What is the Impact of the Presence of a Support Person on Informed Consent
Condition: Surgery; Knowledge, Attitudes, Practice; Prolapse, Vaginal; Urinary Incontinence
MeSH terms: Urinary Incontinence; Uterine Prolapse; Prolapse
Study type: Observational

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.
    

Intervention name(s): Preoperative support person present; Patient Present Only
Intervention type(s): Other; Other
Intervention description(s): Participants who bring a support person to their preoperative appointment.; Patient presents to their preoperative appointment without a support person.
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.
      
Keywords: informed consent; support person