Does a decision aid help patients learn about their treatment options for advanced heart failure?
METHODS: We developed the DA in line with the Ottawa Decision Support Framework and IPDAS for ensuring quality, patient-centered content. We conducted semistructured open-ended interviews with patient candidates for LVAD treatment (n = 15), patients currently with LVADs (n = 15), caregivers of patie...
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| Format: | eBook |
| Language: | English |
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[Washington, D.C.]
Patient-Centered Outcomes Research Institute (PCORI)
[2019], 2019
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| Series: | Final research report
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| Online Access: | |
| Collection: | National Center for Biotechnology Information - Collection details see MPG.ReNa |
| Summary: | METHODS: We developed the DA in line with the Ottawa Decision Support Framework and IPDAS for ensuring quality, patient-centered content. We conducted semistructured open-ended interviews with patient candidates for LVAD treatment (n = 15), patients currently with LVADs (n = 15), caregivers of patients with LVADs (n = 15), LVAD decliners (n = 15), and expert clinicians (n = 11) to generate content based on patient values and decisional needs, and providers' perspectives on knowledge needs for informed consent. Content also included short- and long-term risks and benefits based on the most recent literature. We also received ongoing feedback from patient partners (n = 3) throughout development and testing of the DA. BACKGROUND: Studies indicate that decision-making among patients considering treatment for advanced heart failure (HF) could be improved. Decision aids (DAs) increase knowledge, decrease decisional conflict, increase accurate risk perceptions, increase match between values and choice, and decrease the use of some surgical intervention and screening tests. Left ventricular assist device (LVAD) therapy is the fastest growing treatment for advanced HF. Recognizing this, the American Heart Association recently emphasized the "crucial" need for improved informed consent processes for shared decision-making about LVAD. OBJECTIVES: Our goal was to develop and test a patient-centered DA for decision-making about receiving an LVAD for advanced HF treatment, using the International Patient Decision Aids Standards (IPDAS) Collaboration guidelines, input from patient stakeholders, and advice from clinical experts. Patients rated the DA high in acceptability and usability, with most patients reporting that the DA helped them understand more about risks and benefits of LVAD treatment (94%), the DA helped them understand their options for dealing with HF (85%), they learned something new (83%), and they believe the DA helps someone to make an informed decision about LVAD treatment (94%). CONCLUSIONS: Our findings indicate that our DA enhances LVAD knowledge during a crucial decision-making period, and that the aid is neutral (ie, does not encourage direction of decision) and reflects patient, caregiver, and physician preferences for content and format. LIMITATIONS AND SUBPOPULATION CONCLUSIONS: Results may differ in clinics that lack the experience and infrastructure of our partnering study clinics. Low follow-up (59% across arms) is an additional limitation Of the 52 in the DA study arm and the 53 in the control arm, the rate of follow-up contact was 58% and 64% at 1 week, respectively, and 52% and 58% at 1 month, respectively. Patients in the DA arm exhibited significantly greater LVAD knowledge than the standard education group at 1-week follow-up (68% vs 59%; P = .01), but not at 1-month follow-up (64% vs 61%; P = .47). We found no differences between DA and standard education patients in rates of acceptance vs decline of LVAD treatment (85% vs 78%; P = .74). Secondary outcomes show that recipients of the DA reported greater satisfaction with life postimplant than nonrecipients (28 vs 23 out of 30; P = .008), although both arms reported high satisfaction. We alpha-tested the aid through cognitive interviews (n = 5) and tested acceptability with LVAD patients (n = 10), candidates (n = 10), and clinicians (n = 13) (eg, cardiologists, cardiothoracic surgeons, social workers, LVAD coordinators, and bioethicists) from 5 LVAD clinics in the United States. We conducted a multisite randomized trial of the DA above standard education alone among inpatients considering LVAD treatment for advanced HF (1:1 allocation ratio). We tested superiority of our DA using an independent, 2-sample t test of mean differences in our main outcome of LVAD knowledge using a validated scale. Participants included inpatient LVAD candidates at 5 LVAD clinics. We collected data at 1-day, 1-week, and 1-month follow-up. RESULTS: Of 105 eligible patients, 98 agreed to participate (including both bridge to transplant and destination therapy candidates) and were randomly assigned to the DA or standard education arms. |
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| Physical Description: | 1 PDF file (61 pages) illustrations |