{
  "FullStudy":{
    "Rank":217585,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519479",
          "OrgStudyIdInfo":{
            "OrgStudyId":"3601-2"
          },
          "Organization":{
            "OrgFullName":"Allina Health System",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Palliative Care for Heart Failure Patients",
          "OfficialTitle":"An Examination of Palliative Care as Standard Practice for Heart Failure Patients"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2019",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"April 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 19, 2012",
          "StudyFirstSubmitQCDate":"January 26, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 27, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 15, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 18, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Allina Health System",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to assess the impact of palliative care consultation on quality of life and symptom management for patients hospitalized with acute heart failure with a randomized control trial at Abbott Northwestern Hospital.",
          "DetailedDescription":"Research questions:\n\nQ1. Does the provision of palliative care to heart failure patients yield higher quality of life, increased symptom management, or reduced depression compared to heart failure patients not receiving palliative care?\n\nQ2. Does the provision of palliative care to heart failure patients result in differential use of medical services (lower hospital days and readmission) compared to heart failure patients not receiving systematic palliative care?"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Heart Failure"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Congestive Heart Failure",
              "Heart Failure",
              "Palliative Care",
              "Palliative Medicine"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Supportive Care",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"232",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Palliative Care Consultation",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Participant will get one palliative care consultation while in the hospital. The participants desire for subsequent palliative care visits will be determined and mutually agreed upon at the initial consultation.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Palliative Care Consultation"
                  ]
                }
              },{
                "ArmGroupLabel":"Control",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Usual care for HF patient which may include a palliative care consult if ordered by treating physician.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Control"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Palliative Care Consultation",
                "InterventionDescription":"Intervention patient would receive an inpatient palliative care consultation to focus on comprehensive symptom assessment, create goals of care/treatment plan which include recommendations and referrals.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Palliative Care Consultation"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "palliative care consults",
                    "palliative care medicine"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Control",
                "InterventionDescription":"The control group would receive usual care and could receive a palliative consult if ordered by the treating provider",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Control"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "palliative care consult",
                    "palliative care medicine"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Is there an impact on quality of life with the addition of palliative care intervention?",
                "PrimaryOutcomeDescription":"Assessment Tools:\n\n*Quality of Life-Minnesota Living with Heart Failure questionnaire (MLHF)",
                "PrimaryOutcomeTimeFrame":"Change from baseline in quality of life score at 3 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Differential use of medical services- 30 day readmission",
                "SecondaryOutcomeDescription":"*Number of readmissions in 30 days of discharge from initial enrollment hospitalization.",
                "SecondaryOutcomeTimeFrame":"30 Days"
              },{
                "SecondaryOutcomeMeasure":"Is there an impact on Symptom Severity with the addition of palliative care",
                "SecondaryOutcomeDescription":"Assessment tool:\n\n*Symptom Severity - Edmonton Symptom Assessment scale (ESAS)",
                "SecondaryOutcomeTimeFrame":"Change from baseline in symptom severity score at 3 months"
              },{
                "SecondaryOutcomeMeasure":"Is there an impact on depression with the addition of palliative care intervention?",
                "SecondaryOutcomeDescription":"Assessment Tool:\n\n*Depression- Patient Health Questionnaire (PHQ-9)",
                "SecondaryOutcomeTimeFrame":"Change from baseline in depression score at 3 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAbbott Northwestern Hospital inpatient adults with a diagnosis of acute heart failure\n\nExclusion Criteria:\n\nAre not an inpatient at Abbott Northwestern Hospital\nAre in the ICU\nOn a ventilator\nAre pre-or post heart transplant\nHave a ventricular assist device (VAD)\nDetermined to be actively dying\nHave cognitive impairments such that informed consent would not be possible,\nAre not proficient in the English language",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Justin Kirven, MD",
                "OverallOfficialAffiliation":"Allina Health System",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Abbott Northwestern Hospital",
                "LocationCity":"Minneapolis",
                "LocationState":"Minnesota",
                "LocationZip":"55407",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"19690306",
                "ReferenceType":"background",
                "ReferenceCitation":"Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198."
              },{
                "ReferencePMID":"20818875",
                "ReferenceType":"background",
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              },{
                "ReferencePMID":"12420047",
                "ReferenceType":"background",
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              },{
                "ReferencePMID":"21383364",
                "ReferenceType":"background",
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              },{
                "ReferencePMID":"17081306",
                "ReferenceType":"background",
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              },{
                "ReferencePMID":"11773934",
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              },{
                "ReferencePMID":"9338529",
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              },{
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              },{
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              },{
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              },{
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              },{
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              },{
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              },{
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              },{
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              },{
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              },{
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              },{
                "ReferencePMID":"25479182",
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              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006333",
                "ConditionMeshTerm":"Heart Failure"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000006331",
                "ConditionAncestorTerm":"Heart Diseases"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8004",
                "ConditionBrowseLeafName":"Heart Failure",
                "ConditionBrowseLeafAsFound":"Heart Failure",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8002",
                "ConditionBrowseLeafName":"Heart Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}