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PCORI-1310-06998 Trial of a Decision Support Intervention for Patients and Caregivers Offered Destination Therapy Heart Assist Device (DECIDE-LVAD)

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ClinicalTrials.gov Identifier: NCT02344576
Recruitment Status : Active, not recruiting
First Posted : January 26, 2015
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

The left ventricular assist device (LVAD) is growing rapidly among people dying from end-stage heart failure who are unable to get a heart transplant. These patients elect to live out the remainder of their lives dependent on a partial artificial heart—so-called destination therapy (DT). Although patients may live longer with a DT LVAD, it poses many risks, including stroke, serious infection, and bleeding. Most of these patients have other medical problems that are not fixed by the DT LVAD. Patients must be connected to electricity at all times. A caregiver is required, which often places stress on loved ones. Therefore, the decision whether or not to get a DT LVAD is often an extremely difficult one. Unfortunately, our research shows problems with the way this medical decision is currently being made in hospitals across the United States. Hospitals that offer DT LVAD treatment do not follow a standard process. The forms, pamphlets, websites, and videos used to help patients and families are biased and too difficult for most people to understand. Lastly, this is an emotional and even scary decision for most patients and their families, but the process does not help them deal with these feelings.

Using feedback from patients, caregivers, clinicians, the study team made a paper and video decision aid to help people who are offered DT LVAD make this most difficult of decisions. Unlike the information that is now available, our decision aid focuses on options, fears, and the needs of caregivers, is balanced, and is paired with training for doctors and nurses on how to best talk about DT LVAD. The investigators now propose to test the effectiveness and implementation of this intervention. The investigators will apply the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) evaluative framework to a stepped-wedge, cluster-randomized, controlled trial across 6 medical centers.

Aim 1. Evaluate the Reach and Effectiveness of the DT LVAD shared decision support intervention to improve patient and caregiver experiences.

Hypothesis 1a: The intervention will reach 90% of eligible patients. Hypothesis 1b: Post-implementation, patients and caregivers will have improved decision quality (greater knowledge and higher value-treatment concordance).

Aim 2. Assess the Adoption, Implementation, and Maintenance of the DT LVAD shared decision support intervention across multiple providers and settings.

Hypothesis 2: The intervention will be: adopted by key personnel; implemented consistently; and maintained after trial completion.


Condition or disease Intervention/treatment Phase
Heart Failure Heart-assist Devices Behavioral: DT LVAD Decision Support Intervention Not Applicable

Detailed Description:
The investigators plan to test the effectiveness and implementation of a shared decision support intervention for DT LVAD. Six DT LVAD programs from across the U.S. will participate in a stepped-wedge randomized study design. In this design, each site participates in both the control and intervention phase with the timing of the transition randomly assigned. Sites all begin in the control phase, where usual care consists of the current education, decision making, and informed consent process. When sites reach their randomly assigned time to transition to the intervention, their coordinators and key staff will participate in communication training and decision coaching. The pamphlet and video decision aid will be formally integrated into the existing education, decision making, and informed consent process. In both pre- and post-phases, the investigators will enroll patients and caregivers and survey them prior to their DT LVAD decision (baseline) and then at 1 month and 6 months after to determine the interventions effect on decision quality and a host of secondary outcomes. These patient- and caregiver-centered outcomes will be compared within each hospital before and after implementation to determine the effectiveness of the intervention. The investigators will also survey clinicians before, during, and after implementation of the shared decision support intervention. The implementation will be guided using the well-known RE-AIM evaluative framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). Formal study of the implementation will promote widespread dissemination of this DT LVAD shared decision support.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 445 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for End-Stage Heart Failure
Study Start Date : May 2015
Actual Primary Completion Date : August 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control: Usual Care
Patients and caregivers will receive the current usual education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials.
Experimental: DT LVAD Decision Support Intervention
In the intervention phase of the study, patients and caregivers will receive the new decision support intervention, which consists primarily of decision aid materials about DT LVAD. The standard consent process will also still take place, but will be supplemented with additional decision support.
Behavioral: DT LVAD Decision Support Intervention
Decision coaching and training of staff prior to intervention, to allow for additional decision support to patients and caregivers considering DT LVAD. Decision aid materials will be used with patients and caregivers.




Primary Outcome Measures :
  1. Reach of Intervention (proportion of the target population who participate in the intervention) [ Time Frame: 2 years ]
    Reach is defined as the proportion of the target population who participate in the intervention. We will assess the percentage of patients and caregivers that both receive and remember reviewing the pamphlet and video decision aids.

  2. Effectiveness of Intervention (Decision quality measures consist of 2 domains: knowledge and values. Knowledge: DT LVAD knowledge -Values: Concordance between patients' and caregivers' values and the treatment they choose according) [ Time Frame: Baseline, 1 month, and 6 months of participant enrollment ]

    Effectiveness is assessed based on if the decision support intervention led to a quality decision. Decision quality is defined as "the extent to which the implemented decision reflects the considered preferences of a well-informed patient." By this definition, a decision is "a quality decision" if the treatment chosen is concordant with a knowledgeable patient's values. Decision quality measures consist of 2 domains: knowledge and values.

    • Knowledge: DT LVAD knowledge
    • Values: Concordance between patients' and caregivers' values and the treatment they choose according

  3. Adoption of Intervention (absolute number, proportion, and representativeness of settings and intervention agents (people who deliver the program) who are willing to initiate a program) [ Time Frame: 2 years ]
    The absolute number, proportion, and representativeness of settings and intervention agents (people who deliver the program) who are willing to initiate a program.

  4. Implementation of Intervention (extent to which the intervention is implemented as intended. Consistency of decision aid delivery will be assessed across hospitals, providers, patient subgroups, and time) [ Time Frame: 2 years ]
    The extent to which the intervention is implemented as intended. Consistency of decision aid delivery will be assessed across hospitals, providers, patient subgroups, and time.

  5. Maintenance of Intervention (whether sites decide at the conclusion of the study to maintain, modify, or discontinue the DT LVAD decision support intervention) [ Time Frame: 6 months ]
    Assessing whether sites decide at the conclusion of the study to maintain, modify, or discontinue the DT LVAD decision support intervention.


Secondary Outcome Measures :
  1. Changes in Decision Conflict (Decision Conflict Scale) [ Time Frame: Baseline, 1 month, and 6 months of participant enrollment ]
    Decision Conflict Scale

  2. Changes in Decision Regret (Decision Regret Scale) [ Time Frame: 1 month and 6 months of participant enrollment ]
    Decision Regret Scale

  3. Changes in Stress, Anxiety and Depression (Perceived Stress Scale; Hospital Anxiety and Depression Scale) [ Time Frame: Baseline, 1 month, and 6 months of participant enrollment ]
    Perceived Stress Scale; Hospital Anxiety and Depression Scale

  4. Changes in Quality of life (EuroQol EQ5D (patients only) [ Time Frame: Baseline, 1 month, and 6 months of participant enrollment ]
    EuroQol EQ5D (patients only)

  5. Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale (caregivers only) [ Time Frame: Baseline, 1 month, and 6 months of participant enrollment ]
    Preparedness for Caregiving Scale (caregivers only)

  6. Changes in Bereaved Caregiver Satisfaction with End-of-Life Care (Canadian Health Care Evaluation Project - Bereavement Questionnaire (bereaved caregivers only) [ Time Frame: 1 month and 6 months of participant enrollment ]
    Canadian Health Care Evaluation Project - Bereavement Questionnaire (bereaved caregivers only)

  7. Changes in Preferences for Control of Medical Decisions (Control Preferences Scale (patients only) [ Time Frame: Baseline, 1 month, and 6 months of participant enrollment ]
    Control Preferences Scale (patients only)

  8. Changes in Illness Acceptance (PEACE Illness Acceptance Measure (patients only) [ Time Frame: Baseline, 1 month, and 6 months of participant enrollment ]
    PEACE Illness Acceptance Measure (patients only)

  9. Changes in Patient Satisfaction with Caregiver Involvement (Canadian Health Care Evaluation Project - Patient Questionnaire (patients only) [ Time Frame: 1 month, and 6 months of participant enrollment ]
    Canadian Health Care Evaluation Project - Patient Questionnaire (patients only)

  10. Changes in Family Satisfaction with Patient's Care (Family Satisfaction with Care (caregivers only) [ Time Frame: 1 month, and 6 months of participant enrollment ]
    Family Satisfaction with Care (caregivers only)

  11. Changes in Cognition, literacy and numeracy (Short Portable Mental Status Questionnaire; REALM-R Literacy Assessment; Subjective Numeracy Scale) [ Time Frame: Baseline of participant enrollment ]
    Short Portable Mental Status Questionnaire; REALM-R Literacy Assessment; Subjective Numeracy Scale

  12. Changes in Patient Health Status (Medical record review (patients only) [ Time Frame: Baseline, 1 month, 6 months, and 12 months of participant enrollment ]
    Medical record review (patients only)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients who have advanced heart failure and are being evaluated for DT LVAD
  • Caregivers of patients who are being evaluated for DT LVAD

Exclusion Criteria:

  • Under 18 years of age
  • Non-English Speaking
  • Unable to consent
  • Prisoner
  • Already implanted with DT LVAD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344576


Locations
United States, Colorado
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
United States, Indiana
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine in St.Louis
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Duke University Medicine
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
University of Colorado, Denver
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Larry Allen, MD, MHS University of Colorado School of Medicine

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02344576     History of Changes
Other Study ID Numbers: 14-2102
CDR-1310-06998 ( Other Grant/Funding Number: Patient Centered Outcomes Research Institute )
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by University of Colorado, Denver:
heart failure
heart-assist devices
decision making
decision support techniques
hospice care
palliative care
caregivers

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases