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

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ClinicalTrials.gov Identifier: NCT03966469
Recruitment Status : Completed
First Posted : May 29, 2019
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Elisabeth Sappenfield, Hartford Hospital

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.

Condition or disease Intervention/treatment
Surgery Knowledge, Attitudes, Practice Prolapse, Vaginal Urinary Incontinence Other: Preoperative support person present Other: Patient Present Only

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.

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Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Informed Consent for Pelvic Reconstruction: Does Having a Support Person Matter
Actual Study Start Date : May 17, 2019
Actual Primary Completion Date : January 26, 2020
Actual Study Completion Date : February 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
Support Person Present
Participants who bring a support person with them to their preoperative appointment.
Other: Preoperative support person present
Participants who bring a support person to their preoperative appointment.

Patient Present Only
Participants who present by themselves to their preoperative appointment.
Other: Patient Present Only
Patient presents to their preoperative appointment without a support person.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women planning to undergo pelvic organ prolapse surgery with our Urogynecology team.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03966469


Locations
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United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06103
Sponsors and Collaborators
Hartford Hospital
  Study Documents (Full-Text)

Documents provided by Elisabeth Sappenfield, Hartford Hospital:
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Responsible Party: Elisabeth Sappenfield, Principle Investigator, Hartford Hospital
ClinicalTrials.gov Identifier: NCT03966469    
Other Study ID Numbers: HHC-2018-0251
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data is not available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elisabeth Sappenfield, Hartford Hospital:
informed consent
support person
Additional relevant MeSH terms:
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Urinary Incontinence
Uterine Prolapse
Prolapse
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Pathological Conditions, Anatomical
Uterine Diseases
Pelvic Organ Prolapse