Evaluation of Quality of Care - Risk Assessment Management Programme, HA (QoC RAMP)

October 24, 2017 updated by: Professor Cindy L.K. Lam, The University of Hong Kong

Diabetes mellitus (DM) is one of the major cause 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 risk assessment and management programme (RAMP) to improve the quality of care (QOC) for DM patients in general outpatient clinics (GOPC). The evaluation on the QOC is an essential part of the programme in order to inform future policy. The 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 RAMP programme is achieved. Each RAMP participating clinic and hospital will be invited to complete a structured evaluation questionnaire. The data of all patients who have enrolled into the RAMP for more than one year will be included in the evaluation on the process and outcomes of care.

One thousand two hundred and forty-eight age and disease matched control patients who have not been enrolled into the RAMP programme will be selected for the comparison in the 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 criterion process of care, and achieved the target HbA1c and blood pressure levels.

Data Analysis: Descriptive statistics on proportions of centers or subjects meeting the QOC criteria will be calculated. The changes in the clinical and patient reported outcomes of RAMP subjects will be compared at 12, 24, 36 and 48 months will be compared by paired sample t-test. The clinical outcomes between RAMP subjects and control group will be compared by independent sample t-test or Chi-square test.

Results: The QOC of the RAMP 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 RAMP programme can achieve improvement in QOC for DM patients. 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, 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

Patients with DM who are mostly independent in their activities of daily living and being followed up at GOPC regularly will be recruited. All enrolled patients will undergo a comprehensive risk assessment and screening for complications, who will then be assigned to receive appropriate interventions and education from multi-disciplinary healthcare professionals according to their risk level. Low risk patients will continue with the usual GOPC follow up, medium risk patients will be given additional intervention by an advanced practice nurse (APN), and high risk patients will be given additional intervention by an APN and an associate consultant (AC) in family medicine (FM).

Description

Inclusion Criteria:

  • Patients with DM who are mostly independent in their activities of daily living and being followed up at GOPC regularly will be recruited.

Exclusion Criteria:

  • Patients will be excluded if they 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

Cohorts and Interventions

Group / Cohort
RAMP and Non-RAMP

What is the study measuring?

Primary Outcome Measures

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 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes including, LDL, BP, body mass index (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 PEI and GRS scores at 6 months.
Time Frame: Five years
Baseline and 6-month/12-month/24-month/36-month after the first administration of questionnaire.
Five years
Service utilization outcomes measured by GOPC consultation, SOPC consultation, 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: Colman S.C. Fung, 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

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

January 10, 2014

First Posted (Estimate)

January 13, 2014

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKCTR-1186

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.

Clinical Trials on Diabetes Mellitus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe