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临床试验/NCT07713147
NCT07713147尚未招募不适用

The Effect of the Patient Safety Checklist (PASC) on Surgical Patients' Satisfaction With Discharge Education and Communication Problems: A Randomized Controlled Trial

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2026年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
264
试验地点
1
主要终点
Satisfaction with Discharge Education

研究概览

简要总结

This study aims to examine the effect of using the Patient Safety Checklist (PASC) on surgical patients' satisfaction with discharge education and their communication-related issues.

This study is designed as a post-test control group randomized trial. The main questions it aims to answer are:

H₀₁: There is no difference in discharge education satisfaction levels between surgical patients who use the PASC and those in the control group.

H₀₂: There is no difference in communication problems between surgical patients who use the PASC and those in the control group.

•H₁₁: There is a difference in discharge education satisfaction levels between surgical patients who use the PASC and those in the control group.

H₁₂: There is a difference in communication problems between surgical patients who use the PASC and those in the control group. Research Question:• What are the adherence rates for each item of the PASC Checklist and the overall adherence rate among participants?

Participants will:

  • From the day the decision for surgery is made until hospital discharge, participants will either use the Patient Safety Checklist (PASC) or receive standard perioperative care, according to their group allocation.
  • On the day of discharge, participants will complete the Surgical Patients' Discharge Education Satisfaction Scale, the Healthcare Communication Questionnaire, and the Health Communication Problems Scale.

详细描述

Data Collection Instruments:

Permission to use the scales and the PASC checklist has been obtained from the corresponding authors. Permission for the use of the PASC Checklist, developed by Harris et al. (2022), was obtained in writing from the corresponding author, Assoc. Prof. Kristin Harris, and the content validity process was completed. Written permissions were also obtained via email from Sevinç Meşe for the Surgical Patients' Discharge Education Satisfaction Scale, Eren Can Kalkan for the Healthcare Communication Questionnaire, and Müjdat Yeşildal for the Healthcare Communication Problems Scale.

  1. Descriptive Characteristics Form
  2. Patient Safety Checklist (PASC)
  3. Surgical Patients' Discharge Education Satisfaction Scale
  4. Healthcare Communication Questionnaire
  5. Healthcare Communication Problems Scale Data Collection Process The study will be conducted among patients undergoing elective general surgery at the Ondokuz Mayıs University Health Practice and Research Center. Patients attending the General Surgery Outpatient Clinic who are scheduled for elective surgery will be assessed for eligibility by the researchers. All patients meeting the eligibility criteria will be consecutively enrolled in the study. Following the provision of written informed consent, participants will be randomized to either the intervention or the control group.

The Patient Safety Checklist (PASC) was developed for patient self-use. Data will be collected using both printed and online forms. All participants will receive printed written instructions explaining how to complete the study forms. Participants assigned to the intervention group will additionally receive written instructions regarding the appropriate use of the PASC and the criteria that will be used to evaluate adherence to the checklist.

The 132 patients randomized to the intervention group will receive the Descriptive Characteristics Form and the Patient Safety Checklist (PASC) on the day the decision for surgery is made. Participants will be instructed to use the PASC throughout the entire perioperative period, from the preoperative phase until hospital discharge. The completed PASC will be collected by the researcher on the day of discharge. On the day of discharge, participants in the intervention group will complete the Surgical Patients' Discharge Education Satisfaction Scale, the Healthcare Communication Questionnaire, and the Health Communication Problems Scale using online forms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Care Provider, Outcomes Assessor)

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

  • Willing to participate in the study.
  • Scheduled to undergo elective primary major surgery.
  • Aged 18 years or older.
  • Undergoing a surgical procedure classified as a Category A, B, C, or D (major surgery) according to the Interventional Procedures List of the Turkish Ministry of Health.
  • Able to understand and complete the checklist, with adequate cognitive ability and no impairment that would interfere with participation.
  • Able to provide written informed consent in Turkish.

排除标准

  • Undergoing a surgical procedure classified as Category E according to the Interventional Procedures List published by the Turkish Public Hospitals Institution.
  • Belonging to vulnerable groups, including individuals who are legally restricted, prisoners, or residents of nursing homes.
  • Being scheduled for day surgery.

结局指标

主要结局

Satisfaction with Discharge Education

时间窗: Perioperative period

Surgical Patients' Discharge Education Satisfaction Scale: This scale was developed to assess surgical patients' satisfaction with the discharge education process. It consists of 21 items evaluating whether adequate education and information were provided during discharge. Items are rated on a 5-point Likert scale ranging from 5 = Completely satisfied, 4 = Satisfied, 3 = Partially satisfied, 2 = Dissatisfied, to 1 = Not satisfied at all. The scale has a five-factor structure (discharge timing, individualized information, home care, infection monitoring, and follow-up care), with factor loadings greater than 0.50 for all items. The overall internal consistency of the scale was excellent, with a Cronbach's alpha coefficient of 0.91.

Healthcare Communication

时间窗: Perioperative period

Healthcare Communication Questionnaire: This questionnaire was developed to assess patients' perceptions of healthcare professionals' communication during the delivery of healthcare services. It consists of 13 items rated on a 5-point Likert scale ranging from 1 = Not at all, 2 = Partially, 3 = Adequately, 4 = Quite a lot, to 5 = To the greatest extent. The overall Cronbach's alpha coefficient for the questionnaire was 0.83, while the subscale coefficients ranged from 0.65 to 0.86.

Healthcare Communication Problems

时间窗: Perioperative period

Health Communication Problems Scale: This scale was developed to identify patients' health communication problems and the factors underlying these problems. It consists of 13 items and three subscales: effective communication, social communication, and communication barriers. All items are rated on a 5-point Likert scale, with response options ranging from 1 = Strongly disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, to 5 = Strongly agree. The Cronbach's alpha coefficients for the subscales ranged from 0.77 to 0.88, indicating good internal consistency.

次要结局

未报告次要终点

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Cebeci

PhD

Ondokuz Mayıs University

研究点 (1)

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