An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine.

PURPOSE: Patients are frequently asked to share their personal health information. The objective of this study was to compare the effects on patient experiences of 3 electronic consent (e-consent) versions asking patients to share their health records for research. METHODS: A multi-arm randomized controlled trial was conducted from November 2017 through November 2018. Adult patients (n = 734) were recruited from 4 family medicine clinics in Florida. Using a tablet computer, participants were randomized to (1) a standard e-consent (standard), (2) an e-consent containing standard information plus hyperlinks to additional interactive details (interactive), or (3) an e-consent containing standard information, interactive hyperlinks, and factual messages about data protections and researcher training (trust-enhanced). Satisfaction (1 to 5), subjective understanding (0 to 100), and other outcomes were measured immediately, at 1 week, and at 6 months. RESULTS: A majority of participants (94%) consented to future uses of their health record information for research. No differences in study outcomes between versions were observed at immediate or 1-week follow-up. At 6-month follow-up, compared with the standard e-consent, participants who used the interactive e-consent reported greater satisfaction (B = 0.43; SE = 0.09; P <.001) and subjective understanding (B = 18.04; SE = 2.58; P <.001). At 6-month follow-up, compared with the interactive e-consent, participants who used the trust-enhanced e-consent reported greater satisfaction (B = 0.9; SE = 1.0; P <.001) and subjective understanding (B = 32.2; SE = 2.6, P <.001). CONCLUSIONS: Patients who used e-consents with interactive research details and trust-enhancing messages reported higher satisfaction and understanding at 6-month follow-up. Research institutions should consider developing and further validating e-consents that interactively deliver information beyond that required by federal regulations, including facts that may enhance patient trust in research.

Incorporating Patient Values in Large Language Model Recommendations for Surrogate and Proxy Decisions.

BACKGROUND: Surrogates, proxies, and clinicians making shared treatment decisions for patients who have lost decision-making capacity often fail to honor patients' wishes, due to stress, time pressures, misunderstanding patient values, and projecting personal biases. Advance directives intend to align care with patient values but are limited by low completion rates and application to only a subset of medical decisions. Here, we investigate the potential of large language models (LLMs) to incorporate patient values in supporting critical care clinical decision-making for incapacitated patients in a proof-of-concept study. METHODS: We simulated text-based scenarios for 50 decisionally incapacitated patients for whom a medical condition required imminent clinical decisions regarding specific interventions. For each patient, we also simulated five unique value profiles captured using alternative formats: numeric ranking questionnaires, text-based questionnaires, and free-text narratives. We used pre-trained generative LLMs for two tasks: 1) text extraction of the treatments under consideration and 2) prompt-based question-answering to generate a recommendation in response to the scenario information, extracted treatment, and patient value profiles. Model outputs were compared with adjudications by three domain experts who independently evaluated each scenario and decision. RESULTS AND CONCLUSIONS: Automated extractions of the treatment in question were accurate for 88% (n = 44/50) of scenarios. LLM treatment recommendations received an average Likert score by the adjudicators of 3.92 of 5.00 (five being best) across all patients for being medically plausible and reasonable treatment recommendations, and 3.58 of 5.00 for reflecting the documented values of the patient. Scores were highest when patient values were captured as short, unstructured, and free-text narratives based on simulated patient profiles. This proof-of-concept study demonstrates the potential for LLMs to function as support tools for surrogates, proxies, and clinicians aiming to honor the wishes and values of decisionally incapacitated patients.

Informed consent process in Alpha-1 testing of at-risk children: views of parents and adults tested as children.

Targeted testing programs are identifying increasing numbers of adults affected by Alpha-1 Antitrypsin Deficiency (Alpha-1) who are making decisions about genetic testing for their at-risk children. Although there are possible benefits, there are also potential risks. The purpose of this pilot study was to explore attitudes toward testing at-risk children from the first hand perspective of those involved, identify the benefits and risks experienced therein, and compare the views of parents and adults tested as children (ATC). The results of this pilot study suggest that ATC were significantly more favorable to including children in testing decisions than parents. ATC strongly indicated that they want to be involved in the testing decision and give permission prior to testing (p = 0.007). While the majority of ATC and parents were in favor of newborn screening for Alpha-1, parents had more extreme views, both positive and negative (p = 0.04). Both ATC and parents expressed significantly higher likelihoods of possible risks and benefits following Alpha-1 testing than they actually experienced. Results do not reveal serious harms from testing at-risk children. The two groups indicated that they want information regarding access to insurance, inheritance and expression, impact on anxiety, association with smoking, and usefulness in future planning prior to a decision to test or not to test at risk children. From the resulting data and ethical analysis we recommend that parents and children have relevant information prior to testing for Alpha-1 and that at risk children are directly involved in the decision-making process prior to testing.

Systematic Analysis of Extracting Data on Advance Directives from Patient Electronic Health Records (EHR) in Terminal Oncology Patients.

BACKGROUND: Advance directives are legal documents that include living wills and durable health care power of attorney documents. They are critical components of care for seriously ill patients which are designed to be implemented when a patient is terminally ill and incapacitated. We sought to evaluate potential reasons for why advance directives were not appropriately implemented, by reviewing the electronic health record (EHR) in patients with terminal cancer. METHODS: A retrospective analysis of the EHR of 500 cancer patients from 1/1/2013 to 12/31/2016 was performed. Data points were manually collected and entered in a central database. RESULTS: Of the 500 patients, 160 (32%) had an advance directive (AD). The most common clinical terminology used by physicians indicating a terminal diagnosis was progressive (36.6%) and palliative (31%). The most common clinical terminology indicating incapacity was altered mental status (25.6%), and not oriented (14%). 34 (6.8%) patients met all criteria of having a terminal diagnosis, a documented AD, and were deemed incapacitated. Of these patients who met all of these data points, their ADs were implemented on average 1.7 days (SD: 4.4 days) after which they should have been. This resulted in a total of 58 days of additional care provided. DISCUSSION: This study provided insight on to how ADs are managed in day to day practice in the hospital. From our analysis it appears that physicians are able to identify when a patient is terminal, however, it is typically later than it should have been recognized. Further studies should be performed focusing on harnessing the power of the EHR and providing physicians formative and evaluative feedback of practice patterns to ensure that ADs are honored when appropriate.

Does an interactive trust-enhanced electronic consent improve patient experiences when asked to share their health records for research? A randomized trial.

OBJECTIVE: In the context of patient broad consent for future research uses of their identifiable health record data, we compare the effectiveness of interactive trust-enhanced e-consent, interactive-only e-consent, and standard e-consent (no interactivity, no trust enhancement). MATERIALS AND METHODS: A randomized trial was conducted involving adult participants making a scheduled primary care visit. Participants were randomized into 1 of the 3 e-consent conditions. Primary outcomes were patient-reported satisfaction with and subjective understanding of the e-consent. Secondary outcomes were objective knowledge, perceived voluntariness, trust in medical researchers, consent decision, and time spent using the application. Outcomes were assessed immediately after use of the e-consent and at 1-week follow-up. RESULTS: Across all conditions, participants (N = 734) reported moderate-to-high satisfaction with consent (mean 4.3 of 5) and subjective understanding (79.1 of 100). Over 94% agreed to share their health record data. No statistically significant differences in outcomes were observed between conditions. Irrespective of condition, black participants and those with lower education reported lower satisfaction, subjective understanding, knowledge, perceived voluntariness, and trust in medical researchers, as well as spent more time consenting. CONCLUSIONS: A large majority of patients were willing to share their identifiable health records for research, and they reported positive consent experiences. However, incorporating optional additional information and messages designed to enhance trust in the research process did not improve consent experiences. To improve poorer consent experiences of racial and ethnic minority participants and those with lower education, other novel consent technologies and processes may be valuable. (An Interactive Patient-Centered Consent for Research Using Medical Records; NCT03063268).

Patient preferences toward an interactive e-consent application for research using electronic health records.

OBJECTIVE: The purpose of this study was to assess patient perceptions of using an interactive electronic consent (e-consent) application when deciding whether or not to grant broad consent for research use of their identifiable electronic health record (EHR) information. MATERIALS AND METHODS: For this qualitative study, we conducted a series of 42 think-aloud interviews with 32 adults. Interview transcripts were coded and analyzed using a modified grounded theory approach. RESULTS: We identified themes related to patient preferences, reservations, and mixed attitudes toward consenting electronically; low- and high-information-seeking behavior; and an emphasis on reassuring information, such as data protections and prohibitions against sharing data with pharmaceutical companies. Participants expressed interest in the types of information contained in their EHRs, safeguards protecting EHR data, and specifics on studies that might use their EHR data. DISCUSSION: This study supports the potential value of interactive e-consent applications that allow patients to customize their consent experience. This study also highlights that some people have concerns about e-consent platforms and desire more detailed information about administrative processes and safeguards that protect EHR data used in research. CONCLUSION: This study contributes new insights on how e-consent applications could be designed to ensure that patients' information needs are met when seeking consent for research use of health record information. Also, this study offers a potential electronic approach to meeting the new Common Rule requirement that consent documents contain a "concise and focused" presentation of key information followed by more details.

The problem with advance directives: maybe it is the medium, not the message.

Some of today's most significant bioethical challenges center around decisions to initiate or withhold medical treatment for incapacitated patients. In order to ascertain what treatment the patient would have desired, physicians often rely on written advance directives and designated surrogate decision-makers. Unfortunately, both approaches suffer from numerous shortcomings that ultimately limit their usefulness. Although several strategies have been proposed to improve their value, problems nevertheless remain when relying upon written advance directives. We submit that the problem is the medium, not the message-that written advance directives and/or reliance on surrogate decision-makers are fundamentally inadequate. We hypothesize that videotaped advance directives (VADs) can better communicate the specifics, depth, strength and passion of a patient's wishes, more closely approximating the communication that occurs when a physician discusses these issues directly with a patient. VADs may thus enhance the physician's understanding of the patient's wishes. VADs may also ease family conflict and save physician's considerable time by helping family members reach a stronger consensus on the patient's wishes, and do so in a timelier manner. This article reviews the limitations of written advance directives and surrogate decision-makers and describes why VADs may be helpful in overcoming these limitations.

Advancing End-of-Life Care: lessons learned from a statewide panel.

The Florida Panel for the Study of End-of-Life Care was an innovative and effective approach to the formulation of end-of-life (EOL) policy recommendations that significantly influenced the legislative process and resulted in new EOL legislation. The lessons from this panel's experience are useful to other states considering legislative changes in their EOL policies. Key to the success of the EOL panel was its heterogeneous membership that allowed the collaboration of policy makers, clinicians, ethicists, citizens, and other stakeholders. Also, crucial to the success of the panel were the dimensions of the deliberative process embraced by the panel. This process supported an impressive level of mutual respect, trust, and openness among the panel members that, with only minor exceptions, allowed the members of the panel to rise above the parochial political battles that have often preempted serious debate on controversial EOL issues. The recommendations of the EOL panel led to new state laws on EOL care and improvements in public awareness, professional education, and clinical protocols for implementing patients' wishes. Another major but largely unforeseen consequence of the EOL panel was the development of significant new working alliances among members and organizations. These alliances led to new projects on EOL care and have significantly improved communication and working relationships between organizations and individuals committed to improving EOL care.