Clinical trial NCT03966469: What is the Impact of the Presence of a Support Person on Informed Consent
Official title: Informed Consent for Pelvic Reconstruction: Does Having a Support Person Matter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Knowledge, Attitudes, Practice
Prolapse, Vaginal
Urinary Incontinence
Keywords: informed consent
support person
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women planning to undergo pelvic organ prolapse surgery with our Urogynecology team.

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.

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

Primary outcomes:
measure: Change in Anxiety
timeFrame: Immediately prior to the preoperative visit with the physician and immediately after the preoperative appointment.
Secondary outcomes:
measure: Patient satisfaction immediately after the preoperative appointment: the Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD) questionnaire
timeFrame: Patient satisfaction measured immediately after the preoperative appointment prior to leaving the clinic.
measure: Patient satisfaction prior to surgery: the Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD) questionnaire
timeFrame: Patient satisfaction measured via telephone 2-3 days prior to surgery.
measure: Preparedness at the preoperative appointment
timeFrame: Immediately after the preoperative appointment, the preparedness questionnaire will be provided
measure: Preparedness 2-3 days prior to surgery
timeFrame: 2-3 days prior to scheduled surgery, participants will be called and a preparedness questionnaire asked.
measure: Knowledge after the preoperative appointment
timeFrame: Immediately after the the preoperative appointment involving informed consent.
measure: Knowledge 2-3 days prior to surgery
timeFrame: 2-3 days prior to surgery, participants will receive a phone call where we will ask questions regarding knowledge (complete the knowledge questionnaire)
measure: Phone calls.
timeFrame: From time of enrollment up to the participants 3-5 week postoperative appointment.
measure: Postoperative satisfaction: questionnaire
timeFrame: At the 3-5 week postoperative appointment.
measure: Impression of improvement at postoperative appointment
timeFrame: At the 3-5 week postoperative appointment, patients will be provided the PGI-I questionnaire
measure: Anxiety prior to surgery
timeFrame: 2-3 days prior to surgery
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
References:
citation: 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.