NCT05980741

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

3.1 years

First QC Date

July 19, 2023

Last Update Submit

August 7, 2023

Conditions

Keywords

High-quality nursing, Primary nursing, Roy Adaptation Model, Urological surgery

Outcome Measures

Primary Outcomes (6)

  • Patients' quality of life after surgery

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

    3 months

  • Patient satisfaction

    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 months

  • Postoperative complications

    Postoperative complications include hemorrhage, infection, and anuria

    3 months

  • The postoperative time to flatus

    postoperative recovery 1

    1 month

  • the time for first bowel movement

    postoperative recovery 2

    1 month

  • the length of hospital stay

    postoperative recovery 3

    1 month

Study Arms (4)

control group

NO INTERVENTION

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.

study group High-quality nursing

EXPERIMENTAL

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

study group Clinical Care Pathway

EXPERIMENTAL

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

study group Roy Adaptation Model

EXPERIMENTAL

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

Interventions

High-quality nursing

Also known as: primary nursing
study group High-quality nursing

Clinical Care Pathway

study group Clinical Care Pathway

Roy Adaptation Model

study group Roy Adaptation Model

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with a definite diagnosis of urological disease confirmed by pathological examination or imaging;
  • patients with definite surgical indications;
  • patients with complete follow-up information.

You may not qualify if:

  • patients with hepatic or renal dysfunction or serious organic lesions in other organs;
  • patients with associated lymph node and distant metastases;
  • patients who withdrew during the study;
  • patients with incomplete case and follow-up data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Interventions

Primary Nursing

Intervention Hierarchy (Ancestors)

Nursing CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • E-Jun Peng, Dr.

    Tong Ji Hospital, Tong Medical College, Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: High-quality nursing will be provided to the study group based on primary nursing
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 19, 2023

First Posted

August 8, 2023

Study Start

January 1, 2020

Primary Completion

January 31, 2023

Study Completion

May 31, 2023

Last Updated

August 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations