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

NCT ID: NCT02034695

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2496 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2017-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Diabetes mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RAMP and Non-RAMP

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Professor Cindy L.K. Lam

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cindy L.K. Lam, MD

Role: STUDY_CHAIR

Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong

Colman S.C. Fung, MBBS

Role: PRINCIPAL_INVESTIGATOR

Department of Family Medicine and Primary Care, Faculity of Medicine, The University of Hong Kong

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1186/1471-2296-13-116.

Reference Type RESULT
PMID: 23216708 (View on PubMed)

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 in primary care: a longitudinal comparative study. Cardiovasc Diabetol. 2014 Aug 21;13:127. doi: 10.1186/s12933-014-0127-6.

Reference Type RESULT
PMID: 25142791 (View on PubMed)

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 Aug 14;14:105. doi: 10.1186/s12933-015-0267-3.

Reference Type RESULT
PMID: 26268736 (View on PubMed)

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 cohort study. Diabetes Metab. 2016 Dec;42(6):424-432. doi: 10.1016/j.diabet.2016.07.030. Epub 2016 Aug 24.

Reference Type RESULT
PMID: 27568125 (View on PubMed)

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/s12020-016-1124-1. Epub 2016 Oct 3.

Reference Type RESULT
PMID: 27699706 (View on PubMed)

Fung CS, Wan EY, Jiao F, Lam CL. Five-year change of clinical and complications profile of diabetic patients under primary care: a population-based longitudinal study on 127,977 diabetic patients. Diabetol Metab Syndr. 2015 Sep 17;7:79. doi: 10.1186/s13098-015-0072-x. eCollection 2015.

Reference Type DERIVED
PMID: 26388950 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HKCTR-1186

Identifier Type: -

Identifier Source: org_study_id