- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07458841
Nurse-Led Discharge Program and Primary Care Outcomes: A Proof-of-concept Cluster Randomized Controlled Trial
Effectiveness of the Nurse-led Discharge Interventions in Promoting Hospital Patients' Primary Health Care Outcomes on Discharge: A Proof-of-concept Cluster Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Chronic diseases account for approximately 74% of global deaths and remain the leading cause of morbidity and mortality worldwide and in Hong Kong, particularly ischemic heart disease, cerebrovascular disease, and diabetes-related complications. The growing burden of ageing populations and non-communicable diseases highlights the need to shift healthcare systems from secondary and tertiary care toward prevention-oriented primary health care (PHC).
PHC serves as the first point of contact in a continuous healthcare process and is essential to a sustainable healthcare system. In response, Hong Kong is implementing a PHC reform through the establishment of District Health Centres to enhance population health and reduce pressure on public hospitals. Nurses, as the largest healthcare workforce, play a critical role in PHC delivery; however, nursing training in Hong Kong remains predominantly hospital-focused. Strengthening hospital nurses' roles in PHC-oriented discharge education may improve care continuity, patient self-management, and long-term health outcomes while reducing hospital readmissions and healthcare costs.
The aims of study are as follows:
- To determine the main effect of the Intervention vs. Control group on Patient Activation Measure at 3-month follow-up after discharge (Primary)
- To assess the effects on secondary outcomes at 3-month and 6-month follow-ups
- To identify mediators between intervention and outcomes to inform the potential mechanisms
- To qualitatively explore subjects' perceptions of managing their own health conditions after leaving the hospital and their experience of following the primary healthcare discharge intervention suggested by nurses.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Siu Long Chau, PhD
- Phone Number: +852 6700 9987
- Email: cslmatt@hku.hk
Study Locations
-
-
Hong Kong
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Hong Kong, Hong Kong, Hong Kong, 000000
- 18/F, Metro South Tower 1, 39 Wong Chuk Hang Road, Wong Chuk Hang, Hong Kong
-
Contact:
- Siu Long Chau, PhD
- Phone Number: +852 6700 9987
- Email: cslmatt@hku.hk
-
Principal Investigator:
- Siu Long Chau, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Hong Kong residents aged ≥18 years
- Able to read and communicate in Chinese (Cantonese or Mandarin)
- Being hospitalized for more than 24 hours
- Stable medical condition upon hospital discharge
Exclusion Criteria:
- Having a history of psychiatric/psychological disease or currently on regular psychotropic medications
- Currently participating in other primary healthcare programmes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
|
The primary healthcare discharge education begins by identifying priorities to address related to patients' life situations (using the Instrument for Patient Capacity Assessment) and determining the patient's current level of activation (using the Patient Activation Measure).
A discharge education guide developed by the research team helps to individualize the teaching according to the patient's priorities and activation level.
Subjects in the intervention group will receive the following items with instructions for use upon hospital discharge:
|
|
Active Comparator: Control Group
usual hospital discharge practice
|
The control group will receive the usual hospital discharge practice upon discharge.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The primary outcome is the change in the Patient Activation Measure (PAM) between baseline and 3-month follow-up.
Time Frame: From baseline to 3-month follow up.
|
The PAM is a 13-item self-report questionnaire to measure patient activation level [18].
Patients can go through four levels of activation: (1) disengaged and overwhelmed, (2) becoming aware but still struggling, (3) taking action, and (4) maintaining behaviors and pushing further [18].PAM raw score can be calculated by adding all of the responses to the 13 questions [18].
This score is then converted into an activation score ranging from 0 = no activation to 100 = high activation using a scoresheet provided by Insignia Health.
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From baseline to 3-month follow up.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Siu Long Chau, PhD, HKU
Publications and helpful links
General Publications
- Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.
- Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
- Atkins L, Francis J, Islam R, O'Connor D, Patey A, Ivers N, Foy R, Duncan EM, Colquhoun H, Grimshaw JM, Lawton R, Michie S. A guide to using the Theoretical Domains Framework of behaviour change to investigate implementation problems. Implement Sci. 2017 Jun 21;12(1):77. doi: 10.1186/s13012-017-0605-9.
- Hajat C, Stein E. The global burden of multiple chronic conditions: A narrative review. Prev Med Rep. 2018 Oct 19;12:284-293. doi: 10.1016/j.pmedr.2018.10.008. eCollection 2018 Dec.
- Shmueli A. The Visual Analog rating Scale of health-related quality of life: an examination of end-digit preferences. Health Qual Life Outcomes. 2005 Nov 14;3:71. doi: 10.1186/1477-7525-3-71.
- Chan SS, Wong DC, Cheung YT, Leung DY, Lau L, Lai V, Lam TH. A block randomized controlled trial of a brief smoking cessation counselling and advice through short message service on participants who joined the Quit to Win Contest in Hong Kong. Health Educ Res. 2015 Aug;30(4):609-21. doi: 10.1093/her/cyv023. Epub 2015 Jun 25.
- French SD, Green SE, O'Connor DA, McKenzie JE, Francis JJ, Michie S, Buchbinder R, Schattner P, Spike N, Grimshaw JM. Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework. Implement Sci. 2012 Apr 24;7:38. doi: 10.1186/1748-5908-7-38.
- Merkow RP, Kaji AH, Itani KMF. The CONSORT Framework. JAMA Surg. 2021 Sep 1;156(9):877-878. doi: 10.1001/jamasurg.2021.0549. No abstract available.
- Rowland E, Conolly A. A worked example of contextualising and using reflexive thematic analysis in nursing research. Nurse Res. 2024 Dec 11;32(4):17-27. doi: 10.7748/nr.2024.e1924. Epub 2024 Aug 29.
- Duarte MP, Vieira FA, Baiao VM, Monteiro JS, Ferreira AP, Inda-Filho AJ, Nobrega OT, Ribeiro HS. The 10-Item Physical Function Scale as a Sarcopenia Screening Tool for Patients on Hemodialysis. J Ren Nutr. 2024 Nov;34(6):546-551. doi: 10.1053/j.jrn.2024.05.012. Epub 2024 Jun 5.
- Ingram PB 4th, Clarke E, Lichtenberg JW. Confirmatory Factor Analysis of the Perceived Stress Scale-4 in a Community Sample. Stress Health. 2016 Apr;32(2):173-6. doi: 10.1002/smi.2592. Epub 2014 Jul 4.
- Adzrago D, Walker TJ, Williams F. Reliability and validity of the Patient Health Questionnaire-4 scale and its subscales of depression and anxiety among US adults based on nativity. BMC Psychiatry. 2024 Mar 18;24(1):213. doi: 10.1186/s12888-024-05665-8.
- Weiss ME, Piacentine LB. Psychometric properties of the Readiness for Hospital Discharge Scale. J Nurs Meas. 2006 Winter;14(3):163-80. doi: 10.1891/jnm-v14i3a002.
- Benson T, Potts HWW, Bark P, Bowman C. Development and initial testing of a Health Confidence Score (HCS). BMJ Open Qual. 2019 Jun 7;8(2):e000411. doi: 10.1136/bmjoq-2018-000411. eCollection 2019.
- Chalmers KI, Luker KA, Bramadat IJ. Students' knowledge of and attitudes towards primary health care. Nurse Educ Today. 1998 Jul;18(5):399-405. doi: 10.1016/0021-8634(92)80010-p.
- Schmaderer M, Pozehl B, Hertzog M, Zimmerman L. Psychometric Properties of the Patient Activation Measure in Multimorbid Hospitalized Patients. J Nurs Meas. 2015;23(3):128-41. doi: 10.1891/1061-3749.23.3.E128.
- Chau SL, Luk TT, Wong BYC, Wu YS, Cheung YTD, Ho SY, Kim JH, Lo HHM, Lam TH, Wang MP. A Brief Intervention With Instant Messaging or Regular Text Messaging Support in Reducing Alcohol Use: A Randomized Clinical Trial. JAMA Intern Med. 2024 Jun 1;184(6):641-649. doi: 10.1001/jamainternmed.2024.0343.
- International Council of Nurses. Position statements on primary health care. Geneva, Switzerland: International Council of Nurses; 2024. Retrieved on 05 Oct 2024 from: https://www.icn.ch/what-we-do/position-statements
- Riegel B, Sullivan-Marx E, Fairman J. Meeting global needs in primary care with nurse practitioners. Lancet. 2012 Aug 4;380(9840):449-50. doi: 10.1016/S0140-6736(12)60241-4. No abstract available.
- Boniol M, Kunjumen T, Nair TS, Siyam A, Campbell J, Diallo K. The global health workforce stock and distribution in 2020 and 2030: a threat to equity and 'universal' health coverage? BMJ Glob Health. 2022 Jun;7(6):e009316. doi: 10.1136/bmjgh-2022-009316.
- Adhikari R, Smith P. Global nursing workforce challenges: Time for a paradigm shift. Nurse Educ Pract. 2023 May;69:103627. doi: 10.1016/j.nepr.2023.103627. Epub 2023 Apr 1. No abstract available.
- Health Bureau. Legislative Council Paper No. CB(4)88/2023(03). Hong Kong SAR; 2024. Retrieved on 05 Oct 2024 from: https://www.legco.gov.hk/yr2023/english/panels/hs/papers/hs20230210cb4-88-3-e.pdf
- Allen LN, Pettigrew LM, Exley J, Nugent R, Balabanova D, Villar-Uribe M, Baatiema L, Shubber Z, Mugambi J, Kidd M, Zewdie A, Padula I, Abimbola S. The role of Primary Health Care, primary care and hospitals in advancing Universal Health Coverage. BMJ Glob Health. 2023 Dec 7;8(12):e014442. doi: 10.1136/bmjgh-2023-014442. No abstract available.
- Rifkin SB. Paradigms, policies and people: the future of primary health care. BMJ Glob Health. 2020 Feb 23;5(2):e002254. doi: 10.1136/bmjgh-2019-002254. eCollection 2020. No abstract available.
- Department of Health. Report of population health survey 2020/22, Hong Kong SAR; 2022. Retrieved on 06 Dec 2023 from: https://www.chp.gov.hk/en/static/51256.html
- Wong ELY, Xu RH, Cheung AWL. Measuring the impact of chronic conditions and associated multimorbidity on health-related quality of life in the general population in Hong Kong SAR, China: A cross-sectional study. PLoS One. 2019 Nov 20;14(11):e0224970. doi: 10.1371/journal.pone.0224970. eCollection 2019.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- currently not available
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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