician and immediately after the preoperative appointment.

Secondary Outcomes (10)

• 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.

Study Arms (2)

Support Person Present

Participants who bring a support person with them to their preoperative appointment.

Other: Preoperative support person present

Patient Present Only

Participants who present by themselves to their preoperative appointment.

Other: Patient Present Only

Interventions

Preoperative support person present OTHER

Participants who bring a support person to their preoperative appointment.

Support Person Present

Patient Present Only OTHER

Patient presents to their preoperative appointment without a support person.

Patient Present Only

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women planning to undergo pelvic organ prolapse surgery with our Urogynecology team.

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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06103, United States

Location

Related Publications (1)

• Sappenfield EC, O'Sullivan DM, Steinberg AC. The Value of a Support Person During the Surgical Consent Process: A Prospective Cohort Study. Female Pelvic Med Reconstr Surg. 2022 Jan 1;28(1):27-32. doi: 10.1097/SPV.0000000000001059.

  PMID: 34978544 DERIVED

MeSH Terms

Conditions

Behavior; Uterine Prolapse; Urinary Incontinence

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 29, 2019
• Study Start: May 17, 2019
• Primary Completion: January 26, 2020
• Study Completion: February 25, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)