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An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations (WISDOM)

2016년 10월 5일 업데이트: Icahn School of Medicine at Mount Sinai

An Intervention to Improve ICD Deactivation Conversations (WISDOM - Working to Improve discuSsions About DefibrillatOr Management)

An Implantable Cardioverter-Defibrillator (ICD) is a device implanted in a patient's chest to monitor the heart rhythm and deliver shocks to terminate potentially lethal arrhythmias when necessary. While ICDs reduce sudden cardiac death, patients with ICDs eventually die of heart failure or other diseases. As patients near the end of life, physiologic changes (intrinsic and extrinsic to the heart) may affect the cardiac conduction system, leading to more arrhythmias and increasing the frequency of shocks. Because ICD shocks can cause pain and anxiety and may not prolong a life of acceptable quality, it is appropriate to consider deactivating the shocking function of ICDs as patients' clinical status worsens and death is near. This will be a randomized controlled trial of a physician centered counseling and education intervention to improve clinician-patient communication about the management of ICDs.

연구 개요

상세 설명

An Implantable Cardioverter-Defibrillator (ICD) is a device implanted in a patient's chest to monitor the heart rhythm and deliver shocks to terminate potentially lethal arrhythmias when necessary. While ICDs reduce sudden cardiac death, patients with these devices do eventually die, either of heart failure or other chronic diseases. As a patient's disease worsens, physiologic changes (intrinsic and extrinsic to the heart) may affect the cardiac conduction system, leading to more arrhythmias and increasing the frequency of shocks. Because ICD shocks can cause pain and anxiety and may not prolong a life of acceptable quality, it is appropriate to consider ICD deactivation as a patient's clinical status worsens and death is near. However, these conversations rarely occur. The investigators propose to conduct a randomized clinical trial of a physician-centered patient counseling and support intervention to improve communication between cardiologists and patients with ICDs. The goals of the study are to determine the effectiveness of the intervention to: 1) increase conversations about ICD deactivation, 2) increase the number of patients who have their devices deactivated, and 3) improve mental health outcomes for bereaved caregivers of deceased patients. The unit of randomization is the hospital, the intervention is aimed at cardiologists, and the unit of analysis is the patient. The investigators have created a network of six academic medical centers across the country. The intervention to be delivered consists of three parts. First, the PI will conduct a workshop on communication specific to ICD-deactivation with cardiologists at the intervention centers. Second, when enrolled patients are admitted to the hospital or seen in the outpatient setting, the cardiologist will receive two reminders (one via email, one in the patient chart) that the patient is appropriate for a conversation about ICD deactivation. Finally, cardiologists will receive aggregated feedback about the number of conversations they have conducted and data on patients' satisfaction with conversations every six months. Physicians at usual care hospitals receive a didactic lecture on advance care planning. All patients and surrogates will be interviewed at baseline and then assessed at regular intervals to determine the outcomes of: 1) the prevalence of conversations about ICD deactivation as reported by the patient/surrogate; and 2) the frequency with which patients have their devices deactivated. Caregivers will continue to be interviewed at regular intervals up to 6 months after the patient dies to determine the relationship of the intervention to caregiver mental health outcomes. Given the exponential increase in the number of patients with ICDs, this intervention has the potential to improve the quality of care for thousands of patients near the end of life and their families.

연구 유형

중재적

등록 (실제)

562

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Colorado
      • Denver, Colorado, 미국, 80045
        • University of Colorado - Denver
    • Connecticut
      • New Haven, Connecticut, 미국, 06510
        • Yale New-Haven Hospital
    • Minnesota
      • Rochester, Minnesota, 미국, 55905
        • Mayo Medical Center
    • New York
      • Bronx, New York, 미국, 10023
        • Montefiore Medical Center
      • New York, New York, 미국, 10029
        • Icahn School of Medicine at Mount Sinai
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • Hospital of the University of Pennsylvania

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

Clinicians:

  • At all sites, a core group of approximately 10 heart failure clinicians (physicians, nurses) care exclusively for patients with advanced heart failure in both inpatient and outpatient settings; all of these clinicians are eligible..

Patients:

  • Patient does not currently have a ventricular assist device
  • Age > 18
  • Fluent in English
  • Consistent and reliable access to a phone

For Inpatient:

  • Has had at least 1 other heart failure in the last year, OR
  • Meets all three of the following criteria at time of admission:

    1. BUN > 43
    2. SBP ≤ 115
    3. CR > 2.75 OR
  • Was on inotropes OR intravenous diuretics OR intravenous heart failure treatments in emergency department OR in outpatient setting prior to the current hospital admission

For Outpatient

  • Has had 2 or more heart failure related admissions in the last year OR
  • Has class IV heart failure in the outpatient setting OR
  • Has Class III heart failure in outpatient setting AND 1 heart failure related admission in the last year OR
  • Has Class III heart failure in outpatient setting AND 2 of the following 4 conditions:

    1. Age ≥ 70
    2. BUN ≥ 43
    3. Cr ≥ 2.75
    4. SBP≤115 OR
  • Is on inotropes (e.g., dobutamine, milrinone) OR intravenous diuretics OR intravenous heart failure treatments in emergency department OR in outpatient setting

Caregivers:

  • Age > 18
  • Fluent in English
  • Consistent and reliable access to a phone

Exclusion Criteria for patients:

  • Not having an ICD

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Communication training for cardiologists
The intervention consists of an educational workshop for heart failure physicians, a reminder system, and a system providing aggregated feedback on their conversations with patients about ICD deactivation.

Communication training: a 90 minute workshop to discuss ways to improve communication in patients with serious illness.

Reminders to Cardiologists. Cardiologists will receive reminders to prompt them to have conversations relating to ICD management with patients enrolled in the study.

Audit and feedback. Cardiologists will receive feedback on their rates of conversation as well as data on patient/family satisfaction with their communication skills.

위약 비교기: Control arm
Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.
Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Prevalence of Conversations about ICD Deactivation
기간: after 1st clinical encounter after enrollment for intervention group
Whether deactivation discussion occurred difference between 1st and 3rd clinical encounters after enrollment
after 1st clinical encounter after enrollment for intervention group
Prevalence of Conversations about ICD Deactivation
기간: 3rd clinical encounter after enrollment for intervention group
Whether deactivation discussion occurred difference between 1st and 3rd clinical encounters after enrollment
3rd clinical encounter after enrollment for intervention group
Prevalence of Conversations about ICD Deactivation
기간: 3 months after enrollment for control group
Whether deactivation discussion occurred difference between 3 and 9 months after enrollment
3 months after enrollment for control group
Prevalence of Conversations about ICD Deactivation
기간: 9 months after enrollment for control group
Whether deactivation discussion occurred difference between 3 and 9 months after enrollment
9 months after enrollment for control group

2차 결과 측정

결과 측정
측정값 설명
기간
Prevalence of ICD Deactivation
기간: After 1st encounter after enrollment for intervention group
Whether ICD deactivation occurred difference between 1st and 3rd clinical encounters after enrollment
After 1st encounter after enrollment for intervention group
Prevalence of ICD Deactivation
기간: After 3rd encounter after enrollment for intervention group
Whether ICD deactivation occurred difference between 1st and 3rd clinical encounters after enrollment
After 3rd encounter after enrollment for intervention group
Prevalence of ICD Deactivation
기간: After 3 months after enrollment for control group
Whether ICD deactivation occurred difference between 3 and 9 months after enrollment
After 3 months after enrollment for control group
Prevalence of ICD Deactivation
기간: After 6 months after enrollment for control group
Whether ICD deactivation occurred difference between 3 and 9 months after enrollment
After 6 months after enrollment for control group
Psychological Outcomes in Bereaved Caregivers
기간: 4 weeks after patient death
4 weeks after patient death
Psychological Outcomes in Bereaved Caregivers
기간: 6 months after patient death
6 months after patient death

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2011년 9월 1일

기본 완료 (실제)

2016년 9월 1일

연구 완료 (실제)

2016년 9월 1일

연구 등록 날짜

최초 제출

2011년 10월 13일

QC 기준을 충족하는 최초 제출

2011년 10월 24일

처음 게시됨 (추정)

2011년 10월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 10월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 10월 5일

마지막으로 확인됨

2016년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GCO 09-0618
  • 1R01HL102084-01A1 (미국 NIH 보조금/계약)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

심부전에 대한 임상 시험

Communication training for cardiologists.에 대한 임상 시험

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