NCT07471464

Brief Summary

This study is a prospective cohort study which aims to assess patient satisfaction and preparedness for surgery through two methods of preoperative counseling: standard individual phone calls versus virtual group sessions called Shared Medical Appointments (SMAs). The study will focus on patients undergoing urogynecology prolapse surgeries at Cleveland Clinic. Researchers hypothesize that virtual group counseling will improve patient satisfaction and preparedness compared to individual phone calls. Additionally, the study will evaluate healthcare resource utilization as a secondary outcome. Participants will complete surveys before and after surgery to measure satisfaction and preparedness using validated tools. The study will enroll patients aged 18 and older who can provide informed consent and are scheduled for specific prolapse surgeries. Findings may help improve preoperative counseling practices and enhance patient-centered care.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Dec 2027

First Submitted

Initial submission to the registry

March 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 11, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

March 10, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

surgical counseling

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction

    The Patient Satisfaction Questionnaire-18 (PSQ-18) will assess satisfaction. The PSQ-18 is a validated 18-item questionnaire developed to evaluate satisfaction with medical care in seven domains, namely general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with provider, and accessibility and convenience. Responses are scored on a five-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). The total score for the questionnaire ranges from 18 (dissatisfaction with medical care) to 90 (highest satisfaction with medical care).

    From enrollment until the postoperative visit, 6-8 weeks after surgery

Study Arms (2)

Telehealth Appointment

Patients undergoing preoperative nursing telehealth appointments

virtual appointment

Patients undergoing preoperative shared nursing virtual appointments

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- Participants will be prospectively identified by the primary surgeon's team during the patient's initial consultation when the decision is made to proceed with surgery for pelvic organ prolapse.

You may qualify if:

  • Age \>18y
  • Has decision-making capacity and able to provide informed consent for research participation
  • For patients undergoing SMA: Has active MyChart
  • Able to speak and read English

You may not qualify if:

  • Unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Shannon Wallace, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Petrina LaFaire, MD, MS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 13, 2026

Study Start

June 11, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations