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

Informed Consent for Pelvic Reconstruction: Does Having a Support Person Matter

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Surgery; Knowledge, Attitudes, Practice; Prolapse, Vaginal
• Intervention / Treatment: Other: Preoperative support person present; Other: Patient Present Only

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.

• Study Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06103
      • Hartford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Support Person Present; Participants who bring a support person with them to their preoperative appointment.	Other: Preoperative support person present; Participants who bring a support person to their preoperative appointment.
Patient Present Only; Participants who present by themselves to their preoperative appointment.	Other: Patient Present Only; Patient presents to their preoperative appointment without a support person.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction immediately after the preoperative appointment: the Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD) questionnaire	We will measure satisfaction with the SDS-PFD questionnaire. The SDS-PFD is composed of 6 individual items graded from 1 to 5, with higher scores indicating higher satisfaction.	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	We will measure satisfaction with the SDS-PFD questionnaire. The SDS-PFD is composed of 6 individual items graded from 1 to 5, with higher scores indicating higher satisfaction.	Patient satisfaction measured via telephone 2-3 days prior to surgery.
Preparedness at the preoperative appointment	We will measure preparedness with the preoperative preparedness questionnaire. This is an 11 item questionnaire graded from 1 to 6, with lower scores indicating higher preparedness.	Immediately after the preoperative appointment, the preparedness questionnaire will be provided
Preparedness 2-3 days prior to surgery	We will measure preparedness with the preoperative preparedness questionnaire. This is an 11 item questionnaire graded from 1 to 6, with lower scores indicating higher preparedness.	2-3 days prior to scheduled surgery, participants will be called and a preparedness questionnaire asked.
Knowledge after the preoperative appointment	We will measure knowledge with a knowledge questionnaire. This is a 14 item questionnaire graded in a yes/no format with lower scores indicating lower knowledge.	Immediately after the the preoperative appointment involving informed consent.
Knowledge 2-3 days prior to surgery	We will measure knowledge with a knowledge questionnaire. This is a 14 item questionnaire graded in a yes/no format with lower scores indicating lower knowledge.	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.	We will monitor the incidence of phone calls prior to and after surgery by chart review.	From time of enrollment up to the participants 3-5 week postoperative appointment.
Postoperative satisfaction: questionnaire	We will measure postoperative satisfaction with a postoperative satisfaction questionnaire. This is a 7 item questionnaire with lower scores indicating higher satisfaction/preparedness.	At the 3-5 week postoperative appointment.
Impression of improvement at postoperative appointment	We will measure impression of improvement with a Patient Global Impression of Improvement Questionnaire. This is a 1 item questionnaire graded from 1 to 7, with lower scores indicating greater postoperative improvement condition.	At the 3-5 week postoperative appointment, patients will be provided the PGI-I questionnaire
Anxiety prior to surgery	We will call participant several days prior to surgery and ask Spielberger State-Trait Anxiety Inventory (STAI-6) over the phone. Score ranges from 20 to 80 with higher values indicating higher anxiety.	2-3 days prior to surgery

Collaborators and Investigators

• Sponsor: Hartford Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2019
• Primary Completion (Actual): January 26, 2020
• Study Completion (Actual): February 25, 2020

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 26, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 4, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: informed consent; support person
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Uterine Diseases; Urination Disorders; Pathological Conditions, Anatomical; Pelvic Organ Prolapse; Urinary Incontinence; Prolapse; Uterine Prolapse
• Other Study ID Numbers: HHC-2018-0251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data is not available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No