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临床试验/NCT07471464
NCT07471464招募中不适用

Centered Surgery - Preoperative Counseling and Patient Satisfaction

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2026年6月11日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
106
试验地点
1
主要终点
Patient Satisfaction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Unable to consent

研究组 & 干预措施

Telehealth Appointment

Patients undergoing preoperative nursing telehealth appointments

virtual appointment

Patients undergoing preoperative shared nursing virtual appointments

结局指标

主要结局

Patient Satisfaction

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

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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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