ISRCTN ISRCTN14108310
DOI https://doi.org/10.1186/ISRCTN14108310
Submission date
13/05/2025
Registration date
14/05/2025
Last edited
14/05/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
This study looked at whether a management approach called "Management by Objectives" (MBO) could help reduce safety problems in orthopedic nursing care. The researchers wanted to see if using MBO could improve how nurses perform in their knowledge, practical skills, and communication with patients.

Who can participate?
The study involved patients with fractures who were receiving care in the orthopedic department. They were divided into two groups: one received standard care, and the other received care from nurses using the MBO approach.

What does the study involve?
Participants received regular orthopedic care, but the way nurses managed their work differed. One group had nurses using a goal-setting method (MBO) to guide their care, while the other group received usual care. Researchers then compared the outcomes between the two groups.

What are the possible benefits and risks of participating?
The potential benefit for participants was receiving care that might be more organized and focused on safety and communication. There were no additional risks reported for patients in this study.

Where is the study run from?
Shanxi Bethune Hospital (China)

When is the study starting and how long is it expected to run for?
March 2021 to May 2023

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Xiaohong Zhang, zhangxh2024xh@163.com

Contact information

Dr Xiaohong Zhang
Public, Scientific, Principal Investigator

No. 99 Longcheng Street, Xiaodian District, Taiyuan City, Shanxi Province
Taiyuan City
030032
China

ORCiD logoORCID ID 0009-0004-2128-3924
Phone +86 0351-8368114
Email zhangxh2024xh@163.com

Study information

Study designInterventional non randomized
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typePrevention
Participant information sheet No participant information sheet available
Scientific titleApplication of management by objectives in standardized management of orthopedic nursing safety adverse events: a prospective study
Study objectivesManagement by objectives (MBO) is effective in reducing the incidence of nursing safety adverse events
Ethics approval(s)

Approved 28/04/2022, Ethics committee of Shanxi Bethune Hospital (No. 99 Longcheng Street, Xiaodian District, Taiyuan City, Shanxi Province,030000, China, Taiyuan City, 030032, China; +86 0351 8379723; dyyllwyh@163.com), ref: 2022021

Health condition(s) or problem(s) studiedGoal management in orthopaedic nursing
Intervention384 patients admitted by the Orthopedics Department of our Hospital from May 2021 to April 2023 were selected as the research objects in a prospective manner. The patients were divided into the control group (from May 2021 to April 2022, n=176) and the observation group (from May 2022 to April 2023, n=208) according to their admission time. The nurses for the patients in the observation group adopted Management by Objectives for care while the nurses in the control group provided regular nursing care. The control and observation groups had 9 nurses each.
The patients of the control group were nursed by 9 nurses and intervened in ordinary ways. The nurses introduced the knowledge related to the disease to them, such as preparation and cooperation before examination, treatment methods, medication guidance, precautions, etc., offered psychological counseling to those who had negative moods, and instructed them on diet and exercise.

The nurses in the observation group adopted nursing strategies guided by Management by Objectives in the care provided to the patients. See the following for the details:

Establishing a nursing management team
The team was composed of 9 members in total. The head nurse of the department acted as the team leader, and other members were highly responsible and skilled nurses with more than 5 years of nursing experience. The team held a meeting on a weekly basis to analyze the conditions of nursing management in the Orthopedics Department. Moreover, special training was offered to the nurses of the Orthopedics Department, covering the concept, application, background, purposes, specific measures, and successful cases of Management by Objectives, so as to enable each nurse to fully master and understand Management by Objectives.

Protocol for Implementing Management by Objectives
1. An analysis was carried out on the status quo of the Orthopedics Department to summarize the existing problems in orthopedic nursing management. Each of the problems was analyzed and discussed in detail to find out the fundamental factors related to the quality of nursing management in the Orthopedics Department.
2. An appropriate management system was formulated according to the differences of each nurse in the Orthopedics Department. Specifically, the nurses were appraised on a regular basis to learn the quality and effect of nursing. Moreover, these appraisals were recorded. Nurses who demonstrated excellence in patient care and adherence to the Management by Objectives principles were recognized and rewarded. Those who faced challenges in implementation were provided with additional support and training opportunities to enhance their skills. A log of safety records was established, including the patients’ hidden dangers and nursing safety adverse events, etc. The nurses should check the log on a regular basis, and register the safety adverse events. Meanwhile, they should guide the patients to prevent safety adverse events, thus reducing their risks during hospitalization. The head nurse should organize to hold a meeting regularly, so that they could analyze and summarize the safety adverse events, and put forward reasonable precautionary measures.

The nursing staff in the orthopedic unit was divided into two separate teams of 9 nurses each for the duration of the study. There was no overlap between the nurses in the control and observation groups to prevent contamination of the intervention. Both teams worked similar shifts and had comparable patient loads to ensure comparability. The duration of the intervention was 1 year, and after 1 year post-intervention, the nurse-in-charge was asked to complete a nursing competency assessment questionnaire, and the incidence of adverse events.
Intervention typeBehavioural
Primary outcome measureMeasured at 1 year pot intervention:
1. Nursing level: The nursing level was assessed using a validated tool consisting of four domains: specialty theories, technical operation, education and communication, and risk prevention. Each domain was scored from 0 to 25, with higher scores indicating better performance.
2. Safety adverse events include: Pressure injury, falling out of bed, tumble, unplanned extubation, infusion extravasation, etc.
3. Nursing satisfaction scoring: Nursing satisfaction was assessed using a self-made nursing satisfaction questionnaire.
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/03/2021
Completion date10/05/2023

Eligibility

Participant type(s)Patient
Age groupMixed
Lower age limit13 Years
Upper age limit84 Years
SexBoth
Target number of participants384
Total final enrolment384
Key inclusion criteria1. Patients diagnosed with fractures of upper limbs, lower limbs, or other parts based on their symptoms, signs, or imaging findings
2. The patients’ mental state, intelligence, and consciousness were normal
3. The patients were informed of this research and signed the informed consent
Key exclusion criteria1. Patients accompanied by heart, brain, and renal insufficiency
2. Patients accompanied by serious chronic cardiovascular and cerebrovascular diseases
3. Patients who had coagulation disorders and hematological system diseases
4. Patients who had malignant tumors and were treated by chemotherapy
5. The patients had history of drug or food allergy
Date of first enrolment01/05/2021
Date of final enrolment30/04/2023

Locations

Countries of recruitment

  • China

Study participating centre

Shanxi Bethune Hospital
No. 99 Longcheng Street, Xiaodian District
Taiyuan City
030032
China

Sponsor information

Shanxi Bethune Hospital
Hospital/treatment centre

No. 99 Longcheng Street, Xiaodian District
Taiyuan City
030032
China

Phone +86 0351 8379723
Email dyyllwyh@163.com

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/05/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryPublished as a supplement to the results publication
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planAll data generated or analyzed during this study are included in the published article.

Editorial Notes

13/05/2025: Trial's existence confirmed by Ethics committee of Shanxi Bethune Hospital.