<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/NCT03256734</url>
  </required_header>
  <id_info>
    <org_study_id>H17-01039</org_study_id>
    <nct_id>NCT03256734</nct_id>
  </id_info>
  <brief_title>Does a Complex Care Discharge Planning Initiative Reduce Unplanned Hospital Readmissions? (G78717-Readmits)</brief_title>
  <official_title>Does a Complex Care Discharge Planning Initiative Reduce Unplanned Hospital Readmissions?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Unplanned hospital readmissions are associated with increases in morbidity, mortality, cost&#xD;
      and patient dissatisfaction,. Policymakers continue to seek effective policy solutions to&#xD;
      avoid readmissions in order to improve quality of care and reduce unnecessary expenditures,.&#xD;
      One attempt to reduce readmissions was implemented on June 1 2012, when the Specialist&#xD;
      Services Committee of British Columbia (a partnership of Doctors of BC and the Ministry of&#xD;
      Health) introduced the new &quot;G78717&quot; fee code for physicians. The objective of the fee code&#xD;
      was to create a financial incentive for physicians to provide a point-of-care supplemental&#xD;
      discharge summary to patients and their primary care providers prior to discharge from&#xD;
      hospital. Initially, only urgent hospital admissions were eligible for this incentive payment&#xD;
      but on Nov 1 2015 the incentive was extended to include elective admissions as well. The&#xD;
      other eligibility criteria remained unchanged.&#xD;
&#xD;
      The effectiveness and cost-effectiveness of the fee code intervention is unknown. This study&#xD;
      will address important questions relevant to this policy intervention using rigorous methods&#xD;
      and empirical data.&#xD;
&#xD;
      This study will employ two methods for measuring changes in readmission risk. First, we will&#xD;
      use interrupted (multivariate) time series to measure whether there was a temporal change in&#xD;
      provincial readmission risk associated with the implementation of the new fee code.&#xD;
&#xD;
      We will complement the above analyses with a stronger design, comparing hospitalizations for&#xD;
      which the fee code was charged (intervention group) with a cohort of clinically similar&#xD;
      hospitalizations for which the fee code was not charged (control group). For this approach,&#xD;
      multivariate logistic regression will be the primary statistical method. Using this analytic&#xD;
      strategy, 30-day readmission risk between the intervention and control group will be measured&#xD;
      over time, adjusted for patient-, provider-, and hospitalization-level covariates.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">September 1, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Unplanned hospital readmission within 30 days</measure>
    <time_frame>30 days</time_frame>
    <description>Unplanned hospital readmission within 30 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Unplanned (urgent) hospital readmission within 1 year of index hospital discharge</measure>
    <time_frame>1 year</time_frame>
    <description>Unplanned (urgent) hospital readmission within 1 year of index hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary care visits within 30 days and 1 year of index hospital discharge</measure>
    <time_frame>30 days and 1 year</time_frame>
    <description>Primary care visits within 30 days and 1 year of index hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency department visit</measure>
    <time_frame>30 days and 1 year</time_frame>
    <description>Emergency department visit within 30 days and 1 year of index hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>30 days and 1 year</time_frame>
    <description>Death within 30 days and 1 year of index hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of transitional or stepdown care</measure>
    <time_frame>30 days and 1 year</time_frame>
    <description>Use of transitional or stepdown care (eg. rehabilitation, extended care, intermediate /personal care) after discharge from acute care but prior to return home</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvements in appropriate population-level post-discharge prescription prevalence of an indicated medication</measure>
    <time_frame>60 days</time_frame>
    <description>Using health services records, we will identify a sub-cohort of patients with an index admission for acute coronary syndrome, heart failure, or chronic ischemic heart disease. Within this subcohort, we will determine the proportion of patients who filled at least one prescription for beta-blockers within 60 days of index hospital discharge date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvements in appropriate population-level post-discharge prescription prevalence of a contraindicated medication</measure>
    <time_frame>60 days</time_frame>
    <description>Using health services records, we will identify a sub-cohort of older adults (aged &gt;/=65 years at date of index hospital discharge date). Within this subcohort, we will determine the proportion of patients who filled at least one prescription for a &quot;potentially inappropriate medication&quot; within 60 days of index hospital discharge date. Our list of &quot;potentially inappropriate medications&quot; has been adapted from those listed in the American Geriatrics Society 2015 Updated Beers Criteria.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">300000</enrollment>
  <condition>Patient Readmission</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Policy intervention</intervention_name>
    <description>Incentive payment for physicians</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Our study population will be representative of medical and surgical hospital admissions in&#xD;
        BC.&#xD;
&#xD;
        The Interrupted time series (ITS) cohort will be comprised of hospital separations eligible&#xD;
        for submission of fee code G78717. We will include all urgent admissions to BC hospitals&#xD;
        with discharge dates between 1 Jan 2002 and 30 June 2017 that had a length of stay (LOS) of&#xD;
        &gt;4 days and are associated with a specialist Most Responsible Physician (MRP).&#xD;
&#xD;
        The regression analysis cohort study will be identical to the ITS cohort but will be&#xD;
        restricted to index hospitalization discharge dates between 1 Jun 2012 and 31 Jul 2017 (ie.&#xD;
        the post-G78717 period).&#xD;
&#xD;
        The unit of analysis is the index hospital admission (ie. the initial hospital admission of&#xD;
        interest). Individual patients can contribute multiple hospital admissions to the cohort&#xD;
        over time (although only hospital admissions occurring &gt;30 days after a prior discharge are&#xD;
        eligible as index hospital admissions).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The study population will be comprised of all hospital discharges in British Columbia&#xD;
        between 1 Jan 2002 and 30 June 2017.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        We will exclude separations with the following International Statistical Classification of&#xD;
        Diseases and Related Health Problems, 10th Revision, Canada (ICD-10-CA) codes as the Most&#xD;
        Responsible Diagnosis:&#xD;
&#xD;
          -  Codes O00 - O99 [Pregnancy, childbirth and the puerperium]&#xD;
&#xD;
          -  Codes P00 - P96 [Certain conditions originating in the perinatal period]&#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_contact>
    <last_name>John A Staples, MD</last_name>
    <phone>604-682-2344</phone>
    <email>john.a.staples@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jason M Sutherland, PhD</last_name>
    <phone>604-822-6812</phone>
    <email>jsutherland@chspr.ubc.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Population Data BC</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T 1Z3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tim Choi</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>John Staples</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data stewards are legally prohibited from sharing IPD.</ipd_description>
  </patient_data>
  <!-- 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/NCT03256734
org study id: H17-01039
nct id: NCT03256734
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Unplanned hospital readmissions are associated with increases in morbidity, mortality, cost
      and patient dissatisfaction,. Policymakers continue to seek effective policy solutions to
      avoid readmissions in order to improve quality of care and reduce unnecessary expenditures,.
      One attempt to reduce readmissions was implemented on June 1 2012, when the Specialist
      Services Committee of British Columbia (a partnership of Doctors of BC and the Ministry of
      Health) introduced the new "G78717" fee code for physicians. The objective of the fee code
      was to create a financial incentive for physicians to provide a point-of-care supplemental
      discharge summary to patients and their primary care providers prior to discharge from
      hospital. Initially, only urgent hospital admissions were eligible for this incentive payment
      but on Nov 1 2015 the incentive was extended to include elective admissions as well. The
      other eligibility criteria remained unchanged.

      The effectiveness and cost-effectiveness of the fee code intervention is unknown. This study
      will address important questions relevant to this policy intervention using rigorous methods
      and empirical data.

      This study will employ two methods for measuring changes in readmission risk. First, we will
      use interrupted (multivariate) time series to measure whether there was a temporal change in
      provincial readmission risk associated with the implementation of the new fee code.

      We will complement the above analyses with a stronger design, comparing hospitalizations for
      which the fee code was charged (intervention group) with a cohort of clinically similar
      hospitalizations for which the fee code was not charged (control group). For this approach,
      multivariate logistic regression will be the primary statistical method. Using this analytic
      strategy, 30-day readmission risk between the intervention and control group will be measured
      over time, adjusted for patient-, provider-, and hospitalization-level covariates.
observational model: Cohort
time perspective: Retrospective
measure: Unplanned hospital readmission within 30 days
time frame: 30 days
description: Unplanned hospital readmission within 30 days
measure: Unplanned (urgent) hospital readmission within 1 year of index hospital discharge
time frame: 1 year
description: Unplanned (urgent) hospital readmission within 1 year of index hospital discharge
measure: Primary care visits within 30 days and 1 year of index hospital discharge
time frame: 30 days and 1 year
description: Primary care visits within 30 days and 1 year of index hospital discharge
measure: Emergency department visit
time frame: 30 days and 1 year
description: Emergency department visit within 30 days and 1 year of index hospital discharge
measure: Death
time frame: 30 days and 1 year
description: Death within 30 days and 1 year of index hospital discharge
measure: Use of transitional or stepdown care
time frame: 30 days and 1 year
description: Use of transitional or stepdown care (eg. rehabilitation, extended care, intermediate /personal care) after discharge from acute care but prior to return home
measure: Improvements in appropriate population-level post-discharge prescription prevalence of an indicated medication
time frame: 60 days
description: Using health services records, we will identify a sub-cohort of patients with an index admission for acute coronary syndrome, heart failure, or chronic ischemic heart disease. Within this subcohort, we will determine the proportion of patients who filled at least one prescription for beta-blockers within 60 days of index hospital discharge date.
measure: Improvements in appropriate population-level post-discharge prescription prevalence of a contraindicated medication
time frame: 60 days
description: Using health services records, we will identify a sub-cohort of older adults (aged >/=65 years at date of index hospital discharge date). Within this subcohort, we will determine the proportion of patients who filled at least one prescription for a "potentially inappropriate medication" within 60 days of index hospital discharge date. Our list of "potentially inappropriate medications" has been adapted from those listed in the American Geriatrics Society 2015 Updated Beers Criteria.
intervention type: Other
intervention name: Policy intervention
description: Incentive payment for physicians
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John A Staples, MD
phone: 604-682-2344
email: john.a.staples@gmail.com
last name: Jason M Sutherland, PhD
phone: 604-822-6812
email: jsutherland@chspr.ubc.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: John Staples
investigator title: Clinical Assistant Professor
sharing ipd: No
ipd description: Data stewards are legally prohibited from sharing IPD.