Exploration of New Nursing Models for Urological Surgery

Sponsor
YaNi Peng (Other)
Overall Status
Completed
CT.gov ID
NCT05980741
Collaborator
(none)
300
1
4
40.9
7.3

Study Details

Study Description

Brief Summary

Patients undergoing urological surgery often need to be provided with targeted nursing care to ensure that the therapeutic effects can be fully realized, however, the traditional nursing cannot reach the expect effect.both patient outcome and nurse satisfaction have been reported with high levels of dissatisfaction in the traditional nursing. Therefore, exploring a new, patient-centered and effective nursing mode is needed. In 2010, the Chinese Ministry of Health proposed a project named the High-Quality Care Project to improve nurse and patient outcomes through the transformation of the nursing care delivery system in hospitals. This study aims to compare the new nursing model and the traditional nursing, and to explore a more effective nursing model for urological surgery.

Condition or Disease Intervention/Treatment Phase
  • Procedure: high-quality nursing
  • Procedure: Clinical Care Pathway
  • Procedure: Roy Adaptation Model
N/A

Detailed Description

Patients who underwent urological disease diagnosed and treated in our department were included in this study. The patients were randomly divided into two groups through the random number table method, with a 1:1 ratio. The control group received traditional urological care. The study group comprised 3 subgroups, and each subgroup received different nursing model. All the three new nursing models, including high-quality nursing (primary nursing), Clinical care pathway, and Roy adaptation model.were given to the subgroups respectively.

High-quality nursing refers to effective nursing measures in multiple aspects and dimensions, provided to patients according to their actual conditions by centering on the patients throughout their ongoing treatment, strengthening the primary nursing care, and fully implementing the nursing responsibility including managing complications and providing long-term support and information, to ensure patient satisfaction and to improve the patient's quality of life. Clinical care pathway includes multidisciplinary care plans that provides detailed guidelines for patients with specific clinical problems, and the Roy adaptation model (RAM), proposed by nursing scientist Sister Callista Roy in 1970, offers a comprehensive framework to guide nursing care for patients with chronic diseases.

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
High-quality nursing will be provided to the study group based on primary nursingHigh-quality nursing will be provided to the study group based on primary nursing
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Exploration of New Nursing Models for Urological Surgery
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Jan 31, 2023
Actual Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: control group

Traditional nursing services are provided to the control group, based on functional nursing. The nurses in the ward are assigned to complete different tasks according to their responsibilities, technical knowledge and skills. These tasks are including carrying out health education to the patients, introducing the admission guidelines and ward conditions, informing patients of basic knowledge on diseases, treatment, and nursing, monitoring patient vital signs and so on. The basic medical inspection and care are conducted appropriately. The patients are instructed on the compliance and precautions required during the perioperative period. The wound and drainage are checked regularly after the operation.

Experimental: study group High-quality nursing

High-quality nursing is provided to the study group based on primary nursing. Nurses in primary nursing take responsibility for the total care of a patient and are accountable for his/her care over 24 h a day from the patient's admission to discharge. In this case, nurses have more time to communicate with patients and to establish the nurse-patient relationship. In addition, high-quality nursing offers effective nursing measures to patients in terms of multiple aspects and dimensions through planning patient-centered nursing care, strengthening the perioperative nursing since admission, and fully implementing the nursing responsibility system.

Procedure: high-quality nursing
High-quality nursing
Other Names:
  • primary nursing
  • Experimental: study group Clinical Care Pathway

    The clinical care pathway will be implemented immediately after admission. With the patient as the center of the nursing intervention, a flowable form is chosen to ensure that patients could receive effective nursing interventions throughout the entire hospitalization from the day of admission to the final discharge. In addition to primary care, the present program also unifies the management of nursing resources with the establishment of a highly qualified and professionally competent nursing team. The team members would cooperate with each other and give full play to their respective initiatives, with the common goal of improving the quality of care. The severity of illness, psychological status, and family and social environment in each patient differ, so individualized care plans are developed for each case.

    Procedure: Clinical Care Pathway
    Clinical Care Pathway

    Experimental: study group Roy Adaptation Model

    the Roy Adaptation Model (RAM) offers a comprehensive framework to guide nursing care for patients with chronic diseases. The RAM group receives standard care supplemented with interventions based on the RAM model. Negative emotions measured by the Hospital Anxiety and Depression Scale (HADS), pain intensity by the Visual Analog Scale (VAS), and HRQoL by the 36-Item Short Form Health Survey (SF-36) are measured at the preoperative visit (T0), at 30 days (T1), and at 3 months of (T2) follow-up.

    Procedure: Roy Adaptation Model
    Roy Adaptation Model

    Outcome Measures

    Primary Outcome Measures

    1. Patients' quality of life after surgery [3 months]

      the 36-Item Short Form Health Survey (SF-36)

    2. Patient satisfaction [3 months]

      The patient satisfaction was evaluated by means of an adapted version of Press-Ganey PS scores, which included physician-specific questions and hospital performance questions

    3. Postoperative complications [3 months]

      Postoperative complications include hemorrhage, infection, and anuria

    4. The postoperative time to flatus [1 month]

      postoperative recovery 1

    5. the time for first bowel movement [1 month]

      postoperative recovery 2

    6. the length of hospital stay [1 month]

      postoperative recovery 3

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. patients with a definite diagnosis of urological disease confirmed by pathological examination or imaging;

    2. patients with definite surgical indications;

    3. patients with complete follow-up information.

    Exclusion Criteria:
    1. patients with hepatic or renal dysfunction or serious organic lesions in other organs;

    2. patients with associated lymph node and distant metastases;

    3. patients who withdrew during the study;

    4. patients with incomplete case and follow-up data.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China 430030

    Sponsors and Collaborators

    • YaNi Peng

    Investigators

    • Principal Investigator: E-Jun Peng, Dr., Tong Ji Hospital, Tong Medical College, Huazhong University of Science and Technology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    YaNi Peng, Principal Investigator, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT05980741
    Other Study ID Numbers:
    • TJ-IRB20220940
    First Posted:
    Aug 8, 2023
    Last Update Posted:
    Aug 8, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by YaNi Peng, Principal Investigator, Tongji Hospital

    Study Results

    No Results Posted as of Aug 8, 2023