Pragmatic collaborative care for cardiac inpatients with depression or anxiety
Pragmatic collaborative care for cardiac inpatients with depression or anxiety
批准号:
9307092
负责人:
Jeff C Huffman
金额:
$77.35万
依托单位国家:
美国
项目类别:
财政年份:
2017
资助国家:
美国
项目状态:
已结题
起止时间:
2017-07-01 至 2022-04-30
关键词:
Academic Medical CentersAddressAdherenceAdmission activityAdverse eventAffectAntidepressive AgentsAnxietyAnxiety DisordersBehaviorBehavior TherapyBehavioralBlood PressureCardiacCardiac healthCare given by nursesCaringCase ManagerCharacteristicsCholesterolClient satisfactionClinicalClinical NursingCommunity HospitalsComorbidityComprehensive Health CareConsultCost AnalysisCustomDataData CollectionDeath RateDepressed moodDiabetes MellitusDiagnosisDietDiseaseEffectivenessElectronic Health RecordEnrollmentEventExclusion CriteriaFeedsGeneralized Anxiety DisorderGoalsHealth BenefitHealth Care CostsHealth behaviorHealthcare SystemsHeart DiseasesHeart failureHospitalsInpatientsInternetInterventionIntervention TrialLeadLinkMeasuresMedicalMental DepressionMental HealthMental disordersModelingMonitorMoodsNursesOutcomeOutcome AssessmentOutcome MeasureOutcome StudyOutpatientsPanic DisorderParticipantPatient CarePatient Outcomes AssessmentsPatient riskPatient-Focused OutcomesPatientsPharmaceutical PreparationsPhonationPhysical FunctionPhysical activityPopulationProviderPsychiatristPsychotherapyPublic HealthQuality of lifeQuality-Adjusted Life YearsRecommendationResearchResearch InfrastructureResourcesSiteSmokingSpecialistSystemTelephoneTrainingWeightWorkacute coronary syndromeadverse outcomeanxiousclinical carecohortcollaborative carecostcost effectivecost effectivenesseffective interventionefficacy trialfeedingflexibilityhealth related quality of lifehigh riskhigh risk populationimprovedinclusion criteriainnovationmedication compliancemortalitymotivational enhancement therapynovelnovel strategiesonline resourceoutcome forecastpatient home carepragmatic trialprimary outcomeprogramspsychiatric symptomrandomized trialtreatment as usualtreatment trial
中文摘要
在因急性冠状动脉综合征(ACS)或心力衰竭(HF)住院的患者中,抑郁
焦虑症是常见的,与功能低下、再入院和
死亡率。对这些疾病的单一干预(例如,抗抑郁药)并没有改善医疗结果,
而典型的临床方法(如专家转诊)得不到很好的照顾。新颖、可行、有效
迫切需要干预措施来改善这一高危人群的临床结果。
协作式护理计划使用非医生护理经理和咨询精神病学家来管理
内科疾病患者的精神状况。这些程序的标准版本可以改善智力
健康,但并未持续改善心脏结果。针对这两种目标的新的“混合”护理模式
精神疾病和心脏疾病对医疗结果产生了可喜的影响。然而,这样的节目
通常在患有稳定型心脏病的门诊患者中管理抑郁症,而不是针对更广泛和
高危人群。此外,以前的混合护理模式只包括有限的健康行为
尽管这些行为对心脏预后有重要影响,但这些行为在干预措施中仍具有重要作用。
为了解决这些局限性,我们建议对增强型混合药物进行务实的随机试验
协作性护理计划。这项试验将招募260名住进学术或社区医院的患者
患有抑郁症或焦虑症的急性冠脉综合征或心力衰竭。为期26周的干预将使用护士护理
经理在医院接洽参与者,并在出院后通过电话与他们协调。护士
将提供心理治疗,特别是通过激励性访谈促进健康行为的遵守,
并协助医疗自我监测(例如体重、血压)。护士还会把药物
研究小组精神病学家和心脏病学家向患者的医疗提供者提出的建议,谁将
开出所有治疗的处方。因此,患者将得到与其现有医疗护理相结合的专家指导。
该试验的创新包括:(1)从入院开始的医院到家庭护理管理
并持续到出院后的高危时期,(2)纳入患有多发性精神疾病或
心脏疾病,(3)灵活的三管齐下(精神、行为、心脏)方法,具有更强大的
健康行为干预比之前的任何协作护理计划都要好,以及(4)通过iPad收集数据-
完全集成到临床记录中的互联网系统,允许在患者护理决策中使用这些数据。
该计划将与增强型常规护理进行比较。试验的主要结果衡量标准将是
26周时的身体功能,因为低功能独立地预测新的心脏事件。我们的小说
针对导致急性冠脉综合征/心力衰竭患者功能低下的多个因素的方法应该对此有很大的影响
主要结果。我们还将检查在其他关键患者报告的结果和成本上的组差异
我们将在整个研究期间评估干预对主要心脏事件的影响。
英文摘要
Among patients hospitalized for an acute coronary syndrome (ACS) or heart failure (HF), depression
and anxiety disorders are common and independently associated with poor function, readmissions, and
mortality. Single interventions (e.g., antidepressants) for these disorders have not improved medical outcomes,
and typical clinical approaches (such as specialist referral) are poorly attended. Novel, feasible, and effective
interventions are badly needed to improve clinical outcomes in this high-risk population.
Collaborative care programs use a non-physician care manager and consulting psychiatrists to manage
psychiatric conditions in patients with medical illness. Standard versions of these programs improve mental
health but have not consistently improved cardiac outcomes. New ‘blended’ care models targeting both
psychiatric and cardiac conditions have had promising effects on medical outcomes. However, such programs
have typically managed depression in outpatients with stable cardiac illness, rather than targeting broader and
higher-risk cohorts. Furthermore, prior blended care models have only included limited health behavior
components in their interventions, despite the vital effects of such behaviors on cardiac prognosis.
To address these limitations, we propose a pragmatic randomized trial of an enhanced blended
collaborative care program. The trial will enroll 260 patients admitted to an academic or community hospital for
ACS or HF who have depression or an anxiety disorder. The 26-week intervention will use a nurse care
manager to engage participants in the hospital and coordinate with them by phone post-discharge. The nurse
will provide psychotherapy, specifically promote health behavior adherence using motivational interviewing,
and assist with medical self-monitoring (e.g., weight, blood pressure). The nurse will also transmit medication
recommendations from study team psychiatrists and cardiologists to patients’ medical providers, who will
prescribe all treatments. Patients will thus receive expert guidance integrated into their existing medical care.
The trial’s innovations include: (1) hospital-to-home care management that begins during admission
and continues through the high-risk post-discharge period, (2) inclusion of patients with multiple psychiatric or
cardiac conditions, (3) a flexible three-pronged (psychiatric, behavioral, cardiac) approach with a more robust
health behavior intervention than in any prior collaborative care program, and (4) data collection via an iPad-
internet system that is fully integrated into the clinical record to allow use of this data in patient care decisions.
The program will be compared to enhanced usual care. The trial’s primary outcome measure will be
physical function at 26 weeks, given that low function independently predicts new cardiac events. Our novel
approach targeting multiple contributors to low function in ACS/HF patients should have strong effects on this
main outcome. We will also examine group differences on additional key patient-reported outcomes and cost
metrics, and we will assess the intervention’s impact on major cardiac events throughout the study period.
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会议论文
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海外基金