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

NCT ID: NCT03966469

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 82 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-17
• Study Completion Date: 2020-02-25

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Support Person Present

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

Preoperative support person present

Intervention Type: OTHER

Participants who bring a support person to their preoperative appointment.

Patient Present Only

Participants who present by themselves to their preoperative appointment.

Patient Present Only

Intervention Type: OTHER

Patient presents to their preoperative appointment without a support person.

Interventions

Preoperative support person present

Participants who bring a support person to their preoperative appointment.

Intervention Type: OTHER

Patient Present Only

Patient presents to their preoperative appointment without a support person.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hartford Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elisabeth Sappenfield

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hartford Hospital

Hartford, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34978544 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HHC-2018-0251

Identifier Type: -

Identifier Source: org_study_id