{
  "FullStudy":{
    "Rank":218059,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513265",
          "OrgStudyIdInfo":{
            "OrgStudyId":"S-53664"
          },
          "Organization":{
            "OrgFullName":"Universitaire Ziekenhuizen Leuven",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Rationalisation of Polypharmacy in the Elderly by the RASP Instrument",
          "OfficialTitle":"Rationalisation of Polypharmacy in the Elderly by the RASP Instrument (Rationalisation of Home Medication by an Adjusted STOPP-list in Older Patients): a Prospective, Clinical Trial.",
          "Acronym":"RASP"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2011",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"October 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 27, 2011",
          "StudyFirstSubmitQCDate":"January 16, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"May 21, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"May 22, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Universitaire Ziekenhuizen Leuven",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The aim of this study is to determine whether a clinical pharmacist using the RASP list (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions) can optimise the drug use in elderly inpatients.",
          "DetailedDescription":"Older persons take on average multiple drugs. As people age, there is an apparent increase in pharmacodynamic sensitivity to different making the patient more prone to experience side effects. Alterations in body composition and concomitant changes in pharmacokinetic parameters can also result in a higher risk for adverse drug events. All these factors make the older person, notwithstanding the heterogeneity of this population, more vulnerable for the negative consequences of polypharmacy.\n\nPolypharmacy is a cause of negative clinical outcomes but it still remains unclear which intervention or set of interventions should be used to optimize the prescription of pharmacotherapy in the elderly patient. Therefore, the investigators developed the RASP (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions), a list as tool to reduce polypharmacy adapted to Belgian national prescribing tendencies within geriatric wards. Content and reliability of the RASP have been validated and the investigators aim to further study the impact of the systematic implementation of this RASP on geriatric wards in a prospective cluster randomized controlled trial."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "reduction polypharmacy",
              "clinical outcomes",
              "pharmaceutical care",
              "clinical pharmacy",
              "geriatrics",
              "medication review",
              "potentially inappropriate drugs"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Non-Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Health Services Research",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Care Provider"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"172",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"RASP",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Pharmaceutical care plan, mostly based on the RASP"
                  ]
                }
              },{
                "ArmGroupLabel":"Control group",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"Subjects enrolled in this arm will undergo usual medical and pharmaceutical care with registration of drug use at admission and discharge without interference of RASP or clinical pharmacist."
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Pharmaceutical care plan, mostly based on the RASP",
                "InterventionDescription":"Drug use of subjects enrolled in this arm will be systematically evaluated by a clinical pharmacist, using the RASP list. Potentially inappropriate drug use will be pointed out to the treating physician. The pharmaceutical advice is not limited to the RASP list. Any actual change in drug prescription will be decided by the treating physician based upon comprehensive medical evaluations in each individual patient.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "RASP"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Number of actually stopped or adjusted drugs",
                "PrimaryOutcomeDescription":"At hospital discharge the number of stopped or adjusted drugs will be determined. This variable will be compared between the two arms.",
                "PrimaryOutcomeTimeFrame":"Patients will be followed for the duration of hospital stay, an expected average of 14 days."
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Number of potentially inappropriate drug prescriptions as defined by the RASP.",
                "SecondaryOutcomeTimeFrame":"Patients will be followed for the duration of hospital stay, an expected average of 14 days."
              },{
                "SecondaryOutcomeMeasure":"Actual drug use",
                "SecondaryOutcomeTimeFrame":"Measured on 30 and 90 days post-discharge."
              },{
                "SecondaryOutcomeMeasure":"Number and category of drugs adjusted on recommendations of the clinical pharmacist independent of RASP",
                "SecondaryOutcomeTimeFrame":"Patients will be followed for the duration of hospital stay, an expected average of 14 days."
              },{
                "SecondaryOutcomeMeasure":"Mortality",
                "SecondaryOutcomeTimeFrame":"Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge."
              },{
                "SecondaryOutcomeMeasure":"Number of falls",
                "SecondaryOutcomeTimeFrame":"Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge"
              },{
                "SecondaryOutcomeMeasure":"Quality of Life (EQ-5D-3L)",
                "SecondaryOutcomeTimeFrame":"Patients will be followed for the duration of hospital stay, an expected average of 14 days."
              },{
                "SecondaryOutcomeMeasure":"Length of stay",
                "SecondaryOutcomeTimeFrame":"Determined at discharge, on average after 14 days"
              },{
                "SecondaryOutcomeMeasure":"Rehospitalisation",
                "SecondaryOutcomeTimeFrame":"Within 90 days post-discharge."
              },{
                "SecondaryOutcomeMeasure":"Incidence of delirium",
                "SecondaryOutcomeTimeFrame":"Patients will be followed for the duration of hospital stay, an expected average of 14 days"
              },{
                "SecondaryOutcomeMeasure":"Number of falls post-discharge",
                "SecondaryOutcomeTimeFrame":"Within 90 days post-discharge"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nSigned informed consent by the patient or a caregiver if the patient is incompetent to sign\nConsecutive inclusion of all newly admitted patients to the wards coming from home or the emergency room department\n\nExclusion Criteria:\n\nPatients not admitted to the hospital from home or a nursing home\nPatients unable to communicate in Dutch\nPatients admitted for palliative care\nPatients who do not take any drugs at admission",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Lorenz Van der Linden, PharmD",
                "OverallOfficialAffiliation":"Universitaire Ziekenhuizen Leuven",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Universitaire Ziekenhuizen Leuven",
                "LocationCity":"Leuven",
                "LocationState":"Vlaams-Brabant",
                "LocationZip":"3000",
                "LocationCountry":"Belgium"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"27915457",
                "ReferenceType":"derived",
                "ReferenceCitation":"Van der Linden L, Decoutere L, Walgraeve K, Milisen K, Flamaing J, Spriet I, Tournoy J. Combined Use of the Rationalization of Home Medication by an Adjusted STOPP in Older Patients (RASP) List and a Pharmacist-Led Medication Review in Very Old Inpatients: Impact on Quality of Prescribing and Clinical Outcome. Drugs Aging. 2017 Feb;34(2):123-133. doi: 10.1007/s40266-016-0424-8."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}