Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Quality of Care - Multi-disciplinary Risk Assessment and Management Programme for Patients With Hypertension, HA (QoC RAMP-HT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219958
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Hospital Authority, Hong Kong
Information provided by (Responsible Party):
Professor Cindy L.K. Lam, The University of Hong Kong

Brief Summary:

Hypertension (HT) 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 HT 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 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 HT patients. The information will be used to guide service planning and policy decision making.


Condition or disease
Hypertension

Layout table for study information
Study Type : Observational
Actual Enrollment : 2496 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Quality of Care - Multi-disciplinary Risk Assessment and Management Programme for Patients With Hypertension, HA (QoC RAMP-HT)
Study Start Date : September 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Group/Cohort
RAMP-HT and Non-RAMP-HT



Primary Outcome Measures :
  1. The proportion of clinics that have satisfied each of the structure criteria [ Time Frame: Three years ]
    Final analysis will evaluate the period from August, 2012 to December, 2014.

  2. The proportion of patients who have complied with the criterion process of care. [ Time Frame: Three years ]
    Final analysis will evaluate the period from August, 2012 to December, 2014.

  3. The proportion of patients who have achieved a BP level <140/90mmHg. [ Time Frame: Three years ]
    Final analysis will evaluate the period from August, 2012 to December, 2014.


Secondary Outcome Measures :
  1. LDL [ Time Frame: Three years ]
    Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.

  2. BMI (Body Mass Index) [ Time Frame: Three years ]
    Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.

  3. Occurrence of First Cardiovascular Complication [ Time Frame: Three years ]
    Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.

  4. The change in SF-12v2 scores [ Time Frame: Three years ]
    Baseline and 6-month/12-month/24-month/36-month after the first administration of questionnaire.

  5. PEI (Patient Enablement Index) [ Time Frame: Three years ]
    6-month/12-month/24-month/36-month after the first administration of questionnaire.

  6. GRS (Global Rating of Change Scale) scores [ Time Frame: Three years ]
    6-month/12-month/24-month/36-month after the first administration of questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
All HT patients aged <80, without prior history of diabetes and existing cardiovascular diseases, with suboptimal BP control (average systolic blood pressure (SBP) ≥ 140mmHg or average diastolic blood pressure (DBP) ≥ 90mmHg) who were enrolled into RAMP-HT.
Criteria

Inclusion Criteria:

  • HT
  • aged <80
  • Suboptimal BP control (average systolic blood pressure (SBP) ≥ 140mmHg or average diastolic blood pressure (DBP) ≥ 90mmHg)

Exclusion Criteria:

  • Patients will be excluded if they are unable to understand or communicate in Chinese language, or refuse to give consent.
  • Patients will be excluded if they had prior history of diabetes and existing cardiovascular diseases

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): NCT02219958


Locations
Layout table for location information
Hong Kong
The University of Hong Kong
Hong Kong Island, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Hospital Authority, Hong Kong
Investigators
Layout table for investigator information
Study Chair: Cindy L.K. Lam, MD Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
Principal Investigator: Esther Y.T. Yu, MBBS Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
Publications of Results:
Layout table for additonal information
Responsible Party: Professor Cindy L.K. Lam, Clinical Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02219958    
Other Study ID Numbers: HKCTR-1685
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Keywords provided by Professor Cindy L.K. Lam, The University of Hong Kong:
Hypertension
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases