Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00460

2 Trial Registration Date

2015-07-02

i Registration Status

Prospective

3 Secondary IDs

RGC Ref. No. CUHK14102314

4 Source(s) of Funding

General Research Fund, University Grants Committee

5 Primary Sponsor

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

6 Secondary Sponsor

Not applicable

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Janita Pak Chun Chau

ii Address

8/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

iii Phone

39436226

iv Email

janitachau@cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Janita Pak Chun Chau

ii Address

8/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

iii Phone

39436226

iv Email

janitachau@cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

A longitudinal examination of the association between nurse staffing levels, the practice environment and nurse-sensitive patient outcomes in hospitals

10 Public Title

Association between nurse staffing levels, the practice environment and nurse-sensitive patient outcomes in hospitals

i Public Title in Chinese 研究名稱

醫院護士人力配置、護士工作環境與護理相關的病人結果相關性的縱向研究

11 Short Title (Optional)

Association between nurse staffing levels, the practice environment and nurse-sensitive patient outcomes in hospitals

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-03-05

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Not applicable

15 Intervention

i Types of intervention

Other

Please specify

No intervention is involved in this study.

ii Description/ name of Intervention/article

Not applicable

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Not applicable

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Not applicable

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

All registered nurses, including those in clinical, supervisory, leadership and management roles, who work full time in the study units and have direct patient care responsibilities for 50% or more of their job will be recruited.

ii Exclusion Criteria

Nurses who do not have direct patient care responsibilities for 50% or more of their job will be excluded.

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-08-01

21 Target Sample Size

1400

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

-Registered nurse staffing per unit- shift.
-Number of registered nurses with a baccalaureate level or higher upon entry to the profession staffing per unit- shift.
-Skill mix information, including the number of full-time and part-time registered nurses, enrolled nurses and patient care assistants/healthcare assistants working on each shift.
-Nursing care hours per patient day: number of registered nurses per patient day and number of nursing staff hours (registered nurses, enrolled nurses, patient care assistants/healthcare assistants) per patient day.

24 Secondary Outcome

Pressure ulcers prevalence (hospital acquired); falls prevalence (inpatient falls); falls with injury; restraint prevalence; infection rates (hospital acquired): catheter-associated urinary tract infections; central line catheter-associated bloodstream infections.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-08-22

27 Primary Registry and Trial Identifying Number

ChiCTR-OOC-15006696

28 Date of Registration in Primary Registry

2015-07-02

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Not applicable

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Trial History Detail on 2015-07-02