JMIR Publications

ABSTRACT

Background:

Traumatic injury is responsible for >950,000 hospitalizations in adults over 65 years of age each year.(1) The American College of Surgeons Best Practice Guidelines advise that care for this vulnerable group should include a discussion regarding goals for life-sustaining care (sometimes referred to as “code status”) upon admission.2 However, there are multiple barriers to having effective code status discussions with older injured patients, and the majority of injured older adults do not receive this counseling.20 Randomized trials have demonstrated that video-based interventions are associated with deeper patient understanding and with patient choice that avoids acute cardiopulmonary resuscitation.22 There is limited data for the effectiveness of video-based interventions in the acutely injured population. One identified barrier is the lack of understanding many patients have of the associated risks and benefits of cardiopulmonary resuscitation (CPR) and preconceived unrealistic expectations of its success.3,4 As one of the largest physician barriers to providing code status discussions is time limitation, this lack of knowledge regarding CPR is often never addressed.5-7 When discussions do occur, physicians often use medical jargon and infrequently provide prognostic information.5 As a result, code status discussions are often brief and ineffective at communicating and increasing understanding of life-sustaining interventions, limiting the ability of patients and surrogate decision-makers to make informed decisions about critical care goals.6-8

Objective:

This multidisciplinary, collaborative research project will evaluate the effectiveness of a video aid to improve communication and patient-centered outcomes in older injured adults. This video conversation aid is not intended to replace code status discussions between patients and providers, but to promote these discussions. The goal is to overcome identified barriers to adequate code status discussions including providing a clear message with no medical jargon, supplying accurate prognostic information, and ultimately enhancing informed consent so that patients can ensure that their care choices align with their preferences. We hypothesize that our video aid will increase the rate of code status transitions, with more patients documenting their code status. Additionally, we hypothesize our video aid will improve knowledge of life sustaining care and increase code status discussions.

Methods:

The trial is registered at ClinicalTrials.gov (Identifier: NCT06804226) and was designed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials 2013 guidelines.9 This study was evaluated by the University of Texas at Houston IRB and determined to be exempt (HSC-MS-24-1256). Study Setting: Our trial will be conducted at the Red Duke Trauma Institute at Memorial Hermann- Texas Medical Center. This center is 1 of only 2 adult Level 1 trauma centers in the city of Houston and serves over 7 million people. Approximately 200 geriatric (65yo +) trauma patients are admitted per month, leading to over 2,800 total older adult inpatients per year. Study Population All English or Spanish-speaking patients aged 65 or older admitted to any level of care following traumatic injury will be screened for study eligibility. Patients will be excluded for the following reasons: 1) Prisoners 2) Existing DNR/DNI 3) Patients admitted while on hospice 4) Patients not expected to survive over 24-48 hours. All patients who meet eligibility criteria will be offered enrollment within 48 hours whenever feasible. Intervention Group: A video conversation aid that provides information about life-sustaining care and encourages further goals-of-care discussions with a healthcare provider will be shown to patients or their surrogates upon admission or within 48 hours, whenever feasible. The video aid is available in both English and Spanish. Surrogates are required for patients who are incapacitated and unable to make their own informed, rational decisions regarding their medical care. This video will be administered by a research assistant who is not part of the patient’s care team. The script for the video was created by a multidisciplinary team of emergency medicine, palliative care, geriatric medicine, internal medicine, and trauma surgery disciplines. After consensus agreement from providers, the script for the video aid was revised based on feedback from community patient representatives and patients. Adjustments were made to simplify medical language based on feedback and to accommodate patients with low health literacy. The final video was produced by the Kashu animation company at a 4th grade reading level in English and Spanish versions. Usual Care Group: Patients and/or surrogates will participate in discussions surrounding life-sustaining care at healthcare providers’ discretion. This task is most often completed by resident physicians, but there is no standardization regarding participants or timing. Procedures and Outcomes: A research assistant will administer a survey to each participant electronically via QuestionPro® at discharge. For patients who die during admission, surrogate decision-makers will be contacted after discharge. Demographics, injury characteristics, length of stay, pre-existing advanced directives, and disposition will be collected using the institutional trauma registry. Each participant will be assigned a study-specific number. The Primary Outcome will be the rate of transition(s) in code status. Prior institutional data showed that a minority of patients have advanced directives or code status discussions with their providers; therefore, this serves as a proxy for increased patient or surrogate knowledge. Secondary Outcomes will include perceived successfulness of CPR, knowledge of life-sustaining care outcomes and complications following CPR, participant desire for more information regarding life-sustaining care, hospital-free days, intensive care unit (ICU)-free days, ventilator-free days, discharge disposition, decisional conflict score, and rate of interventional procedures (e.g., tracheostomy, feeding tube placement, dialysis initiation). The remaining secondary outcomes will be collected from the electronic medical record. Informed Consent: A waiver of written consent was granted by the UTHealth Houston IRB based on category III exemption and 45 Code of Federal Regulations 46, as the intervention does not pose more than minimal risk to patients or caregivers.23 The informative video can be considered a “benign behavioral intervention that is brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and there is no reason to think the subjects will find the interventions offensive or embarrassing.”21 Additionally, there is no standard of care regarding optimal patient decisional counseling and this intervention is a reasonable strategy for usual care. Therefore, we will obtain verbal consent for enrollment and patients will receive a letter of intent prior to survey completion. Randomization and Blinding This is a single-center randomized trial. Randomization will be performed in a 1:1 ratio between the intervention and usual care groups using REDCap. We plan to stratify based on whether the patient or a surrogate watches the video aid. Allocation will be performed by the REDCap randomization module, after which a research assistant will administer the intervention. The video will be administered by the research assistant; thus, providers will be blinded to treatment group. The project statistician will be blinded to group assignment. Sample Size Calculation: We will plan to conduct the largest feasible RCT over 18 months of enrollment. We conservatively estimate that at least 15 patients will be enrolled per month, with the potential for 270 randomized patients during the study period. A Bayesian analysis will be performed to estimate the probability of treatment benefit. This estimate is based on recommendations for pilot trials with limited sample size and power in frequentist analyses to identify conclusive treatment effects.10 Data Analysis Plan: Analysis will be performed on a per-patient basis. For patients who are incapacitated and unable to consent for themselves, their surrogate decision-makers will serve as the subject for analysis. The number of screened patients and reasons for exclusion will be reported. Protocol violations and reasons for those violations will be reported and detailed. All analyses will be based on the intention-to-treat principle. Regarding the primary endpoint, we will estimate the risk ratio (RR) between the intervention and usual care groups, together with a 95% Wald confidence interval. For other outcome variables, we will implement two-group comparisons by using the Wald test for dichotomous variables and the Wilcoxon rank sum test for continuous variables. Hospital-free days, ICU-free days, and ventilator-free days are, respectively, the numbers of days free of hospital stays, ICU stays, and ventilator use in the first 30 days after admission.11 In case of a death event, these variables are set to value zero. The PI will audit data collection to ensure the data are accurate, consistent, complete, and reliable. For the primary endpoint, in addition to the frequentist inference, we will also conduct Bayesian analysis to enhance the knowledge gained from the study. Bayesian analysis enhances the clinical decision-making process by integrating existing evidence with data from a new study to estimate the probability of an outcome of interest. In contrast, Frequentist analysis assesses the likelihood of observing the obtained results or more extreme outcomes. For each group, we will use the conjugate beta prior for the probability of transition in code status. The parameter values for beta distribution will be chosen to center a symmetric distribution at 0.5, and the corresponding distribution for RR will be centered at 1 with a credible interval of 0.5-2.0, resulting in a neutral prior.19 Additionally, we will perform sensitivity analysis by identifying suitable beta prior distributions to generate enthusiastic and skeptical priors. We will use the software JAGS (version 4.3.2) for Bayesian analysis. All other statistical analyses will be performed by using the SAS software (version 9.4, the SAS Institute, Cary, NC). We plan to perform several subgroup analyses including comparison based on race, gender, health literacy assessed via the validated BRIEF Health Literacy Screening Tool25, and surrogate vs patient observing the video. Management of Data Information and data from patients included in the study will be accessed only by designated study personnel and the data will be collected in a secure database and de-identified. Research Approval The IRB of McGovern Medical School at UTHealth Houston approved the study protocol on January 21st 2025. Enrollment began on March 15th 2025 and is scheduled to continue for 18 months.

Results:

Discussion Video-based interventions to inform code status have been reported to be effective in empowering patients to make informed choices regarding advanced care and improving knowledge; studies of these interventions are often limited to oncology, medicine, and outpatient settings.12-17 Previous single-center studies conducted in medical ICUs have found video interventions beneficial in improving resident comfort with conducting code status discussions.17 Additionally, patients and surrogates who received a video intervention demonstrated a better understanding of CPR, resuscitation terminology, and medical resuscitation options.16 A single-center RCT conducted on admitted medicine patients found that those receiving a video intervention were more likely to choose do-not-resuscitate and do-not-intubate status over full code status.18 Video conversation aids to improve code status discussions have not been evaluated in geriatric trauma patients. Proposed benefits of a video-based intervention include overcoming time constraints and discomfort with difficult conversations of the healthcare team; video aids also allow for standardization of information conveyed and adjustment for low health literacy. On the other hand, video-based interventions may not overcome the problem of limited prognostic information. It is unknown whether a video-based intervention would prompt earlier and more comprehensive discussions about life-sustaining care or inhibit them.16 The proposed project is innovative in that it aims to evaluate and implement an intervention in a unique patient population – geriatric trauma patients – that has not been previously studied. This trial will evaluate the effectiveness of our video intervention by measuring the rate of code status transitions and assessing baseline knowledge of CPR and code status. We expect that a minority of patients have advanced directives. Additionally, most patients do not receive adequate counseling regarding goals for life-sustaining care. Limitations One major limitation to our study is that our video intervention will only be offered in English or Spanish and thus our results are not applicable to patients who speak other languages. Limited English proficiency has been associated with reduced decision-making ability and poor doctor-patient communication.24 Lastly, the results may not be generalizable since this is a single center trial.

Conclusions:

In summary, the ADVISE trial builds upon previous research on geriatric trauma patients and advanced care planning, utilizing a video intervention to enhance code status discussions in this specific patient population. We anticipate that our video conversation aid will be an effective means to increase patient/surrogate knowledge regarding goals for life-sustaining care and will empower patients to have a discussion with their provider regarding their healthcare goals. Clinical Trial: The trial is registered at ClinicalTrials.gov (Identifier: NCT06804226)