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Completed

NCT Number: NCT03966469

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

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.

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Key information

Conditions

Surgery Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Knowledge, Attitudes, Practice Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Prolapse, Vaginal Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Uterine Diseases Uterine Prolapse

Age range

18 year–89 year

Sex eligibility

Female

Study type

Observational

Primary location

Hartford Hospital

Hartford, Connecticut, 06103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative support person present

Other

Participants who bring a support person to their preoperative appointment.

Patient Present Only

Other

Patient presents to their preoperative appointment without a support person.

Primary outcomes

  1. Change in Anxiety

    Time frame: Immediately prior to the preoperative visit with the physician and immediately after the preoperative appointment.

    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.

Secondary outcomes

  1. Patient satisfaction immediately after the preoperative appointment: the Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD) questionnaire

    Time frame: Patient satisfaction measured immediately after the preoperative appointment prior to leaving the clinic.

    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.

  2. Patient satisfaction prior to surgery: the Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD) questionnaire

    Time frame: Patient satisfaction measured via telephone 2-3 days prior to surgery.

    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.

  3. Preparedness at the preoperative appointment

    Time frame: Immediately after the preoperative appointment, the preparedness questionnaire will be provided

    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.

  4. Preparedness 2-3 days prior to surgery

    Time frame: 2-3 days prior to scheduled surgery, participants will be called and a preparedness questionnaire asked.

    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.

  5. Knowledge after the preoperative appointment

    Time frame: Immediately after the the preoperative appointment involving informed consent.

    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.

  6. Knowledge 2-3 days prior to surgery

    Time frame: 2-3 days prior to surgery, participants will receive a phone call where we will ask questions regarding knowledge (complete the knowledge questionnaire)

    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.

  7. Phone calls.

    Time frame: From time of enrollment up to the participants 3-5 week postoperative appointment.

    We will monitor the incidence of phone calls prior to and after surgery by chart review.

  8. Postoperative satisfaction: questionnaire

    Time frame: At the 3-5 week postoperative appointment.

    We will measure postoperative satisfaction with a postoperative satisfaction questionnaire. This is a 7 item questionnaire with lower scores indicating higher satisfaction/preparedness.

  9. Impression of improvement at postoperative appointment

    Time frame: At the 3-5 week postoperative appointment, patients will be provided the PGI-I questionnaire

    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.

  10. Anxiety prior to surgery

    Time frame: 2-3 days 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.

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 29, 2019
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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