Abstract
Background: Heart failure (HF) is a progressive, costly, highly symptomatic, and deadly disease process that affects more than 6 million people in the United States alone. The burden of HF is felt by patients, caregivers, and treatment teams alike. Often times, the symptom burden increases as the disease worsens. In an effort to alleviate symptoms and extend life, heart failure teams may offer novel, high-tech treatments and devices and complicated medication regimens to patients. Patients and their caregivers are then tasked with making complex treatment-related decisions for which they may be inadequately prepared. Furthermore, despite the high mortality rate associated with heart failure, current rates of advance care planning discussions and advance directive completion remain very low. Decisions, therefore, are made that may not be congruent with patient and/or caregiver wishes or based on an accurate understanding of diagnosis, prognosis, and likely outcomes. This in turn, is associated with poor-quality decision making, decisional conflict, and later regret. Recently, the use of a theory-based decision aid has been shown to improve quality decision making, decrease decisional conflict, and later regret, in other chronic populations such as oncology. The use of decision aids has been shown to enhance communication between patients, caregivers, and treatment teams, while also promoting a quality decision-making process.
Purpose: The primary aim of this pilot study was to test the feasibility and acceptability of an intervention, an Advance Directive Decision Aid, among hospitalized HF patients and their designated caregivers. The secondary aim was to describe the levels of decisional conflict and regret associated with ACP discussion and consideration of completing an advance directive in a sample of hospitalized HF patients and their caregivers.
Methods: This mixed-methods pilot study used convenience sampling to recruit 30 dyads (30 patients and 30 caregivers) from the inpatient HF service over a 12-month period. Feasibility was assessed by tracking: a) the number of eligible dyads versus the consented dyads, and reasons for refusal to participate; b) the number of those who enrolled and completed the study with reason for non-completion; and c) the amount of recorded time to deliver each intervention session while the patient and caregiver completed the decision balance sheet for an advance directive. Provider acceptability was measured by completion of a follow-up survey. Patient and caregiver acceptability were assessed by completion of a follow-up survey and a semi-structured interview. Patient and caregiver decisional conflict and regret were measured by completing a decisional conflict scale (DCS) and a decisional regret scale (DRS) following completion of the intervention.
Results: The intervention, an Advance Directive Decision Aid, was rated favorably by patients, caregivers, and clinicians. Qualitative findings from the interviews supported and expanded the survey data. Both patients and caregivers reported decreased anxiety and gratitude about ACP discussions. Despite characterizing the intervention as positive and helpful, patients reported that the intervention did not prompt them to complete advance directives. They explained that they did not feel a sense of urgency, nor did they believe that an advance directive would change their caregiver’s understanding of treatment desires. Participants enrolled in this study were mostly Caucasian males, 54% were diagnosed with HF <1 year, and 70% were NYHA IV. The mean age of participants was 56.5 years (SD = 12.17) and those in the refusal sample were found to be significantly younger (p = 0.011). While the intervention was found to be favorable, there were several issues such as caregiver presence, willingness to discuss ACP and advance directives, and denial of illness severity that made this intervention less feasible. Patients and caregivers expressed moderate decisional conflict, though there was no statistical difference between the two groups. However, caregivers were found to have significantly more decisional regret compared to patients (p = 0.008).
Implications and Conclusion: In the short term, results of this study revealed that the intervention was acceptable and that patients and caregivers appreciated the conversation; however, ACP and completion of advance directives remain difficult to discuss and are often avoided. Information obtained from this pilot study will inform a future randomized controlled trial to determine the intervention effect for patients with HF. This trial will include modifications such as: a) providing well-timed end-points to assess decisional conflict and later regret; b) enrolling in both inpatient and outpatient settings; c) adding a health-related quality of life assessment; and d) increasing engagement of physicians with the ACP discussions by introducing the purpose of the decision aid and advanced practice provider who will help with the process, as well as helping to affirm the decision to complete an advance directive at the end of the ACP session for patients with heart failure.
