<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02219958</url>
  </required_header>
  <id_info>
    <org_study_id>HKCTR-1685</org_study_id>
    <nct_id>NCT02219958</nct_id>
  </id_info>
  <brief_title>Evaluation of Quality of Care - Multi-disciplinary Risk Assessment and Management Programme for Patients With Hypertension, HA (QoC RAMP-HT)</brief_title>
  <official_title>Evaluation of Quality of Care - Multi-disciplinary Risk Assessment and Management Programme for Patients With Hypertension, HA (QoC RAMP-HT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Authority, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypertension (HT) is one of the major cause of morbidity and among the top 10 causes of&#xD;
      deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority (HA) has&#xD;
      initiated service improvement through introducing the risk assessment and management&#xD;
      programme (RAMP) to improve the quality of care (QOC) for HT patients in general outpatient&#xD;
      clinics (GOPC). The evaluation on the QOC is an essential part of the programme in order to&#xD;
      inform future policy. The Department of Family Medicine and Primary Care (FMPC) of the&#xD;
      University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of the&#xD;
      QOC of the programme.&#xD;
&#xD;
      The Action Learning and Audit Spiral methodologies to measure whether the target standard of&#xD;
      care intended by the RAMP programme is achieved. Each RAMP participating clinic and hospital&#xD;
      will be invited to complete a structured evaluation questionnaire. The data of all patients&#xD;
      who have enrolled into the RAMP for more than one year will be included in the evaluation on&#xD;
      the process and outcomes of care.&#xD;
&#xD;
      One thousand two hundred and forty-eight age and disease matched control patients who have&#xD;
      not been enrolled into the RAMP programme will be selected for the comparison in the outcomes&#xD;
      of care. A hundred and thirty participants will be followed up by telephone to evaluate the&#xD;
      effect of the programme in quality of life (QOL), patient enablement, and global rating of&#xD;
      change in health condition at baseline and 6 months after enrolment. Data on the process of&#xD;
      care will be retrieved from the HA medical records.&#xD;
&#xD;
      Main Outcome Measures: The primary outcomes are the proportion of participants who have&#xD;
      received the criterion process of care, and achieved the target blood pressure levels.&#xD;
&#xD;
      Data Analysis: Descriptive statistics on proportions of centers or subjects meeting the QOC&#xD;
      criteria will be calculated. The changes in the clinical and patient reported outcomes of&#xD;
      RAMP subjects will be compared at 12, 24, 36 and 48 months will be compared by paired sample&#xD;
      t-test. The clinical outcomes between RAMP subjects and control group will be compared by&#xD;
      independent sample t-test or Chi-square test.&#xD;
&#xD;
      Results: The QOC of the RAMP programme will be determined. Areas of deficiency and possible&#xD;
      areas for quality enhancement will be identified.&#xD;
&#xD;
      Conclusion: The results of this study will provide empirical evidence on whether the HA's&#xD;
      RAMP programme can achieve improvement in QOC for HT patients. The information will be used&#xD;
      to guide service planning and policy decision making.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of clinics that have satisfied each of the structure criteria</measure>
    <time_frame>Three years</time_frame>
    <description>Final analysis will evaluate the period from August, 2012 to December, 2014.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of patients who have complied with the criterion process of care.</measure>
    <time_frame>Three years</time_frame>
    <description>Final analysis will evaluate the period from August, 2012 to December, 2014.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of patients who have achieved a BP level &lt;140/90mmHg.</measure>
    <time_frame>Three years</time_frame>
    <description>Final analysis will evaluate the period from August, 2012 to December, 2014.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>LDL</measure>
    <time_frame>Three years</time_frame>
    <description>Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI (Body Mass Index)</measure>
    <time_frame>Three years</time_frame>
    <description>Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of First Cardiovascular Complication</measure>
    <time_frame>Three years</time_frame>
    <description>Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in SF-12v2 scores</measure>
    <time_frame>Three years</time_frame>
    <description>Baseline and 6-month/12-month/24-month/36-month after the first administration of questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEI (Patient Enablement Index)</measure>
    <time_frame>Three years</time_frame>
    <description>6-month/12-month/24-month/36-month after the first administration of questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GRS (Global Rating of Change Scale) scores</measure>
    <time_frame>Three years</time_frame>
    <description>6-month/12-month/24-month/36-month after the first administration of questionnaire.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2496</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>RAMP-HT and Non-RAMP-HT</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All HT patients aged &lt;80, without prior history of diabetes and existing cardiovascular&#xD;
        diseases, with suboptimal BP control (average systolic blood pressure (SBP) ≥ 140mmHg or&#xD;
        average diastolic blood pressure (DBP) ≥ 90mmHg) who were enrolled into RAMP-HT.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HT&#xD;
&#xD;
          -  aged &lt;80&#xD;
&#xD;
          -  Suboptimal BP control (average systolic blood pressure (SBP) ≥ 140mmHg or average&#xD;
             diastolic blood pressure (DBP) ≥ 90mmHg)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded if they are unable to understand or communicate in Chinese&#xD;
             language, or refuse to give consent.&#xD;
&#xD;
          -  Patients will be excluded if they had prior history of diabetes and existing&#xD;
             cardiovascular diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cindy L.K. Lam, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Esther Y.T. Yu, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong Island</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <results_reference>
    <citation>Yu EY, Wan EY, Chan KH, Wong CK, Kwok RL, Fong DY, Lam CL. Evaluation of the quality of care of a multi-disciplinary Risk Factor Assessment and Management Programme for Hypertension (RAMP-HT). BMC Fam Pract. 2015 Jun 19;16:71. doi: 10.1186/s12875-015-0291-0.</citation>
    <PMID>26088560</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Professor Cindy L.K. Lam</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02219958
org study id: HKCTR-1685
nct id: NCT02219958
lead sponsor: 
collaborator: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
measure: The proportion of clinics that have satisfied each of the structure criteria
time frame: Three years
description: Final analysis will evaluate the period from August, 2012 to December, 2014.
measure: The proportion of patients who have complied with the criterion process of care.
time frame: Three years
description: Final analysis will evaluate the period from August, 2012 to December, 2014.
measure: The proportion of patients who have achieved a BP level <140/90mmHg.
time frame: Three years
description: Final analysis will evaluate the period from August, 2012 to December, 2014.
measure: LDL
time frame: Three years
description: Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.
measure: BMI (Body Mass Index)
time frame: Three years
description: Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.
measure: Occurrence of First Cardiovascular Complication
time frame: Three years
description: Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.
measure: The change in SF-12v2 scores
time frame: Three years
description: Baseline and 6-month/12-month/24-month/36-month after the first administration of questionnaire.
measure: PEI (Patient Enablement Index)
time frame: Three years
description: 6-month/12-month/24-month/36-month after the first administration of questionnaire.
measure: GRS (Global Rating of Change Scale) scores
time frame: Three years
description: 6-month/12-month/24-month/36-month after the first administration of questionnaire.
arm group label: RAMP-HT and Non-RAMP-HT
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cindy L.K. Lam, MD
role: Study Chair
affiliation: Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
last name: Esther Y.T. Yu, MBBS
role: Principal Investigator
affiliation: Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
facility: 
country: Hong Kong
citation: Yu EY, Wan EY, Chan KH, Wong CK, Kwok RL, Fong DY, Lam CL. Evaluation of the quality of care of a multi-disciplinary Risk Factor Assessment and Management Programme for Hypertension (RAMP-HT). BMC Fam Pract. 2015 Jun 19;16:71. doi: 10.1186/s12875-015-0291-0.
PMID: 26088560
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Professor Cindy L.K. Lam
investigator title: Clinical Professor
mesh term: Hypertension