Evaluation of Quality of Care - Patient Empowerment Programme, HA (QoC PEP)

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

Diabetes mellitus (DM) and hypertension (HT) are major causes of morbidity and among the top 10 causes of deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority (HA) has initiated service improvement through introducing the patient empowerment programme (PEP) to improve the quality of care (QOC) for DM and HT patients. The evaluation on the QOC is an essential part of the programme in order to inform future policy. The Family Medicine Unit (FMU) 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 PEP programme is achieved. Each PEP participating clinic and non-government organization (NGO) will be invited to complete a structured evaluation questionnaire. The data of all patients who have enrolled into the PEP for more than one year will be included in the evaluation on the process and outcomes of care. A hundred and thirty participants 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 and 6 months after enrolment. Data on the process of care will be retrieved from the HA medical records. Main Outcome Measures: The primary outcomes are the proportion of participants who have received the planned process of care and achieved the target HbA1c and blood pressure levels.

Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be calculated. The changes in clinical, service, and patient reported outcomes at 6 and 12 months will assessed by paired sample t-test. The audit cycle will be repeated annually over a period of 5 years.

Results: The QOC of the PEP 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 PEP programme can enhance QOC for patients with diabetes mellitus (DM) or hypertension (HT). The information will be used to guide service planning and policy decision making.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

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

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

All patients who have been enrolled into the PEP programme will be included in the evaluation on process of care; whereas all enrolled subjects who have been recruited for more than 12 months in the programme will be included in the evaluation on the clinical outcomes of care. An equal number of a random sample of eligible subjects who refused to take part in the PEP will be used as controls for the evaluation on the clinical outcomes of care.

Description

Inclusion Criteria:

  • Eligible patients who are ambulatory, have stable mental and emotional conditions, and follow up at general outpatients clinics (GOPC) and family medicine specialist clinics (FMSC) regularly will be recruited for the PEP programme.

Exclusion Criteria:

  • Patients will be excluded if they have severe heart failure, end stage renal failure (ESRF) or advanced eye diseases, are unable to understand or communicate in Chinese language, or refuse to give consent.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Diabetes mellitus (DM) and hypertension (HT)
Diabetes mellitus (DM) and/or hypertension (HT) patients in Hong Kong

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of clinics/NGO that have satisfied each of the set 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 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 DM patients who have achieved a HbA1c level <7%.
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 HT/ DM patients who have achieved the target blood pressure.
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

Outcome Measure
Measure Description
Time Frame
Clinical outcomes including LDL, BMI, and cardiovascular complications.
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
Patient reported outcomes (PRO) measured by the change in SF-12v2 scores, the Patient Enablement Index (PEI) and Global Rating of Change Score (GRS) at 6 months, and change in patient's knowledge on disease at 12 months.
Time Frame: Five years
Baseline and 6-month/12-month/24-month/36-month after the first administration of questionnaire.
Five years
GOPC consultation, SOPC, A&E and 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

The University of Hong Kong

Collaborators

Hospital Authority, Hong Kong

Investigators

  • Study Chair: Cindy L.K. Lam, MD, Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
  • Principal Investigator: William C.W. Wong, MD, Department of Family Medicine and Primary Care, Faculty 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

September 1, 2010

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

August 30, 2013

First Posted (Estimate)

September 5, 2013

Study Record Updates

Last Update Posted (Actual)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 5, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKCTR-1187

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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