Video Intervention and Goals-of-Care Documentation in Hospitalized Older Adults: The VIDEO-PCE Randomized Clinical Trial.

Importance: Despite the benefits of goals-of-care (GOC) communication, many hospitalized individuals never communicate their goals or preferences to clinicians. Objective: To assess whether a GOC video intervention delivered by palliative care educators (PCEs) increased the rate of GOC documentation. Design, Setting, and Participants: This pragmatic, stepped-wedge cluster randomized clinical trial included patients aged 65 years or older admitted to 1 of 14 units at 2 urban hospitals in New York and Boston from July 1, 2021, to October 31, 2022. Intervention: The intervention involved PCEs (social workers and nurses trained in GOC communication) facilitating GOC conversations with patients and/or their decision-makers using a library of brief, certified video decision aids available in 29 languages. Patients in the control period received usual care. Main Outcome and Measures: The primary outcome was GOC documentation, which included any documentation of a goals conversation, limitation of life-sustaining treatment, palliative care, hospice, or time-limited trials and was obtained by natural language processing. Results: A total of 10 802 patients (mean [SD] age, 78 [8] years; 51.6% male) were admitted to 1 of 14 hospital units. Goals-of-care documentation during the intervention phase occurred among 3744 of 6023 patients (62.2%) compared with 2396 of 4779 patients (50.1%) in the usual care phase (P < .001). Proportions of documented GOC discussions for Black or African American individuals (865 of 1376 [62.9%] vs 596 of 1125 [53.0%]), Hispanic or Latino individuals (311 of 548 [56.8%] vs 218 of 451 [48.3%]), non-English speakers (586 of 1059 [55.3%] vs 405 of 863 [46.9%]), and people living with Alzheimer disease and related dementias (520 of 681 [76.4%] vs 355 of 570 [62.3%]) were greater during the intervention phase compared with the usual care phase. Conclusions and Relevance: In this stepped-wedge cluster randomized clinical trial of older adults, a GOC video intervention delivered by PCEs resulted in higher rates of GOC documentation compared with usual care, including among Black or African American individuals, Hispanic or Latino individuals, non-English speakers, and people living with Alzheimer disease and related dementias. The findings suggest that this form of patient-centered care delivery may be a beneficial decision support tool. Trial Registration: ClinicalTrials.gov Identifier: NCT04857060.

Forms or Free-Text? Measuring Advance Care Planning Activity Using Electronic Health Records.

Advance care planning (ACP) discussions seek to guide future serious illness care. These discussions may be recorded in the electronic health record by documentation in clinical notes, structured forms and directives, and physician orders. Yet, most studies of ACP prevalence have only examined structured electronic health record elements and ignored data existing in notes. We sought to investigate the relative comprehensiveness and accuracy of ACP documentation from structured and unstructured electronic health record data sources. We evaluated structured and unstructured ACP documentation present in the electronic health records of 435 patients with cancer drawn from three separate healthcare systems. We extracted structured ACP documentation by manually annotating written documents and forms scanned into the electronic health record. We coded unstructured ACP documentation using a rule-based natural language processing software that identified ACP keywords within clinical notes and was subsequently reviewed for accuracy. The unstructured approach identified more instances of ACP documentation (238, 54.7% of patients) than the structured ACP approach (187, 42.9% of patients). Additionally, 16.6% of all patients with structured ACP documentation only had documents that were judged as misclassified, incomplete, blank, unavailable, or a duplicate of a previously entered erroneous document. ACP documents scanned into electronic health records represent a limited view of ACP activity. Research and measures of clinical practice with ACP should incorporate information from unstructured data.

A Pilot Randomized Trial of an Advance Care Planning Video Decision Support Tool for Adolescents and Young Adults With Advanced Cancer.

BACKGROUND: Adolescents and young adults (AYAs) with advanced cancer often receive intensive end-of-life care, yet it is unclear if this is goal-concordant. Advance care planning (ACP) video tools may promote identification and communication of AYA preferences. PATIENTS AND METHODS: We conducted a dual-site, 1:1 pilot randomized controlled trial of a novel video-based ACP tool in 50 dyads of AYA patients aged 18 to 39 years with advanced cancer and their caregivers. ACP readiness and knowledge, preferences for future care, and decisional conflict were obtained pre, post, and 3 months after the intervention and compared between groups. RESULTS: Of the 50 AYA/caregiver dyads enrolled, 25 (50%) were randomized to the intervention. Participants primarily identified as female, white, and non-Hispanic. Most AYAs (76%) and caregivers (86%) identified their overall goal as life-prolonging preintervention; less identified this goal postintervention (42% AYAs; 52% caregivers). There was no significant difference in change in proportion of AYAs or caregivers choosing life-prolonging care, CPR, or ventilation between arms postintervention or at 3 months. The change in participant scores for ACP knowledge (AYAs and caregivers) and ACP readiness (AYAs) from preintervention to postintervention was greater in the video arm compared with the control arm; the difference in caregivers' scores for decisional conflict from preintervention to postintervention in the video arm was statistically significant (15 vs 7; P=.005). Feedback from the video participants was overwhelmingly positive; of the 45 intervention participants who provided video feedback, 43 (96%) found the video helpful, 40 (89%) were comfortable viewing the video, and 42 (93%) indicated they would recommend the video to other patients facing similar decisions. CONCLUSIONS: Most AYAs with advanced cancer and their caregivers preferred life-prolonging care in advanced illness, with fewer preferring this type of care postintervention. A brief video-based ACP tool was well-liked by participants and improved caregiver decisional certainty. Videos may be a useful tool to inform AYAs and caregivers about end-of-life care options and promote ACP discussions.

"There is No Communication": A Qualitative Examination of Deaf Signers' Experiences With Advance Care Planning.

Objective(s): Deaf American Sign Language (ASL) users are subject to health care disparities resulting from communication and language barriers. Currently, few resources on advance care planning and end-of-life care exist in ASL. This study explores Deaf ASL users' perceptions and experiences with end-of-life care and advance care planning. Methods: Semi-structured 1:1 interviews with Deaf signers were translated, and transcribed into English by a bilingual researcher. Investigators inductively coded transcripts and identified themes of barriers, facilitators, knowledge, and sources of information regarding end-of-life care. Participants' knowledge of advance care planning and completion of advance care planning documents were evaluated using a brief assessment. Results: Eleven Deaf ASL users participated in the study with two deaf interviewers. Participants reported barriers to end-of-life care including poor provider communication, inaccessible sources, and inadequate provision of accommodations, leading to patient distrust. Participants' understanding of advance care planning was facilitated by accessible forms of communication and their social networks, such as family, friends, and Deaf peers. Participants primarily gained information on end-of-life care from first-hand familial experience, peers, and media. Participants' mean advance care planning knowledge was 4.6 out of 15 (SD = 2.6). Conclusions: Deaf ASL users face scarce accessible resources around end-of-life care, lowering their ability to understand and proceed with advance care planning. Implementation of ASL accessible advance care planning educational tools in health care settings is needed.

Association of an Advance Care Planning Video and Communication Intervention With Documentation of Advance Care Planning Among Older Adults: A Nonrandomized Controlled Trial.

Importance: COVID-19 has disproportionately killed older adults and racial and ethnic minority individuals, raising questions about the relevance of advance care planning (ACP) in this population. Video decision aids and communication skills training offer scalable delivery models. Objective: To assess whether ACP video decision aids and a clinician communication intervention improved the rate of ACP documentation during an evolving pandemic, with a focus on African American and Hispanic patients. Design, Setting, and Participants: The Advance Care Planning: Communicating With Outpatients for Vital Informed Decisions trial was a pre-post, open-cohort nonrandomized controlled trial that compared ACP documentation across the baseline pre-COVID-19 period (September 15, 2019, to March 14, 2020), the COVID-19 wave 1 period (March 15, 2020, to September 14, 2020), and an intervention period (December 15, 2020, to June 14, 2021) at a New York metropolitan area ambulatory network of 22 clinics. All patients 65 years or older who had at least 1 clinic or telehealth visit during any of the 3 study periods were included. Main Outcomes and Measures: The primary outcome was ACP documentation. Results: A total of 14 107 patients (mean [SD] age, 81.0 [8.4] years; 8856 [62.8%] female; and 2248 [15.9%] African American or Hispanic) interacted with clinicians during the pre-COVID-19 period; 12 806 (mean [SD] age, 81.2 [8.5] years; 8047 [62.8%] female; and 1992 [15.6%] African American or Hispanic), during wave 1; and 15 106 (mean [SD] 80.9 [8.3] years; 9543 [63.2%] female; and 2535 [16.8%] African American or Hispanic), during the intervention period. Clinicians documented ACP in 3587 patients (23.8%) during the intervention period compared with 2525 (17.9%) during the pre-COVID-19 period (rate difference [RD], 5.8%; 95% CI, 0.9%-7.9%; P = .01) and 1598 (12.5%) during wave 1 (RD, 11.3%; 95% CI, 6.3%-12.1%; P < .001). Advance care planning was documented in 447 African American patients (30.0%) during the intervention period compared with 233 (18.1%) during the pre-COVID-19 period (RD, 11.9%; 95% CI, 4.1%-15.9%; P < .001) and 130 (11.0%) during wave 1 (RD, 19.1%; 95% CI, 11.7%-21.2%; P < .001). Advance care planning was documented for 222 Hispanic patients (21.2%) during the intervention period compared with 127 (13.2%) during the pre-COVID-19 period (RD, 8.0%; 95% CI, 2.1%-10.9%; P = .004) and 82 (10.2%) during wave 1 (RD, 11.1%; 95% CI, 5.5%-14.5%; P < .001). Conclusions and Relevance: This intervention, implemented during the evolving COVID-19 pandemic, was associated with higher rates of ACP documentation, especially for African American and Hispanic patients. Trial Registration: ClinicalTrials.gov Identifier: NCT04660422.

Effect of a Video-Assisted Advance Care Planning Intervention on End-of-Life Health Care Transitions Among Long-Stay Nursing Home Residents.

OBJECTIVE: To determine the relationship between an advance care planning (ACP) video intervention, Pragmatic Trial of Video Education in Nursing Homes (PROVEN), and end-of-life health care transitions among long-stay nursing home residents with advanced illness. DESIGN: Pragmatic cluster randomized clinical trial. Five ACP videos were available on tablets or online at intervention facilities. PROVEN champions employed by nursing homes (usually social workers) were directed to offer residents (or their proxies) ≥1 video under certain circumstances. Control facilities employed usual ACP practices. SETTING AND PARTICIPANTS: PROVEN occurred from February 2016 to May 2019 in 360 nursing homes (119 intervention, 241 control) owned by 2 health care systems. This post hoc study of PROVEN data analyzed long-stay residents ≥65 years who died during the trial who had either advanced dementia or cardiopulmonary disease (advanced illness). We required an observation time ≥90 days before death. The analytic sample included 923 and 1925 advanced illness decedents in intervention and control arms; respectively. METHODS: Outcomes included the proportion of residents with 1 or more hospital transfer (ie, hospitalization, emergency department use, or observation stay), multiple (≥3) hospital transfers during the last 90 days of life, and late transitions (ie, hospital transfer during the last 3 days or hospice admission on the last day of life). RESULTS: Hospital transfers in the last 90 days of life among decedents with advanced illness were significantly lower in the intervention vs control arm (proportion difference = -1.7%, 95% CI -3.2%, -0.1%). The proportion of decedents with multiple hospital transfers and late transitions did not differ between the trial arms. CONCLUSIONS AND IMPLICATIONS: Video-assisted ACP was modestly associated with reduced hospital transfers in the last 90 days of life among nursing home residents with advanced illness. The intervention was not significantly associated with late health care transitions and multiple hospital transfers.

Impact of an Advance Care Planning Video Intervention on Care of Short-Stay Nursing Home Patients.

BACKGROUND/OBJECTIVES: To assess whether an advance care planning (ACP) video intervention impacts care among short-stay nursing home (NH) patients. DESIGN: PRagmatic trial of Video Education in Nursing Homes (PROVEN) was a pragmatic cluster randomized clinical trial. SETTING: A total of 360 NHs (N = 119 intervention, N = 241 control) owned by two healthcare systems. PARTICIPANTS: A total of 2,538 and 5,290 short-stay patients with advanced dementia or cardiopulmonary disease (advanced illness) in the intervention and control arms, respectively; 23,302 and 50,815 short-stay patients without advanced illness in the intervention and control arms, respectively. INTERVENTION: Five ACP videos were available on tablets or online. Designated champions at each intervention facility were instructed to offer a video to patients (or proxies) on admission. Control facilities used usual ACP practices. MEASUREMENTS: Follow-up time was at most 100 days for each patient. Outcomes included hospital transfers per 1000 person-days alive and the proportion of patients experiencing more than one hospital transfer, more than one burdensome treatment (tube-feeding, parenteral therapy, invasive mechanical intervention, and intensive care unit admission), and hospice enrollment. Champions recorded whether a video was offered in the patients' electronic medical record. RESULTS: There was no significant reduction in hospital transfers per 1000 person-days alive in the intervention versus control groups with advanced illness (rate (95% confidence interval (CI)), 12.3 (11.6-13.1) vs 13.2 (12.5-13.7); rate difference: -0.8; 95% CI = -1.8-0.2)). There was a nonsignificant reduction in hospital transfers per 1000 person-days alive in the intervention versus control among short-stay patients without advanced illness. Secondary outcomes did not differ between groups among patients with and without advanced illness. Based on champion only reports 14.2% and 15.3% of eligible short-stay patients with and without advanced illness were shown videos, respectively. CONCLUSION: An ACP video program did not significantly reduce hospital transfers, burdensome treatment, or hospice enrollment among short-stay NH patients; however, fidelity to the intervention was low.

Use of a Supportive Kidney Care Video Decision Aid in Older Patients: A Randomized Controlled Trial.

BACKGROUND: There are few studies of patient-facing decision aids that include supportive kidney care as an option. We tested the efficacy of a video decision aid on knowledge of supportive kidney care among older patients with advanced CKD. METHODS: Participants (age ≥ 65 years with advanced CKD) were randomized to receive verbal or video education. Primary outcome was knowledge of supportive kidney care (score range 0-3). Secondary outcomes included preference for supportive kidney care, and satisfaction and acceptability of the video. RESULTS: Among all participants (n = 100), knowledge of supportive kidney care increased significantly after receiving education (p < 0.01); however, there was no difference between study arms (p = 0.68). There was no difference in preference for supportive kidney care between study arms (p = 0.49). In adjusted analyses, total health literacy score (aOR 1.08 [95% CI: 1.003-1.165]) and nephrologists' answer of "No" to the Surprise Question (aOR 4.87 [95% CI: 1.22-19.43]) were associated with preference for supportive kidney care. Most felt comfortable watching the video (96%), felt the content was helpful (96%), and would recommend the video to others (96%). CONCLUSIONS: Among older patients with advanced CKD, we did not detect a significant difference between an educational verbal script and a video decision aid in improving knowledge of supportive kidney care or preferences. However, patients who received video education reported high satisfaction and acceptability ratings. Future research will determine the effectiveness of a supportive kidney care video decision aid on real-world patient outcomes. TRIAL REGISTRATION: NCT02698722 (ClinicalTrials.gov).

Advance Care Planning Video Intervention Among Long-Stay Nursing Home Residents: A Pragmatic Cluster Randomized Clinical Trial.

Importance: Standardized, evidenced-based approaches to conducting advance care planning (ACP) in nursing homes are lacking. Objective: To test the effect of an ACP video program on hospital transfers, burdensome treatments, and hospice enrollment among long-stay nursing home residents with and without advanced illness. Design, Setting, and Participants: The Pragmatic Trial of Video Education in Nursing Homes was a pragmatic cluster randomized clinical trial conducted between February 1, 2016, and May 31, 2019, at 360 nursing homes (119 intervention and 241 control) in 32 states owned by 2 for-profit corporations. Participants included 4171 long-stay residents with advanced dementia or cardiopulmonary disease (hereafter referred to as advanced illness) in the intervention group and 8308 long-stay residents with advanced illness in the control group, 5764 long-stay residents without advanced illness in the intervention group, and 11 773 long-stay residents without advanced illness in the control group. Analyses followed the intention-to-treat principle. Interventions: Five 6- to 10-minute ACP videos were made available on tablet computers or online. Designated champions (mostly social workers) in intervention facilities were instructed to offer residents (or their proxies) the opportunity to view a video(s) on admission and every 6 months. Control facilities used usual ACP practices. Main Outcomes and Measures: Twelve-month outcomes were measured for each resident. The primary outcome was hospital transfers per 1000 person-days alive in the advanced illness cohort. Secondary outcomes included the proportion of residents with or without advanced illness experiencing 1 or more hospital transfer, 1 or more burdensome treatment, and hospice enrollment. To monitor fidelity, champions completed reports in the electronic record whenever they offered to show residents a video. Results: The study included 4171 long-stay residents with advanced illness in the intervention group (2970 women [71.2%]; mean [SD] age, 83.6 [9.1] years), and 8308 long-stay residents with advanced illness in the control group (5857 women [70.5%]; mean [SD] age, 83.6 [8.9] years), 5764 long-stay residents without advanced illness in the intervention group (3692 women [64.1%]; mean [SD] age, 81.5 [9.2] years), and 11 773 long-stay residents without advanced illness in the control group (7467 women [63.4%]; mean [SD] age, 81.3 [9.2] years). There was no significant reduction in hospital transfers per 1000 person-days alive in the intervention vs control groups (rate [SE], 3.7 [0.2]; 95% CI, 3.4-4.0 vs 3.9 [0.3]; 95% CI, 3.6-4.1; rate difference [SE], -0.2 [0.3]; 95% CI, -0.5 to 0.2). Secondary outcomes did not significantly differ between trial groups among residents with and without advanced illness. Based on champions' reports, 912 of 4171 residents with advanced illness (21.9%) viewed ACP videos. Facility-level rates of showing ACP videos ranged from 0% (14 of 119 facilities [11.8%]) to more than 40% (22 facilities [18.5%]). Conclusions and Relevance: This study found that an ACP video program was not effective in reducing hospital transfers, decreasing burdensome treatment use, or increasing hospice enrollment among long-stay residents with or without advanced illness. Intervention fidelity was low, highlighting the challenges of implementing new programs in nursing homes. Trial Registration: ClinicalTrials.gov Identifier: NCT02612688.

A mixed methods analysis of patients' advance care planning values in outpatient oncology: Person-Centered Oncologic Care and Choices (P-COCC).

PURPOSE: Person-Centered Oncologic Care and Choices (P-COCC) combines an advance care planning (ACP) value-focused patient interview with a care goal video decision aid. Our randomized study showed that P-COCC was acceptable but increased participant distress, compared with video-alone and usual care study arms. This mixed methods approach explores the ACP values in the P-COCC arm and their relationship to the distress phenomenon. METHODS: Qualitative thematic analysis of the 46 audio-recorded P-COCC interview transcripts with advanced gastrointestinal cancer patients was performed by multiple reviewers. Quantitative (Likert scale) changes in ACP values were compared across study arms. ACP themes and value change were analyzed in participants with increased distress. RESULTS: Transcript analysis resulted in thematic saturation and identified eight distinct themes on ACP values relating to end-of-life wishes, communication needs, and psychosocial supports. Of 98 participants (33 P-COCC, 43 videos, 22 usual care) who completed the change in value measure, there was no difference detected with P-COCC compared with either video (p = 0.052) or usual care (p = 0.105) arms alone, but P-COCC led to a frequency distribution of more change in personal values compared with the other study arms combined (p = 0.043). Among the subset of P-COCC participants with increased distress, there was no statistical relationship with change in values. CONCLUSIONS: The ACP paradigm P-COCC both informs and supports patients in individualized, value-based decision-making. Distress is not associated with changes in ACP values and may be a necessary, at least transient, byproduct of discussing sensitive but pertinent topics about end-of-life medical care.

Black Nursing Home Residents More Likely to Watch Advance Care Planning Video.

BACKGROUND/OBJECTIVES: This study aims to identify resident characteristics associated with being offered and subsequently shown an advance care planning (ACP) video in the Pragmatic Trial of Video Education in Nursing Homes (PROVEN) and if differences are driven by within- and/or between-facility differences. DESIGN: Cross-sectional study, from March 1, 2016, to May 31, 2018. SETTING: A total of 119 PROVEN intervention nursing homes (NHs). PARTICIPANTS: A total of 43 303 new NH admissions. MEASUREMENTS: Data came from the Minimum Data Set and an electronic record documenting whether a video was offered and shown to residents. We conduct both naïve logistic regression models and hierarchical logistic models, controlling for NH fixed effects, to examine the overall differences in offer and show rate by resident characteristics. RESULTS: In naïve regression models, compared to white residents, black residents are 7.8 percentage point (pp) (95% confidence interval [CI] = -9.1 to -6.5 pp) less likely to be offered the video. These differences decrease to 1.3 pp (95% CI = -2.61 to -0.02 pp) when accounting for NH fixed effects. In fully adjusted models, black residents compared to white residents were 2.1 pp more likely to watch the video contingent on being offered (95% CI = 0.4-3.7 pp). Residents with cognitive impairment were less likely to be offered and shown the video. CONCLUSIONS: After controlling for NH fixed effects, there were smaller racial differences in being offered the video, but once offered, black residents were more likely to watch the video. This suggests that black residents are receptive to this type of ACP intervention but need to be given an opportunity to be exposed. J Am Geriatr Soc 68:603-608, 2020.

Understanding implementation fidelity in a pragmatic randomized clinical trial in the nursing home setting:a mixed-methods examination.

BACKGROUND: The Pragmatic Trial of Video Education in Nursing Homes (PROVEN) is one of the first large pragmatic randomized clinical trials (pRCTs) to be conducted in U.S. nursing homes (N = 119 intervention and N = 241 control across two health-care systems). The trial aims to evaluate the effectiveness of a suite of videos to improve advance care planning (ACP) for nursing home patients. This report uses mixed methods to explore the optimal and suboptimal conditions necessary for implementation fidelity within pRCTs in nursing homes. METHODS: PROVEN's protocol required designated facility champions to offer an ACP video to long-stay patients every 6 months during the 18-month implementation period. Champions completed a video status report, stored within electronic medical records, each time a video was offered. Data from the report were used to derive each facility's adherence rate (i.e., cumulative video offer). Qualitative interviews held after 15 months with champions were purposively sampled from facilities within the highest and lowest adherence rates (i.e., those in the top and bottom quintiles). Two researchers analyzed interview data thematically using a deductive approach based upon six domains of the revised Conceptual Framework for Implementation Fidelity (CFIF). Matrices were developed to compare coded narratives by domain across facility adherence status. RESULTS: In total, 28 interviews involving 33 champions were analyzed. Different patterns were observed across high- versus low-adherence facilities for five CFIF domains. In low-adherence nursing homes, (1) there were limited implementation resources (Context), (2) there was often a perceived negative patient or family responsiveness to the program (Participant Responsiveness), and (3) champions were reticent in offering the videos (Recruitment). In high-adherence nursing homes, (1) there was more perceived patient and family willingness to engage in the program (Participant Responsiveness), (2) champions supplemented the video with ACP conversations (Quality of Delivery), (3) there were strategic approaches to recruitment (Recruitment), and (4) champions appreciated external facilitation (Strategies to Facilitate Implementation). CONCLUSIONS: Critical lessons for implementing pRCTs in nursing homes emerged from this report: (1) flexible fidelity is important (i.e., delivering core elements of an intervention while permitting the adaptation of non-core elements), (2) reciprocal facilitation is vital (i.e., early and ongoing stakeholder engagement in research design and, reciprocally, researchers' and organizational leaders' ongoing support of the implementation), and (3) organizational and champion readiness should be formally assessed early and throughout implementation to facilitate remediation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02612688. Registered on 19 November 2015.

Barriers and facilitators to implementing a pragmatic trial to improve advance care planning in the nursing home setting.

BACKGROUND: The PRagmatic trial Of Video Education in Nursing homes (PROVEN) aims to test the effectiveness of an advance care planning (ACP) video intervention. Relatively little is known about the challenges associated with implementing ACP interventions in the nursing home (NH) setting, especially within a pragmatic trial. To address this research gap, this report sought to identify facilitators of and barriers to implementing PROVEN from the perspective of the Champions charged with introducing the ACP video program delivery to patients and families. METHODS: In semi-structured telephone interviews at 4 and 15 months of the 18-month implementation period, ACP Champions at all PROVEN intervention facilities (N = 119) were asked about their perceptions of program implementation. Forty interviews were purposively sampled, transcribed, and analyzed using a hybrid deductive/inductive approach to thematic analysis incorporating the Consolidated Framework for Implementation Research's domains: Intervention Characteristics (IC), Inner Setting (IS), Characteristics of Individuals (CI), Outer Setting (OS), and Process (P). RESULTS: Implementation facilitators identified by Champions included: the intervention's adaptable mode of presentation and minimal time burden (IC) as well as the program's customizable delivery to patients and families and opportunity for group reflection on implementation among ACP Champions (P). Barriers included mandated protocol-driven aspects of the program (OS), limited time to deliver the intervention (IS), and lack of perceived relevance and emotional readiness for ACP amongst stakeholders (CI). CONCLUSIONS: Despite the promise of PROVEN's intervention for improving ACP in nursing homes, unchangeable setting and characteristics of Champions, patients, and family members presented implementation barriers. Researchers need to engage all program participants (i.e., facility staff, patients, and families), in addition to corporate-level stakeholders, in early pragmatic trial design to minimize such obstacles. Further, despite the facilitating nature of PROVEN's implementation processes, the study encountered tension between scientific rigor and real-world demands. Researchers need to optimize the real-world authenticity of pragmatic trial design while avoiding excessive implementation protocol deviations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02612688. Registered 19 November 2015.

Nursing Home Characteristics Associated With Implementation of an Advance Care Planning Video Intervention.

OBJECTIVES: Advance care planning (ACP) is important to ensure that nursing home (NH) residents receive care concordant with their goals. Video interventions have been developed to improve the process of ACP. Yet, little is known about which NH characteristics are associated with implementation of ACP video interventions in clinical practice. Our objective was to examine NH-level characteristics associated with the implementation of an ACP video intervention as part of the Pragmatic trial of Video Education in Nursing Homes (PROVEN) trial. DESIGN: Cross-sectional study of NHs in PROVEN. SETTING AND PARTICIPANTS: 119 NHs randomized to receive the ACP video intervention. MEASUREMENTS: The outcomes were the proportion of short- (<100 days) and long-stay (≥100 days) NH residents who were (1) offered to watch a video and (2) shown a video, aggregated to the NH-level, and measured using electronic forms of video offers. The association between outcomes and NH facility characteristics (eg, staffing, resident acuity) and participation in other aspects of the PROVEN trial (eg, monthly check-in calls) were estimated using multivariate linear regression models. NH characteristics were measured using data from Online Survey Certification and Reporting data, Long-term Care: Facts on Care in the US and NH Compare. RESULTS: Offer rates were 69% [standard deviation (SD): 28] for short-stay and 56% (SD: 20) for long-stay residents. Show rates were 19% (SD: 21) for short-stay and 17% (SD: 17) for long-stay residents. After adjusting for NH characteristics, compared to 1-star NHs, higher star-rated NHs had higher offer rates. Champions' participation in check-in calls was positively associated with both outcomes for long-stay residents. CONCLUSIONS/IMPLICATIONS: Lower-quality NHs seem unable to integrate a novel ACP video education program into routine care processes. Ongoing support for and engagement with NH staff to champion the intervention throughout implementation is important for the success of a pragmatic trial within NHs.

Concordance Between Proxy Level of Care Preference and Advance Directives Among Nursing Home Residents With Advanced Dementia: A Cluster Randomized Clinical Trial.

CONTEXT: Care consistent with goals is the desired outcome of advance care planning (ACP). OBJECTIVES: The objectives of this study were to examine concordance between advance directives and proxy care preferences among nursing home residents with advanced dementia and to determine the impact of an ACP video on concordance. METHODS: Data were from Educational Video to Improve Nursing home Care in End-stage dementia, a cluster randomized clinical trial conducted in 64 Boston-area facilities (32/arm) from 2013 to 2017. Participants included advanced dementia residents and their proxies (N = 328 dyads). At the baseline and quarterly (up to 12 months), proxies stated their preferred level of care for the resident (comfort, basic, or intensive) and advance directives for specific treatments (resuscitation, hospitalization, tube-feeding, intravenous hydration, antibiotics) were abstracted from the charts. At the baseline, proxies in intervention facilities viewed an ACP video. Their care preferences after viewing it were shared via a written communication with the primary care team. At each assessment, concordance between directives and proxy preferences was determined. RESULTS: Among the residents (mean age, 86.6 years; 19.5% male), the most prevalent directive was DNR (89.3%) and foregoing antibiotics was least common (parenteral, 8.2%; any type, 4.0%). Concordance between directives and each level of care preference was as follows: comfort, 7%; basic, 49%; and intensive, 58%. When comfort care was preferred, concordance was higher in intervention versus control facilities (10.8% vs. 2.5%; adjusted odds ratio, 2.48; 95% CI, 1.01-6.09). CONCLUSION: Better alignment between preferences for comfort-focused care and advance directives is needed in advanced dementia. An ACP video may help achieve that goal.

Health Literacy Mediates Racial Disparities in Cardiopulmonary Resuscitation Knowledge among Chronic Kidney Disease Patients.

Black patients with chronic kidney disease (CKD) receive more cardiopulmonary resuscitation (CPR) than other racial groups, and knowledge of CPR influences preferences for care. As limited health literacy disproportionately affects Blacks and contributes to disparities in end-of-life (EOL) care, we investigated whether health literacy mediates racial disparities in CPR knowledge. Black and White adult patients with advanced CKD completed CPR knowledge surveys. Health literacy was assessed using the Rapid Estimate of Adult Literacy in Medicine. Among 149 patients, Black patients were more likely to have limited health literacy and lower mean CPR knowledge scores than White patients. In adjusted analyses, health literacy mediated racial differences in CPR knowledge. Knowledge of CPR is lower among Black compared with White CKD patients and health literacy is a mediator of this difference. Future CPR educational interventions should target health literacy barriers to improve informed decision-making and decrease racial disparities at the end of life.

A dynamic application of PRECIS-2 to evaluate implementation in a pragmatic, cluster randomized clinical trial in two nursing home systems.

BACKGROUND: PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary-2) can assess how clinical trial design decisions (along the explanatory-pragmatic continuum) influence the applicability of trial results to intended stakeholders. The tool has been used to assess features of trials during the trial design phase and also upon completion. The ongoing PRagmatic trial Of Video Education in Nursing homes (PROVEN), which is evaluating the effectiveness of a suite of videos to improve advance care planning, is one of the first large pragmatic, cluster randomized trials within nursing home health care systems. While certain features of pragmatic trials remain static once designed (e.g., recruitment, outcomes), successful implementation of a system-wide program requires on-going evaluation and adaptation. This report's objectives were to apply PRECIS-2 in a novel manner during the actual conduct of the PROVEN trial to assess how dynamic adaptations shifted implementation to either a more explanatory or a more pragmatic approach. METHODS: We assessed PROVEN's protocol as initially designed according to the three PRECIS-2 domains pertinent to implementation: (1) Organization, (2) Flexibility-Delivery, and (3) Flexibility-Adherence. We then applied this framework to conduct a formative evaluation of decisions made while the trial was ongoing to adapt the implementation approach along the pragmatic versus the explanatory continuum in response to emergent challenges. RESULTS: Based on the PRECIS-2 rubric, the initial design of the PROVEN implementation approach reflected a hybrid of pragmatic and explanatory features. Most notably, within the Flexibility-Delivery, the trial had a relatively pragmatic approach to protocol delivery by front-line nursing home providers, balanced with a more explanatory approach to protocol monitoring enabled by the analytic capabilities of the research team. This more intensive monitoring proved critical in revealing implementation problems once the study began. Dynamic adaptations made in response to these challenges generally reflected shifts to more explanatory approaches within the Flexibility-Delivery and Flexibility-Adherence domains including ever more intensive compliance monitoring, as well as detailed coaching of front-line providers delivering the intervention by the research team. CONCLUSIONS: Pragmatic trials conducted in the nursing home setting may benefit from a more dynamic approach to implementation. Allowing fluidity between pragmatic and explanatory features may still preserve the trial's applicability to intended stakeholders' needs. PRECIS-2 provides a useful formative evaluation tool to assess these adaptations in "real-time." TRIAL REGISTRATION: US National Library of Medicine, ClinicalTrials.gov, ID: NCT02612688 . Registered on 19 November 2015.

An Advance Care Planning Video Decision Support Tool for Nursing Home Residents With Advanced Dementia: A Cluster Randomized Clinical Trial.

Importance: Better advance care planning (ACP) can help promote goal-directed care in patients with advanced dementia. Objectives: To test whether an ACP video (vs usual care) has an effect on documented advance directives, level of care preferences, goals-of-care discussions, and burdensome treatments among nursing home residents with advanced dementia. Design, Setting, and Participants: The Educational Video to Improve Nursing home Care in End-stage dementia (EVINCE) trial was a cluster randomized clinical trial conducted between February 2013 and July 2017, at 64 Boston-area nursing homes (32 facilities per arm). A total of 402 residents with advanced dementia and their proxies (intervention arm, n = 212; control arm, n = 190) were assessed quarterly for 12 months. Interventions: A 12-minute ACP video for proxies with written communication of their preferred level of care (comfort, basic, or intensive) to the primary care team. Main Outcomes and Measures: The primary outcome was the proportion of residents with do-not-hospitalize (DNH) directives by 6 months. Secondary outcomes included preference for comfort care, documented directives to withhold tube-feeding and intravenous hydration, documented goals-of-care discussions, and burdensome treatments (hospital transfers, tube-feeding, or parenteral therapy) per 1000 resident-days. Exploratory analyses examined associations between trial arm and documented advance directives when comfort care was preferred. Results: The mean age of the 402 study residents was 86.7 years [range, 67-102 years]; 350 were white (87.1%) and 323 were female (80.3%), with DNH directives that by 6 months did not differ between arms (63% in both arms; adjusted odds ratio [AOR], 1.08; 95% CI, 0.69-1.69). Preferences for comfort care, directives to withhold intravenous hydration, and burdensome treatments did not differ between arms. Residents in intervention vs control facilities were more likely to have directives for no tube-feeding at 6 months (70.10% vs 61.90%; AOR, 1.79; 95% CI, 1.13-2.82) and all other time periods, and documented goals-of-care discussions at 3 months (16.10% vs 7.90%; AOR, 2.58; 95% CI, 1.20-5.54). When comfort care was preferred, residents in the intervention arm were more likely to have both DNH and no tube-feeding directives (72.20% vs 52.80%; AOR, 2.68; 95% CI, 2.68-5.85). Conclusions and Relevance: An ACP video did not have an effect on preferences, DNH status, or burdensome treatments among residents with advanced dementia, but did increase directives to withhold tube-feeding. When proxies preferred comfort care, advance directives of residents in the intervention arm were more likely to align with that preference. Trial Registration: clinicaltrials.gov Identifier: NCT01774799.

Association of Prognostic Estimates With Burdensome Interventions in Nursing Home Residents With Advanced Dementia.

Importance: Prognostication in advanced dementia is challenging but may influence care. Objectives: To determine the accuracy of proxies' prognostic estimates for nursing home residents with advanced dementia, identify factors associated with those estimates, and examine the association between their estimates and use of burdensome interventions. Design, Setting, and Participants: Data were combined from 2 studies that prospectively followed 764 residents with advanced dementia and their proxies in Boston-area nursing homes for 12 months: (1) the Study of Pathogen Resistance and Exposure to Antimicrobials in Dementia, conducted from September 2009 to November 2012 (362 resident/proxy dyads; 35 facilities); and (2) the Educational Video to Improve nursing home Care in End-Stage Dementia, conducted from March 2013 to July 2017 (402 resident/proxy dyads; 62 facilities). Proxies were the residents' formally or informally designated medical decision makers. Main Outcomes and Measures: During quarterly telephone interviews, proxies stated whether they believed the resident would live less than 1 month, 1 to 6 months, 7 to 12 months, or more than 12 months. Prognostic estimates were compared with resident survival. Resident and proxy characteristics associated with proxy prognostic estimates were determined. The association between prognostic estimates and whether residents experienced any of the following was determined: hospital transfers, parenteral therapy, tube feeding, venipunctures, and bladder catheterizations. Results: The residents' mean (SD) age was 86.6 (7.3) years; 631 (82.6%) were women and 133 (17.4%) were men. Of the 764 residents, 310 (40.6%) died later than 12 months. Proxies estimated survival with moderate accuracy (C statistic, 0.67). When proxies perceived the resident would die within 6 months, they were more likely to report being asked (183 [7.2%] of 2526) vs not being asked (126 [5.0%] of 2526) about goals of care by nursing home clinicians (adjusted odds ratio [AOR], 1.94; 95% CI, 1.50-2.52). Residents were less likely to experience burdensome interventions when the proxy prognostic estimate was less than 6 months (89 [4.4%] of 2031) vs greater than 6 months (1008 [49.6%] of 2031) (AOR, 0.46; 95% CI, 0.34-0.62). Conclusions and Relevance: Proxies estimated the prognosis of nursing home residents with advanced dementia with moderate accuracy. Having been asked about their opinion about the goal of care was associated with the proxies' perception that the resident had less than 6 months to live and that perception was associated with a lower likelihood the resident experienced burdensome interventions.