<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/NCT02986425</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1181-9400</org_study_id>
    <nct_id>NCT02986425</nct_id>
  </id_info>
  <brief_title>OPtimising thERapy to Prevent Avoidable Hospital Admissions in the Multimorbid Older People</brief_title>
  <acronym>OPERAM</acronym>
  <official_title>OPERAM: OPtimising thERapy to Prevent Avoidable Hospital Admissions in the Multimorbid Older People: a Cluster Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cork University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Basel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Utrecht University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>European Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>State Secretariat for Education Research and Innovation, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this Randomised Controlled Trial (RCT) is to evaluate whether the Systematic&#xD;
      Tool to Reduce Inappropriate Prescribing (STRIP) including STRIP assistant (STRIPA)&#xD;
      implemented by an appropriately qualified team will lead to an improvement in clinical and&#xD;
      economic outcomes among patients aged 70 years and more with multimorbidity and polypharmacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Drug-related morbidity and mortality is an increasing problem in European healthcare systems.&#xD;
      Multimorbidity, polypharmacy and old age are important risk factors for drug-related hospital&#xD;
      admissions (DRA). The reported incidence of DRAs in the elderly may be as high as 30% of all&#xD;
      acute cases, and about half of DRAs are likely to be preventable. They are mainly related to&#xD;
      prescribing problems and non-compliance with drug regimens. A significant proportion of&#xD;
      healthcare costs are spent on unnecessary interventions and inappropriate medications. The&#xD;
      Systematic Tool to Reduce Inappropriate Prescribing (STRIP) is a structured method to perform&#xD;
      a medication review to optimise pharmacotherapy.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      European multi-centre, cluster randomised, controlled trial of people aged 70 years or older,&#xD;
      with multimorbidity and polypharmacy, being on an ambulatory visit or on a hospital stay in&#xD;
      one of the four participating centres in Ireland, Belgium, Switzerland and the Netherlands. A&#xD;
      cluster is defined around a treating physician, i.e. the treating physician is randomised and&#xD;
      defines the allocation of his patients. Clusters of patients will be randomised to the&#xD;
      intervention arm receiving STRIP for optimising therapy or to the control arm undergoing&#xD;
      usual clinical care. The patients of physicians who are allocated to the intervention group&#xD;
      will undergo a systematic drug review and pharmacotherapy optimisation by a physician and a&#xD;
      pharmacist using STRIP, including the STRIPA software. That provides the research team with a&#xD;
      recommendation of changes in the patient's medication. Based on STRIPA recommendation and&#xD;
      agreement on changes to the patients' pharmacotherapy between the team of the research&#xD;
      physician and pharmacist and the prescribing physician, will the patient receive structured&#xD;
      counselling about his/her medication; general practitioners will receive a report. Patients&#xD;
      will be further followed for 1 year with follow-up phone calls after 2, 6 and 12 months. For&#xD;
      the purpose of this trial, all hospitalisations during follow-up of participants will be&#xD;
      adjudicated to assess their relationship to adverse drug events.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      The primary objective is to assess the effect of a structured medication review and&#xD;
      pharmacotherapy optimisation using the STRIP on drug-related hospitalisations (DRA) caused by&#xD;
      over-, mis-, and underuse or over-, mis-, and underprescribing of medications.&#xD;
&#xD;
      Secondary objectives will be to assess the impact of pharmacotherapy optimisation on falls,&#xD;
      quality of life, polypharmacy, medication changes, activities of daily living, and mortality.&#xD;
&#xD;
      Statistical considerations:&#xD;
&#xD;
      80 clusters with a cluster size ranging from 12 to 38 participants will be included.&#xD;
      Therefore, 2000 patients, 1000 patients in each arm, will be recruited over 18 months. The&#xD;
      trial will have 80% power with this sample size.&#xD;
&#xD;
      The primary analysis will be an intention-to-treat (ITT) analysis, whereby all randomised&#xD;
      patients will be included in the group they were allocated to.&#xD;
&#xD;
      The primary outcome of drug-related admission will be analysed using a random-effects&#xD;
      competing risk proportional hazards model that accounts for the competing risk of death and&#xD;
      for clustering of data within centre and prescribing physician.&#xD;
&#xD;
      Overall survival will be analysed using a random-effects Cox proportional hazards model that&#xD;
      accounts for clustering of data within centre and prescribing physician. The analysis of&#xD;
      falls will also take into account the competing risk of death. Continuous outcomes will be&#xD;
      analysed by random-effects linear regression. All effect measures will be accompanied by 95%&#xD;
      confidence intervals and all p-values will be two-sided.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">October 2019</completion_date>
  <primary_completion_date type="Actual">October 2019</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients with confirmed DRA after discharge from the index hospitalisation</measure>
    <time_frame>12 months</time_frame>
    <description>The primary outcome is defined as the first confirmed DRA after discharge from the index hospitalisation within a period of 12 months.&#xD;
Confirmation of a drug-related hospital admission will be assessed by an independent and blinded adjudication committee (per site). Prolongation of the index hospitalisation and prolongation of any following hospitalisations will not be adjudicated for drug-relatedness. Adjudication is done according to specific guidelines.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of survivors</measure>
    <time_frame>12 months</time_frame>
    <description>Including causes of death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cancer deaths</measure>
    <time_frame>12 months</time_frame>
    <description>As subgroup of all deaths this is considered a negative control outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with hospitalisations</measure>
    <time_frame>12 months</time_frame>
    <description>Detected during the follow-up phone calls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with falls</measure>
    <time_frame>12 months</time_frame>
    <description>Detected during the follow-up phone calls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' degree of poly-pharmacy</measure>
    <time_frame>12 months</time_frame>
    <description>Degree of polypharmacy, defined as the number of regular long-term medications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' quality of life</measure>
    <time_frame>12 months</time_frame>
    <description>Quality of life as measured by the visual analogue scale of the European Quality of Life-5 Dimensions instrument (EQ-5D)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' level of pain/discomfort</measure>
    <time_frame>12 months</time_frame>
    <description>Item form EQ-5D questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' basic activities of daily living</measure>
    <time_frame>12 months</time_frame>
    <description>Measured by questionnaire Barthel Index Basic Activities of Daily Living (ADL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' drug compliance</measure>
    <time_frame>12 months</time_frame>
    <description>Measured by the Morisky Medication Adherence Questionnaire (MMAS-8)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically significant drug-drug interactions</measure>
    <time_frame>2 months</time_frame>
    <description>Assessed based on using STRIPA including the list of diagnosis form the Index Hospitalisation and the updated medication list at follow-up. Assessment will be done at the end of the trial, when all data was collected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of drug overuse</measure>
    <time_frame>2 months</time_frame>
    <description>Assessed based on using STRIPA including the list of diagnosis form the Index Hospitalisation and the updated medication list at follow-up. Assessment will be done at the end of the trial, when all data was collected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of drug underuse</measure>
    <time_frame>2 months</time_frame>
    <description>Assessed based on using STRIPA including the list of diagnosis form the Index Hospitalisation and the updated medication list at follow-up. Assessment will be done at the end of the trial, when all data was collected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of potentially inappropriate medications</measure>
    <time_frame>2 months</time_frame>
    <description>Assessed based on using STRIPA including the list of diagnosis form the Index Hospitalisation and the updated medication list at follow-up. Assessment will be done at the end of the trial, when all data was collected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a serious adverse event</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2009</enrollment>
  <condition>3 or More Chronic Conditions for 6 Months or Longer</condition>
  <condition>5 or More Regular Drugs</condition>
  <arm_group>
    <arm_group_label>STRIP intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will take place during the initial hospital admission (Index Hospitalisation) or an equivalent situation for outpatients. STRIP is a structured method to perform pharmacotherapy optimisation. The STRIP-intervention consists of 9 steps.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants in the control group will receive medication review by the prescribing physicians in accordance with usual care. If an extended drug review is in place in a ward/specialty corresponding characteristics are collected on cluster level.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>STRIP intervention</intervention_name>
    <description>The STRIP intervention consists of 9 steps:&#xD;
structured history taking of medication&#xD;
recording medication and diagnoses in STRIPA&#xD;
structured drug review based on the STRIPA with the integrated Screening Tool of Older Person's Prescriptions (STOPP)/ Screening Tool to Alert Doctors to the Right Treatment (START) criteria&#xD;
communication and discussion of the structured drug review with prescribing physician with possible adaptation of the recommendation&#xD;
shared decision-making with the patient with possible adaptation of the recommendation&#xD;
optional revision based on new accumulating data during hospitalisation (e.g. new diagnoses, adverse drug reactions)&#xD;
generation of general practioner (GP) report&#xD;
delivery of the report to the patient and to the GP (optional additional direct communication)&#xD;
follow-up</description>
    <arm_group_label>STRIP intervention</arm_group_label>
    <other_name>Systematic drug review</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Standard care in the department where the trial is conducted. To keep the patients and the blinded team members blinded one questionnaire will be conducted by the intervention team in both arms. This is considered a SHAM intervention.</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Standard care</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  People 70 years of age or older&#xD;
&#xD;
          -  Multimorbidity: 3 or more coexistent chronic conditions defined by 3 distinct&#xD;
             International Classification of Diseases (ICD-10) codes with an estimated duration of&#xD;
             6 months or more or based on a clinical decision&#xD;
&#xD;
          -  Polypharmacy i.e. five or more different regular drugs (defined as authorised&#xD;
             medications with registration numbers) for more than 30 days.&#xD;
&#xD;
          -  In inpatient: Estimated minimal length of stay within the cluster is sufficient to&#xD;
             apply the intervention&#xD;
&#xD;
          -  If outpatient: prescribing physician has GP function and has a planned appointment to&#xD;
             conduct intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent or to obtain informed consent from a proxy for&#xD;
             patients with cognitive impairment&#xD;
&#xD;
          -  Direct admission to palliative care (&lt; 24h after admission)&#xD;
&#xD;
          -  Has passed or will pass a systematic structured drug review during this&#xD;
             hospitalisation or within the last two months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicolas Rodondi, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of Ambulatory Care Department of General Internal Medicine Inselspital, Bern University Hospital, University of Bern, Switzerland; and Institute of Primary Health Care (BIHAM), University of Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cliniques universitaires Saint-Luc</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept. of Medicine (Geriatrics), University College Cork</name>
      <address>
        <city>Cork</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3508</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Bern and University Hospital Bern (Inselspital)</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Ireland</country>
    <country>Netherlands</country>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Leendertse AJ, Egberts AC, Stoker LJ, van den Bemt PM; HARM Study Group. Frequency of and risk factors for preventable medication-related hospital admissions in the Netherlands. Arch Intern Med. 2008 Sep 22;168(17):1890-6. doi: 10.1001/archinternmed.2008.3.</citation>
    <PMID>18809816</PMID>
  </reference>
  <reference>
    <citation>Gillespie U, Alassaad A, Henrohn D, Garmo H, Hammarlund-Udenaes M, Toss H, Kettis-Lindblad A, Melhus H, Morlin C. A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. Arch Intern Med. 2009 May 11;169(9):894-900. doi: 10.1001/archinternmed.2009.71.</citation>
    <PMID>19433702</PMID>
  </reference>
  <reference>
    <citation>Howard RL, Avery AJ, Slavenburg S, Royal S, Pipe G, Lucassen P, Pirmohamed M. Which drugs cause preventable admissions to hospital? A systematic review. Br J Clin Pharmacol. 2007 Feb;63(2):136-47. doi: 10.1111/j.1365-2125.2006.02698.x. Epub 2006 Jun 26.</citation>
    <PMID>16803468</PMID>
  </reference>
  <reference>
    <citation>Laws MB. Adverse drug reactions as cause of admission to hospital: definition of adverse drug reactions needs to include overdose. BMJ. 2004 Aug 21;329(7463):459-60; author reply 460. doi: 10.1136/bmj.329.7463.459-b. No abstract available.</citation>
    <PMID>15321917</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>October 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>August 24, 2020</last_update_submitted>
  <last_update_submitted_qc>August 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug Utilization Review</keyword>
  <keyword>Older people</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be deposited in the Bern Open Repository and Information System (BORIS) (www.boris.unibe.ch). BORIS allows searching and is indexed by search engines. All items are stored with a unique Digital Object Identifier (DOI) that can be referenced in respective publication.&#xD;
The whole study database in csv format, and will include README files, metadata, information about the performed processing and analytical steps, variable definitions, and references to vocabularies used to help secondary users to understand and reuse the data.&#xD;
Data will only be shared upon request. Data use proposals will be evaluated by the OPERAM publication committee.&#xD;
The data is owned by the sponsor-investigators. In case of data sharing, a data sharing agreement between the external party and the sponsor-investigator will need to be agreed on and signed.</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/NCT02986425
org study id: U1111-1181-9400
nct id: NCT02986425
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The objective of this Randomised Controlled Trial (RCT) is to evaluate whether the Systematic
      Tool to Reduce Inappropriate Prescribing (STRIP) including STRIP assistant (STRIPA)
      implemented by an appropriately qualified team will lead to an improvement in clinical and
      economic outcomes among patients aged 70 years and more with multimorbidity and polypharmacy.
Background:

      Drug-related morbidity and mortality is an increasing problem in European healthcare systems.
      Multimorbidity, polypharmacy and old age are important risk factors for drug-related hospital
      admissions (DRA). The reported incidence of DRAs in the elderly may be as high as 30% of all
      acute cases, and about half of DRAs are likely to be preventable. They are mainly related to
      prescribing problems and non-compliance with drug regimens. A significant proportion of
      healthcare costs are spent on unnecessary interventions and inappropriate medications. The
      Systematic Tool to Reduce Inappropriate Prescribing (STRIP) is a structured method to perform
      a medication review to optimise pharmacotherapy.

      Design:

      European multi-centre, cluster randomised, controlled trial of people aged 70 years or older,
      with multimorbidity and polypharmacy, being on an ambulatory visit or on a hospital stay in
      one of the four participating centres in Ireland, Belgium, Switzerland and the Netherlands. A
      cluster is defined around a treating physician, i.e. the treating physician is randomised and
      defines the allocation of his patients. Clusters of patients will be randomised to the
      intervention arm receiving STRIP for optimising therapy or to the control arm undergoing
      usual clinical care. The patients of physicians who are allocated to the intervention group
      will undergo a systematic drug review and pharmacotherapy optimisation by a physician and a
      pharmacist using STRIP, including the STRIPA software. That provides the research team with a
      recommendation of changes in the patient's medication. Based on STRIPA recommendation and
      agreement on changes to the patients' pharmacotherapy between the team of the research
      physician and pharmacist and the prescribing physician, will the patient receive structured
      counselling about his/her medication; general practitioners will receive a report. Patients
      will be further followed for 1 year with follow-up phone calls after 2, 6 and 12 months. For
      the purpose of this trial, all hospitalisations during follow-up of participants will be
      adjudicated to assess their relationship to adverse drug events.

      Objectives:

      The primary objective is to assess the effect of a structured medication review and
      pharmacotherapy optimisation using the STRIP on drug-related hospitalisations (DRA) caused by
      over-, mis-, and underuse or over-, mis-, and underprescribing of medications.

      Secondary objectives will be to assess the impact of pharmacotherapy optimisation on falls,
      quality of life, polypharmacy, medication changes, activities of daily living, and mortality.

      Statistical considerations:

      80 clusters with a cluster size ranging from 12 to 38 participants will be included.
      Therefore, 2000 patients, 1000 patients in each arm, will be recruited over 18 months. The
      trial will have 80% power with this sample size.

      The primary analysis will be an intention-to-treat (ITT) analysis, whereby all randomised
      patients will be included in the group they were allocated to.

      The primary outcome of drug-related admission will be analysed using a random-effects
      competing risk proportional hazards model that accounts for the competing risk of death and
      for clustering of data within centre and prescribing physician.

      Overall survival will be analysed using a random-effects Cox proportional hazards model that
      accounts for clustering of data within centre and prescribing physician. The analysis of
      falls will also take into account the competing risk of death. Continuous outcomes will be
      analysed by random-effects linear regression. All effect measures will be accompanied by 95%
      confidence intervals and all p-values will be two-sided.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Patients with confirmed DRA after discharge from the index hospitalisation
time frame: 12 months
description: The primary outcome is defined as the first confirmed DRA after discharge from the index hospitalisation within a period of 12 months.
Confirmation of a drug-related hospital admission will be assessed by an independent and blinded adjudication committee (per site). Prolongation of the index hospitalisation and prolongation of any following hospitalisations will not be adjudicated for drug-relatedness. Adjudication is done according to specific guidelines.
measure: Number of survivors
time frame: 12 months
description: Including causes of death
measure: Number of cancer deaths
time frame: 12 months
description: As subgroup of all deaths this is considered a negative control outcome.
measure: Number of patients with hospitalisations
time frame: 12 months
description: Detected during the follow-up phone calls
measure: Number of patients with falls
time frame: 12 months
description: Detected during the follow-up phone calls
measure: Patients' degree of poly-pharmacy
time frame: 12 months
description: Degree of polypharmacy, defined as the number of regular long-term medications
measure: Patients' quality of life
time frame: 12 months
description: Quality of life as measured by the visual analogue scale of the European Quality of Life-5 Dimensions instrument (EQ-5D)
measure: Patients' level of pain/discomfort
time frame: 12 months
description: Item form EQ-5D questionnaire
measure: Patients' basic activities of daily living
time frame: 12 months
description: Measured by questionnaire Barthel Index Basic Activities of Daily Living (ADL)
measure: Patients' drug compliance
time frame: 12 months
description: Measured by the Morisky Medication Adherence Questionnaire (MMAS-8)
measure: Number of clinically significant drug-drug interactions
time frame: 2 months
description: Assessed based on using STRIPA including the list of diagnosis form the Index Hospitalisation and the updated medication list at follow-up. Assessment will be done at the end of the trial, when all data was collected
measure: Number of drug overuse
time frame: 2 months
description: Assessed based on using STRIPA including the list of diagnosis form the Index Hospitalisation and the updated medication list at follow-up. Assessment will be done at the end of the trial, when all data was collected
measure: Number of drug underuse
time frame: 2 months
description: Assessed based on using STRIPA including the list of diagnosis form the Index Hospitalisation and the updated medication list at follow-up. Assessment will be done at the end of the trial, when all data was collected
measure: Number of potentially inappropriate medications
time frame: 2 months
description: Assessed based on using STRIPA including the list of diagnosis form the Index Hospitalisation and the updated medication list at follow-up. Assessment will be done at the end of the trial, when all data was collected
measure: Number of patients with a serious adverse event
time frame: 12 months
arm group label: STRIP intervention
arm group type: Experimental
description: The intervention will take place during the initial hospital admission (Index Hospitalisation) or an equivalent situation for outpatients. STRIP is a structured method to perform pharmacotherapy optimisation. The STRIP-intervention consists of 9 steps.
arm group label: Control
arm group type: Sham Comparator
description: Participants in the control group will receive medication review by the prescribing physicians in accordance with usual care. If an extended drug review is in place in a ward/specialty corresponding characteristics are collected on cluster level.
intervention type: Other
intervention name: STRIP intervention
description: The STRIP intervention consists of 9 steps:
structured history taking of medication
recording medication and diagnoses in STRIPA
structured drug review based on the STRIPA with the integrated Screening Tool of Older Person's Prescriptions (STOPP)/ Screening Tool to Alert Doctors to the Right Treatment (START) criteria
communication and discussion of the structured drug review with prescribing physician with possible adaptation of the recommendation
shared decision-making with the patient with possible adaptation of the recommendation
optional revision based on new accumulating data during hospitalisation (e.g. new diagnoses, adverse drug reactions)
generation of general practioner (GP) report
delivery of the report to the patient and to the GP (optional additional direct communication)
follow-up
arm group label: STRIP intervention
other name: Systematic drug review
intervention type: Other
intervention name: Control
description: Standard care in the department where the trial is conducted. To keep the patients and the blinded team members blinded one questionnaire will be conducted by the intervention team in both arms. This is considered a SHAM intervention.
arm group label: Control
other name: Standard care
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Nicolas Rodondi, Prof.
role: Principal Investigator
affiliation: Head of Ambulatory Care Department of General Internal Medicine Inselspital, Bern University Hospital, University of Bern, Switzerland; and Institute of Primary Health Care (BIHAM), University of Bern
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Ireland
country: Netherlands
country: Switzerland
citation: Leendertse AJ, Egberts AC, Stoker LJ, van den Bemt PM; HARM Study Group. Frequency of and risk factors for preventable medication-related hospital admissions in the Netherlands. Arch Intern Med. 2008 Sep 22;168(17):1890-6. doi: 10.1001/archinternmed.2008.3.
PMID: 18809816
citation: Gillespie U, Alassaad A, Henrohn D, Garmo H, Hammarlund-Udenaes M, Toss H, Kettis-Lindblad A, Melhus H, Morlin C. A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. Arch Intern Med. 2009 May 11;169(9):894-900. doi: 10.1001/archinternmed.2009.71.
PMID: 19433702
citation: Howard RL, Avery AJ, Slavenburg S, Royal S, Pipe G, Lucassen P, Pirmohamed M. Which drugs cause preventable admissions to hospital? A systematic review. Br J Clin Pharmacol. 2007 Feb;63(2):136-47. doi: 10.1111/j.1365-2125.2006.02698.x. Epub 2006 Jun 26.
PMID: 16803468
citation: Laws MB. Adverse drug reactions as cause of admission to hospital: definition of adverse drug reactions needs to include overdose. BMJ. 2004 Aug 21;329(7463):459-60; author reply 460. doi: 10.1136/bmj.329.7463.459-b. No abstract available.
PMID: 15321917
responsible party type: Sponsor
mesh term: Chronic Disease
sharing ipd: No
ipd description: Data will be deposited in the Bern Open Repository and Information System (BORIS) (www.boris.unibe.ch). BORIS allows searching and is indexed by search engines. All items are stored with a unique Digital Object Identifier (DOI) that can be referenced in respective publication.
The whole study database in csv format, and will include README files, metadata, information about the performed processing and analytical steps, variable definitions, and references to vocabularies used to help secondary users to understand and reuse the data.
Data will only be shared upon request. Data use proposals will be evaluated by the OPERAM publication committee.
The data is owned by the sponsor-investigators. In case of data sharing, a data sharing agreement between the external party and the sponsor-investigator will need to be agreed on and signed.