<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/NCT03257605</url>
  </required_header>
  <id_info>
    <org_study_id>PHARM-GENOME-PACE 1173</org_study_id>
    <nct_id>NCT03257605</nct_id>
  </id_info>
  <brief_title>A Pharmacist Implemented Pharmacogenomics Service in the Program of All-inclusive Care for the Elderly</brief_title>
  <acronym>PACE</acronym>
  <official_title>Implementation of a Pharmacist-Led Pharmacogenomics Service for the Program of All-inclusive Care for the Elderly (PHARM-GENOME-PACE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tabula Rasa HealthCare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Coriell Life Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tabula Rasa HealthCare</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>
      The aim of this study is to evaluate and describe the feasibility of implementing a&#xD;
      pharmacist-led pharmacogenomics service for the Program of All-inclusive Care for the Elderly&#xD;
      (PACE), a community-based practice setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine if a pharmacogenomics (PGx) service can become a component of everyday practice,&#xD;
      feasibility assessments are needed. While some researchers have begun to assess the&#xD;
      feasibility of implementing PGx into pharmacy practice in community-based practice settings,&#xD;
      none that we are aware have assessed such feasibility for the Program of All-inclusive Care&#xD;
      for the Elderly (PACE). The primary objective of this feasibility study is to evaluate the&#xD;
      processes that were involved in implementing a pharmacist-led PGx service for PACE and to&#xD;
      describe process-related challenges and solutions associated with implementation. Secondary&#xD;
      objectives include: describe pharmacists' roles in the implementation process; report&#xD;
      aggregate PGx test results, including genetic variants and drug-gene interactions; and&#xD;
      describe pharmacists' recommendations to personalize drug regimens for PACE participants and&#xD;
      prescribers' acceptance of these recommendations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2014</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">June 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Implementation Primary</measure>
    <time_frame>24 months</time_frame>
    <description>Qualitative description of process-related challenges and successes as assessed by observation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implementation Secondary</measure>
    <time_frame>24 months</time_frame>
    <description>Qualitative description of pharmacists' roles as assessed by observation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacogenomic Testing</measure>
    <time_frame>24 months</time_frame>
    <description>Quantitative description of pharmacogenomic testing results as assessed by analysis of genotype and phenotype</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacist Recommendations</measure>
    <time_frame>24 months</time_frame>
    <description>Qualitative and quantitative descriptions of pharmacists' pharmacogenomic-based recommendations to prescribers as assessed by evaluation of consultations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prescriber Acceptances</measure>
    <time_frame>24 months</time_frame>
    <description>Qualitative and quantitative descriptions of prescribers' acceptances of pharmacists' recommendations as assessed by responses and post-consultation drug profile reviews</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">296</enrollment>
  <condition>Pharmacogenomics</condition>
  <condition>Medication Therapy Management</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <description>Participants enrolled in PACE who underwent pharmacogenomics testing as part of their medical care and also consented to the use of their de-identified data for research purposes.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        In the United States, PACE is a medical home model for participants &gt;=55 years of age who&#xD;
        are certified by their state as needing nursing-facility level of care but can reside&#xD;
        safely in the community through PACE, as an alternative to institutionalization.&#xD;
        Participants enrolled in PACE who underwent pharmacogenomics testing as part of their&#xD;
        medical care and also consented to the use of their de-identified data for research&#xD;
        purposes were eligible for inclusion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant enrolled in PACE contractually receiving pharmacy services from Tabula&#xD;
             Rasa Healthcare (CareKinesis Pharmacy) during the project time period (May 2014&#xD;
             through June 2016); and&#xD;
&#xD;
          -  PACE prescriber ordered a pharmacogenomics test for the participant as part of&#xD;
             clinical care; and,&#xD;
&#xD;
          -  PACE participant consented to a pharmacogenomics test; and,&#xD;
&#xD;
          -  CareKinesis pharmacist provided a consultation directly to PACE prescriber based on&#xD;
             the participant's pharmacogenomics test results.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant dis-enrolled from PACE prior to receiving pharmacogenomics test results&#xD;
             and/or prior to CareKinesis pharmacist providing consultative services; or,&#xD;
&#xD;
          -  Participant did not complete the pharmacogenomics test.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin T Bain, PharmD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tabula Rasa HealthCare</affiliation>
  </overall_official>
  <reference>
    <citation>Evans WE, McLeod HL. Pharmacogenomics--drug disposition, drug targets, and side effects. N Engl J Med. 2003 Feb 6;348(6):538-49. doi: 10.1056/NEJMra020526. No abstract available.</citation>
    <PMID>12571262</PMID>
  </reference>
  <reference>
    <citation>Hocum BT, White JR Jr, Heck JW, Thirumaran RK, Moyer N, Newman R, Ashcraft K. Cytochrome P-450 gene and drug interaction analysis in patients referred for pharmacogenetic testing. Am J Health Syst Pharm. 2016 Jan 15;73(2):61-7. doi: 10.2146/ajhp150273.</citation>
    <PMID>26721535</PMID>
  </reference>
  <reference>
    <citation>Evans WE, Johnson JA. Pharmacogenomics: the inherited basis for interindividual differences in drug response. Annu Rev Genomics Hum Genet. 2001;2:9-39. doi: 10.1146/annurev.genom.2.1.9.</citation>
    <PMID>11701642</PMID>
  </reference>
  <reference>
    <citation>Tannenbaum C, Sheehan NL. Understanding and preventing drug-drug and drug-gene interactions. Expert Rev Clin Pharmacol. 2014 Jul;7(4):533-44. doi: 10.1586/17512433.2014.910111. Epub 2014 Apr 19.</citation>
    <PMID>24745854</PMID>
  </reference>
  <reference>
    <citation>Ferreri SP, Greco AJ, Michaels NM, O'Connor SK, Chater RW, Viera AJ, Faruki H, McLeod HL, Roederer MW. Implementation of a pharmacogenomics service in a community pharmacy. J Am Pharm Assoc (2003). 2014 Mar-Apr;54(2):172-80. doi: 10.1331/JAPhA.2014.13033.</citation>
    <PMID>24632932</PMID>
  </reference>
  <reference>
    <citation>Haga SB, LaPointe NM, Cho A, Reed SD, Mills R, Moaddeb J, Ginsburg GS. Pilot study of pharmacist-assisted delivery of pharmacogenetic testing in a primary care setting. Pharmacogenomics. 2014 Sep;15(13):1677-86. doi: 10.2217/pgs.14.109.</citation>
    <PMID>25410893</PMID>
  </reference>
  <reference>
    <citation>Haga SB, Allen LaPointe NM, Moaddeb J, Mills R, Patel M, Kraus WE. Pilot study: incorporation of pharmacogenetic testing in medication therapy management services. Pharmacogenomics. 2014 Nov;15(14):1729-1737. doi: 10.2217/pgs.14.118.</citation>
    <PMID>25493566</PMID>
  </reference>
  <reference>
    <citation>Moaddeb J, Mills R, Haga SB. Community pharmacists' experience with pharmacogenetic testing. J Am Pharm Assoc (2003). 2015 Nov-Dec;55(6):587-594. doi: 10.1331/JAPhA.2015.15017.</citation>
    <PMID>26409205</PMID>
  </reference>
  <reference>
    <citation>Welch BM, Kawamoto K. Clinical decision support for genetically guided personalized medicine: a systematic review. J Am Med Inform Assoc. 2013 Mar-Apr;20(2):388-400. doi: 10.1136/amiajnl-2012-000892. Epub 2012 Aug 25.</citation>
    <PMID>22922173</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacogenomics</keyword>
  <keyword>Medication Therapy Management</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Information about participants' drugs will not be shared with either the laboratory company or laboratory interpretive company. There will be no disclosure of participant information and no details of participant identity will be part of any presentation or publication of the research. Participant confidentiality will be held in strict trust by the project investigators. This confidentiality extends to any participation-related information as well as biological samples and PGx test results. The project data or other information generated will be held in strict confidence. No information concerning the project or the data will be released to any unauthorized third party without prior written consent.</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/NCT03257605
org study id: PHARM-GENOME-PACE 1173
nct id: NCT03257605
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate and describe the feasibility of implementing a
      pharmacist-led pharmacogenomics service for the Program of All-inclusive Care for the Elderly
      (PACE), a community-based practice setting.
To determine if a pharmacogenomics (PGx) service can become a component of everyday practice,
      feasibility assessments are needed. While some researchers have begun to assess the
      feasibility of implementing PGx into pharmacy practice in community-based practice settings,
      none that we are aware have assessed such feasibility for the Program of All-inclusive Care
      for the Elderly (PACE). The primary objective of this feasibility study is to evaluate the
      processes that were involved in implementing a pharmacist-led PGx service for PACE and to
      describe process-related challenges and solutions associated with implementation. Secondary
      objectives include: describe pharmacists' roles in the implementation process; report
      aggregate PGx test results, including genetic variants and drug-gene interactions; and
      describe pharmacists' recommendations to personalize drug regimens for PACE participants and
      prescribers' acceptance of these recommendations.
observational model: Cohort
time perspective: Retrospective
measure: Implementation Primary
time frame: 24 months
description: Qualitative description of process-related challenges and successes as assessed by observation
measure: Implementation Secondary
time frame: 24 months
description: Qualitative description of pharmacists' roles as assessed by observation
measure: Pharmacogenomic Testing
time frame: 24 months
description: Quantitative description of pharmacogenomic testing results as assessed by analysis of genotype and phenotype
measure: Pharmacist Recommendations
time frame: 24 months
description: Qualitative and quantitative descriptions of pharmacists' pharmacogenomic-based recommendations to prescribers as assessed by evaluation of consultations
measure: Prescriber Acceptances
time frame: 24 months
description: Qualitative and quantitative descriptions of prescribers' acceptances of pharmacists' recommendations as assessed by responses and post-consultation drug profile reviews
arm group label: Study group
description: Participants enrolled in PACE who underwent pharmacogenomics testing as part of their medical care and also consented to the use of their de-identified data for research purposes.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Kevin T Bain, PharmD, MPH
role: Principal Investigator
affiliation: Tabula Rasa HealthCare
citation: Evans WE, McLeod HL. Pharmacogenomics--drug disposition, drug targets, and side effects. N Engl J Med. 2003 Feb 6;348(6):538-49. doi: 10.1056/NEJMra020526. No abstract available.
PMID: 12571262
citation: Hocum BT, White JR Jr, Heck JW, Thirumaran RK, Moyer N, Newman R, Ashcraft K. Cytochrome P-450 gene and drug interaction analysis in patients referred for pharmacogenetic testing. Am J Health Syst Pharm. 2016 Jan 15;73(2):61-7. doi: 10.2146/ajhp150273.
PMID: 26721535
citation: Evans WE, Johnson JA. Pharmacogenomics: the inherited basis for interindividual differences in drug response. Annu Rev Genomics Hum Genet. 2001;2:9-39. doi: 10.1146/annurev.genom.2.1.9.
PMID: 11701642
citation: Tannenbaum C, Sheehan NL. Understanding and preventing drug-drug and drug-gene interactions. Expert Rev Clin Pharmacol. 2014 Jul;7(4):533-44. doi: 10.1586/17512433.2014.910111. Epub 2014 Apr 19.
PMID: 24745854
citation: Ferreri SP, Greco AJ, Michaels NM, O'Connor SK, Chater RW, Viera AJ, Faruki H, McLeod HL, Roederer MW. Implementation of a pharmacogenomics service in a community pharmacy. J Am Pharm Assoc (2003). 2014 Mar-Apr;54(2):172-80. doi: 10.1331/JAPhA.2014.13033.
PMID: 24632932
citation: Haga SB, LaPointe NM, Cho A, Reed SD, Mills R, Moaddeb J, Ginsburg GS. Pilot study of pharmacist-assisted delivery of pharmacogenetic testing in a primary care setting. Pharmacogenomics. 2014 Sep;15(13):1677-86. doi: 10.2217/pgs.14.109.
PMID: 25410893
citation: Haga SB, Allen LaPointe NM, Moaddeb J, Mills R, Patel M, Kraus WE. Pilot study: incorporation of pharmacogenetic testing in medication therapy management services. Pharmacogenomics. 2014 Nov;15(14):1729-1737. doi: 10.2217/pgs.14.118.
PMID: 25493566
citation: Moaddeb J, Mills R, Haga SB. Community pharmacists' experience with pharmacogenetic testing. J Am Pharm Assoc (2003). 2015 Nov-Dec;55(6):587-594. doi: 10.1331/JAPhA.2015.15017.
PMID: 26409205
citation: Welch BM, Kawamoto K. Clinical decision support for genetically guided personalized medicine: a systematic review. J Am Med Inform Assoc. 2013 Mar-Apr;20(2):388-400. doi: 10.1136/amiajnl-2012-000892. Epub 2012 Aug 25.
PMID: 22922173
responsible party type: Sponsor
sharing ipd: No
ipd description: Information about participants' drugs will not be shared with either the laboratory company or laboratory interpretive company. There will be no disclosure of participant information and no details of participant identity will be part of any presentation or publication of the research. Participant confidentiality will be held in strict trust by the project investigators. This confidentiality extends to any participation-related information as well as biological samples and PGx test results. The project data or other information generated will be held in strict confidence. No information concerning the project or the data will be released to any unauthorized third party without prior written consent.