Effectiveness of a Shared Decision-Making Intervention for Patients Offered a Destination Therapy LVAD for End-Stage Heart Failure: DECIDE-LVAD

Educational Objectives

After completing the activity, the clinician will be better able to improve shared decision making in patients with end-stage heart failure who are considering a left ventricular assist device as destination therapy.

Summary

Interviewer: Bernard J. Gersh, CHB, DPHIL, MB, MACC

Take-home Messages:

• Although many resources are available to patients considering a left ventricular assist device (LVAD) as destination therapy, most such resources do not discuss options, and none meet International Patient Decision Aid Standards criteria.
• Formal integration of a shared decision support program for considering destination therapy with an LVAD was associated with improved decision quality and a reduction in implantation.
• Future development of patient-oriented educational resources should aim to be comprehensive, unbiased, and easy to understand.

An expanding array of life-prolonging technologies is being offered to older and sicker patients with end-stage HF. For example, LVADs are being used as “destination therapy” for some people dying from HF who are ineligible for heart transplantation. Among the 6 million Americans who currently have HF, destination LVAD therapy could be an option for ≤250,000 of them each year.

For these patients, 2-year survival is <10% without the LVAD, versus ≈70% with the partial artificial heart.¹ The downside is the significant risk that accompanies use of an LVAD, including stroke (1 in 10 will have a disabling stroke), serious infection, severe bleeding (2 in 10 will have a serious bleed requiring medical attention), and reoperation. There are also significant lifestyle effects, including the need for patients to be connected to electricity at all times. As a result, a caregiver is required, which often places stress on families and loved ones. Therefore, the decision whether to get an LVAD is often an extremely difficult one that requires understanding of the benefits as well as the risks and burdens.

Larry A. Allen, MD, MHS, noted that being a candidate for destination therapy means a patient has advanced age or multiple comorbidities, or (in most cases) both. So, these patients are likely to have advanced HF plus many other medical problems; he said, “Here we are offering them an extremely complex therapy that involves major cardiac surgery and then a lifestyle afterwards that requires caregiving, care of the device, and frequent complications.”

Therefore, he and his colleagues developed and validated a decision aid for use with patients with advanced HF considering destination LVAD placement.² Ideally, decision aids standardize the shared decision-making process by ensuring that all participants have the necessary information, that there is consensus building about the preferred treatment, and that agreement is reached on the final choice.

A decision aid was certainly needed. Dr. Allen and colleagues showed that, before their efforts, hospitals offering destination therapy LVADs did not follow a standard process.³ The forms, pamphlets, websites, and videos used to help patients and families were biased and too difficult for most people to understand. In brief, patient education was deferred to marketing.

In 2014, they identified 77 LVAD educational materials. Their analysis revealed:³

• 97% discussed benefits;
• 53% mentioned any risks;
• 36% mentioned lifestyle considerations;
• 1% mentioned palliative care or hospice; and
• met a majority of International Patient Decision Aid Standards.

Those standards require that patients receive information about options, are presented with probabilities (unbiased and understandable), are provided with methods for clarifying values, and then are given structured guidance for deliberation and communication. Available resources failed these standards, were above the reading level of average Americans, and were biased toward accepting LVAD therapy.

DECIDE-LVAD

Once development and alpha testing were finished,¹ Dr. Allen — the principal investigator — and colleagues designed a trial to compare their decision aid to standard care for patients with advanced HF considering destination LVAD implantation. They now have the first report from this trial.

DEVICE-LVAD used a stepped wedge cluster randomized trial design.⁴ This approach has gained rapidly in popularity over the past decade. It is different from the conventional parallel arm cluster design in that all clusters (e.g., communities, schools, or — in this case — hospitals) eventually receive the intervention rather than only one-half of the study participants (the hospitals). Thus, each site starts with a control period of 4 months or longer, during which nothing changes in their standard practice; over time, the study centers transition to a 4-month roll-out period, and then an intervention period.

Enrollment occurred before formal education, with data collection occurring before and after formal education in addition to 1 and 6 months following implantation. The delivery of the decision aid was made by clinicians, not by research coordinators.

The primary objective was to characterize the scope and quality of available LVAD educational materials — in other words, “decision quality,” defined as the extent to which medical decision making reflected well-informed patient preferences. There were 2 coprimary endpoints: knowledge and values-treatment concordance. Secondary outcomes included decision conflict, regret, depression, and quality of life.

From 2015 to 2017, 248 patients were enrolled: 135 during control and 113 during intervention periods.⁵ At enrollment 23.8% were in intensive care, 24.1% older than 70 years, 15.7% women, 24.2% racial/ethnic minority, and 26.3% college graduates.

Patient knowledge (mean test performance) during the decision-making period improved from 59.5% to 64.9% in control compared to 59.1% to 70.0% in intervention (p = 0.03). Stated values were assessed using a scale of 1 to 10, in which 1 was defined as “do everything I can to live longer,” while 10 was a desire “to live with whatever time I have left.” At 1 month, there was a mean scale score of 2.37 in the control and 3.33 in the intervention (p = 0.033) groups.

Patient-reported treatment preference at 1 month favored LVAD more in the control than intervention group (overall p < 0.001). Correlation between stated values and patient-reported treatment preference at 1 month was stronger in intervention than control. However, there was no improved correlation between stated values and actual treatment received by 6 months for intervention compared to control.

The adjusted rate of LVAD implantation by 6 months was higher during the control period (79.9%) than the intervention period (53.9%; p = 0.008, adjusted for site and time period), meaning there was a 26% decrease in patients going on to LVAD. There were no differences in decision conflict, decision regret, or preferred control.

Based on the results, a shared decision-making intervention for LVAD implantation as destination therapy seems to improve patient decision quality, as measured by patient knowledge, and the resulting decision showed concordance between stated values and patient-reported treatment preference.

Dr. Allen added, “It suggests that this intervention — education and cultural change via a 26-minute video — led to an actual decrease in the choice of a quarter-million-dollar therapy for their heart failure, which I think is quite striking.”

Readings

1. 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;7:1003-13.
2. Thompson JS, Matlock DD, McIlvennan CK, Jenkins AR, Allen LA. Development of a Decision Aid for Patients with Advanced Heart Failure Considering a Destination Therapy Left Ventricular Assist Device. JACC Heart Fail 2015;3:965-76. http://heartfailure.onlinejacc.org/content/3/12/965
3. Iacovetto MC, Matlock DD, McIlvennan CK, et al. 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;7:905-11.
4. McIlvennan CK, Thompson JS, Matlock DD, et al. A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for Advanced Heart Failure: DECIDE-LVAD: Rationale, Design, and Pilot Data. J Cardiovasc Nurs 2016;31:E8-E20.
5. Allen LA, McIlvennan CK, Thompson JS, et al. Effectiveness of an intervention supporting shared decision making for destination therapy left ventricular assist device: the DECIDE-LVAD randomized stepped-wedge trial. JAMA-IM. Accepted for publication 12/28/17.

Disclosures

Larry A. Allen, MD, FACC
Boston Scientific Corp (C); Janssen Global Services LLC (C); Johnson and Johnson Services Inc (C); Novartis AG (C); ZS Pharma Inc (C)

Interviewer: Bernard J. Gersh, CHB, DPHIL, MB, MACC
Boston Scientific Corp (D); Janssen Global Services LLC (D,O); Kowa Co Ltd (D); Medtronic (D); Abbott (D); TEVA Pharmaceutical Industries Ltd (D); Sirtex SIR (O); Xenon (O)

Acknowledgements

CME/CE INFO

Accreditation:

The Audio- Digest Foundation is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Audio- Digest Foundation designates this enduring material for a maximum of 0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Audio Digest Foundation is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's (ANCC's) Commission on Accreditation. Audio Digest Foundation designates this activity for 0 CE contact hours.

Lecture ID:

AC500404

Expiration:

This CME course qualifies for AMA PRA Category 1 Credits™ for 3 years from the date of publication.

Instructions:

To earn CME/CE credit for this course, you must complete all the following components in the order recommended: (1) Review introductory course content, including Educational Objectives and Faculty/Planner Disclosures; (2) Listen to the audio program and review accompanying learning materials; (3) Complete posttest (only after completing Step 2) and earn a passing score of at least 80%. Taking the course Pretest and completing the Evaluation Survey are strongly recommended (but not mandatory) components of completing this CME/CE course.

Estimated time to complete this CME/CE course:

Approximately 2x the length of the recorded lecture to account for time spent studying accompanying learning materials and completing tests.

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