A Randomized Controlled Trial of an Advance Care Planning Video Decision Support Tool for Patients with Advanced Heart Failure

Abstract

Background

Conversations about goals of care and CPR/intubation for patients with advanced health failure (HF) can be difficult. This study examined the impact of a video decision support tool and a patient checklist on advance care planning (ACP) for patients with HF.

Methods

Multi-site randomized controlled trial of a video-assisted intervention and ACP checklist versus a verbal description in 246 patients ≥ 64 years with HF and an estimated likelihood of death of > 50% within two years. Intervention participants received a verbal description for goals of care (life-prolonging care, limited care, and comfort care) and CPR/intubation plus a six-minute video depicting the three levels of care and CPR/intubation as well as ACP checklist. Controls received only the verbal description. The primary analysis compared the proportion of patients preferring comfort care between study arms immediately after the intervention. Secondary outcomes were CPR/intubation preferences and knowledge (6-item test, range 0-6) after intervention.

Results

In the intervention group, 27 (22%) chose life-prolonging, 31 (25%) limited, 63 (51%) comfort, with two (2%) uncertain. In the control group, 50 (41%) chose life-prolonging, 27 (22%) limited, 37 (30%) comfort, with eight (7%) uncertain (P<0.001). Intervention participants (vs. controls) were more likely to forgo CPR (68% vs. 35%, P <0.001) and intubation (77% vs. 48%, P <0.001), and had higher mean knowledge scores (4.1 vs. 3.0; P < 0.001).

Conclusions

Patients with HF who viewed a video were more informed, more likely to select a focus on comfort, and less likely to desire CPR/intubation compared to patients receiving verbal information only.

Due to the prognostic uncertainty of heart failure, and the multiple advanced therapies potentially available, it is difficult to know when the opportune time is to broach discussions about care preferences and future care options for patients with advanced heart failure.¹ A recent consensus statement has suggested that patients have a discussion about overall goals of care annually.² However, it is still challenging even for the best intentioned clinician to know how to have these discussions. Despite major advances in life-saving therapies, heart failure remains a highly morbid disease; patients with heart failure also have a much lower rate of utilization of end-of-life resources such as hospice.³

Advance care planning (ACP) is a process of shared decision-making that informs and engages patients to ensure that the care delivered is concordant with their informed wishes.⁴ ACP is recognized as a standard for high-quality patient-centered care.^{4, 5} Video decision support tools encourage ACP by stimulating informed conversations and helping people think about the choices they face.^{4, 6} Video tools can help people envision future circumstances and deliberate about their decisions.^{4, 7, 8}

Our group, the Video Images of Disease for Ethical Outcomes (VIDEO) Consortium, has developed and evaluated several decision support tools to assist patients with ACP.^7-11 Our previous work in patients with cancer suggests that video tools serve as catalysts to spark ACP conversations by informing patients about their options, leading to care decisions that are more aligned with patients' preferences and values.^{7, 9, 10} Extending this research to patients with heart failure is important given its high prevalence and associated morbidity and mortality.¹²

We conducted a randomized trial of a goals-of-care video and ACP checklist among patients with advanced heart failure. Our primary hypothesis was that patients in the video-assisted intervention arm would be more likely to prefer medical care focused on quality of life and comfort compared to those who received only a verbal description of their options. Secondary hypotheses were that the video-assisted group would be less likely to want CPR attempted or to be placed on a ventilator, more knowledgeable about their options, more likely to have ACP conversations with their physicians, and more likely to prefer what their physicians would choose for themselves in such circumstances.

Methods

Setting

We conducted this study with 246 patients from seven teaching hospitals (Massachusetts General Hospital (N=92), Newton-Wellesley Hospital (N=49), University of Colorado Hospital (N=40), Brigham and Women's Hospital (N=33), Boston Medical Center (N=18), Nashville Veterans Administration Medical Center (N=8), and Vanderbilt University Medical Center (N=6)). Institutional Review Board approval was obtained at each hospital. Study participants provided written informed consent.

Participants

We enrolled 246 participants from 6/28/2012 to 2/7/2015. Eligibility criteria included: (1) ≥ 64 years of age; (2) ability to provide informed consent; (3) ability to communicate in English; and (4) an established diagnosis of advanced heart failure with limited prognosis as defined by the criteria in Appendix A. We excluded patients with a score ≤ 6 on the Short Portable Mental Status Questionnaire.¹³

Study recruitment, data collection, and intervention administration, were done by trained research assistants (RA: MDs or RNs) at each hospital. The RAs underwent standardized training in all aspects of the research protocol including use of structured scripts to administer the questionnaires.

RAs reviewed records of hospitalized and ambulatory patients with advanced heart failure to identify potential subjects. Each patient's attending physician was asked to confirm eligibility and approve approaching the patient for participation. Eligible patients were invited to participate and informed consent was obtained from those who agreed.

Following informed consent, the RA administered the Short Portable Mental Status Questionnaire to confirm final study eligibility. The RA administered a baseline questionnaire (demographics, self-reported health status, goals-of-care preferences, CPR/intubation preferences, and knowledge questions), after which participants were randomized to either the video-assisted intervention or verbal control arm. We used a central, computer-generated 2:2 block randomization design stratified by use of an implantable cardioverter-defibrillator (ICD) at each institution, with assignments concealed in numbered envelopes.

Video-Assisted Intervention Arm

Participants randomized to the video-assisted intervention arm first listened to a description of the three goals of care read out loud by the RA (Appendix B). Then, participants viewed a 6-minute goals-of-care video for patients with advanced heart failure on an iPad in the presence of the RA. Intervention participants were also given a patient checklist (Appendix C) reviewing ACP. The RA provided the patient checklist to the patients at the end of the interview (after completion of the post-intervention questionnaire). The RAs were instructed to defer questions regarding the checklist and encourage patients to discuss their questions with their physicians; notably, patients did not ask any questions about the checklist during the study.

We used standardized procedures to minimize interaction between RAs and patients while viewing the video. Specifically, RAs were not permitted to comment or answer questions while the patient viewed the video; participants were instructed to watch the video without interruption and had no further exposure to the video.

VIDEO EMBED CODE HERE

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The video begins with a physician introducing the patient to ACP and a three part goals-of-care framework (life-prolonging care, limited medical care, and comfort care), which was used and tested in previous studies.^{9, 14} In the video, life-prolonging care images included: a simulated code with clinicians conducting CPR and intubation on a mannequin; an intensive care unit with a ventilated patient being tended by respiratory therapists; and medications including vasopressors administered through a venous catheter. Visual images depicting limited medical care included: a patient getting medications via a peripheral intravenous catheter; scenes from a typical medical ward service; and a patient wearing a nasal cannula. The video depiction of comfort care included: a patient receiving oral medications at home; a patient with nasal cannula on oxygen at home; and a medical attendant assisting a patient with self-care. In its development, the video's design, script, scenes, and structure were reviewed for accuracy and appropriateness by experts in cardiology, critical care, geriatrics, palliative care, decision-making, health literacy, medical ethics, and patients with heart failure. The research team performed all filming and editing of the video prior to this study's protocol development following previously published criteria.¹⁵ All providers and patients included in the video (or their proxies) gave consent to be filmed.

We obtained video-assisted intervention participants' goals-of-care, CPR/intubation preferences, and knowledge prior to randomization during the baseline interview (baseline questionnaire), and immediately after listening to the description of the goals of care and viewing the video (post-intervention questionnaire). Patients with questions after viewing the video were referred back to their attending physician.

Verbal Control Arm

After randomization, participants in the verbal control arm listened to the same description of the three goals of care used in the video arm read out loud by the RA (Appendix B). Participants in the control group did not watch the video or receive the ACP checklist. We used standardized procedures across sites to minimize interaction between RAs and patients during the interview. Specifically, RAs were not permitted to comment or answer questions while the patient listened to the verbal narrative or answered the interview questions; control participants were instructed to ask any questions they may have regarding goals of care to their physicians.

We obtained verbal control participants' goals-of-care, CPR/intubation preferences, and knowledge prior to randomization during the baseline interview (baseline questionnaire), and then immediately after listening to the description of the goals of care (post-intervention questionnaire). Patients with questions after hearing the verbal description were referred back to their attending physician.

Data Collection and Outcomes

The baseline questionnaire included the following self-reported variables: age, race, gender, education, marital status, religion, health status, goals-of-care preferences, CPR/intubation preferences, and knowledge of ACP options.

We categorized patients' goals-of-care preferences as follows: 1) life-prolonging care; 2) limited medical care; 3) comfort care; or 4) unsure. We categorized patients' CPR preferences as “yes, attempt CPR”, “no, do not attempt CPR”, or “not sure”. Similarly, we categorized intubation preferences as “yes, attempt intubation”, “no, do not attempt intubation”, or “not sure”.

We assessed patients' knowledge of goals of care as in previous studies, using five true/false questions and one multiple choice question, each worth 1-point, for a summary score of 0-6 (higher score reflects greater knowledge) (Appendix D).^{7, 9, 10}

In both arms, the post-intervention questionnaire included the following self-reported variables: goals-of-care preferences, CPR/intubation preferences, and knowledge questions.

We also asked the attending physician for each participant to report what code status (full code; do not resuscitate (DNR); DNR and do not intubate; or do not hospitalize/comfort only/hospice) they would prefer for themselves if they were in the patient's situation (clinicians' preferences).

We conducted follow-up interviews with participants over the phone at one and three-month intervals after study enrollment. During the follow-up interviews, participants reported whether they had discussed goals of care with a clinician since the last study interview.

Statistical Analysis

All participants' characteristics and outcomes were summarized using frequency and percentage for categorical variables and means +/- standard deviation (SD) for continuous variables. The primary outcome was participants' stated goals-of-care preferences post-intervention which was defined as immediately after listening to the description of the goals of care for the verbal control arm, and immediately after listening to the description of the goals of care and viewing the video for the video-assisted intervention arm.

We compared goals-of-care preferences, CPR and intubation preferences between the video-assisted intervention and verbal control arms using chi-square tests. We used a two sample t-test to compare participants' mean knowledge scores between the two arms. To compare the agreement between participants' CPR and intubation preferences with their clinicians' code preferences, 16 participants without documented clinician's preference were excluded from the analysis. Participants who were uncertain about their preferences were considered as preferring CPR or intubation for this analysis. We used the kappa statistics to summarize the agreement for each study arm. Lastly, we used Fisher's exact tests to compare goals-of-care discussions (at follow-up at one month and three months) between the two arms limited to patients with follow-up at each time point.

All reported P values were two sided with a P < 0.05 considered statistically significant. We targeted a sample size of 246 subjects (123 subjects in each arm) to have 80% power for detecting a 20% absolute difference in preferences between the two groups assuming that 50% of participants in the control group would choose comfort care.

Results

Study Participants

A total of 682 patients were assessed for eligibility (Figure 1). Seventy-seven patients were excluded for clinical reasons as they did not meet eligibility criteria, 124 patients were excluded based on physician's request, and 167 were excluded for other reasons (Appendix Table S1). We approached 314 patients for study participation. Five patients failed the mental status examination, and 63 declined (20%).

Figure 1.

CONSORT Participant Flow Diagram.

Half of the 246 participants were randomized to the video-assisted intervention arm (N=123), and half to the verbal control arm (N=123). Participants were mostly Caucasian (85%) with a mean age of 81 (SD = 8), and 61% were male. Most participants had New York Heart Association Class III disease (91%) and 28% had an ICD (Table).

Table. Participants' baseline characteristics and preferences.

Variables	Verbal Control (N = 123)	Video Intervention (N = 123)	P-Value
Age, mean (SD), y	81 (9)	81 (8)	0.79
Women, N (%)	47 (38)	50 (41)	0.70
Race, N (%)			0.48
White	102 (83)	106 (86)
Black	17 (14)	11 (9)
Other	4 (3)	6 (5)
Education, N (%)			0.68
Elementary	10 (8)	6 (5)
Some high school	11 (9)	9 (7)
High school graduate	46 (37)	52 (42)
Some college	20 (16)	24 (20)
College graduate	16 (13)	18 (15)
Post-graduate	20 (16)	14 (11)
Religion, N (%)			0.61
Catholic	57 (46)	62 (50)
Christian (non-Catholic)	33 (27)	38 (31)
Jewish	12 (10)	9 (7)
Other	21 (17)	14 (11)
Marital status, N (%)			0.68
Married or with a partner	56 (46)	57 (46)
Widowed	46 (37)	40 (33)
Divorced	12 (10)	12 (10)
Single	9 (7)	14 (11)
Self-reported health status, N (%)			0.67
Excellent	4 (3)	1 (1)
Very good	14 (11)	12 (10)
Good	32 (26)	34 (28)
Fair	41 (33)	46 (37)
Poor	32 (26)	30 (24)
NYHA-Class, N (%)			0.36
II	0 (0)	2 (2)
III	112 (91)	111 (90)
IV	11 (9)	10 (8)
ICD, N (%)			0.89
Yes	36 (29)	34 (28)
Enrollment location, N (%)			0.99
Inpatient	62 (50.4)	61 (49.6)
Clinic or home	61 (49.6)	62 (50.4)
Baseline goals of care preferences, N (%)			0.61
Life prolonging care	38 (31)	46 (37)
Limited medical care	17 (14)	13 (11)
Comfort care	45 (37)	44 (36)
Not sure	23 (19)	19 (15)
Baseline CPR preferences N (%)			0.83
Yes	69 (56)	67 (54)
No	40 (33)	44 (36)
Not sure	14 (11)	12 (10)
Baseline intubation preferences, N (%)			0.80
Yes	50 (41)	55 (45)
No	57 (46)	54 (44)
Not sure	16 (13)	14 (11)
Baseline knowledge, mean (SD)	2.8 (1.5)	2.7 (1.4)	0.38

^*Percentages may not add to 100% due to missing data or rounding.

Goals-of-Care Preferences

Participants' goals-of-care preferences in both arms were similar at baseline (Table). Following the intervention, more participants in the video-assisted intervention arm preferred comfort care compared to those in the verbal control arm. In the video-assisted arm, 27 (22%) preferred life-prolonging care, 31 (25%) preferred limited medical care, 63 (51%) preferred comfort care, and two (2%) were uncertain. In the verbal control arm, 50 (41%) preferred life-prolonging care, 27 (22%) preferred limited medical care, 37 (30%) preferred comfort care, and eight (7%) were uncertain (P < 0.001) (Figure 2).

Figure 2.

Patients' post-intervention goals-of-care preferences.

CPR and Intubation Preferences

The proportion of participants in the video-assisted intervention and verbal control arms wanting to forgo CPR and intubation was similar at baseline (Table). Post intervention, more participants in the video-assisted intervention arm preferred to forgo CPR and intubation (68% and 76%, respectively) compared to those in the verbal control arm (35% and 48%, respectively) (P < 0.001, P < 0.001, respectively) (Figure 3).

Figure 3.

A: Patients' and clinicians' post-intervention CPR preferences.

B: Patients' and clinicians' post-intervention intubation preferences.

Knowledge Scores

Baseline knowledge scores were similar between the two groups at baseline (Table). After randomization, participants in the video-assisted intervention arm had higher mean knowledge scores compared to the control participants (4.1 +/- 1.4 vs. 3.0 +/- 1.5, P < 0.001).

Comparing Patients' and Clinicians' Preferences

A majority of clinicians would choose to forgo CPR and intubation for themselves if they were in the patient's situation (Figure 3). The concordance of clinicians' and patients' code preferences for CPR and intubation was higher in the video-assisted intervention arm (kappa=0.13 for CPR and kappa=0.14 for MV, respectively) than in the verbal control arm (kappa=-0.05 for CPR and kappa=0.06 for MV, respectively).

Follow-Up Goals-of-Care Conversations

One and three-month follow-ups were completed for 73 (59%) and 66 (53%) participants from the video-assisted intervention arm and 63 (51%) and 52 (42%) participants from the verbal control, respectively. The follow-up rates were not significantly different between groups (Appendix Table S2). At follow-up, participants randomized to the video-assisted intervention arm were more likely to report goals-of-care conversations with health care providers compared to verbal control participants at one month (40% vs. 6%, respectively, P < 0.001) and three months (61% vs. 15%, respectively, P < 0.001) (Figure 4).

Figure 4.

Patient-reported conversations with health care providers regarding their goals of care at one and three months follow-up.

Comfort with the Video

The video was highly acceptable to participants assigned the intervention. Among the 123 video-assisted intervention participants, 97 (79%) were “very comfortable,” 24 (20%) were “somewhat comfortable,” and 1 (1%) was “not comfortable” watching the video. When asked whether they would recommend the video to other patients, 101 (82%) would “definitely recommend,” 17 (14%) would “probably recommend,” and 4 (3%) would “not recommend” the video.

Discussion

This study evaluates an innovative approach to informing and involving patients with advanced heart failure in decisions surrounding their care. Video-assisted intervention patients were more knowledgeable about their care options, more likely to prefer medical care focused on quality of life and comfort, and more likely to prefer to forgo invasive interventions compared to patients in the verbal control group. Moreover, video-assisted intervention patients were more likely to make decisions that were concordant with the decisions that physicians caring for them anticipated making for themselves in the same situation, and were more likely to initiate ACP conversations with their providers.

This trial is an important step forward because heart disease is the leading cause of death worldwide and because ACP has been slow to come to this clinical arena.^{16, 17} Patients' underestimation of poor prognosis, clinicians' lack of communication training, and clinicians' uncertainty regarding the trajectory of heart failure partly account for the lack of ACP conversations.^18-20 However, patients and families deserve to learn their options regarding goals of care and to be able to make decisions and communicate them to someone who can help them meet those goals. Our approach using video decision support tools offers a scalable solution to enhance these conversations and ACP more broadly.

Videos help people foresee how they might feel about different health states, medical interventions, and the consequences of different actions.²¹ Decision support tools such as described in this paper can empower and activate patients, providers, and health systems to ensure patients receive medical care that is aligned with their preferences.²² Interestingly, when provided with a verbal narrative alone, control patients in this study changed towards desiring more life-prolonging measures in terms of their goals of care, although not statistically significant. It is plausible that at baseline prior to the verbal narrative, control patients did not have an understanding of this particular framework in terms of thinking about goals of care. Thus, their preferences after the verbal narrative reflect their exposure to these preferences. Notably, fewer patients were unsure of their preferences after the verbal narrative or the video intervention.

In this study, the video tool improved patients' understanding of their options, influenced their preferences, and served as a catalyst to actually having the conversation with their clinician, the rate-limiting step in patient-centered care.²³ Activating patients with advanced heart failure to initiate ACP conversations with their providers alleviates provider unease and uncertainty about discussing ACP under circumstances of prognostic uncertainty. Our video-assisted approach was designed to stimulate and supplement---not supplant---the conversations patients should have with their clinicians. We believe that the success of the intervention shows that patients can be empowered to engage clinicians in ACP, a focus of recent national guideline changes promoting ACP as the standard of care.² Video decision support tools can play a significant role in strengthening discussions with providers who may not feel comfortable having these discussions otherwise.

Our study has several important limitations. First, data collectors were not blinded to the randomization; while this may have introduced bias, previous randomized studies in ACP have seldom been blinded to ease the burden on participants of addressing sensitive topics and because the nature of such interventions makes blinding challenging. Second, our study included predominantly white patients limiting the generalizability of our findings. Third, in the intervention arm, patients viewed the video and received an ACP checklist. While the checklist is considered an important component of the intervention to remind patients to discuss ACP with their clinicians, we do not believe that the checklist itself accounts for the differences in outcomes seen with this study. Notably patients' preferences and knowledge about CPR were assessed before they had a chance to review the checklist. Fourth, while the video-assisted intervention led to more goals-of-care conversations between patients and providers, we do not have any information on documented ACP discussions such as advanced directives or Do-Not-Resuscitate Orders, or hospice utilization. Finally, visual media can be manipulated to favor a particular decision. We are quite sensitive to this concern and extensively vetted all aspects of the video with a range of stakeholders. Further, the fact that participants had an overwhelmingly positive impression of the video (96% recommend) and that the video led to increased knowledge is re-assuring.

As the Institute of Medicine recently pointed out, although ACP and effective communication between patients and physicians are recognized as a standard for high-quality care “achieving such a partnership is a challenge.”⁴ Medicare's recent interest in billing mechanisms for reimbursement related to ACP is clearly an attempt to stimulate such conversations.²⁴ Tools to empower patients and promote shared decision-making related to ACP can help ensure this time is well spent and may be required for payment. Video decision support tools provide a standardized and cost-effective means to address the immediate communication needs of our health care system and ensure that patients get care that reflects their well-informed wishes.

Clinical Perspective.

What is new?

• A video decision aid for patients with advanced heart failure encouraged patients to have advance care planning conversations with their physicians, better informed patients about their goals-of-care options, led to more patients desiring care focusing on comfort and avoiding cardiopulmonary resuscitation and intubation, and increased the incidence of patient-doctor conversation.

What are the clinical implications?

• Advance care planning Video decision aids stimulate and supplement patient-physician communication, enhance patients' understanding of their goals-of-care options, and ensure that patients get care that reflects their well-informed wishes.