Dataset Information

Impact of advance care planning on the care of patients with heart failure: study protocol for a randomized controlled trial.

ABSTRACT: Despite the promise and popularity of advance care planning, there is insufficient evidence that advance care planning helps patients to meet their end-of-life care preferences, especially in Asian settings. Thus, the proposed study aims to assess whether patients with advanced heart failure who are receiving advance care planning have a greater likelihood of receiving end-of-life care consistent with their preferences compared to patients receiving usual care. Secondary objectives are to compare differences in health care expenditures, quality of life, anxiety and depression, understanding of own illness, participation in decision-making and concordance with their caregiver's preferences for end-of-life care, between patients with advanced heart failure receiving advance care planning and usual care.This is a two-arm randomized controlled trial of advance care planning versus usual care (control) conducted at two institutions in Singapore. Two hundred and eighty-two patients with advanced heart failure (n?=?94 in the advance care planning arm; n?=?188 in the control arm receiving usual care) will be recruited from these centers and followed for 1 year or until they die, whichever is earlier. Additionally, the study will include up to one caregiver per patient enrolled.If advance care planning is proven to be effective, the results will help to promote its uptake among health care providers and patients both within Singapore and in other countries.NCT02299180 . Registered on 18 November 2014.

SUBMITTER: Malhotra C

PROVIDER: S-EPMC4902978 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Impact of advance care planning on the care of patients with heart failure: study protocol for a randomized controlled trial.

Malhotra Chetna C Sim David Kheng Leng DK Jaufeerally Fazlur F Vikas Nivedita Nadkarni NN Sim Genevieve Wong Cheng GW Tan Boon Cheng BC Ng Clarice Shu Hwa CS Tho Pei Leng PL Lim Jingfen J Chuang Claire Ya-Ting CY Fong Florence Hui Mei FH Liu Joy J Finkelstein Eric A EA

Trials 20160610 1

<h4>Background</h4>Despite the promise and popularity of advance care planning, there is insufficient evidence that advance care planning helps patients to meet their end-of-life care preferences, especially in Asian settings. Thus, the proposed study aims to assess whether patients with advanced heart failure who are receiving advance care planning have a greater likelihood of receiving end-of-life care consistent with their preferences compared to patients receiving usual care. Secondary objec ...[more]

PMID: 27287330

Similar Datasets

Project description: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.

Project description:BackgroundClose to half of all deaths in Norway occur in nursing homes, which signals a need for good communication on end-of-life care. Advance care planning (ACP) is one means to that end, but in Norwegian nursing homes, ACP is not common. This paper describes the protocol of a project evaluating an ACP-intervention in Norwegian nursing homes. The aims of this research project were to promote the possibility for conversations about the end of life with patients and relatives; promote patient autonomy; create a better foundation for important decisions in the case of medical emergencies and at the end of life; and gain experiences in order to find out what characterizes good ACP and good implementation strategies.Methods/designThis study was a mixed method study including a cluster-randomized clinical trial. Eight nursing home wards or "clusters" were pair-matched, and one ward from each pair was randomly selected for a 12-month intervention. The intervention consisted of implementing an ACP-guideline. Implementation strategies were training and supervision of project teams and staff in using the guideline, written information to patients and next of kin, and information meetings with nursing home staff. The project was evaluated using both quantitative and qualitative data, and both outcome and process evaluation. Quantitative data included patient chart reviews of ACP, diagnoses, patient preferences for decision-making and treatment, values and wishes that are more general, documented life-prolonging treatment and hospitalizations, and concordance between patient wishes and treatment. The primary outcome was documented ACP. Qualitative data included observations of conversations, interviews with patients, next of kin and health care personnel, logs from project coordinators and conversations, and transcripts from meetings with project teams in the intervention group.DiscussionThis project attempted to increase the quality and use of ACP in Norwegian nursing homes (NH). A mixed methods approach, inclusion of patients with dementia, attempts to involve, as many patients as possible, and a sustainable implementation plan adapted to real life in nursing homes were strengths of the project.

Project description:Advance care planning (ACP) is a process whereby patients prepare for medical decision-making. The traditional objective of ACP has focused on the completion of advance directives. We have developed a new paradigm of ACP focused on preparing patients and their loved ones for communication and informed medical decision-making. To operationalize this new paradigm of ACP, we created an interactive, patient-centered website called PREPARE ( www.prepareforyourcare.org ) designed for diverse older adults.This randomized controlled trial with blinded outcome assessment is designed to determine the efficacy of PREPARE to engage older Veterans in the ACP process. Veterans who are???60 years of age, have???two medical conditions, and have seen a primary care physician???two times in the last year are being randomized to one of two study arms. The PREPARE study arm reviews the PREPARE website and an easy-to-read advance directive. The control arm only reviews the advance directive. The primary outcome is documentation of an advance directive and ACP discussions. Other clinically important outcomes using validated surveys include ACP behavior change process measures (knowledge, contemplation, self-efficacy, and readiness) and a full range of ACP action measures (identifying a surrogate, identifying values and goals, choosing leeway or flexibility for the surrogate, communicating with clinicians and surrogates, and documenting one's wishes). We will also assess satisfaction with decision-making and Veteran activation within primary care visits by direct audio recording. To examine the outcomes at 1 week, 3 months, and 6 months between the two study arms, we will use mixed effects linear, Poisson, or negative binomial regression and mixed effects logistic regression.This study will determine whether PREPARE increases advance directive completion rates and engagement with the ACP process. If PREPARE is efficacious, it could prove to be an easy and effective intervention to help older adults engage in the ACP process within or outside of the medical environment. PREPARE may also help older adults communicate their medical wishes and goals to their loved ones and clinicians, improve medical decision-making, and ensure their wishes are honored over the life course.ClinicalTrials.gov NCT01550731 . Registered on 8 December 2011.

Project description:AimsEarly engagement in advance care planning (ACP) is recommended in heart failure (HF) management. We investigated the preferences of patients with HF regarding ACP and end-of-life (EOL) care, including their desired timing of ACP initiation.Methods and resultsData were collected using a 92-item questionnaire survey, which was directly distributed to hospitalized patients by dedicated physicians and nurses in a university hospital setting. One-hundred eighty-seven patients agreed to participate (response rate: 92.6%), and 171 completed the survey [valid response rate: 84.7%; men: 67.3%; median age: 73.0 (63.0-81.0) years]. Logistic regression analyses were conducted to identify the predictors of positive attitudes towards ACP. Most recognized ACP as important for their care (n = 127, 74.3%), 48.1% stated that ACP should be initiated after repeated HF hospitalizations in the past year, and 29.0% preferred ACP to begin during the first or second HF hospitalization. Only 21.7% of patients had previously engaged in ACP conversations during HF management. Positive attitudes towards ACP were associated with lower depressive symptoms [two-item Patient Health Questionnaire; odds ratio (OR): 0.75, 95% confidence interval (CI): 0.61-0.92, P-value: 0.006], marriage (OR: 2.53, 95% CI: 1.25-5.12, P-value: 0.010), and a high educational level (OR: 2.66, 95% CI: 1.28-5.56, P-value: 0.009), but not with severity of HF (represented by Seattle Heart Failure Model risk score). Regarding EOL care, while 'Saying what one wants to tell loved ones' (83.4%), 'Dying a natural death' (81.8%), and 'Being able to stay at one's favorite place' (75.6%) were the three most important factors for patients, preferences for 'Receiving sufficient treatment' (56.5%) and 'Knowing what to expect about future condition' (50.3%) were divergent.ConclusionsDespite patients' preferences for ACP conversations, there was a discrepancy between preference and engagement in ACP among patients hospitalized for HF. Patients' preferences regarding EOL care may differ; physicians need to consider the appropriate ACP approach to align with patients' care goals.

Project description:BackgroundAdvance care planning (ACP) is a process involving conversations between patients, loved ones, and healthcare providers that consider patient preferences for the types of medical therapies received at the end of life. Underserved populations, including Black, Hispanic, rural, and low-income communities are less likely to engage in ACP than other communities, a health inequity that results in lower-quality care and reduced hospice utilization. The purpose of this trial is to compare efficacy of two interventions intended to motivate ACP (particularly advance directive completion) for those living in underserved communities.MethodsThis 3-armed cluster, randomized controlled mixed methods design is being conducted in 75 community venues in underserved communities across the USA. The goal of the trial is to compare the efficacy of two interventions at motivating ACP. Arm 1 uses an end-of-life conversation game (Hello); Arm 2 uses a nationally utilized workshop format for ACP conversations (The Conversation Project); and Arm 3 uses an attention control game (TableTopics). Events are held in partnership with 75 local community-based host organizations and will involve 1500 participants (n=20 per event). The primary outcome is completion of a visually verified advance directive at 6 months post-event. Primary analyses compare efficacy of each intervention to each other and the control arm. Secondary mixed methods outcomes include (a) other ACP behaviors and engagement; (b) communication quality; (c) impact of sociocultural environment on ACP (via qualitative interviews); and (d) implementation and sustainability. Subgroup analyses examine outcomes for Black, Hispanic, and rural groups in particular.DiscussionThis trial will add to the evidence base behind various conversational ACP interventions, examine potential mechanisms of action for such interventions, and provide qualitative data to better understand the sociocultural environment of how community-based ACP interventions are experienced by underserved populations. Results will also provide important data for future researchers to learn whether visual verification of advance directives is necessary or whether reliance on self-reported outcomes is of comparable value. Data from this study will inform ways to effectively motivate underserved communities to participate in advance care planning.Trial registrationClinicalTrials.gov NCT04612738. Registered on October 12, 2020. All information from the WHO Trial Registration Data Set can be found within the protocol.

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.

Dataset Information

Impact of advance care planning on the care of patients with heart failure: study protocol for a randomized controlled trial.

Publications

Impact of advance care planning on the care of patients with heart failure: study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets