<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/NCT03804905</url>
  </required_header>
  <id_info>
    <org_study_id>103-2018</org_study_id>
    <nct_id>NCT03804905</nct_id>
  </id_info>
  <brief_title>STUDIIO-Diabetes Pilot: STUdy of Drug Insurance to Improve Outcomes of Diabetes</brief_title>
  <official_title>A Pilot Pragmatic Randomized Controlled Trial to Evaluate the Impact of Improving Access to Drugs on Type 2 Diabetes Care, Outcomes and Costs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</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>
      Canada is the only country with a universal health insurance system that does not provide&#xD;
      coverage for prescription drugs to all residents. One-third of working-age Canadians have no&#xD;
      insurance. Importantly, many of these uninsured patients already face other barriers to good&#xD;
      health: low income, new immigrants, single mothers, etc. For these patients, taking&#xD;
      prescription drugs - especially chronic disease treatments that may be required lifelong -&#xD;
      can be difficult due to high costs. Patients skip doses, delay renewing prescriptions, or&#xD;
      simply do not fill prescriptions recommended by their doctors, because they do not have&#xD;
      insurance to cover the costs of prescriptions. Previous research by the study team has&#xD;
      suggested that the lack of a universal drug insurance program for working-age Canadians&#xD;
      affects the health and well-being of low-income people with diabetes. The goal of this&#xD;
      research is to determine the clinical and economic impact of providing drug coverage for&#xD;
      uninsured type 2 diabetics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous research has found that lowering patients' out-of-pocket costs has a positive impact&#xD;
      on health service utilization, risk factor control and patient-reported health for many&#xD;
      chronic diseases, including diabetes, hypertension, HIV and asthma. Among patients with&#xD;
      chronic disease, medication adherence was inversely associated with hospitalization rates and&#xD;
      total healthcare costs, and these relationships were far stronger for diabetes than for any&#xD;
      other chronic disease. A recent meta-analysis of eight observational studies showed that&#xD;
      adherence with diabetes medications is associated reduction in cardiovascular events,&#xD;
      all-cause mortality and all-cause hospitalization. However, virtually all of this previous&#xD;
      research has been observational. Only one rigorous intervention study has examined the impact&#xD;
      of reducing patient borne drug costs on clinical outcomes. The outcome of this study showed&#xD;
      that free medications led to health outcome improvements and a trend towards lower costs.&#xD;
&#xD;
      The goal of this research project is to determine the impact of providing drug coverage to&#xD;
      uninsured individuals with one of the most costly chronic diseases, type 2 diabetes. The&#xD;
      ultimate goal is to evaluate if lowering out-of-pocket drug costs for uninsured patients is&#xD;
      effective and cost-effective to reduce disease morbidity and mortality. Will policy&#xD;
      intervention to reduce patients' drug costs would actually translate into improvements in&#xD;
      their health outcomes? What impact a universal program would have on overall drug&#xD;
      utilization? What total budget impact such a program might have? What extent the cost savings&#xD;
      accrued from improving health outcomes might offset the program's implementation costs.&#xD;
      Answering these questions will provide essential evidence to inform decision making for a&#xD;
      national publicly-funded pharmacare program.&#xD;
&#xD;
      It will demonstrate how medication utilization changes when access improves, and will&#xD;
      identify if barriers to utilization other than affordability exist. Crucially, the economic&#xD;
      analyses will help policy makers understand the budget impact and cost-effectiveness of a&#xD;
      pharmacare intervention. Thus, this research will provide vital information for policy makers&#xD;
      crafting a program to provide free drugs to all uninsured Canadians with chronic disease.&#xD;
      Such a program is anticipated to have a positive impact on patient experience: to improve&#xD;
      health equity and access for vulnerable patients; to facilitate greater medication adherence;&#xD;
      and to enhance shared decision-making between patients and their clinicians for effective&#xD;
      self-management care paths. The ultimate impact of this research will be evidence for the&#xD;
      cost effectiveness or even cost savings of a drug insurance program aimed at the improving&#xD;
      access to medications for disadvantaged patients who are currently uninsured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">April 1, 2023</start_date>
  <completion_date type="Anticipated">March 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lacking medication insurance</measure>
    <time_frame>During 2 month run-in period</time_frame>
    <description>Proportion of type 2 diabetes patients aged 25 to 64 who self-report that they lack medication insurance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Online questionnaire during the run-in period</measure>
    <time_frame>During 2 month run-in period</time_frame>
    <description>Proportion of type 2 diabetes patients aged 25 to 64 who complete the secure online questionnaire during the run-in period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response to the insurance status question</measure>
    <time_frame>During 2 month run-in period</time_frame>
    <description>Proportion of type 2 diabetes patients aged 25 to 64 who responded to the insurance status question on the online questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recipient of no-cost medications</measure>
    <time_frame>One year</time_frame>
    <description>Proportion of patients in the intervention group who receive medications from the Trillium Health Partners outpatient pharmacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from allocation to use of Trillium Health Partners outpatient pharmacy</measure>
    <time_frame>One year</time_frame>
    <description>Time from allocation to the intervention group to use of the Trillium Health Partners outpatient pharmacy</description>
  </secondary_outcome>
  <other_outcome>
    <measure>All-cause mortality or cardiovascular complications</measure>
    <time_frame>One year</time_frame>
    <description>All-cause mortality, or hospitalization for myocardial infarction, acute coronary syndrome, coronary revascularization, stroke or heart failure.</description>
  </other_outcome>
  <other_outcome>
    <measure>Other chronic diabetes complications</measure>
    <time_frame>One year</time_frame>
    <description>Amputation, retinal photocoagulation, vitrectomy, intravitreal injection, incident microalbuminuria, incident chronic kidney disease</description>
  </other_outcome>
  <other_outcome>
    <measure>Acute diabetes complications</measure>
    <time_frame>One year</time_frame>
    <description>Emergency department visit or hospitalization for hypo or hyperglycemia</description>
  </other_outcome>
  <other_outcome>
    <measure>A1c control</measure>
    <time_frame>One year</time_frame>
    <description>A1c level</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood pressure control</measure>
    <time_frame>One year</time_frame>
    <description>Systolic and diastolic blood pressure levels</description>
  </other_outcome>
  <other_outcome>
    <measure>LDL-cholesterol control</measure>
    <time_frame>One year</time_frame>
    <description>LDL-cholesterol levels</description>
  </other_outcome>
  <other_outcome>
    <measure>Medication adherence for study drugs</measure>
    <time_frame>One year</time_frame>
    <description>Medication possession ratio</description>
  </other_outcome>
  <other_outcome>
    <measure>Medication adherence for non-study drugs</measure>
    <time_frame>One year</time_frame>
    <description>Medication possession ratio</description>
  </other_outcome>
  <other_outcome>
    <measure>Health care utilization</measure>
    <time_frame>One year</time_frame>
    <description>Ambulatory physician visits, emergency department visits, hospitalizations</description>
  </other_outcome>
  <other_outcome>
    <measure>Health care costs</measure>
    <time_frame>One year</time_frame>
    <description>Total health care costs across sectors</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">144</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Medication Adherence</condition>
  <condition>Medication Compliance</condition>
  <condition>Medication Nonadherence</condition>
  <arm_group>
    <arm_group_label>No-cost Medications</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible patients of physicians allocated to the no-cost medications arm will receive free medications through Trillium Health Partners outpatient pharmacy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Eligible patients of physicians allocated to the usual care arm will continue to access their medications through self-pay or other mechanisms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No-cost Medications</intervention_name>
    <description>Patients will be connected to Trillium Health Partners outpatient pharmacy, and they will be given an information sheet with further details. The patients will get free access to diabetes, blood pressure and cholesterol medications and for glucose test strips. They can attend the pharmacy in person or arrange for home delivery.</description>
    <arm_group_label>No-cost Medications</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of type 2 diabetes record in family physician's electronic medical&#xD;
             record&#xD;
&#xD;
          -  lack of medication insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>December 19, 2022</last_update_submitted>
  <last_update_submitted_qc>December 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 2 Diabetes Mellitus</keyword>
  <keyword>Medication Compliance</keyword>
  <keyword>Medication Insurance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT03804905
org study id: 103-2018
nct id: NCT03804905
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Canada is the only country with a universal health insurance system that does not provide
      coverage for prescription drugs to all residents. One-third of working-age Canadians have no
      insurance. Importantly, many of these uninsured patients already face other barriers to good
      health: low income, new immigrants, single mothers, etc. For these patients, taking
      prescription drugs - especially chronic disease treatments that may be required lifelong -
      can be difficult due to high costs. Patients skip doses, delay renewing prescriptions, or
      simply do not fill prescriptions recommended by their doctors, because they do not have
      insurance to cover the costs of prescriptions. Previous research by the study team has
      suggested that the lack of a universal drug insurance program for working-age Canadians
      affects the health and well-being of low-income people with diabetes. The goal of this
      research is to determine the clinical and economic impact of providing drug coverage for
      uninsured type 2 diabetics.
Previous research has found that lowering patients' out-of-pocket costs has a positive impact
      on health service utilization, risk factor control and patient-reported health for many
      chronic diseases, including diabetes, hypertension, HIV and asthma. Among patients with
      chronic disease, medication adherence was inversely associated with hospitalization rates and
      total healthcare costs, and these relationships were far stronger for diabetes than for any
      other chronic disease. A recent meta-analysis of eight observational studies showed that
      adherence with diabetes medications is associated reduction in cardiovascular events,
      all-cause mortality and all-cause hospitalization. However, virtually all of this previous
      research has been observational. Only one rigorous intervention study has examined the impact
      of reducing patient borne drug costs on clinical outcomes. The outcome of this study showed
      that free medications led to health outcome improvements and a trend towards lower costs.

      The goal of this research project is to determine the impact of providing drug coverage to
      uninsured individuals with one of the most costly chronic diseases, type 2 diabetes. The
      ultimate goal is to evaluate if lowering out-of-pocket drug costs for uninsured patients is
      effective and cost-effective to reduce disease morbidity and mortality. Will policy
      intervention to reduce patients' drug costs would actually translate into improvements in
      their health outcomes? What impact a universal program would have on overall drug
      utilization? What total budget impact such a program might have? What extent the cost savings
      accrued from improving health outcomes might offset the program's implementation costs.
      Answering these questions will provide essential evidence to inform decision making for a
      national publicly-funded pharmacare program.

      It will demonstrate how medication utilization changes when access improves, and will
      identify if barriers to utilization other than affordability exist. Crucially, the economic
      analyses will help policy makers understand the budget impact and cost-effectiveness of a
      pharmacare intervention. Thus, this research will provide vital information for policy makers
      crafting a program to provide free drugs to all uninsured Canadians with chronic disease.
      Such a program is anticipated to have a positive impact on patient experience: to improve
      health equity and access for vulnerable patients; to facilitate greater medication adherence;
      and to enhance shared decision-making between patients and their clinicians for effective
      self-management care paths. The ultimate impact of this research will be evidence for the
      cost effectiveness or even cost savings of a drug insurance program aimed at the improving
      access to medications for disadvantaged patients who are currently uninsured.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
measure: Lacking medication insurance
time frame: During 2 month run-in period
description: Proportion of type 2 diabetes patients aged 25 to 64 who self-report that they lack medication insurance
measure: Online questionnaire during the run-in period
time frame: During 2 month run-in period
description: Proportion of type 2 diabetes patients aged 25 to 64 who complete the secure online questionnaire during the run-in period
measure: Response to the insurance status question
time frame: During 2 month run-in period
description: Proportion of type 2 diabetes patients aged 25 to 64 who responded to the insurance status question on the online questionnaire
measure: Recipient of no-cost medications
time frame: One year
description: Proportion of patients in the intervention group who receive medications from the Trillium Health Partners outpatient pharmacy
measure: Time from allocation to use of Trillium Health Partners outpatient pharmacy
time frame: One year
description: Time from allocation to the intervention group to use of the Trillium Health Partners outpatient pharmacy
measure: All-cause mortality or cardiovascular complications
time frame: One year
description: All-cause mortality, or hospitalization for myocardial infarction, acute coronary syndrome, coronary revascularization, stroke or heart failure.
measure: Other chronic diabetes complications
time frame: One year
description: Amputation, retinal photocoagulation, vitrectomy, intravitreal injection, incident microalbuminuria, incident chronic kidney disease
measure: Acute diabetes complications
time frame: One year
description: Emergency department visit or hospitalization for hypo or hyperglycemia
measure: A1c control
time frame: One year
description: A1c level
measure: Blood pressure control
time frame: One year
description: Systolic and diastolic blood pressure levels
measure: LDL-cholesterol control
time frame: One year
description: LDL-cholesterol levels
measure: Medication adherence for study drugs
time frame: One year
description: Medication possession ratio
measure: Medication adherence for non-study drugs
time frame: One year
description: Medication possession ratio
measure: Health care utilization
time frame: One year
description: Ambulatory physician visits, emergency department visits, hospitalizations
measure: Health care costs
time frame: One year
description: Total health care costs across sectors
arm group label: No-cost Medications
arm group type: Experimental
description: Eligible patients of physicians allocated to the no-cost medications arm will receive free medications through Trillium Health Partners outpatient pharmacy.
arm group label: Usual care
arm group type: No Intervention
description: Eligible patients of physicians allocated to the usual care arm will continue to access their medications through self-pay or other mechanisms.
intervention type: Other
intervention name: No-cost Medications
description: Patients will be connected to Trillium Health Partners outpatient pharmacy, and they will be given an information sheet with further details. The patients will get free access to diabetes, blood pressure and cholesterol medications and for glucose test strips. They can attend the pharmacy in person or arrange for home delivery.
arm group label: No-cost Medications
criteria: 
gender: All
minimum age: 25 Years
maximum age: 64 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2