The protocol was approved by the institutional review board for both institutions and all subjects provided informed consent. This study was part of a larger study evaluating the use of video decision-support tools in advance care planning.17
Elderly patients participating in the larger study whose surrogates were present during the clinic visit were asked to participate in the present study. Patients and their surrogates were recruited from a convenience sample at 2 urban geriatric clinics affiliated with 2 teaching hospitals in the greater Boston area. Recruitment occurred between September 1, 2007, and May 30, 2008. All scheduled English-speaking patients 65 years or older who presented to the clinic with their designated surrogate were given a flier by the clinic staff outlining the study. At the end of the clinic visit, patients and surrogates were asked by clinic staff if they were interested in participating in the study. If they indicated interest, the patient was brought to a private room alone and was initially interviewed for eligibility based on a Short Portable Mental Status Questionnaire (SPMSQ)18
score of greater than or equal to 7 (scores <7 indicate moderate or severe cognitive impairment) and the ability to provide informed consent. After the patient completed the interview, the surrogate, who was not present during the patient’s interview, was then brought into the private room and completed the interview separately. Inclusion criteria for the surrogate were ability to provide informed consent and being the patient’s designated surrogate.
Study Design and Randomization
After obtaining informed consent from both the patient and the surrogate, all patient-surrogate dyads were randomized into 1 of 2 decision-making modalities: (1) listening to a verbal narrative describing advanced dementia (control group); or (2) listening to a verbal narrative followed by viewing a 2-minute video decision-support tool visually depicting a patient with advanced dementia (intervention group). Randomization was based on a computer-generated randomization scheme, and followed the randomization order of the larger study from which this subgroup was taken. Individual assignments were concealed in numbered envelopes until the pair was randomized. All data were collected in a quiet room in the clinic area by a trained member of the research team (A.E.V.) who followed a structured script. The patient and surrogate were interviewed separately and were unaware of each other’s answers to the survey.
For both randomization groups, the interviewer read aloud a description of advanced dementia based on the Functional Assessment Staging (FAST)19
stage 7a. The FAST criteria include 7 stages of dementia (1–7), with the later stages depicting more advanced disease. Stage 7 is further broken down into 6 substages (7a–7f). Stage 7a is generally considered the threshold for advanced dementia, and the threshold for advanced dementia used in our previous studies.14
Advanced dementia was described as an incurable illness of the brain caused by many years of Alzheimer’s disease or a series of strokes; its salient features are the inability to communicate understandably with others, inability to walk without assistance, and inability to feed oneself (see Appendix 1
Patients randomized to the intervention group viewed the video decision support tool on a portable computer after listening to the same verbal narrative. The 2-minute video depicts the principal features of advanced dementia as described in the narrative. The video presents an 80-year-old female patient with advanced dementia together with her 2 daughters in the nursing home setting. The patient fails to respond to their attempts at conversation (inability to communicate). The patient is next shown being pushed in a wheelchair (inability to ambulate). Last, the patient is hand-fed pureed food (inability to feed oneself). Consent to film the patient with advanced dementia and to use the video for research purposes was obtained from the patient’s designated health care proxy before filming.
The development of the video followed a systematic approach,20
starting with a review of the dementia literature. We then used a panel of physicians with an iterative process of comments to review the design, content, and structure of the video intervention. This panel included 5 geriatricians and 5 neurologists, all of whom specialize in the care of patients with dementia.
The video was filmed without the use of prompts or stage directions to convey a candid realism in the style known as cinema verite.21
All filming and editing were done by the principal investigator (A.E.V.) following previously published filming criteria.22
(The video is available at: www.ACPdecisions.com
Data Collection and Other Variables
The interviewer was not blinded to randomization group. Each patient was interviewed before and after receiving the verbal narrative alone or the narrative plus the video decision-support tool using structured questionnaires. The baseline structured interview (15 minutes) included the following components: demographic data and knowledge about advanced dementia. Sociodemographic data included age, race, gender, educational status, and marital status. Race was self-reported. Having a previous relationship with someone with advanced dementia was also obtained. Knowledge of advanced dementia was assessed using 5 true/false questions that asked patients and their surrogates whether advanced dementia is curable and if patients with advanced dementia are able to communicate with others, recognize family members, ambulate, and feed themselves. Thus, knowledge scores ranged from 0 to 5, with higher scores indicating better knowledge.
Immediately after receiving the verbal narrative alone or narrative plus video, a second structured in-person interview (15 minutes) was conducted that included the following components: knowledge of advanced dementia and preferences for goals of care; and for the intervention group, comfort using the video decision-support tool. The knowledge questions were identical to those asked in the baseline interview.
Each surrogate, who was not present during the interview with the patient and was unaware of the patient’s answers, was asked an identical set of questions with the sole exception that each surrogate was asked to predict the preferences for the goals of care for their loved one using the substituted judgment criterion.
Preferences for goals of care were presented as 3 options: life-prolonging care, limited care, and comfort care (see Appendix 1
). Examples of the kinds of care implied by each goal were verbally described to participants. The first option, life-prolonging care, was described as aiming to prolong life at any cost. It translates into all potentially indicated medical care that is available in a modern-day hospital, including cardiopulmonary resuscitation and treatment in the intensive care unit. The second option, limited care, was described as aiming to maintain physical functioning. It is consistent with treatments such as hospitalization, intravenous fluids, and antibiotics, but not with attempted cardiopulmonary resuscitation (CPR) and treatment in the intensive care unit (ICU). The third option, comfort care, was described as aiming to maximize comfort and to relieve pain. Treatments are focused on the relief of symptoms. It is compatible with oxygen and analgesics but not with intravenous (IV) therapies and hospitalization unless necessary to provide comfort. The aim is to relieve pain and to be kept as pain-free as possible. Comfort care does not include CPR, respirators, ICU care, and generally would not include IV therapy or hospitalization. Following these explanations, patients were asked their preferences in the event they developed advanced dementia. Surrogates were asked to predict which preference their loved ones would pick.
For those patients and surrogates randomized to the video intervention group, a 4-point Likert scale was used to assess perceived value of the video by asking them whether they had a better understanding of the disease after viewing the video, if they were comfortable watching the video, and if they would recommend the video to others. These questions were asked at the end of the oral survey. The survey is available on request.
Patient-surrogate dyads were analyzed based on the decision-making modality to which they were randomized. The primary outcome measure for patients was their preferences for care if in a state of advanced dementia categorized as 3 options (life-prolonging, limited, or comfort). The primary outcome measure for surrogates was the preferences they felt their loved one would choose based on the substituted judgment criterion. Additional outcomes included change in knowledge scores for both patients and subjects before compared with after receiving the verbal narrative or video.
All subject characteristics and outcomes were described using proportions for categorical variables and means (SD) for continuous variables. Concordance rates for patient-surrogate dyads were the proportions of surrogates who chose the same preference as their loved one over the total number of dyads in the randomization group. Chi-square tests were used to compare the concordance rate and 2 sample t tests were used to compare change in knowledge scores from before to after the intervention between the 2 randomization groups. All reported P values are 2-sided, with P <.05 considered as statistically significant. Data were analyzed using SAS software, version 9.1 (SAS Institute Inc, Cary, NC).