Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00558

2 Trial Registration Date

2017-06-29

i Registration Status

Prospective

3 Secondary IDs

14152631

4 Source(s) of Funding

Health and Medical Research Fund

5 Primary Sponsor

Food and Health Bureau

6 Secondary Sponsor

Not applicable

Function

Not Applicable

Please specify

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

i Name

Helen YL Chan

ii Address

7/F Esther Lee Building. The Nethersole School of Nursing. The Chinese University of Hong Kong. Shatin. Hong Kong.

iii Phone

39438099

iv Email

helencyl@cuhk.edu.hkk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Helen YL Chan

ii Address

7/F Esther Lee Building. The Nethersole School of Nursing. The Chinese University of Hong Kong. Shatin. Hong Kong.

(This is the lead PI of the study, whereas Cheng Po Po Peggy is the site PI who helped to apply the ethics approval in the capacity of HA staff)

iii Phone

39438099

iv Email

helencyl@cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

9 Official Scientific Title of the Study

Effects of a structured advance care planning among patients with advanced illness in acute care settings: a stepped-wedge cluster randomised controlled trial

10 Public Title

Effects of a structured advance care planning among patients with advanced illness in acute care settings: a stepped-wedge cluster randomised controlled trial

i Public Title in Chinese 研究名稱

預設照顧計劃討論指引對病情嚴重住院者之效用：梯級楔式隨機對照試驗

11 Short Title (Optional)

Advance care planning in hospital

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?

2016-06-22

iii Full Name of IRB/IEC

Kowloon West Cluster Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

KW/FR-16-085(99-03)

14 Medical Condition Being Studied

Patients with advanced diseases

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Advance Care Planning

iii Dosage form of the intervention

face to face conversation

iv Dosage of the intervention

1 session

v Duration of the intervention

15 - 60 minutes

vi Frequency of the intervention

Not applicable

16 Comparative Treatments

i Description/ name of comparative treatments

Information leaflet

ii Dosage form of the comparative treatments

Written information

iii Dosage of the comparative treatments

Not applicable

iv Duration of the comparative treatments

Not applicable

v Frequency of the comparative treatments

Not applicable

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

aged 18 or over

meet either two general indicators of health deterioration or one clinical indicator of an advanced illness condition in the Supportive and Palliative Care Indicators Tool (SPICT)

able to communicate in Cantonese

ii Exclusion Criteria

mentally incompetent or unable to communicate

receiving psychiatric treatment

have been referred to the palliative care service at the time of recruitment

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Stepped wedge cluster randomised controlled trial

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Crossover

v Study Phase

1

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-08-16

21 Target Sample Size

3

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Documentation of ACP discussion

ii The metric or method of measurement used

Documentary review

iii The timepoint(s) of primary interest

3 months

24 Secondary Outcome

i The Name of the outcome

End of life care communication

ii The metric or method of measurement used

Phone follow up

iii The timepoint(s) of primary interest

3 months

Secondary Outcome

i The Name of the outcome

Quality of life

ii The metric or method of measurement used

mQOLC-E

iii The timepoint(s) of primary interest

3 months

Secondary Outcome

i The Name of the outcome

Nurses' self efficacy in ACP

ii The metric or method of measurement used

Questionnaire

iii The timepoint(s) of primary interest

Before and After training

Secondary Outcome

i The Name of the outcome

Satisfaction with intervention

ii The metric or method of measurement used

Questionnaire

iii The timepoint(s) of primary interest

3 months

Secondary Outcome

i The Name of the outcome

Therapeutic Intervention Scoring System

ii The metric or method of measurement used

Documentary review

iii The timepoint(s) of primary interest

6 months

Secondary Outcome

i The Name of the outcome

Experience with the intervention

ii The metric or method of measurement used

Focus group interview

iii The timepoint(s) of primary interest

3 months

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-11-11

27 Primary Registry and Trial Identifying Number

ChiCTR-IIC-17011833

28 Date of Registration in Primary Registry

2017-06-29

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Trial History Detail on 2017-07-03