Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00460

2 Trial Registration Date

2015-07-02

iRegistration 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

Not Applicable

Please specify

7Responsible 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

Hong Kong SAR

8Research 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

Hong Kong SAR

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

13Research 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

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2013.101

14 Medical Condition Being Studied

Not applicable

15Intervention

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

Not applicable

iv Dosage of the intervention

Not applicable

v Duration of the intervention

Not applicable

vi Frequency of the intervention

Not applicable

16Comparative Treatments

i Description/ name of comparative treatments

Not applicable

ii Dosage form of the comparative treatments

Not applicable

iii Dosage of the comparative treatments

Not applicable

iv Duration of the comparative treatments

Not applicable

v Frequency of the comparative treatments

Not applicable

17Key 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

99

v Gender

Both Male and Female

18 Study Type

Observational

19Study 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

Other

Please specify

Not applicable

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-08-01

21 Target Sample Size

1400

22 Recruitment Status

Complete

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.

25Study Information/Publication

i Study Information/Publication Available?

Yes

ii Link to Study Information/Publication

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4670525/

26Last 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

Back History

Trial Detail