Centered Surgery - Preoperative Counseling and Patient Satisfaction

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Organ Prolapse

Detailed Description

The study titled "Patient Centered Surgery - Preoperative Counseling and Patient Satisfaction" aims to evaluate patient satisfaction and preparedness for surgery based on the method of preoperative counseling provided by the nursing team. The primary aim is to compare patient satisfaction with preoperative nursing visits conducted through virtual shared medical appointments (SMA) versus individual phone calls. It is hypothesized that virtual group calls will improve patient satisfaction compared to phone calls. Secondary aims include comparing patient preparedness for surgery between the two methods and assessing healthcare resource utilization, such as patient-initiated phone calls, unscheduled office visits, emergency room visits, and inpatient readmissions, following urogynecology surgery. It is hypothesized that virtual group calls will enhance patient preparedness and reduce healthcare resource utilization compared to phone calls.

The study will employ a prospective cohort design to evaluate patient satisfaction and preparedness for surgery based on preoperative teaching methods. Participants will be recruited over a 24-month period, with follow-up lasting up to the postoperative appointment, typically scheduled 7-9 weeks after surgery. The study will be conducted from January 1, 2026, to January 1, 2028. The primary outcome will be patient satisfaction as measured by the validated Patient Satisfaction Questionnaire-18 (PSQ-18) following preoperative education appointments. Secondary outcomes include patient satisfaction measured at the 6-8-week postoperative visit, as well as healthcare resource utilization assessed up to 12 weeks following surgery.

Eligibility criteria include patients scheduled for major urogynecology surgeries for apical prolapse at Cleveland Clinic sites. Eligible surgeries include vaginal colpopexy, vaginal hysteropexy, obliterative procedures, laparoscopic sacrocolpopexy, and laparoscopic uterosacral ligament suspension, with or without accompanying procedures such as hysterectomy, salpingectomy, anterior/posterior colporrhaphy, and mid-urethral sling placement. Participants must be over 18 years of age, have decision-making capacity, and be able to provide informed consent. For the SMA group, patients must have active MyChart access and be able to speak and read English. Patients unable to consent will be excluded.

Study procedures involve screening and recruitment, which will occur during the patient's initial consultation when surgery is recommended. Eligible participants will receive a recruitment letter via MyChart describing the study and providing instructions for accessing the REDCap survey. If no response is received, a follow-up MyChart message will be sent, and investigators may follow up via telephone using a scripted protocol. Participants who opt into the study will complete surveys electronically via REDCap. Preoperative surveys include the PSQ-18 to assess patient satisfaction and the Patient Preparedness Questionnaire (PPQ) to measure preparedness for surgery. Postoperative surveys will consist of the PSQ-18 only. Participants will receive reminders to complete surveys within 48-72 hours after their visits, with no more than two reminders per survey.

Data collection will be conducted using REDCap, with information abstracted from EPIC electronic health records and linked to survey responses. Identifiable data, including medical record numbers and email addresses, will be used for survey distribution and data collection but will be de-identified for analysis. Data will be securely stored on Cleveland Clinic devices and accessed only by investigators approved by the Institutional Review Board (IRB). Statistical analysis will be performed using JMP Pro version 17.0 software, with support from Cleveland Clinic Quantitative Health Sciences. Patient satisfaction scores from the PSQ-18 will be treated as continuous data and analyzed using t-tests to compare mean scores between groups. Healthcare utilization will be analyzed individually and as a composite, while adverse events will be evaluated using the Clavien-Dindo Grading System for surgical complications. Descriptive statistics will summarize demographic and clinical characteristics.

The study aims to recruit approximately 106 participants, with 53 patients per group to achieve 80% power to detect a 5.5-point difference in PSQ-18 scores between groups. Privacy and confidentiality will be prioritized, with all data managed electronically in REDCap and protected by Cleveland Clinic firewalls. Identifiable information will be removed prior to analysis. Findings will be disseminated through presentations at scientific meetings and publications in gynecologic journals. No data sharing will occur, and the study does not require a Data Monitoring Committee as it involves data collection only. Recruitment efforts will include educating surgeons and advanced practice providers about the study during Urogynecology Section Research Meetings.

• Study Type: Observational
• Enrollment (Estimated): 106

Contacts and Locations

• Study Contact: Name: Petrina LaFaire, MD, MS; Phone Number: 216-445-8090; Email: lafairp@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Petrina LaFaire, MD, MS; Phone Number: 216-445-8090; Email: lafairp@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Unable to consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Telehealth Appointment; Patients undergoing preoperative nursing telehealth appointments
virtual appointment; Patients undergoing preoperative shared nursing virtual appointments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Shannon Wallace, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: surgical counseling
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pathological Conditions, Signs and Symptoms; Pelvic Organ Prolapse
• Other Study ID Numbers: 26-029 (The Cleveland Clinic Foundation Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No