Chronic DiseaseQoC NAHCNCT02307929
Evaluation of Quality of Care - Nurse Allied Health Clinic Programme, HA
An observational study of Chronic Disease, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
In the past two decades, as a result of population aging and shifts in patient needs, we have seen an increased demand for chronic disease management (CDM) delivered in the community. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- How many people
- 2,496 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2010to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients enrolled in any of the programmes (fall prevention, continence care, mental wellness, wound care, respiratory disease management and medication management and compliance clinics) in Hong Kong Primary care.
Who may be able to join
- Falls Prevention (FP) All patients who are 60 years and above, who live in community, and who have a history of falls in the past 12 months or who are potential fallers (e.g. co-existing chronic disease, have lower limb weakness or decrease in mobility) are eligible to be recruited to the FP clinic.
- Continence Care (CC) Patients who are >18 years old, living in the community reporting bladder or bowel problems,lower urinary tract symptoms (LUTS), constipation, and/or faecal incontinence are eligible to be recruited to the CC clinic.
- Mental Wellness (MW) Patients who are >18 years old presenting with mild psychological health problems or who are having difficulty with coping with everyday life demands will be eligible to be recruited to the MW clinic.
- Wound Care (WC) Patients who are >18 years old who are receiving regular wound care in the GOPC and have hard-to-heal or complicated wounds will be recruited to the WC clinic.
- Respiratory Disease Management (respiratory clinic) Patients aged 40 years or above who are either current smokers or ex-smokers with respiratory symptoms or who are known to have Chronic obstructive pulmonary disease (COPD) are eligible to be recruited to the respiratory clinic.
- Medication Management and Compliance Clinic (MMCC) Patients who have chronic disease with poor or questionable drug compliance, or who are on multiple medication (polypharmacy), or who are using medications or pharmaceutical devices that warrant special attention are eligible to be recruited to the MMCC programme.
Who cannot join
- Continence Care (CC) Patients who live in residential care facilities will be excluded.
- Mental Wellness (MW) Patients will be excluded if they live in a residential facility or have immediate psychiatric risk.
- Respiratory Disease Management (respiratory clinic) Patients will be excluded if they have shortness of breath due to ischaemic heart disease or have respiratory symptoms due to infectious lung diseases.
- In all programmes:
- Patients will be excluded if they are unable to understand or communicate in Chinese language,or if they refuse to give consent.
- In-depth study of NAHC CC programme:
- NAHC participants: all new patients with LUTS. Patients will be excluded if they are unable to understand or communicate in Chinese language,or if they refuse to give consent.
- Control: a modified The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaire is used to screen for patient eligibility in general-outpatient clinics. Patients will be excluded if they are aged < 18 years, could not understand Cantonese, refuse to participate, or are too ill to give consent. Patients are also excluded if they have received any service from a nurse-led primary care clinic or a specialist clinic within the past one year for his/her LUTS.
Trial locations and contacts
1 site in 1 country.
About this study
In the past two decades, as a result of population aging and shifts in patient needs, we have seen an increased demand for chronic disease management (CDM) delivered in the community. The Hong Kong Government introduced six nurse allied health clinics (NAHC) programme to assist the delivery of care to facilitate the increased demand on chronic disease management (CDM) in the community, which are currently being piloted within the government funded general outpatient clinics (GOPC) of the Hospital Authority (HA). These programmes are designed to enhance CDM in primary care through patient empowerment and use of multi-disciplinary nurse and allied health led teams, and aim for secondary prevention and treat-to-target for specific health conditions. This model of care has already been established in a number of countries, namely United Kingdom, Australia, Canada and United States, where multi-disciplinary allied-health clinics, nurse practitioners and nurse-led clinics have already been integrated into routine practice in primary care (Thomas, Cullum et al. 2000; Laurant, Reeves et al. 2005).
The six NAHC programmes which have been developed to date address falls prevention (FP), continence care (CC), mental wellness (MW), wound care (WC), respiratory disease management (respiratory clinic) and medication management and compliance (MMCC). The evaluation on the QOC is an essential part of the programme in order to inform future policy. he Department of Family Medicine and Primary Care (FMPC) of the University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of the QOC of the programme.
Read more
The Action Learning and Audit Spiral methodologies to measure whether the target standard of care intended by the NAHC programme is achieved. Each NAHC participating clinic will be invited to complete a structured evaluation questionnaire. Anonymized data of all patients who have enrolled into the NAHC programme for more than 6 months will be included in the evaluation on the process and outcomes of care. Data on the process of care will be retrieved from the HA medical records.
In-depth study of NAHC CC programme: In order to compare the outcomes over time between subjects who have and who have not participated in the NAHC Continence Care Programme, three hundred and sixty control patients who have not been enrolled into the NAHC CC programme will be selected for the comparison in the outcomes of care. Subjects will be followed up by telephone to evaluate the effect of the programme in quality of life (QOL), patient enablement, and global rating of change in health condition at baseline , 12-month and 24-month after enrollment.
Main Outcome Measures: The primary outcomes are the proportion of participants who have received the planned process of care and have improvement in clinical outcomes.
Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be calculated. The changes in clinical, service and patient reported outcomes between baseline and discharge will assessed by paired sample t-test. The audit cycle will be repeated 4 times over a period of 5 years.
In-depth study of NAHC CC programme: the clinical outcomes between NAHC CC subjects and control group will be compared by independent sample t-test or Chi-square test.
Results: The QOC of the NAHC programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified.
Conclusion: The results of this study will provide empirical evidence on whether the HA's NAHC programmes enhance the QOC of their participating patients. This information will be used to guide service planning and policy decision making.
- Conditions
- Chronic Disease
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Disease Management | Aging population with the need of Chronic Disease Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of clinics that have satisfied each of the structure criteria.
Interim analysis will evaluate the period from August, 2009 to December, 2010; to December, 2011; to December, 2012; to December, 2013. Final analysis will evaluate the period from August, 2009 to December, 2014.
Measured: Five years
The proportion of patients who have complied with the criterion process of care.
Interim analysis will evaluate the period from August, 2009 to June, 2011; to December, 2011; to December, 2012; to December, 2013. Final analysis will evaluate the period from August, 2009 to December, 2014.
Measured: Five years
The proportion of patients who have achieved the target of outcomes of care
Interim analysis will evaluate the period from August, 2009 to June, 2011; to December, 2011; to December, 2012; to December, 2013. Final analysis will evaluate the period from August, 2009 to December, 2014.
Measured: Five years
Secondary outcomes (2)
Patient reported outcomes (PRO) measured by the change in Short Form-12v2 scores, the Patient Enablement Index and Global Rating of Change Scale scores (In-depth study of NAHC CC programme)
Baseline, 12-month and 24-month after the first administration of questionnaire.
Measured: 2 years
Service utilization outcomes measured by GOPC consultation, Specialist Out-patient Clinics consultation, A&E and hospital attendance rates in the past 12 months.hospital attendance rates in the past 12 months.
Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 5 years.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startSep 2010
- Primary completionSep 2015
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,496 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, Professor Cindy L.K. Lam, The University of Hong Kong
- Investigators
- Cindy L.K. Lam, MD, Study chair, Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong KongW.Y. Chin, MBBS, Principal investigator, Department of Family Medicine and Primary Care, Faculity of Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307929
- Sponsor's protocol ID
- HKCTR-1189
- Acronym
- QoC NAHC
- Status last verified
- Sep 2017
- First submitted
- 28 Aug 2013
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Chin WY, Choi EP, Lam CL. The effect of timing of incentive payments on response rates for cohort study telephone interviews in primary care setting with cost-minimization analysis, a randomized controlled trial. BMC Med Res Methodol. 2015 Oct 6;15:79. doi: 10.1186/s12874-015-0073-3.
PubMed 26445404
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Quality of Care - Nurse Allied Health Clinic Programme, HA
- ClinicalTrials.gov ID
- NCT02307929
- Acronym / sponsor ID
- QoC NAHC / HKCTR-1189
- Conditions
- Chronic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,496 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Study start
- Sep 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the past two decades, as a result of population aging and shifts in patient needs, we have seen an increased demand for chronic disease management (CDM) delivered in the community. The Hong Kong Government introduced six nurse allied health clinics (NAHC) programme to assist the delivery of care to facilitate the increased demand on chronic disease management (CDM) in the community, which are currently being piloted within the government funded general outpatient clinics (GOPC) of the Hospital Authority (HA). These programmes are designed to enhance CDM in primary care through patient empowerment and use of multi-disciplinary nurse and allied health led teams, and aim for secondary prevention and treat-to-target for specific health conditions. This model of care has already been established in a number of countries, namely United Kingdom, Australia, Canada and United States, where multi-disciplinary allied-health clinics, nurse practitioners and nurse-led clinics have already been integrated into routine practice in primary care (Thomas, Cullum et al. 2000; Laurant, Reeves et al. 2005).
The six NAHC programmes which have been developed to date address falls prevention (FP), continence care (CC), mental wellness (MW), wound care (WC), respiratory disease management (respiratory clinic) and medication management and compliance (MMCC). The evaluation on the QOC is an essential part of the programme in order to inform future policy. he Department of Family Medicine and Primary Care (FMPC) of the University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of the QOC of the programme.
The Action Learning and Audit Spiral methodologies to measure whether the target standard of care intended by the NAHC programme is achieved. Each NAHC participating clinic will be invited to complete a structured evaluation questionnaire. Anonymized data of all patients who have enrolled into the NAHC programme for more than 6 months will be included in the evaluation on the process and outcomes of care. Data on the process of care will be retrieved from the HA medical records.
In-depth study of NAHC CC programme: In order to compare the outcomes over time between subjects who have and who have not participated in the NAHC Continence Care Programme, three hundred and sixty control patients who have not been enrolled into the NAHC CC programme will be selected for the comparison in the outcomes of care. Subjects will be followed up by telephone to evaluate the effect of the programme in quality of life (QOL), patient enablement, and global rating of change in health condition at baseline , 12-month and 24-month after enrollment.
Main Outcome Measures: The primary outcomes are the proportion of participants who have received the planned process of care and have improvement in clinical outcomes.
Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be calculated. The changes in clinical, service and patient reported outcomes between baseline and discharge will assessed by paired sample t-test. The audit cycle will be repeated 4 times over a period of 5 years.
In-depth study of NAHC CC programme: the clinical outcomes between NAHC CC subjects and control group will be compared by independent sample t-test or Chi-square test.
Results: The QOC of the NAHC programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified.
Conclusion: The results of this study will provide empirical evidence on whether the HA's NAHC programmes enhance the QOC of their participating patients. This information will be used to guide service planning and policy decision making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Disease Management | – | –Aging population with the need of Chronic Disease Management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled in any of the programmes (fall prevention, continence care, mental wellness, wound care, respiratory disease management and medication management and compliance clinics) in Hong Kong Primary care.
Key inclusion criteria (6 listed)
- Falls Prevention (FP) All patients who are 60 years and above, who live in community, and who have a history of falls in the past 12 months or who are potential fallers (e.g. co-existing chronic disease, have lower limb weakness or decrease in mobility) are eligible to be recruited to the FP clinic.
- Continence Care (CC) Patients who are >18 years old, living in the community reporting bladder or bowel problems,lower urinary tract symptoms (LUTS), constipation, and/or faecal incontinence are eligible to be recruited to the CC clinic.
- Mental Wellness (MW) Patients who are >18 years old presenting with mild psychological health problems or who are having difficulty with coping with everyday life demands will be eligible to be recruited to the MW clinic.
- Wound Care (WC) Patients who are >18 years old who are receiving regular wound care in the GOPC and have hard-to-heal or complicated wounds will be recruited to the WC clinic.
- Respiratory Disease Management (respiratory clinic) Patients aged 40 years or above who are either current smokers or ex-smokers with respiratory symptoms or who are known to have Chronic obstructive pulmonary disease (COPD) are eligible to be recruited to the respiratory clinic.
Key exclusion criteria (8 listed)
- Continence Care (CC) Patients who live in residential care facilities will be excluded.
- Mental Wellness (MW) Patients will be excluded if they live in a residential facility or have immediate psychiatric risk.
- Respiratory Disease Management (respiratory clinic) Patients will be excluded if they have shortness of breath due to ischaemic heart disease or have respiratory symptoms due to infectious lung diseases.
- Patients will be excluded if they are unable to understand or communicate in Chinese language,or if they refuse to give consent.
- NAHC participants: all new patients with LUTS. Patients will be excluded if they are unable to understand or communicate in Chinese language,or if they refuse to give consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of clinics that have satisfied each of the structure criteria.
Time frame: Five years
Interim analysis will evaluate the period from August, 2009 to December, 2010; to December, 2011; to December, 2012; to December, 2013. Final analysis will evaluate the period from August, 2009 to December, 2014.
The proportion of patients who have complied with the criterion process of care.
Time frame: Five years
Interim analysis will evaluate the period from August, 2009 to June, 2011; to December, 2011; to December, 2012; to December, 2013. Final analysis will evaluate the period from August, 2009 to December, 2014.
The proportion of patients who have achieved the target of outcomes of care
Time frame: Five years
Interim analysis will evaluate the period from August, 2009 to June, 2011; to December, 2011; to December, 2012; to December, 2013. Final analysis will evaluate the period from August, 2009 to December, 2014.
2 secondary outcomes
Patient reported outcomes (PRO) measured by the change in Short Form-12v2 scores, the Patient Enablement Index and Global Rating of Change Scale scores (In-depth study of NAHC CC programme)
Time frame: 2 years
Service utilization outcomes measured by GOPC consultation, Specialist Out-patient Clinics consultation, A&E and hospital attendance rates in the past 12 months.hospital attendance rates in the past 12 months.
Time frame: Five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Derived from this study: PubMed 26445404Chin WY, Choi EP, Lam CL. The effect of timing of incentive payments on response rates for cohort study telephone interviews in primary care setting with cost-minimization analysis, a randomized controlled trial. BMC Med Res Methodol. 2015 Oct 6;15:79. doi: 10.1186/s12874-015-0073-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy L.K. Lam, MD study chair
Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
W.Y. Chin, MBBS principal investigator
Department of Family Medicine and Primary Care, Faculity of Medicine, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of clinics that have satisfied each of the structure criteria. (time frame: Five years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02307929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.