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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02344576
Other study ID # 14-2102
Secondary ID CDR-1310-06998
Status Completed
Phase N/A
First received
Last updated
Start date May 2015
Est. completion date February 2018

Study information

Verified date March 2020
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 445
Est. completion date February 2018
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Colorado School of Medicine Aurora Colorado
United States Brigham and Women's Hospital Boston Massachusetts
United States Duke University Medicine Durham North Carolina
United States St. Vincent Indianapolis Hospital Indianapolis Indiana
United States Mayo Clinic Rochester Minnesota
United States Washington University School of Medicine in St.Louis Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (33)

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. — View Citation

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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. Review. — View Citation

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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. — View Citation

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. — View Citation

Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Piña 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. — View Citation

Helfrich CD, Li YF, Sharp ND, Sales AE. Organizational readiness to change assessment (ORCA): development of an instrument based on the Promoting Action on Research in Health Services (PARIHS) framework. Implement Sci. 2009 Jul 14;4:38. doi: 10.1186/1748-5908-4-38. — View Citation

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. — View Citation

Heyland DK, Cook DJ, Rocker GM, Dodek PM, Kutsogiannis DJ, Skrobik Y, Jiang X, Day AG, Cohen SR; Canadian Researchers at the End of Life Network. The development and validation of a novel questionnaire to measure patient and family satisfaction with end-of-life care: the Canadian Health Care Evaluation Project (CANHELP) Questionnaire. Palliat Med. 2010 Oct;24(7):682-95. doi: 10.1177/0269216310373168. Epub 2010 Jul 6. — View Citation

Iacovetto MC, Matlock DD, McIlvennan CK, Thompson JS, Bradley W, LaRue SJ, Allen LA. Educational resources for patients considering a left ventricular assist device: a cross-sectional review of internet, print, and multimedia materials. Circ Cardiovasc Qual Outcomes. 2014 Nov;7(6):905-11. doi: 10.1161/CIRCOUTCOMES.114.000892. Epub 2014 Oct 14. — View Citation

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. Erratum in: J Heart Lung Transplant. 2015 Oct;34(10):1356. Timothy Baldwin, J [corrected to Baldwin, J T]. — View Citation

Matlock DD, Spatz ES. Design and testing of tools for shared decision making. Circ Cardiovasc Qual Outcomes. 2014 May;7(3):487-92. doi: 10.1161/CIRCOUTCOMES.113.000289. Epub 2014 Apr 8. Review. — View Citation

McIlvennan CK, Allen LA, Nowels C, Brieke A, Cleveland JC, Matlock DD. Decision making for destination therapy left ventricular assist devices: "there was no choice" versus "I thought about it an awful lot". Circ Cardiovasc Qual Outcomes. 2014 May;7(3):374-80. doi: 10.1161/CIRCOUTCOMES.113.000729. Epub 2014 May 13. — View Citation

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. — View Citation

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. Review. — View Citation

Mdege ND, Man MS, Taylor Nee Brown CA, Torgerson DJ. Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation. J Clin Epidemiol. 2011 Sep;64(9):936-48. doi: 10.1016/j.jclinepi.2010.12.003. Epub 2011 Mar 16. Review. — View Citation

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. Review. — View Citation

O'Connor AM, Wennberg JE, Legare F, Llewellyn-Thomas HA, Moulton BW, Sepucha KR, Sodano AG, King JS. Toward the 'tipping point': decision aids and informed patient choice. Health Aff (Millwood). 2007 May-Jun;26(3):716-25. — View Citation

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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. Epub 2007 Aug 6. — View Citation

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. — View Citation

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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. Erratum in: N Engl J Med. 2018 Aug 16;379(7):697. — View Citation

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* Note: There are 33 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline 2 (post-education: average 3 days after enrollment)
Primary 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%).
Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment)
Primary 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. At time of intervention phase start
Primary 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. Baseline 2 (post-education: average 3 days after enrollment)
Primary 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. 6 months after study enrollment end date
Primary 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).
Baseline 1 (enrollment) and 1 Month Follow-Up
Secondary Changes in Decision Conflict (Decision Conflict Scale) Decision Conflict Scale: 16-items, scoring 0-100 with higher score indicating greater decisional conflict. Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
Secondary Changes in Decision Regret (Decision Regret Scale) Decision Regret Scale: 5-items, scoring 0-100 with higher score indicating greater decision regret. 1 Month Follow-Up, and 6 Month Follow-Up
Secondary 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. Baseline 1 (enrollment), 1 month Follow-Up, and 6 Month Follow-Up
Secondary 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". Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up
Secondary 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. Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up
Secondary 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. 6 Month Follow-Up
Secondary 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. Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
Secondary 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. Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
Secondary 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). 1 Month Follow-Up, and 6 Month Follow-Up
Secondary 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. 6 Month Follow-Up
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