Patient Safety Checklist (PASC) in Surgical Patients ((PASC))

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery
• Intervention / Treatment: Other: Standard Care (in control arm); Behavioral: Using a PASC Checklist

Detailed Description

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.

The 132 patients randomized to the control group will complete only the Descriptive Characteristics Form at enrollment and will receive routine standard care throughout the perioperative period. On the day of discharge, participants in the control group will also complete the Surgical Patients' Discharge Education Satisfaction Scale, the Healthcare Communication Questionnaire, and the Health Communication Problems Scale using online forms. All printed study materials from both groups will be collected by the researcher during the discharge process.

Ethical Considerations:

The trial was approved by the Clinical Research Ethics Committee (Ethical IRB: OMÜ KAEK 2025/479-15.10.2025 Sayı: B.30.2. ODM.0.20.08/669-884). All procedures adhered to the ethical principles for human experimentation and the World Medical Association Declaration of Helsinki. Prior to data collection, institutional permissions will be obtained from the hospitals where the study will be conducted. Participants will receive detailed information about the study procedures and will sign a voluntary participation consent form.

Sample size calculation:

The required sample size was calculated using G*Power 3.1.9.7. A total of 210 participants (105 per group) will be enrolled, based on an effect size (Cohen's d) of 0.50, a power of 95%, and a two-sided significance level of α = 0.05. Since no comparable study reporting an expected dropout rate was identified, a 20 % attrition rate was assumed based on common practice in experimental clinical studies. The sample size obtained from the power analysis was inflated accordingly to account for potential dropouts. Accordingly, the total sample size was determined to be 264 participants, with 132 participants allocated to each group.

Randomization and allocation Participants will be stratified according to the treating surgeon to minimize potential confounding related to differences in surgical practice and perioperative care. Within each stratum, participants will be randomized in a 1:1 ratio to either the intervention or control group using block randomization generated by Randomizer.org. The randomization sequence will be generated by an independent statistician before participant recruitment begins. To ensure allocation concealment, each randomly generated allocation and its corresponding group assignment will be placed in sequentially numbered, sealed, opaque envelopes. After written informed consent has been obtained and eligibility has been confirmed, participants will be assigned to either the PASC intervention group or the standard care control group according to the next envelope in sequence. All eligible patients will be consecutively screened and recorded.

The intervention will be delivered to all participants in the intervention group according to a standardized protocol, and outcome assessments will be conducted at the same time point using validated measurement instruments. To reduce analytical bias, study groups will be coded as Group 1 and Group 2 before data analysis, and all statistical analyses will be performed by an independent statistician blinded to group allocation. Treating surgeons will also be blinded to treatment allocation. However, due to the nature of the intervention, neither the researcher delivering the intervention nor the participants can be blinded.

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatma Cebeci, Dr.; Phone Number: +903623121919 +0905453215207; Email: fatma.cebeci@omu.edu.tr
• Study Contact Backup: Name: Bahadır B Güngör, Proff.; Phone Number: +03623121919 +905332563753; Email: bgungor@omu.edu.tr

Study Locations

• Turkey (Türkiye)
  • Atakum
    • Samsun, Atakum, Turkey (Türkiye), 55100
      • Ondokuz Mayıs University Health Practice and Research Center
      • Contact: Fatma Cebeci, PhD; Phone Number: +903623121919 +905453215207; Email: fatma.cebeci@omu.edu.tr
      • Contact: Bahadır B Güngör, Prof.; Phone Number: +905303203706; Email: bgungor@omu.edu.tr
      • Principal Investigator: Fatma Cebeci, PhD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients using the PASC 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.	Other: Standard Care (in control arm); The 132 patients randomized to the control group will complete only the Descriptive Characteristics Form at enrollment and will receive routine standard care throughout the perioperative period; Behavioral: Using a PASC Checklist; The Patient Safety Checklist (PASC) was developed for patient self-use.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.
Active Comparator: Patients receiving standard care; The 132 patients randomized to the control group will complete only the Descriptive Characteristics Form at enrollment and will receive routine standard care throughout the perioperative period.	Other: Standard Care (in control arm); The 132 patients randomized to the control group will complete only the Descriptive Characteristics Form at enrollment and will receive routine standard care throughout the perioperative period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with Discharge Education	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.	Perioperative period
Healthcare Communication	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.	Perioperative period
Healthcare Communication Problems	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.	Perioperative period

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University
• Collaborators: University of Bergen; Western Norway University of Applied Sciences; Oslo Metropolitan University
• Investigators: Principal Investigator: Fatma Cebeci, Dr., Ondokuz Mayıs University

Publications and helpful links

General Publications

• Harris K, Softeland E, Moi AL, Harthug S, Ravnoy M, Storesund A, Jurmy E, Thakkar B, Haaverstad R, Skeie E, Valen HW, Sevdalis N, Haugen AS. Development and validation of patients' surgical safety checklist. BMC Health Serv Res. 2022 Feb 25;22(1):259. doi: 10.1186/s12913-022-07470-z.
• Gremigni P, Sommaruga M, Peltenburg M. Validation of the Health Care Communication Questionnaire (HCCQ) to measure outpatients' experience of communication with hospital staff. Patient Educ Couns. 2008 Apr;71(1):57-64. doi: 10.1016/j.pec.2007.12.008. Epub 2008 Feb 19.

Helpful Links

• Health Communication Problems: A Scale Development Study
• Development of Discharge Training Satisfaction Scale for Surgical Patients

Study record dates

Study Major Dates

• Study Start (Estimated): September 20, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: surgery; Communication; discharge; patient safety; PASC; checklist
• Additional Relevant MeSH Terms: Behavior; Communication; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: OndokusMU 2025/479

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because participant-level data sharing was not included in the informed consent process. Study findings will be reported in aggregate form in scientific publications.

Drug and device information, study documents

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