An interventional study of Standard Care (in control arm) and Using a PASC Checklist in Surgery, sponsored by Ondokuz Mayıs University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Supportive care
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:
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.
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.
719 studies on the registry are indexed under Communication; 159 are open to participants now.
This study's planned enrollment of 264 is above the median of 144 across 571 interventional studies indexed under Communication.
Browse Communication studies →Ondokuz Mayıs University is the lead sponsor of 277 studies on the registry; 62 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Perioperative period
Plan to share: No — 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.
Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.
Of 390 non-industry interventional studies with no phase under Communication, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 3 months is below that.
Counting every sponsor, half of 394 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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