Evaluation of Quality of Care - Risk Assessment Management Programme, HA

Diabetes Mellitus Clinical Trial

— QoC RAMP  

Official title:

Evaluation of Quality of Care - Risk Assessment Management Programme, HA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034695
• Other study ID #: HKCTR-1186
• Status: Completed
• Phase: N/A
• First received: August 28, 2013
• Last updated: October 24, 2017
• Start date: September 2010
• Est. completion date: April 2017

Study information

• Verified date: October 2017
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2496
• Est. completion date: April 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Hospital Authority, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (5)

Fung CS, Chin WY, Dai DS, Kwok RL, Tsui EL, Wan YF, Wong W, Wong CK, Fong DY, Lam CL. Evaluation of the quality of care of a multi-disciplinary risk factor assessment and management programme (RAMP) for diabetic patients. BMC Fam Pract. 2012 Dec 5;13:116. — View Citation

Jiao F, Fung CS, Wan YF, McGhee SM, Wong CK, Dai D, Kwok R, Lam CL. Effectiveness of the multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) for diabetic microvascular complications: A population-based co — View Citation

Jiao F, Fung CS, Wan YF, McGhee SM, Wong CK, Dai D, Kwok R, Lam CL. Long-term effects of the multidisciplinary risk assessment and management program for patients with diabetes mellitus (RAMP-DM): a population-based cohort study. Cardiovasc Diabetol. 2015 — View Citation

Jiao FF, Fung CS, Wong CK, Wan YF, Dai D, Kwok R, Lam CL. Effects of the Multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) on biomedical outcomes, observed cardiovascular events and cardiovascular risks — View Citation

Wan EY, Fung CS, Wong CK, Choi EP, Jiao FF, Chan AK, Chan KH, Lam CL. Effectiveness of a multidisciplinary risk assessment and management programme-diabetes mellitus (RAMP-DM) on patient-reported outcomes. Endocrine. 2017 Feb;55(2):416-426. doi: 10.1007/s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Five years
Primary	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.	Five years
Primary	The proportion of patients who have achieved a HbA1c level <7%.	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	Clinical outcomes including, LDL, BP, body mass index (BMI), and cardiovascular complications.	Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 5 years.	Five years
Secondary	Patient reported outcomes (PRO) measured by the change in SF-12v2 scores, the PEI and GRS scores at 6 months.	Baseline and 6-month/12-month/24-month/36-month after the first administration of questionnaire.	Five years
Secondary	Service utilization outcomes measured by GOPC consultation, SOPC consultation, A&E and 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.	Five years