Root Cause Analysis–based Risk Management Nursing Protocol For Patients With Gastric Ulcer

Summary

This protocol describes a root cause analysis-based risk management nursing workflow for hospitalized patients with gastric ulcers, including risk identification, causal analysis, individualized intervention, dynamic reassessment, discharge education, and follow-up.

Abstract

Gastric ulcer is a chronic digestive disorder characterized by recurrence, complications, and reduced quality of life. Although pharmacological treatment remains essential, variability in nursing processes, incomplete risk identification, and insufficient follow-up may hinder recovery and long-term disease control. Root cause analysis (RCA) is a structured quality-improvement method used to identify underlying causes of care-related risks and to guide targeted corrective action. This article describes a reproducible RCA-based risk management nursing workflow for hospitalized patients with gastric ulcers. In this retrospective comparative implementation, 240 patients admitted between January 2021 and December 2024 were identified from hospital records and classified, according to the nursing model documented during hospitalization, into a routine-care group and an RCA-based nursing group, with 120 patients in each group. The workflow includes multidisciplinary team formation, identification of representative nursing risk events, timeline reconstruction, root-cause classification, individualized intervention planning, dynamic inpatient reassessment, discharge education, and structured post-discharge follow-up. Outcome assessment procedures include evaluation of nursing effectiveness, complications, recurrence, patient satisfaction, and quality of life using gastroscopy, hospital records, a structured satisfaction assessment, and the Short Form-36 (SF-36). In this retrospective comparative study, patients managed under the RCA-based workflow showed more favorable outcomes than those receiving routine nursing care. This protocol provides an operational framework for integrating RCA into gastric ulcer nursing practice and may support reproducible risk management in other chronic disease care settings.

Introduction

Gastric ulcer is a common digestive disorder with a multifactorial etiology involving Helicobacter pylori infection, abnormal gastric acid secretion, drug-induced mucosal injury, dietary habits, and psychosocial factors¹. With changes in lifestyle, eating patterns, and stress exposure, peptic ulcer disease continues to impose a substantial clinical burden worldwide². Many patients with gastric ulcer experience persistent abdominal pain, poor appetite, and sleep disturbance, and those who develop complications such as bleeding or perforation often show marked impairment in health-related quality of life³. Although pharmacological treatment, including acid suppression and H. pylori eradication, remains central to disease management, the quality, consistency, and continuity of nursing care still influence recovery, recurrence control, and long-term well-being⁴. Conventional nursing models often focus on symptom observation and support for medical treatment, while giving less attention to recurrent care-process risks, patient-specific barriers to adherence, and structured continuity management⁵. As a result, nursing quality may vary across patients, and improvements in quality of life may remain limited⁶. Strengthening nursing quality and promoting sustained recovery in patients with gastric ulcer, therefore, remain important goals in clinical nursing practice.

Root cause analysis (RCA) has been introduced into healthcare as a structured quality-improvement method for examining adverse events, process failures, and recurrent care-related risks⁷. Rather than addressing only the visible outcome of a problem, RCA seeks to identify underlying causal factors across personnel, workflow, communication, education, and management processes⁸. In nursing settings, RCA-based approaches have been used to connect risk analysis with targeted corrective action and practice improvement⁹. Compared with conventional nursing management, an RCA-based approach offers several methodological advantages. It improves risk identification by shifting assessment from surface-level symptom management to cause-oriented analysis of repeated nursing problems. It strengthens intervention design by linking identified causes to specific and operational corrective measures, such as medication guidance, dietary management, psychological support, monitoring, and follow-up. It also improves outcome monitoring because the same risk framework used during causal analysis can be applied during reassessment and continuity management, thereby increasing procedural consistency and reproducibility across stages of care¹⁰.

From a practical perspective, this protocol is most suitable for hospitalized patients with gastric ulcers who require coordinated nursing management across admission, inpatient care, discharge preparation, and early post-discharge follow-up. It is particularly useful in settings where recurrent problems such as poor medication adherence, inadequate diet control, insufficient recognition of warning symptoms, psychological stress, or loss to follow-up are commonly observed. The protocol is also better suited to wards that can support multidisciplinary review, standardized documentation, and follow-up contact after discharge. Its applicability may be more limited in settings with highly incomplete nursing records, insufficient staffing for RCA review, lack of structured follow-up resources, or emergency clinical situations in which immediate stabilization takes priority over process-based nursing reassessment.

Despite the growing use of RCA in healthcare quality management, reproducible descriptions of RCA-based nursing workflows for gastric ulcers remain limited. In addition, when quality of life is evaluated in patients with chronic digestive disease, the Chinese version of the Short Form-36 (SF-36) has demonstrated acceptable validity and reliability in populations including patients with chronic gastritis and peptic ulcer¹¹. Disease-specific patient-reported outcome instruments for peptic ulcer have also shown good psychometric properties and may provide useful support for structured outcome assessment¹². On this basis, the present study describes and evaluates an RCA-based risk management nursing protocol for hospitalized patients with gastric ulcers. By constructing a gastric ulcer-specific nursing risk framework, identifying key risk factors through RCA, and developing individualized management plans, this study aims to provide a more standardized and operational approach to nursing care within a retrospective comparative study framework, with observed outcomes including nursing effectiveness, complications, recurrence, patient satisfaction, and quality of life.

Protocol

All procedures involving human participants were performed in accordance with the ethical standards of the institutional and national research committee and with the Declaration of Helsinki. This retrospective comparative study was approved by the Ethics Committee of Luzhou People’s Hospital (approval no. LLW202601008). De-identified clinical data extracted from hospital records were used for the retrospective review. Written informed consent from patients or their legal representatives was obtained before follow-up contact and questionnaire completion when required by the ethics committee.

1. Identification of eligible patients and definition of study groups

NOTE: The overall study workflow is shown in Figure 1.

1. Define the medical-record review period as January 2021 to December 2024.
   1. Search the hospital electronic medical record system for patients admitted during this period with a documented diagnosis of gastric ulcer.
2. Screening of eligible cases
   1. Confirm gastric ulcer by reviewing the gastroscopy report for each candidate case.
   2. Include cases with a gastroscopy-confirmed diagnosis, complete inpatient nursing records, available baseline clinical information, and follow-up data sufficient for endpoint assessment.
   3. Exclude cases with incomplete key diagnostic records, severe hepatic dysfunction, severe renal dysfunction, severe mental disorders, malignant tumors, or other conditions that prevent reliable comparison of nursing outcomes.
      CAUTION: Exclude cases with missing key source documents rather than inferring eligibility from partial records.
3. Confirmation of analyzable records
   1. Review baseline demographic data, admission nursing assessments, gastroscopy findings, inpatient nursing records, discharge documentation, and follow-up records for each eligible case.
   2. Retain only cases with sufficiently complete records for group classification and endpoint extraction.
4. Classification of the study groups
   1. Review the documented nursing model for each retained case.
   2. Classify cases as the control group when the record documents routine nursing care only.

2. Definition of routine nursing care in the control group

1. Definition of baseline assessment
   1. Extract admission records of vital signs, abdominal symptoms, appetite, sleep, bowel habits, medication history, and prior ulcer-related treatment history.
   2. Extract baseline gastroscopy findings from the endoscopy report or medical record.
2. Definition of inpatient routine care
   1. Extract records of symptom observation, vital-sign monitoring, and physician notification for acute deterioration.
   2. Extract medication administration records, including missed doses, delayed administration, and documented adverse reactions when available.
   3. Extract records of routine medication education, dietary advice, and basic emotional support.
3. Definition of discharge instruction
   1. Extract discharge records covering medication adherence, diet control, warning symptoms, outpatient review timing, smoking cessation advice, and alcohol restriction.
   2. Mark undocumented routine nursing items as undocumented.
      CAUTION: Do not assume completion of a routine nursing step when the corresponding record is absent.

3. Definition of RCA-based risk management nursing in the observation group

1. Definition of the RCA team
   1. Confirm whether the documented RCA process involved a quality-control nurse, senior clinical nurses, a gastroenterologist, and a clinical pharmacist.
   2. Define the team coordinator as the quality-control nurse and define the remaining members as contributors to event review, clinical-risk clarification, and medication-related analysis.
2. Definition of representative nursing risk events
   1. Review nursing notes, shift handover records, medication administration records, physician notification records, discharge education records, and follow-up records for recurrent or clinically meaningful nursing problems.
   2. Select representative events when they show repeated occurrence, direct relevance to complications or recurrence, delayed recognition of warning symptoms, poor adherence affecting treatment continuity, insufficient discharge understanding, or loss to follow-up.
   3. Group target events into the following categories: poor medication adherence, high psychological stress, improper diet, delayed recognition of gastrointestinal bleeding, insufficient discharge understanding, and loss to follow-up.
      NOTE: Select representative events based on recurrence frequency, clinical relevance, and modifiability, rather than solely on severity.
3. Definition of event-timeline reconstruction
   1. Reconstruct the care timeline for each representative event from admission to discharge and follow-up.
   2. Record the sequence of assessment, education, medication administration, symptom reporting, physician notification, discharge instruction, and follow-up contact.
   3. Mark the first point at which omission, delay, misunderstanding, communication failure, incomplete documentation, or interruption of follow-up became evident.
4. Definition of root-cause analysis
   1. Review whether each representative event was discussed in a structured RCA meeting.
   2. Confirm whether cause-oriented questioning was used to identify why the event occurred, why it was not prevented earlier, and which care-process failure allowed it to continue.
   3. Classify documented root causes into one or more of the following domains: knowledge deficit, patient behavior, nurse-patient communication, workflow failure, follow-up failure, or insufficient psychosocial support.
      NOTE: Focus on root-cause classification of modifiable care-process factors rather than on individual blame.
5. Definition of individualized risk assessment
   1. Review whether the patient’s knowledge level, medication adherence risk, dietary management risk, psychological stress, discharge understanding, literacy level, family support, and follow-up reliability were assessed.
   2. Record each domain as low risk, moderate risk, or high risk when such classification is documented or can be directly mapped from the nursing assessment form.
6. Definition of targeted intervention application
   1. Record repeated medication education and adherence reminders when poor medication understanding, missed doses, or delayed administration were identified.
   2. Record individualized diet instruction when improper food intake, uncertainty about trigger foods, or poor dietary compliance was identified.
   3. Record psychological support and repeated communication when anxiety, stress, poor cooperation, or avoidance behavior was identified.
   4. Record teach-back education and family participation when discharge understanding was incomplete, or communication barriers were present.
   5. Record strengthened warning-sign instruction when there was a risk of delayed recognition of bleeding, severe pain, or other acute deterioration.
   6. Record structured follow-up scheduling before discharge when recurrence risk or loss-to-follow-up risk was judged to be moderate or high.
      NOTE: Define intervention adjustment triggers as persistent nonadherence, new warning symptoms, poor discharge understanding, or unreliable follow-up contact.
7. Definition of dynamic reassessment
   1. Review whether medication adherence, dietary compliance, psychological status, discharge understanding, and warning-sign recognition were reassessed during hospitalization and before discharge.
   2. Record whether the nursing plan was adjusted when moderate-risk or high-risk problems persisted after the previous intervention.
8. Definition of discharge management
   1. Review whether reliable contact information was confirmed before discharge.
   2. Review whether discharge instruction covered medication use, diet control, warning symptoms, review timing, and conditions requiring immediate medical attention.
   3. Review whether patient understanding was checked by repeat explanation or teach-back.
9. Definition of post-discharge follow-up
   1. Confirm whether follow-up was performed once every 2 weeks during the first month after discharge and once monthly thereafter until the end of the 6 month follow-up period.
   2. Define telephone contact as the primary follow-up mode and archived mobile-message follow-up as an adjunct mode when written reminders or repeated contact were needed.
   3. Extract follow-up records covering medication adherence, dietary compliance, abdominal symptoms, recurrence-related warning signs, outpatient review completion, and lifestyle management.
   4. Record nursing advice provided after identification of nonadherence, symptom worsening, or misunderstanding of home management.
   5. Record urgent referral advice when melena, hematemesis, syncope, sudden worsening abdominal pain, or other signs of acute deterioration are reported.
      CAUTION: Treat reported bleeding symptoms, syncope, or sudden severe abdominal pain as warning events requiring urgent medical evaluation rather than routine follow-up advice.
10. Definition of follow-up completion
    1. Extract the follow-up date, contact mode, patient response, identified risk problems, nursing advice, and next scheduled contact from each follow-up record.
    2. Record at least two re-contact attempts before classifying a patient as temporarily unreachable.

4. Extraction of study variables

1. Extraction of baseline variables
   1. Extract age, sex, medical history, and other baseline demographic and clinical characteristics from the medical record.
   2. Extract baseline gastroscopy findings and admission nursing assessments from the source documents.
2. Extraction of inpatient nursing variables
   1. Extract records related to symptoms, medication use, diet management, psychological status, education delivery, and discharge instruction during hospitalization.
   2. Extract records of RCA team review, representative event identification, root-cause classification, risk reassessment, and intervention adjustment for the observation group.
3. Extraction of follow-up variables
   1. Extract follow-up records from the hospital archive, telephone follow-up log, and archived mobile-message documentation when available.
   2. Extract post-discharge data on complications, recurrence, quality of life, and nursing satisfaction.

5. Assessment of outcomes

1. Definition of follow-up timing
   1. Define the follow-up period as 6 months after discharge.
   2. Use the latest available follow-up review and gastroscopy record within the predefined window for endpoint assessment.
2. Assessment of ulcer healing
   1. Review baseline and follow-up gastroscopy reports.
   2. Estimate ulcer area as length × width using the maximum length and width recorded in the endoscopy report.
      NOTE: Use the original endoscopy report at each time point, rather than a retrospective visual estimate from stored images, whenever possible.
3. Classification of nursing effectiveness
   1. Classify a case as markedly effective when no ulcer lesion is detected on follow-up gastroscopy.
   2. Classify a case as effective when the estimated ulcer area is reduced by more than 50% relative to baseline.
   3. Classify a case as ineffective when no significant improvement is observed.
4. Recording of complications and recurrence
   1. Record upper gastrointestinal bleeding, perforation, and other predefined complications during follow-up.
   2. Define recurrence as reappearance of a gastric ulcer on follow-up gastroscopy after prior healing, or clear worsening of the original lesion during follow-up, including rehospitalization due to gastric ulcer when supported by medical records.
5. Assessment of quality of life
   1. Administer the SF-36 questionnaire at the end of follow-up under nurse guidance, or extract the completed questionnaire from the archived follow-up record when already available.
   2. Score the eight domains according to the official scoring method and convert each domain to a 0–100 scale.
6. Assessment of nursing satisfaction
   1. Administer the hospital nursing satisfaction questionnaire at the end of follow-up, or extract the completed questionnaire from the archived record when available.
   2. Score the questionnaire across the five domains of service attitude, communication clarity, response timeliness, health education, and continuity support.
   3. Classify responses as satisfied, basically satisfied, or dissatisfied according to the predefined hospital scoring rule.
      NOTE: Interpret nursing satisfaction results as supportive outcome data rather than as a stand-alone externally validated patient-reported measure.

6. Performance of statistical analysis

1. Preparation of the dataset
   1. Enter all extracted data into an electronic data file.
   2. Check all entries twice for completeness, internal consistency, and transcription accuracy.
   3. Code categorical variables numerically and define missing values explicitly before analysis.
2. Definition of the analysis population
   1. Include all eligible cases with complete baseline grouping information in the descriptive analysis.
   2. Define the final analysis sample for each endpoint according to the availability of the corresponding follow-up data.
      NOTE: Do not describe the analysis as intention-to-treat because this was a retrospective comparative study.
3. Analysis of the data
   1. Import the cleaned dataset into statistical analysis software.
   2. Use two-sided tests for all comparisons.
   3. Review continuous variables for approximate distributional suitability before applying parametric tests.
4. Comparison of continuous variables
   1. Express continuous variables as mean ± standard deviation.
   2. Compare groups using independent-samples t tests when the data approximately follow a normal distribution.
5. Comparison of categorical variables
   1. Express categorical variables as counts and percentages.
   2. Compare groups using chi-square tests, or use Fisher’s exact test when expected cell counts are <5.
6. Definition of significance
   1. Consider differences statistically significant when P < 0.05.
   2. Report very small P values as P < 0.001.

Results

Study-group classification and analysis of the population

The study flow is summarized in Figure 1. A total of 286 candidate cases were initially identified from hospital records during the predefined review period. After screening for gastroscopy-confirmed diagnosis, recording completeness, and applying predefined exclusion criteria, 240 eligible patients were included in the retrospective comparative analysis, with 120 patients ...

Discussion

This study evaluated a root cause analysis (RCA)-based risk management nursing protocol for hospitalized patients with gastric ulcers and compared its documented clinical performance with that of routine nursing care. Under the conditions of this retrospective comparative study, the RCA-based workflow was associated with higher nursing effectiveness, lower complication and recurrence rates, better SF-36 scores, and higher nursing satisfaction. These findings support the practical value of organizing gastric ulcer nursing...

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Data abstraction form	Self-developed in this study	N/A	Used for retrospective extraction of baseline, inpatient, and follow-up data
Dynamic risk reassessment sheet	Self-developed in this study	Supplementary Table S3	Used to define reassessment domains and intervention triggers in the RCA-based workflow
Eligibility screening checklist	Self-developed in this study	Supplementary Table S1	Used for retrospective case screening and eligibility confirmation
Endoscopy video processor	Olympus	CV-190	Compatible video processor for endoscopic examination
Gastric ulcer education manual	Self-developed in this study	N/A	Used for discharge education and teach-back support in the RCA-based nursing workflow
Health-related quality-of-life instrument	QualityMetric	SF-36v2 Health Survey	Used for 8-domain quality-of-life assessment
Messaging platform for follow-up communication	Tencent	Weixin / WeChat	Used as an adjunct communication tool for post-discharge follow-up when applicable
Nursing satisfaction questionnaire	Self-developed in this study	Supplementary Table S5	Structured 5-domain, 100-point instrument used for hospital-based satisfaction assessment
Post-discharge follow-up checklist	Self-developed in this study	Supplementary Table S4	Used to standardize telephone or messaging-based follow-up review
RCA event review worksheet	Self-developed in this study	Supplementary Table S2	Used for event logging and root-cause review
Statistical analysis software	IBM	SPSS Statistics 25.0	Used for statistical analysis
Video gastroscope	Olympus	GIF-HQ190	Used for diagnostic and follow-up upper gastrointestinal endoscopy