<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/NCT02191111</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00047475</org_study_id>
    <secondary_id>201300643</secondary_id>
    <nct_id>NCT02191111</nct_id>
  </id_info>
  <brief_title>A Cluster-randomized Controlled Knowledge Translation Feasibility Study in Alberta Community Pharmacies</brief_title>
  <official_title>A Cluster-randomized Controlled Knowledge Translation Feasibility Study in Alberta Community Pharmacies Using the PARiHS Framework</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alberta Innovates Health Solutions</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Waterloo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Mississippi Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Despite evidence of benefit for pharmacist involvement in chronic disease&#xD;
      management, the provision of these services in community pharmacy has been suboptimal. The&#xD;
      Promoting Action on Research Implementation in Health Services (PARiHS) framework suggests&#xD;
      that for knowledge translation to be effective, there must be evidence of benefit, a context&#xD;
      conducive to implementation, and facilitation to support uptake. We hypothesize that while&#xD;
      the evidence and context components of this framework are satisfied, that uptake into&#xD;
      practice has been insufficient because of a lack of facilitation. This protocol describes the&#xD;
      rationale and methods of a feasibility study to test a facilitated pharmacy practice&#xD;
      intervention based on the PARiHS framework, to assist community pharmacists in increasing the&#xD;
      number of formal and documented medication management services completed for patients with&#xD;
      diabetes, dyslipidemia, and hypertension.&#xD;
&#xD;
      Methods: A cluster-randomized before-after design will compare ten pharmacies from within a&#xD;
      single organization, with the unit of randomization being the pharmacy. Pharmacies will be&#xD;
      randomized to facilitated intervention based on the PARiHS framework or usual practice. The&#xD;
      Alberta Context Tool will be used to establish the context of practice in each pharmacy.&#xD;
      Pharmacies randomized to the intervention will receive task-focused facilitation from an&#xD;
      external facilitator, with the goal of developing alternative team processes to allow the&#xD;
      greater provision of medication management services for patients with diabetes, hypertension,&#xD;
      and dyslipidemia. The primary outcome will be a process evaluation of the needs of community&#xD;
      pharmacies to provide more clinical services, the acceptability and uptake of modifications&#xD;
      made, and the willingness of pharmacies to participate. Secondary outcomes will include the&#xD;
      change in the number of formal and documented medication management services in the&#xD;
      aforementioned chronic conditions provided 6 months before, versus after, the intervention&#xD;
      between the two groups, and identification of feasible quantitative outcomes for evaluating&#xD;
      the effect of the intervention on patient care outcomes.&#xD;
&#xD;
      Results: To date, the study has identified and enrolled the ten pharmacies required and&#xD;
      initiated the intervention process.&#xD;
&#xD;
      Conclusion: This study will be the first to examine the role of facilitation in pharmacy&#xD;
      practice, with the goal of scalable and sustainable practice change.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Please see the following publication for a detailed description of the work:&#xD;
&#xD;
      Pilot and Feasibility Studies 01/2015; 1(2). DOI: 10.1186/2055-5784-1-2&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Service Counts From Baseline to End of Intervention Period</measure>
    <time_frame>6 month intervention period vs. 6 month baseline prior to intervention</time_frame>
    <description>Difference in the number of billable services (influenza vaccinations, Comprehensive Annual Care Plans and follow-ups, and Standard Medication Management Assessments and follow-ups) between the intervention period and the 6-months prior to intervention (baseline)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Chronic Diseases</condition>
  <arm_group>
    <arm_group_label>Task-focused facilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An external, task-focused facilitation, informed by an evaluation of contextual factors using the Alberta Context Tool (ACT), will be applied to train community pharmacies to develop alternative team processes that enable a greater number of medication management services to be provided to patients with diabetes, hypertension, and/or dyslipidemia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These sites will continue practice as usual, with no contact from study staff.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Task-focused facilitation</intervention_name>
    <description>An external, task-focused facilitation, informed by an evaluation of contextual factors using the Alberta Context Tool (ACT), will be applied to train community pharmacies to develop alternative team processes that enable a greater number of medication management services to be provided to patients with diabetes, hypertension, and/or dyslipidemia.</description>
    <arm_group_label>Task-focused facilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pharmacies: Community pharmacy locations of a medium-sized pharmacy chain with an&#xD;
             interest in and the ability to provide medication management services, but have not&#xD;
             fully integrated these activities&#xD;
&#xD;
          -  Patients: Any Alberta residents qualifying for pharmacy clinical services as defined&#xD;
             by the Alberta Pharmacy Fee Framework&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ross T Tsuyuki, PharmD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Meagen M Rosenthal, BA, MA, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sherilyn KD Houle, BSP, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Waterloo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>EPICORE Centre, University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2M8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.pilotfeasibilitystudies.com/content/1/1/2</url>
    <description>Study protocol</description>
  </link>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <results_first_submitted>September 15, 2016</results_first_submitted>
  <results_first_submitted_qc>April 8, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 5, 2023</results_first_posted>
  <last_update_submitted>April 8, 2022</last_update_submitted>
  <last_update_submitted_qc>April 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacist</keyword>
  <keyword>Pharmacy practice</keyword>
  <keyword>Patient care</keyword>
  <keyword>Community pharmacy</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Dyslipidemia</keyword>
  <keyword>Pharmaceutical care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Task-focused Facilitation</title>
          <description>An external, task-focused facilitation, informed by an evaluation of contextual factors using the Alberta Context Tool (ACT), will be applied to train community pharmacies to develop alternative team processes that enable a greater number of medication management services to be provided to patients with diabetes, hypertension, and/or dyslipidemia.&#xD;
Task-focused facilitation: An external, task-focused facilitation, informed by an evaluation of contextual factors using the Alberta Context Tool (ACT), will be applied to train community pharmacies to develop alternative team processes that enable a greater number of medication management services to be provided to patients with diabetes, hypertension, and/or dyslipidemia.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>These sites will continue practice as usual, with no contact from study staff.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="NA">Number of participants assigned NA because the unit of analysis was pharmacies not patients.</participants>
                <participants group_id="P2" count="NA">Number of participants assigned NA because the unit of analysis was pharmacies not patients.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="NA">Number of participants assigned NA because the unit of analysis was pharmacies not patients.</participants>
                <participants group_id="P2" count="NA">Number of participants assigned NA because the unit of analysis was pharmacies not patients.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="NA"/>
                <participants group_id="P2" count="NA"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Unit of analysis pharmacies</population>
      <group_list>
        <group group_id="B1">
          <title>Task-focused Facilitation</title>
          <description>An external, task-focused facilitation, informed by an evaluation of contextual factors using the Alberta Context Tool (ACT), will be applied to train community pharmacies to develop alternative team processes that enable a greater number of medication management services to be provided to patients with diabetes, hypertension, and/or dyslipidemia.&#xD;
Task-focused facilitation: An external, task-focused facilitation, informed by an evaluation of contextual factors using the Alberta Context Tool (ACT), will be applied to train community pharmacies to develop alternative team processes that enable a greater number of medication management services to be provided to patients with diabetes, hypertension, and/or dyslipidemia.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>These sites will continue practice as usual, with no contact from study staff.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="NA"/>
            <count group_id="B2" value="NA"/>
            <count group_id="B3" value="NA"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>Pharmacies</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Age data not collected</units>
          <param>Number</param>
          <units_analyzed>Pharmacies</units_analyzed>
          <class_list>
            <class>
              <title>Pharmacies</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Pharmacies</units>
          <param>Number</param>
          <units_analyzed>Pharmacies</units_analyzed>
          <class_list>
            <class>
              <title>Pharmacies</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alberta context tool, semi-structured interviews, medication management counts, close out interviews</title>
          <description>The Alberta Context Tool is designed to obtain a measure of the organizational culture of a clinical setting. The scale is measured on a series of 5-point Likert scales from strongly disagree to strongly agree or never to almost always. Each of the five items is assigned a number from 1 (strongly disagree/never) to 5 (strongly agree/almost always). Composite scores (mean scores taken of responses to each item) are calculate for each of the sub-scales and combined for a total score. The higher the score the more a site demonstrates the sub-scale characteristic.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>Pharmacies</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.86" lower_limit="1" upper_limit="5"/>
                    <measurement group_id="B2" value="3.14" lower_limit="1" upper_limit="5"/>
                    <measurement group_id="B3" value="3" lower_limit="1" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Service Counts From Baseline to End of Intervention Period</title>
        <description>Difference in the number of billable services (influenza vaccinations, Comprehensive Annual Care Plans and follow-ups, and Standard Medication Management Assessments and follow-ups) between the intervention period and the 6-months prior to intervention (baseline)</description>
        <time_frame>6 month intervention period vs. 6 month baseline prior to intervention</time_frame>
        <population>Units of measure were community pharmacies</population>
        <group_list>
          <group group_id="O1">
            <title>Task-focused Facilitation</title>
            <description>An external, task-focused facilitation, informed by an evaluation of contextual factors using the Alberta Context Tool (ACT), will be applied to train community pharmacies to develop alternative team processes that enable a greater number of medication management services to be provided to patients with diabetes, hypertension, and/or dyslipidemia.&#xD;
Task-focused facilitation: An external, task-focused facilitation, informed by an evaluation of contextual factors using the Alberta Context Tool (ACT), will be applied to train community pharmacies to develop alternative team processes that enable a greater number of medication management services to be provided to patients with diabetes, hypertension, and/or dyslipidemia.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>These sites will continue practice as usual, with no contact from study staff.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Service Counts From Baseline to End of Intervention Period</title>
          <description>Difference in the number of billable services (influenza vaccinations, Comprehensive Annual Care Plans and follow-ups, and Standard Medication Management Assessments and follow-ups) between the intervention period and the 6-months prior to intervention (baseline)</description>
          <population>Units of measure were community pharmacies</population>
          <units>Billable pharmacy services</units>
          <param>Count of Units</param>
          <units_analyzed>Billable pharmacy services</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Billable pharmacy services</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4557"/>
                <count group_id="O2" value="5886"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>CACP (Baseline)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="172"/>
                    <measurement group_id="O2" value="284"/>
                  </measurement_list>
                </category>
                <category>
                  <title>CACP (Study Period)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="121"/>
                    <measurement group_id="O2" value="166"/>
                  </measurement_list>
                </category>
                <category>
                  <title>CACP Follow-Up (Baseline)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="295"/>
                    <measurement group_id="O2" value="507"/>
                  </measurement_list>
                </category>
                <category>
                  <title>CACP Follow-Up (Study Period)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="372"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SMMA (Baseline)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="115"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SMMA (Study Period)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SMMA Follow-Up (Baseline)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="105"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SMMA Follow-Up (Study Period)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SMMA Diabetes (Baseline)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SMMA Diabetes (Study Period)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SMMA Diabetes Follow-Up (Baseline)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SMMA Diabetes Follow-Up (Study Period)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SMMA Tobacco (Baseline)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SMMA Tobacco (Study Period)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SMMA Tobacco Follow-Up (Baseline)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SMMA Tobacco Follow-Up (Study Period)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Influenza Vaccinations (Baseline)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="406"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Influenza Vaccinations (Study Period)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3199"/>
                    <measurement group_id="O2" value="4140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Adverse events were not collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>Task-focused Facilitation</title>
          <description>An external, task-focused facilitation, informed by an evaluation of contextual factors using the Alberta Context Tool (ACT), will be applied to train community pharmacies to develop alternative team processes that enable a greater number of medication management services to be provided to patients with diabetes, hypertension, and/or dyslipidemia.&#xD;
Task-focused facilitation: An external, task-focused facilitation, informed by an evaluation of contextual factors using the Alberta Context Tool (ACT), will be applied to train community pharmacies to develop alternative team processes that enable a greater number of medication management services to be provided to patients with diabetes, hypertension, and/or dyslipidemia.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>These sites will continue practice as usual, with no contact from study staff.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Meagen Rosenthal</name_or_title>
      <organization>University of Mississippi</organization>
      <phone>662-915-2475</phone>
      <email>mmrosent@olemiss.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02191111
org study id: Pro00047475
secondary id: 201300643
nct id: NCT02191111
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Background: Despite evidence of benefit for pharmacist involvement in chronic disease
      management, the provision of these services in community pharmacy has been suboptimal. The
      Promoting Action on Research Implementation in Health Services (PARiHS) framework suggests
      that for knowledge translation to be effective, there must be evidence of benefit, a context
      conducive to implementation, and facilitation to support uptake. We hypothesize that while
      the evidence and context components of this framework are satisfied, that uptake into
      practice has been insufficient because of a lack of facilitation. This protocol describes the
      rationale and methods of a feasibility study to test a facilitated pharmacy practice
      intervention based on the PARiHS framework, to assist community pharmacists in increasing the
      number of formal and documented medication management services completed for patients with
      diabetes, dyslipidemia, and hypertension.

      Methods: A cluster-randomized before-after design will compare ten pharmacies from within a
      single organization, with the unit of randomization being the pharmacy. Pharmacies will be
      randomized to facilitated intervention based on the PARiHS framework or usual practice. The
      Alberta Context Tool will be used to establish the context of practice in each pharmacy.
      Pharmacies randomized to the intervention will receive task-focused facilitation from an
      external facilitator, with the goal of developing alternative team processes to allow the
      greater provision of medication management services for patients with diabetes, hypertension,
      and dyslipidemia. The primary outcome will be a process evaluation of the needs of community
      pharmacies to provide more clinical services, the acceptability and uptake of modifications
      made, and the willingness of pharmacies to participate. Secondary outcomes will include the
      change in the number of formal and documented medication management services in the
      aforementioned chronic conditions provided 6 months before, versus after, the intervention
      between the two groups, and identification of feasible quantitative outcomes for evaluating
      the effect of the intervention on patient care outcomes.

      Results: To date, the study has identified and enrolled the ten pharmacies required and
      initiated the intervention process.

      Conclusion: This study will be the first to examine the role of facilitation in pharmacy
      practice, with the goal of scalable and sustainable practice change.
Please see the following publication for a detailed description of the work:

      Pilot and Feasibility Studies 01/2015; 1(2). DOI: 10.1186/2055-5784-1-2
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in Service Counts From Baseline to End of Intervention Period
time frame: 6 month intervention period vs. 6 month baseline prior to intervention
description: Difference in the number of billable services (influenza vaccinations, Comprehensive Annual Care Plans and follow-ups, and Standard Medication Management Assessments and follow-ups) between the intervention period and the 6-months prior to intervention (baseline)
arm group label: Task-focused facilitation
arm group type: Experimental
description: An external, task-focused facilitation, informed by an evaluation of contextual factors using the Alberta Context Tool (ACT), will be applied to train community pharmacies to develop alternative team processes that enable a greater number of medication management services to be provided to patients with diabetes, hypertension, and/or dyslipidemia.
arm group label: Control
arm group type: No Intervention
description: These sites will continue practice as usual, with no contact from study staff.
intervention type: Behavioral
intervention name: Task-focused facilitation
description: An external, task-focused facilitation, informed by an evaluation of contextual factors using the Alberta Context Tool (ACT), will be applied to train community pharmacies to develop alternative team processes that enable a greater number of medication management services to be provided to patients with diabetes, hypertension, and/or dyslipidemia.
arm group label: Task-focused facilitation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ross T Tsuyuki, PharmD, MSc
role: Principal Investigator
affiliation: University of Alberta
last name: Meagen M Rosenthal, BA, MA, PhD
role: Study Director
affiliation: University of Alberta
last name: Sherilyn KD Houle, BSP, PhD
role: Study Director
affiliation: University of Waterloo
facility: 
country: Canada
url: http://www.pilotfeasibilitystudies.com/content/1/1/2
description: Study protocol
responsible party type: Sponsor
mesh term: Chronic Disease
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 