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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966469
• Other study ID #: HHC-2018-0251
• Status: Completed
• Start date: May 17, 2019
• Est. completion date: February 25, 2020

Study information

• Verified date: April 2020
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 25, 2020
• Est. primary completion date: January 26, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Knowledge, Attitudes, Practice
• Prolapse
• Prolapse, Vaginal
• Surgery
• Urinary Incontinence
• Uterine Prolapse

Intervention

Other:
• Preoperative support person present
Participants who bring a support person to their preoperative appointment.
• Patient Present Only
Patient presents to their preoperative appointment without a support person.

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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)
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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