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

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ClinicalTrials.gov Identifier: NCT02034695
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
Hospital Authority, Hong Kong
Information provided by (Responsible Party):
Professor Cindy L.K. Lam, The University of Hong Kong

Study Description
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Brief Summary:

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.


Condition or disease
Diabetes Mellitus

Study Design
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Study Type : Observational
Actual Enrollment : 2496 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Quality of Care - Risk Assessment Management Programme, HA
Study Start Date : September 2010
Actual Primary Completion Date : September 2016
Actual Study Completion Date : April 2017
Groups and Cohorts
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Group/Cohort
RAMP and Non-RAMP


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034695


Locations
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Hong Kong
The University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Hospital Authority, Hong Kong
Investigators
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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
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Professor Cindy L.K. Lam, Clinical Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02034695    
Other Study ID Numbers: HKCTR-1186
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Keywords provided by Professor Cindy L.K. Lam, The University of Hong Kong:
Diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases