Patient Safety Checklist (PASC) in Surgical Patients

NCT07713147 | Not Yet Recruiting

• 1 other identifier: OndokusMU 2025/479
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery

Keywords

surgery; checklist; patient safety; PASC; Communication; discharge

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Patients using the PASC checklist

EXPERIMENTAL

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); Behavioral: Using a PASC Checklist

Patients receiving standard care

ACTIVE COMPARATOR

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)

Interventions

Standard Care (in control arm) OTHER

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

Patients receiving standard care; Patients using the PASC checklist

Using a PASC Checklist BEHAVIORAL

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.

Patients using the PASC checklist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead
• Oslo Metropolitan University: collaborator
• University of Bergen: collaborator
• Western Norway University of Applied Sciences: collaborator

Study Sites (1)

Ondokuz Mayıs University Health Practice and Research Center

Samsun, Atakum, 55100, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 35216592 BACKGROUND

• 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.

  PMID: 18243632 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Communication

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Fatma Cebeci, Dr.

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Cebeci, Dr.

CONTACT

+0905453215207; fatma.cebeci@omu.edu.tr

Bahadır B Güngör, Proff.

CONTACT

+905332563753; bgungor@omu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: This study is a randomized, double-blind, posttest-only, parallel-group controlled trial.

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): September 20, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)