Evaluation of Quality of Care - Nurse Allied Health Clinic Programme, HA (QoC NAHC)

September 5, 2017 updated by: Professor Cindy L.K. Lam, The University of Hong Kong

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2496

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong Island, Hong Kong
        • The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Chronic Disease Management
Aging population with the need of Chronic Disease Management

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Five years
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.
Five years
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.
Five years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline, 12-month and 24-month after the first administration of questionnaire.
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
Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 5 years.
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Authority, Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Cindy L.K. Lam, MD, Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
  • Principal Investigator: W.Y. Chin, MBBS, Department of Family Medicine and Primary Care, Faculity of Medicine, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HKCTR-1189

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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