Heart FailureDECIDE-LVADNCT02344576

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

A study testing DT LVAD Decision Support Intervention in people with Heart Failure and Heart-assist Devices, run by University of Colorado, Denver at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure, Heart-assist Devices
What is being tested?: DT LVAD Decision Support Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 445 participants
Where: 6 sitesUnited States
Study dates: May 2015to Feb 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

University of Colorado School of Medicine
Aurora, Colorado, 80045
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Duke University Medicine
Durham, North Carolina, 27710
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260
Mayo Clinic
Rochester, Minnesota, 55905
Washington University School of Medicine in St.Louis
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for End-Stage Heart Failure

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.

Read the 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.

Conditions: Heart Failure, Heart-assist Devices
Being tested: DT LVAD Decision Support Intervention
Keywords: heart failure, heart-assist devices, decision making, decision support techniques, hospice care, palliative care, caregivers
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DT LVAD Decision Support InterventionBehavioural
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.

Study groups in NCT02344576
Study group	Role	What they receive
Control: Usual Care	No intervention	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.
DT LVAD Decision Support Intervention	Experimental	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. Receives: Behavioral: DT LVAD Decision Support Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Reach of Intervention
Reach: The proportion of the target population who participate in the intervention. We will assess the percentage of patients and caregivers that receive the pamphlet and video decision aids.
Measured: Baseline 2 (post-education: average 3 days after enrollment)
Effectiveness of Intervention: Knowledge
Effectiveness: 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.
This is part one of the decision quality measure:
-Knowledge: DT LVAD knowledge score improvement from Baseline 1 (enrollment) to Baseline 2 (post-education), measured by percentage of score improvement (scale of 0-100%).
Measured: Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment)
Adoption of Intervention
Adoption: The absolute number of settings who are willing to initiate a program. We will assess the number of sites who agreed to be part of the study and who initiate intervention at intervention period.
Measured: At time of intervention phase start
Implementation of Intervention
Implementation: The extent to which the intervention is implemented as intended. We will assess implementation by surveying the consistency of decision aid delivery by the sites to the enrolled patients.
Measured: Baseline 2 (post-education: average 3 days after enrollment)
Maintenance of Intervention
Maintenance: Assessing whether sites decide at the conclusion of the study to maintain, modify, or discontinue a program. We will assess maintenance by counting the number of sites who continue the intervention after the study enrollment period has ended.
Measured: 6 months after study enrollment end date
Effectiveness of Intervention: Values-Choice Concordance
Effectiveness: Assessed based on if the decision support intervention led to a quality decision (see "Knowledge" outcome measure for full description). This is part two of the decision quality measure:
-Values: Concordance between patients' and caregivers' stated values and their treatment choice at 1-Month. Values measured on a Likert scale of 1-10, with 1 being "Do everything I can to live longer, even if that means having major surgery and being dependent on a machine" and 10 being "Live with whatever time I have left, without going through major surgery or being dependent on a machine"; correlated with patient-reported treatment decision of accepted or declined DT LVAD. Measured by kendall's tau correlation coefficient, which ranges 1 to -1, score closer to 1 or -1 shows greater values-choice concordance (a correlation coefficient of 0 means no concordance). Confidence intervals obtained from the distribution after 500 bootstrap samples (2.5, 97.5 percentiles).
Measured: Baseline 1 (enrollment) and 1 Month Follow-Up

Secondary outcomes (10)

Changes in Decision Conflict (Decision Conflict Scale)
Decision Conflict Scale: 16-items, scoring 0-100 with higher score indicating greater decisional conflict.
Measured: Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
Changes in Decision Regret (Decision Regret Scale)
Decision Regret Scale: 5-items, scoring 0-100 with higher score indicating greater decision regret.
Measured: 1 Month Follow-Up, and 6 Month Follow-Up
Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2)
Perceived Stress Scale (collected at Baseline 1 and 6-month follow-up only):10-items, scoring 0-40 with higher score indicating greater stress.; Patient Health Questionnaire-2: 2-items, score of 0-6 with higher score indicating greater depression.
Measured: Baseline 1 (enrollment), 1 month Follow-Up, and 6 Month Follow-Up
Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only])
EuroQol Visual Analogue Scale (patients only): 1-item scale, score of 0-100 with 0 being "worst imaginable health state" and 100 being "best imaginable health state".
Measured: Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up
Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale [Caregivers Only])
Preparedness for Caregiving Scale (caregivers only): 8-items, scoring 0-4 with higher score indicating more preparedness.
Measured: Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up
Changes in Bereaved Caregiver Satisfaction With End-of-Life Care (Canadian Health Care Evaluation Project - Bereavement Questionnaire [Bereaved Caregivers Only])
Canadian Health Care Evaluation Project - Bereavement Questionnaire (bereaved caregivers only): Score of 0-100 with higher score indicating greater satisfaction.
Measured: 6 Month Follow-Up
Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only])
Control Preferences Scale (patients only) includes 2 parts: "Preferred" and "Actual" ("Actual" at 1-Month and 6-Month only). Each is a 1-item question with 5-answer options, assessing preferred or actual control in decision making. "Active role" indicated if 1 of first 3 answer options were selected: for "Preferred", those 3 answer options were "I prefer to make the final selection about which treatment I will receive", "I prefer to make the final selection of my treatment after seriously considering my doctor's opinion", or "I prefer that my doctor and I share responsibility for deciding which treatment is best"; for "Actual", answer options were "I made the final selection about which treatment I would receive", "I made the final selection of my treatment after seriously considering my doctor's opinion", or "My doctor and I shared responsibility for deciding which was treatment best for me". The percentage of patients who selected an "active" response option was calculated.
Measured: Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only)
PEACE Illness Acceptance Measure (patients only): 2 part measure: part 1 measures illness acceptances (questions 1-5 of 12-items), scoring 5-20 with higher score indicating greater acceptance of illness; part 2 measures struggle with illness (questions 6-12 of 12-items), scoring 7-28 with higher score indicating greater struggle with illness.
Measured: Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
Changes in Family Satisfaction With Patient's Care (Family Satisfaction With Care [Caregivers Only])
Family Satisfaction with Care (caregivers only): The 10-item "Family Satisfaction with Decision-Making around Care of Critically Ill Patients" subscale of the Family Satisfaction with Care in the Intensive Care Unit-24. Scoring for each question was on a scale of 0-100, with 0 indicating low satisfaction and 100 indicating high satisfaction; combined total of all 10 questions was taken for final mean score of 0-100 (higher score indicating higher satisfaction).
Measured: 1 Month Follow-Up, and 6 Month Follow-Up
Changes in Patient Treatment Status (Medical Record Review (Patients Only)
Medical record review (patients only): Treatment received by 6 months, below numbers reported as number of participants who received an LVAD.
Measured: 6 Month Follow-Up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Feb 2018

First posted26 Jan 2015 (estimated)
Study startMay 2015
Primary completionAug 2017
Study completionFeb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (42)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 445 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02344576
Sponsor's protocol ID: 14-2102
Other IDs: CDR-1310-06998
Acronym: DECIDE-LVAD
Status last verified: Mar 2020
First submitted: 16 Jan 2015
Last updated: 19 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.
PubMed 24352519
Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19. doi: 10.1161/HHF.0b013e318291329a. Epub 2013 Apr 24.
PubMed 23616602
Miller LW, Guglin M. Patient selection for ventricular assist devices: a moving target. J Am Coll Cardiol. 2013 Mar 26;61(12):1209-21. doi: 10.1016/j.jacc.2012.08.1029. Epub 2013 Jan 2.
PubMed 23290542
Hershberger RE, Nauman D, Walker TL, Dutton D, Burgess D. Care processes and clinical outcomes of continuous outpatient support with inotropes (COSI) in patients with refractory endstage heart failure. J Card Fail. 2003 Jun;9(3):180-7. doi: 10.1054/jcaf.2003.24.
PubMed 12815567
Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, Stevenson LW, Dembitsky W, Long JW, Ascheim DD, Tierney AR, Levitan RG, Watson JT, Meier P, Ronan NS, Shapiro PA, Lazar RM, Miller LW, Gupta L, Frazier OH, Desvigne-Nickens P, Oz MC, Poirier VL; Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med. 2001 Nov 15;345(20):1435-43. doi: 10.1056/NEJMoa012175.
PubMed 11794191
Rogers JG, Butler J, Lansman SL, Gass A, Portner PM, Pasque MK, Pierson RN 3rd; INTrEPID Investigators. Chronic mechanical circulatory support for inotrope-dependent heart failure patients who are not transplant candidates: results of the INTrEPID Trial. J Am Coll Cardiol. 2007 Aug 21;50(8):741-7. doi: 10.1016/j.jacc.2007.03.063. Epub 2007 Aug 6.
PubMed 17707178
Slaughter MS, Rogers JG, Milano CA, Russell SD, Conte JV, Feldman D, Sun B, Tatooles AJ, Delgado RM 3rd, Long JW, Wozniak TC, Ghumman W, Farrar DJ, Frazier OH; HeartMate II Investigators. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009 Dec 3;361(23):2241-51. doi: 10.1056/NEJMoa0909938. Epub 2009 Nov 17.
PubMed 19920051
Grady KL, Meyer PM, Dressler D, Mattea A, Chillcott S, Loo A, White-Williams C, Todd B, Ormaza S, Kaan A, Costanzo MR, Piccione W. Longitudinal change in quality of life and impact on survival after left ventricular assist device implantation. Ann Thorac Surg. 2004 Apr;77(4):1321-7. doi: 10.1016/j.athoracsur.2003.09.089.
PubMed 15063260
McIlvennan CK, Magid KH, Ambardekar AV, Thompson JS, Matlock DD, Allen LA. Clinical outcomes after continuous-flow left ventricular assist device: a systematic review. Circ Heart Fail. 2014 Nov;7(6):1003-13. doi: 10.1161/CIRCHEARTFAILURE.114.001391. Epub 2014 Oct 7.
PubMed 25294625
Kirklin JK, Naftel DC, Kormos RL, Stevenson LW, Pagani FD, Miller MA, Baldwin JT, Young JB. Fifth INTERMACS annual report: risk factor analysis from more than 6,000 mechanical circulatory support patients. J Heart Lung Transplant. 2013 Feb;32(2):141-56. doi: 10.1016/j.healun.2012.12.004.
PubMed 23352390
Flint KM, Matlock DD, Lindenfeld J, Allen LA. Frailty and the selection of patients for destination therapy left ventricular assist device. Circ Heart Fail. 2012 Mar 1;5(2):286-93. doi: 10.1161/CIRCHEARTFAILURE.111.963215. No abstract available.
PubMed 22438521
Allen LA, Stevenson LW, Grady KL, Goldstein NE, Matlock DD, Arnold RM, Cook NR, Felker GM, Francis GS, Hauptman PJ, Havranek EP, Krumholz HM, Mancini D, Riegel B, Spertus JA; American Heart Association; Council on Quality of Care and Outcomes Research; Council on Cardiovascular Nursing; Council on Clinical Cardiology; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Surgery and Anesthesia. Decision making in advanced heart failure: a scientific statement from the American Heart Association. Circulation. 2012 Apr 17;125(15):1928-52. doi: 10.1161/CIR.0b013e31824f2173. Epub 2012 Mar 5. No abstract available.
PubMed 22392529
McIlvennan CK, Allen LA. To DT or not to DT, that is the question: working toward a comprehensive, patient-centered perspective on left ventricular assist device for destination therapy. Circ Cardiovasc Qual Outcomes. 2014 Jan;7(1):13-4. doi: 10.1161/CIRCOUTCOMES.113.000762. Epub 2014 Jan 14. No abstract available.
PubMed 24425698
Baker K, Flattery M, Salyer J, Haugh KH, Maltby M. Caregiving for patients requiring left ventricular assistance device support. Heart Lung. 2010 May-Jun;39(3):196-200. doi: 10.1016/j.hrtlng.2009.07.007. Epub 2009 Oct 1.
PubMed 20457339
Fowler FJ Jr, Levin CA, Sepucha KR. Informing and involving patients to improve the quality of medical decisions. Health Aff (Millwood). 2011 Apr;30(4):699-706. doi: 10.1377/hlthaff.2011.0003.
PubMed 21471491

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for End-Stage Heart Failure
ClinicalTrials.gov ID: NCT02344576
Acronym / sponsor ID: DECIDE-LVAD / 14-2102
Conditions: Heart Failure, Heart-assist Devices
Keywords: heart failure, heart-assist devices, decision making, decision support techniques, hospice care, palliative care, caregivers
Study type: Interventional
Recruitment status: Completed
Enrolment: 445 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: May 2015 (actual)
Primary completion: Aug 2017 (actual)
Study completion: Feb 2018 (actual)
First posted: 26 Jan 2015 (estimated)
Results: Posted 19 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control: Usual Care	No intervention	–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.
DT LVAD Decision Support Intervention	Experimental	Behavioral: DT LVAD Decision Support InterventionIn 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DT LVAD Decision Support InterventionDecision 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.	Behavioural	DT LVAD Decision Support Intervention

Primary outcome

Reach of Intervention
Time frame: Baseline 2 (post-education: average 3 days after enrollment)
Reach: The proportion of the target population who participate in the intervention. We will assess the percentage of patients and caregivers that receive the pamphlet and video decision aids.
Effectiveness of Intervention: Knowledge
Time frame: Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment)
Effectiveness: 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. This is part one of the decision quality measure: -Knowledge: DT LVAD knowledge score improvement from Baseline 1 (enrollment) to Baseline 2 (post-education), measured by percentage of score improvement (scale of 0-100%).
Adoption of Intervention
Time frame: At time of intervention phase start
Adoption: The absolute number of settings who are willing to initiate a program. We will assess the number of sites who agreed to be part of the study and who initiate intervention at intervention period.
Implementation of Intervention
Time frame: Baseline 2 (post-education: average 3 days after enrollment)
Implementation: The extent to which the intervention is implemented as intended. We will assess implementation by surveying the consistency of decision aid delivery by the sites to the enrolled patients.
Maintenance of Intervention
Time frame: 6 months after study enrollment end date
Maintenance: Assessing whether sites decide at the conclusion of the study to maintain, modify, or discontinue a program. We will assess maintenance by counting the number of sites who continue the intervention after the study enrollment period has ended.
Effectiveness of Intervention: Values-Choice Concordance
Time frame: Baseline 1 (enrollment) and 1 Month Follow-Up
Effectiveness: Assessed based on if the decision support intervention led to a quality decision (see "Knowledge" outcome measure for full description). This is part two of the decision quality measure: -Values: Concordance between patients' and caregivers' stated values and their treatment choice at 1-Month. Values measured on a Likert scale of 1-10, with 1 being "Do everything I can to live longer, even if that means having major surgery and being dependent on a machine" and 10 being "Live with whatever time I have left, without going through major surgery or being dependent on a machine"; correlated with patient-reported treatment decision of accepted or declined DT LVAD. Measured by kendall's tau correlation coefficient, which ranges 1 to -1, score closer to 1 or -1 shows greater values-choice concordance (a correlation coefficient of 0 means no concordance). Confidence intervals obtained from the distribution after 500 bootstrap samples (2.5, 97.5 percentiles).

10 secondary outcomes

Changes in Decision Conflict (Decision Conflict Scale)
Time frame: Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
Changes in Decision Regret (Decision Regret Scale)
Time frame: 1 Month Follow-Up, and 6 Month Follow-Up
Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2)
Time frame: Baseline 1 (enrollment), 1 month Follow-Up, and 6 Month Follow-Up
Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only])
Time frame: Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up
Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale [Caregivers Only])
Time frame: Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up
Changes in Bereaved Caregiver Satisfaction With End-of-Life Care (Canadian Health Care Evaluation Project - Bereavement Questionnaire [Bereaved Caregivers Only])
Time frame: 6 Month Follow-Up
Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only])
Time frame: Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only)
Time frame: Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
Changes in Family Satisfaction With Patient's Care (Family Satisfaction With Care [Caregivers Only])
Time frame: 1 Month Follow-Up, and 6 Month Follow-Up
Changes in Patient Treatment Status (Medical Record Review (Patients Only)
Time frame: 6 Month Follow-Up

Results and safety

Results posted to the registry on 19 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patient Control	142	135
Patient Intervention	121	113
Caregiver Control	111	111
Caregiver Intervention	71	71

Primary outcome: Reach of Intervention

Time frame: Baseline 2 (post-education: average 3 days after enrollment). Count of participants. Unit: Participants

Measure	Patient Intervention n = 113	Caregiver Intervention n = 71
Value	107	64

Population analysed: Reach pertains to only those participants in the intervention phase, and therefore the control arms are not included here.

Primary outcome: Effectiveness of Intervention: Knowledge

Time frame: Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment). Mean (Standard Error). Unit: percentage of score improvement

Measure	Patient Control n = 135	Patient Intervention n = 113	Caregiver Control n = 111	Caregiver Intervention n = 71
Value	5.4 (1.6)	10.9 (1.9)	9.1 (1.7)	13.9 (2.2)

Population analysed: Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Effectiveness analysis, as this data was collected in surveys.

Primary outcome: Adoption of Intervention

Time frame: At time of intervention phase start. Count of units. Unit: Sites

Measure	Sites n = 184
Value	6

Population analysed: Adoption is measured by sites only; does not apply to the "Patient" and "Caregiver" arms. Adoption pertains to only the intervention phase; thus, for "overall number of participants analyzed", includes patients and caregivers in intervention phase only.

Primary outcome: Implementation of Intervention

Time frame: Baseline 2 (post-education: average 3 days after enrollment). Number. Unit: percentage of eligible participants

Measure	Patient Intervention n = 113
Provided by Clinician (Non-Study Personnel)	98.3
Patient Kept Decision Aids	90.9
Clinician Went through Pamphlet with Patient	26.4
Patient Viewed Video in Clinical Setting	46.8

Population analysed: Implementation was collected for patient participants only; does not apply to the "Caregiver" arm. Implementation pertains to only patients in the intervention phase; control arms are not included here.Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patient Control	87 of 135 (64.4%)	117 of 135 (86.7%)	31 of 135
Patient Intervention	57 of 113 (50.4%)	78 of 113 (69%)	39 of 113

Limitations and caveats (from the sponsor): Limitations include: 1) Missing data were somewhat frequent and concentrated among the group of patients who did not undergo implantation of DT LVAD. Our models adjusted for missing data as possible. 2) The population was mostly white males.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24352519Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.
Background: PubMed 23616602Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19. doi: 10.1161/HHF.0b013e318291329a. Epub 2013 Apr 24.
Background: PubMed 23290542Miller LW, Guglin M. Patient selection for ventricular assist devices: a moving target. J Am Coll Cardiol. 2013 Mar 26;61(12):1209-21. doi: 10.1016/j.jacc.2012.08.1029. Epub 2013 Jan 2.
Background: PubMed 12815567Hershberger RE, Nauman D, Walker TL, Dutton D, Burgess D. Care processes and clinical outcomes of continuous outpatient support with inotropes (COSI) in patients with refractory endstage heart failure. J Card Fail. 2003 Jun;9(3):180-7. doi: 10.1054/jcaf.2003.24.
Background: PubMed 11794191Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, Stevenson LW, Dembitsky W, Long JW, Ascheim DD, Tierney AR, Levitan RG, Watson JT, Meier P, Ronan NS, Shapiro PA, Lazar RM, Miller LW, Gupta L, Frazier OH, Desvigne-Nickens P, Oz MC, Poirier VL; Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med. 2001 Nov 15;345(20):1435-43. doi: 10.1056/NEJMoa012175.
Background: PubMed 17707178Rogers JG, Butler J, Lansman SL, Gass A, Portner PM, Pasque MK, Pierson RN 3rd; INTrEPID Investigators. Chronic mechanical circulatory support for inotrope-dependent heart failure patients who are not transplant candidates: results of the INTrEPID Trial. J Am Coll Cardiol. 2007 Aug 21;50(8):741-7. doi: 10.1016/j.jacc.2007.03.063. Epub 2007 Aug 6.
Background: PubMed 19920051Slaughter MS, Rogers JG, Milano CA, Russell SD, Conte JV, Feldman D, Sun B, Tatooles AJ, Delgado RM 3rd, Long JW, Wozniak TC, Ghumman W, Farrar DJ, Frazier OH; HeartMate II Investigators. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009 Dec 3;361(23):2241-51. doi: 10.1056/NEJMoa0909938. Epub 2009 Nov 17.
Background: PubMed 15063260Grady KL, Meyer PM, Dressler D, Mattea A, Chillcott S, Loo A, White-Williams C, Todd B, Ormaza S, Kaan A, Costanzo MR, Piccione W. Longitudinal change in quality of life and impact on survival after left ventricular assist device implantation. Ann Thorac Surg. 2004 Apr;77(4):1321-7. doi: 10.1016/j.athoracsur.2003.09.089.
Background: PubMed 25294625McIlvennan CK, Magid KH, Ambardekar AV, Thompson JS, Matlock DD, Allen LA. Clinical outcomes after continuous-flow left ventricular assist device: a systematic review. Circ Heart Fail. 2014 Nov;7(6):1003-13. doi: 10.1161/CIRCHEARTFAILURE.114.001391. Epub 2014 Oct 7.
Background: PubMed 23352390Kirklin JK, Naftel DC, Kormos RL, Stevenson LW, Pagani FD, Miller MA, Baldwin JT, Young JB. Fifth INTERMACS annual report: risk factor analysis from more than 6,000 mechanical circulatory support patients. J Heart Lung Transplant. 2013 Feb;32(2):141-56. doi: 10.1016/j.healun.2012.12.004.
Background: PubMed 22438521Flint KM, Matlock DD, Lindenfeld J, Allen LA. Frailty and the selection of patients for destination therapy left ventricular assist device. Circ Heart Fail. 2012 Mar 1;5(2):286-93. doi: 10.1161/CIRCHEARTFAILURE.111.963215. No abstract available.
Background: PubMed 22392529Allen LA, Stevenson LW, Grady KL, Goldstein NE, Matlock DD, Arnold RM, Cook NR, Felker GM, Francis GS, Hauptman PJ, Havranek EP, Krumholz HM, Mancini D, Riegel B, Spertus JA; American Heart Association; Council on Quality of Care and Outcomes Research; Council on Cardiovascular Nursing; Council on Clinical Cardiology; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Surgery and Anesthesia. Decision making in advanced heart failure: a scientific statement from the American Heart Association. Circulation. 2012 Apr 17;125(15):1928-52. doi: 10.1161/CIR.0b013e31824f2173. Epub 2012 Mar 5. No abstract available.
Decision Aids for Patients Considering Destination Therapy Left Ventricular Assist DeviceLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Larry Allen, MD, MHS principal investigator

University of Colorado School of Medicine

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DT LVAD Decision Support Intervention in people with Heart Failure and Heart-assist Devices, run by University of Colorado, Denver at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reach of Intervention (time frame: Baseline 2 (post-education: average 3 days after enrollment)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02344576, which also lists 42 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.