<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/NCT01732302</url>
  </required_header>
  <id_info>
    <org_study_id>2012 1266-31</org_study_id>
    <nct_id>NCT01732302</nct_id>
  </id_info>
  <brief_title>Educational Intervention to Reduce Drug-related Hospitalizations in Elderly Primary Health Care Patients</brief_title>
  <official_title>Educational Intervention to Reduce Drug-related Hospitalizations and Visits in Emergency Departments in Elderly Primary Health Care Patients - a Cluster-randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Stockholm</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether an educational intervention given towards&#xD;
      health care providers working in primary health care centers can reduce inappropriate&#xD;
      prescribing in the elderly patient and thus reduce number and length of drug-related&#xD;
      hospitalizations as well as number of emergency department visits in this patient group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inappropriate medication in the elderly patient leads to substantial morbidity, possibly&#xD;
      causing up to 20% of hospitalizations in this patient group (1). To improve prescribing and&#xD;
      thus reduce undesired drug effects is a great challenge for doctors and nurses in primary&#xD;
      health care.&#xD;
&#xD;
      Performance of drug utilization reviews is recommended in order to reduce the negative impact&#xD;
      of inappropriate prescribing in the elderly. However, scientific evidence on their efficacy&#xD;
      is lacking, especially regarding patient-related health outcomes (2,3). Most studies are&#xD;
      carried out in inpatient care, making it difficult to draw conclusions regarding primary&#xD;
      health care (2). Moreover, studies in this scientific field diverge regarding the content and&#xD;
      structure of drug utilization reviews, which implies that comparison between studies becomes&#xD;
      challenging, if not impossible.&#xD;
&#xD;
      This trial aims at educating health care providers in how to perform drug utilization&#xD;
      reviews, and to help them implement theory into practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite outcome: Unplanned hospitalisation or emergency department visit</measure>
    <time_frame>9 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Unplanned hospitalisation</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency department visit</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of drug utilization reviews</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with polypharmacy</measure>
    <time_frame>9 months</time_frame>
    <description>polypharmacy: 5-9 drugs/patient excessive polypharmacy: 10 and more drugs/patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inappropriate drug use according to national guidelines</measure>
    <time_frame>9 months</time_frame>
    <description>see link</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with contraindicated drugs regarding renal function</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of drugs with inappropriate drug dose regarding renal function</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of drug interactions</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Polypharmacy</condition>
  <condition>Adverse Drug Reaction</condition>
  <arm_group>
    <arm_group_label>Educational intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Primary health care centers (PHCC) in the intervention group will be visited twice by a pharmacist within a period of three months. At the first visit, an educational intervention will focus on two properties: on the one hand, feed-back of actual patient data of the PHCC illustrating the primary-health-care-specific characteristics of inappropriate prescribing in the elderly patient will be given. Education of relevant subjects will be given in relation to detected problems. On the other hand, a clinical routine regarding the performance of drug utilization reviews will be developed in cooperation with the health care providers. At the second visit 3 months later, the developed concept will be critically reviewed and eventually developed further.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed educational intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Primary health care centers in the delayed intervention group will receive the same intervention as described above with 9 months delay.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational intervention</intervention_name>
    <description>Primary health care centers (PHCC) in the intervention group will be visited twice by a pharmacist within a period of three months. At the first visit, an educational intervention will focus on two properties: on the one hand, feed-back of actual patient data of the PHCC illustrating the primary-health-care-specific characteristics of inappropriate prescribing in the elderly patient will be given. Education of relevant subjects will be given in relation to detected problems. On the other hand, a clinical routine regarding the performance of drug utilization reviews will be developed in cooperation with the health care providers. At the second visit 3 months later, the developed concept will be critically reviewed and eventually developed further.</description>
    <arm_group_label>Educational intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary health care center in Stockholm County&#xD;
&#xD;
          -  authorized by Stockholm County Council since at least 3 years&#xD;
&#xD;
          -  at least 5% of patients attributed to primary health care center are 65 years and&#xD;
             older&#xD;
&#xD;
          -  primary health care center takes care of at least 10 home care patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 3000 patients listed in primary health care center&#xD;
&#xD;
          -  primary health care centers where researchers carrying out the present study work&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Hasselström, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet</name>
      <address>
        <city>Huddinge</city>
        <zip>14183</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Beijer HJ, de Blaey CJ. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci. 2002 Apr;24(2):46-54. doi: 10.1023/a:1015570104121.</citation>
    <PMID>12061133</PMID>
  </reference>
  <reference>
    <citation>Spinewine A, Schmader KE, Barber N, Hughes C, Lapane KL, Swine C, Hanlon JT. Appropriate prescribing in elderly people: how well can it be measured and optimised? Lancet. 2007 Jul 14;370(9582):173-184. doi: 10.1016/S0140-6736(07)61091-5.</citation>
    <PMID>17630041</PMID>
  </reference>
  <reference>
    <citation>Stewart S, Pearson S, Luke CG, Horowitz JD. Effects of home-based intervention on unplanned readmissions and out-of-hospital deaths. J Am Geriatr Soc. 1998 Feb;46(2):174-80. doi: 10.1111/j.1532-5415.1998.tb02535.x.</citation>
    <PMID>9475445</PMID>
  </reference>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>October 18, 2013</last_update_submitted>
  <last_update_submitted_qc>October 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 21, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Lars Agreus</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Drug Utilization Review</keyword>
  <keyword>Aged</keyword>
  <keyword>Aged, 80 and over</keyword>
  <keyword>Primary Health Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Drug-Related Side Effects and Adverse Reactions</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/NCT01732302
org study id: 2012 1266-31
nct id: NCT01732302
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether an educational intervention given towards
      health care providers working in primary health care centers can reduce inappropriate
      prescribing in the elderly patient and thus reduce number and length of drug-related
      hospitalizations as well as number of emergency department visits in this patient group.
Inappropriate medication in the elderly patient leads to substantial morbidity, possibly
      causing up to 20% of hospitalizations in this patient group (1). To improve prescribing and
      thus reduce undesired drug effects is a great challenge for doctors and nurses in primary
      health care.

      Performance of drug utilization reviews is recommended in order to reduce the negative impact
      of inappropriate prescribing in the elderly. However, scientific evidence on their efficacy
      is lacking, especially regarding patient-related health outcomes (2,3). Most studies are
      carried out in inpatient care, making it difficult to draw conclusions regarding primary
      health care (2). Moreover, studies in this scientific field diverge regarding the content and
      structure of drug utilization reviews, which implies that comparison between studies becomes
      challenging, if not impossible.

      This trial aims at educating health care providers in how to perform drug utilization
      reviews, and to help them implement theory into practice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Composite outcome: Unplanned hospitalisation or emergency department visit
time frame: 9 months
measure: Unplanned hospitalisation
time frame: 9 months
measure: Emergency department visit
time frame: 9 months
measure: Length of hospital stay
time frame: 9 months
measure: All cause mortality
time frame: 9 months
measure: Number of drug utilization reviews
time frame: 9 months
measure: Number of patients with polypharmacy
time frame: 9 months
description: polypharmacy: 5-9 drugs/patient excessive polypharmacy: 10 and more drugs/patient
measure: Inappropriate drug use according to national guidelines
time frame: 9 months
description: see link
measure: Number of patients with contraindicated drugs regarding renal function
time frame: 9 months
measure: Number of drugs with inappropriate drug dose regarding renal function
time frame: 9 months
measure: Number of drug interactions
time frame: 9 months
arm group label: Educational intervention
arm group type: Experimental
description: Primary health care centers (PHCC) in the intervention group will be visited twice by a pharmacist within a period of three months. At the first visit, an educational intervention will focus on two properties: on the one hand, feed-back of actual patient data of the PHCC illustrating the primary-health-care-specific characteristics of inappropriate prescribing in the elderly patient will be given. Education of relevant subjects will be given in relation to detected problems. On the other hand, a clinical routine regarding the performance of drug utilization reviews will be developed in cooperation with the health care providers. At the second visit 3 months later, the developed concept will be critically reviewed and eventually developed further.
arm group label: Delayed educational intervention
arm group type: No Intervention
description: Primary health care centers in the delayed intervention group will receive the same intervention as described above with 9 months delay.
intervention type: Other
intervention name: Educational intervention
description: Primary health care centers (PHCC) in the intervention group will be visited twice by a pharmacist within a period of three months. At the first visit, an educational intervention will focus on two properties: on the one hand, feed-back of actual patient data of the PHCC illustrating the primary-health-care-specific characteristics of inappropriate prescribing in the elderly patient will be given. Education of relevant subjects will be given in relation to detected problems. On the other hand, a clinical routine regarding the performance of drug utilization reviews will be developed in cooperation with the health care providers. At the second visit 3 months later, the developed concept will be critically reviewed and eventually developed further.
arm group label: Educational intervention
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Jan Hasselström, MD, PhD
role: Principal Investigator
affiliation: Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet
facility: 
country: Sweden
citation: Beijer HJ, de Blaey CJ. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci. 2002 Apr;24(2):46-54. doi: 10.1023/a:1015570104121.
PMID: 12061133
citation: Spinewine A, Schmader KE, Barber N, Hughes C, Lapane KL, Swine C, Hanlon JT. Appropriate prescribing in elderly people: how well can it be measured and optimised? Lancet. 2007 Jul 14;370(9582):173-184. doi: 10.1016/S0140-6736(07)61091-5.
PMID: 17630041
citation: Stewart S, Pearson S, Luke CG, Horowitz JD. Effects of home-based intervention on unplanned readmissions and out-of-hospital deaths. J Am Geriatr Soc. 1998 Feb;46(2):174-80. doi: 10.1111/j.1532-5415.1998.tb02535.x.
PMID: 9475445
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Lars Agreus
investigator title: Professor
mesh term: Drug-Related Side Effects and Adverse Reactions