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Advance care planning for vulnerable older adults within an Accountable Care Organization: study protocol for the IMPACT randomised controlled trial.

ABSTRACT: INTRODUCTION:Patients with multimorbidity plus additional impairments (eg, mobility limitations, disability, cognitive impairments or frailty) are at the highest risk for poor healthcare outcomes. Advanced care planning (ACP) provides patients and their surrogates the opportunity to discuss their goals, values and priorities for healthcare-particularly in the context of end-of-life care. ACP discussions promote more person-centred care; however, it is currently underused. There is a tremendous need for systematic, scalable approaches to individualised ACP that promotes patient and family engagement. Here we describe the study protocol for a randomised effectiveness trial of a nurse navigator and informatics intervention designed to improve the documentation and quality of ACP discussions. METHODS AND ANALYSIS:This is a randomised, pragmatic, effectiveness trial; patients aged 65 years and older who have multimorbidity plus impairments in either physical function (eg, mobility limitations or disability) or cognition, and/or frailty within an affiliated Accountable Care Organization were eligible. The electronic health record was used to develop an automatic prescreening system for eligible patients (n=765) and participants were randomised in a 1:1 ratio to either the nurse navigator-led ACP pathway or usual care. Our primary outcomes are documentation of ACP discussions within the EHR along with the quality of ACP discussions. Secondary outcomes include a broad range of ACP actions (eg, usage of ACP billing codes, choosing a surrogate decision-maker and advance directive documentation). Outcomes will be measured over 12 months of follow-up. ETHICS AND DISSEMINATION:This study has been approved by the appropriate Institutional Review Boards and is guided by input from patient and clinical advisory boards. The results of this study will inform a scalable solution to ACP discussions throughout our healthcare system and statewide. TRIALS REGISTRATION NUMBER:NCT03609658.

SUBMITTER: Gabbard J

PROVIDER: S-EPMC6924763 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Advance care planning for vulnerable older adults within an Accountable Care Organization: study protocol for the IMPACT randomised controlled trial.

Gabbard Jennifer J Pajewski N M NM Callahan Kathryn E KE Dharod Ajay A Foley Kristie K Ferris Keren K Moses Adam A Grey Carl C Williamson Jeff J

BMJ open 20191215 12

<h4>Introduction</h4>Patients with multimorbidity plus additional impairments (eg, mobility limitations, disability, cognitive impairments or frailty) are at the highest risk for poor healthcare outcomes. Advanced care planning (ACP) provides patients and their surrogates the opportunity to discuss their goals, values and priorities for healthcare-particularly in the context of end-of-life care. ACP discussions promote more person-centred care; however, it is currently underused. There is a trem ...[more]

PMID: 31843844

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Project description:ImportanceAdvance care planning (ACP), especially among vulnerable older adults, remains underused in primary care. Additionally, many ACP initiatives fail to integrate directly into the electronic health record (EHR), resulting in infrequent and disorganized documentation.ObjectiveTo determine whether a nurse navigator-led ACP pathway combined with a health care professional-facing EHR interface improves the occurrence of ACP discussions and their documentation within the EHR.Design, setting, and participantsThis was a randomized effectiveness trial using the Zelen design, in which patients are randomized prior to informed consent, with only those randomized to the intervention subsequently approached to provide informed consent. Randomization began November 1, 2018, and follow-up concluded November 1, 2019. The study population included patients 65 years or older with multimorbidity combined with either cognitive or physical impairments, and/or frailty, assessed from 8 primary care practices in North Carolina.InterventionsParticipants were randomized to either a nurse navigator-led ACP pathway (n = 379) or usual care (n = 380).Main outcomes and measuresThe primary outcome was documentation of a new ACP discussion within the EHR. Secondary outcomes included the usage of ACP billing codes, designation of a surrogate decision maker, and ACP legal form documentation. Exploratory outcomes included incident health care use.ResultsAmong 759 randomized patients (mean age 77.7 years, 455 women [59.9%]), the nurse navigator-led ACP pathway resulted in a higher rate of ACP documentation (42.2% vs 3.7%, P < .001) as compared with usual care. The ACP billing codes were used more frequently for patients randomized to the nurse navigator-led ACP pathway (25.3% vs 1.3%, P < .001). Patients randomized to the nurse navigator-led ACP pathway more frequently designated a surrogate decision maker (64% vs 35%, P < .001) and completed ACP legal forms (24.3% vs 10.0%, P < .001). During follow-up, the incidence of emergency department visits and inpatient hospitalizations was similar between the randomized groups (hazard ratio, 1.17; 95% CI, 0.92-1.50).Conclusions and relevanceA nurse navigator-led ACP pathway integrated with a health care professional-facing EHR interface increased the frequency of ACP discussions and their documentation. Additional research will be required to evaluate whether increased EHR documentation leads to improvements in goal-concordant care.Trial registrationClinicalTrials.gov Identifier: NCT03609658.

Project description:Background/objectivesAdvance care planning (ACP) rates are low in diverse, vulnerable older adults, yet little is known about the unique barriers they face and how these barriers impact ACP documentation rates.DesignValidated questionnaires listing patient, family/friend, and clinician/system-level ACP barriers and an open-ended question on ACP barriers.SettingTwo San Francisco public/Department of Veterans Affairs hospitals.ParticipantsOne thousand two hundred and forty-one English and Spanish-speaking patients, aged 55 and older, with two or more chronic conditions.MeasurementsThe open-ended question on ACP barriers was analyzed using content analysis. We conducted chart review for prior ACP documentation. We used chi-square/Wilcoxon rank-sum tests and logistic regression to assess associations between ACP barriers and demographic characteristics/ACP documentation.ResultsParticipant mean age was 65 ± 7.4 years; they were 74% from racial/ethnic minority groups, 36% Spanish-speaking, and 36% with limited health literacy. A total of 26 barriers were identified (15 patient, 4 family/friend, 7 clinician/system-level), and 91% reported at least one ACP barrier (mean: 5.6 ± 4.0). The most common barriers were: (patient-level) discomfort thinking about ACP (60%), wanting to leave health decisions to "God" (44%); (family/friend-level) not wanting to burden friends/family (33%), assuming friends/family already knew their preferences (31%); (clinician/system-level) assuming doctors already knew their preferences (41%), and mistrust (37%). Compared with those with no barriers, participants with at least one reported barrier were more likely to be from a racial/ethnic minority group (76% vs 53%), Spanish-speaking (39% vs 6%), with fair-to-poor health (48% vs 34%), and limited health literacy (39% vs 9%) (p < 0.001 for all). Participants who reported barriers were less likely to have ACP documentation (adjusted odds ratio = 0.64, 95% confidence interval [0.42, 0.98]).ConclusionEnglish- and Spanish-speaking older adults reported 26 unique barriers to ACP, with higher barriers among vulnerable populations, and barriers were associated with lower ACP documentation. Barriers must be considered when developing customized ACP interventions for diverse older adults.

Project description:IntroductionAdvance care planning (ACP) is a process that allows patients to identify their goals for medical care. Traditionally, ACP has focused on completing advance directives; however, we have expanded the ACP paradigm to also prepare patients to communicate their wishes and make informed decisions. To this end, we created an ACP website called PREPARE (http://www.prepareforyourcare.org) to prepare diverse English-speaking and Spanish-speaking older adults for medical decision-making. Here, we describe the study protocol for a randomised controlled efficacy trial of PREPARE in a safety-net setting. The goal is to determine the efficacy of PREPARE to engage diverse English-speaking and Spanish-speaking older adults in a full spectrum of ACP behaviours.Methods and analysisWe include English-speaking and Spanish-speaking adults from an urban public hospital who are ≥55 years old, have ≥2 chronic medical conditions and have seen a primary care physician ≥2 times in the last year. Participants are randomised to the PREPARE intervention (review PREPARE and an easy-to-read advance directive) or the control arm (only the easy-to-read advance directive). The primary outcome is documentation of an advance directive and/or ACP discussion. Secondary outcomes include ACP behaviour change processes measured with validated surveys (eg, self-efficacy, readiness) and a broad range of ACP actions (eg, choosing a surrogate, identifying goals for care, discussing ACP with clinicians and/or surrogates). Using blinded outcome ascertainment, outcomes will be measured at 1 week and at 3, 6 and 12 months, and compared between study arms using mixed-effects logistic regression and mixed-effects linear, Poisson or negative binomial regression.Ethics and disseminationThis study has been approved by the appropriate Institutional Review Boards and is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of this study will be disseminated to academic and community stakeholders.Trial registration numbersNCT01990235; NCT02072941; Pre-results.

Project description:ImportanceAccountable care contracts hold physician groups financially responsible for the quality and cost of health care delivered to patients. Focusing on clinically vulnerable patients, those with serious conditions who are responsible for the greatest proportion of spending, may result in the largest effects on both patient outcomes and financial rewards for participating physician groups.ObjectiveTo estimate the effect of Medicare accountable care organization (ACO) contracts on spending and high-cost institutional use for all Medicare beneficiaries and for clinically vulnerable beneficiaries.Design, setting, and participantsFor this cohort study, 2 study populations were defined: the overall Medicare population and the clinically vulnerable subgroup of Medicare beneficiaries. The overall Medicare population was based on a random 40% sample drawn from continuously enrolled fee-for-service beneficiaries with at least 1 evaluation and management visit in a calendar year. The clinically vulnerable study population included all Medicare beneficiaries 66 years or older who had at least 3 Hierarchical Condition Categories (HCCs). Beneficiaries entered the cohort during the quarter between January 2009 to December 2011 when they first had at least 3 HCCs and remained in the cohort until death. Cohort entry was restricted to the preperiod to account for potential changes in coding practices after ACO implementation. Difference-in-difference estimations were used to compare changes in health care outcomes for Medicare beneficiaries attributed to physicians in ACOs with those attributed to non-ACO physicians from January 2009 to December 2013.ExposuresMedicare ACOs beginning contracts in January 2012, April 2012, July 2012, and January 2013 through the Pioneer and Medicare Shared Savings Programs.Main outcomes and measuresTotal spending per beneficiary-quarter, spending categories, use of hospitals and emergency departments, ambulatory care sensitive admissions, and 30-day readmissions.ResultsTotal spending decreased by $34 (95% CI, -$52 to -$15) per beneficiary-quarter after ACO contract implementation across the overall Medicare population (n = 15 592 600) and decreased $114 in clinically vulnerable patients (n = 8 673 823) (95% CI, -$178 to -$50). In the overall Medicare cohort, hospitalizations and emergency department visits decreased by 1.3 and 3.0 events per 1000 beneficiaries per quarter, respectively (95% CIs: -2.1 to -0.4 and -4.8 to -1.3), and hospitalizations and emergency department visits decreased in the clinically vulnerable cohort by 2.9 and 4.1 events per 1000 beneficiaries per quarter, respectively (95% CIs: -5.2 to -0.7 and -7.1 to -1.2). Changes in total spending associated with ACOs did not vary by clinical condition of beneficiaries.Conclusions and relevanceMedicare ACO programs are associated with modest reductions in spending and use of hospitals and emergency departments. Savings were realized through reductions in use of institutional settings in clinically vulnerable patients.

Project description:BackgroundGroup visits can support health behavior change and self-efficacy. In primary care, an advance care planning (ACP) group visit may leverage group dynamics and peer mentorship to facilitate education and personal goal setting that result in ACP engagement.ObjectiveTo determine whether the ENgaging in Advance Care Planning Talks (ENACT) group visits intervention improves ACP documentation and readiness in older adults.MethodsThis randomized clinical trial was conducted among geriatric primary care patients from the University of Colorado Hospital Seniors Clinic, Aurora, CO, from August 2017 to November 2019. Participants randomized to ENACT group visits (n = 55) participated in two 2-hour sessions with discussions of ACP topics and use of ACP tools (i.e., Conversation Starter Kit, Medical Durable Power of Attorney form, and PREPARE videos). Participants randomized to the control arm (n = 55) received the Conversation Starter Kit and a Medical Durable Power of Attorney form by mail. The primary outcomes included presence of ACP documents or medical decision-maker documentation in the electronic health record (EHR) at 6 months, and a secondary outcome was ACP readiness (validated four-item ACP Engagement Survey) at 6 months.ResultsParticipants were a mean of 77 years old, 60% female, and 79% white. At 6 months, 71% of ENACT participants had an advance directive in the EHR (26% higher) compared with 45% of control arm participants (P < .001). Similarly, 93% of ENACT participants had decision-maker documentation in the EHR (29% higher) compared with 73% in the control arm (P < .001). ENACT participants trended toward higher readiness to engage in ACP compared with control (4.56 vs 4.13; P = .16) at 6 months.ConclusionAn ACP group visit increased ACP documentation and readiness to engage in ACP behavior change. Primary care teams can explore implementation and adaptation of ACP group visits into routine care, as well as longer-term impact on patient health outcomes. J Am Geriatr Soc 68:2382-2389, 2020.

Project description:ImportanceCOVID-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.ObjectiveTo 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 participantsThe 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 measuresThe primary outcome was ACP documentation.ResultsA 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 relevanceThis intervention, implemented during the evolving COVID-19 pandemic, was associated with higher rates of ACP documentation, especially for African American and Hispanic patients.Trial registrationClinicalTrials.gov Identifier: NCT04660422.

Project description:BackgroundTo assure patient-centred end-of-life care, palliative interventions need to account for patients' preferences. Advance care planning (ACP) is a structured approach that allows patients, relatives and physicians to discuss end-of-life decisions. Although ACP can improve several patient related outcomes, the implementation of ACP remains difficult. The col-ACP-study (collaborative advance care planning) will investigate a new ACP procedure (col-ACP-intervention (German: Hand-in-Hand Intervention)) in palliative cancer patients and their relatives that addresses individual values and targets barriers of communication before an ACP process.MethodsIn a randomised controlled trial, 270 cancer patients without curative treatment options and their relatives will receive either 1) col-ACP 2) a supportive intervention (active control group) or 3) standard medical care (TAU). col-ACP comprises two steps: a) addressing various barriers of patients and relatives that discourage them from discussing end-of-life issues followed by b) a regular, structured ACP procedure. The col-ACP-intervention consists of 6 sessions. Primary endpoint is the patients' quality of life 16 weeks after randomisation. Secondary endpoints include measurements of distress; depression; communication barriers; caregivers' quality of life; existence of ACP or advance directives; the consistence of end of life care; and others. Patients will be followed up for 13 months. Multivariate analyses will be carried out. Qualitative evaluation of the intervention will be conducted.DiscussionAugmentation of a regular ACP program by a structured psycho-oncological intervention is an innovative approach to target barriers of communication about end-of-life issues. Study findings will help to understand the value of such a combined intervention in palliative care.Trial registrationClinicalTrials.gov Identifier: NCT03387436 (Date of registration: 01/02/2018, retrospectively registered.

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Advance care planning for vulnerable older adults within an Accountable Care Organization: study protocol for the IMPACT randomised controlled trial.

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Advance care planning for vulnerable older adults within an Accountable Care Organization: study protocol for the IMPACT randomised controlled trial.

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