Dataset Information

Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer.

ABSTRACT: INTRODUCTION:Advance care planning (ACP) is associated with improved health outcomes for patients with cancer, and its absence is associated with unfavourable outcomes for patients and their caregivers. However, older adults do not complete ACP at expected rates due to patient and clinician barriers. We present the original design, methods and rationale for a trial aimed at improving ACP for older patients with advanced cancer and the modified protocol in response to changes brought by the COVID-19 pandemic. METHODS AND ANALYSIS:The Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly study is a pragmatic, stepped-wedge cluster randomised trial examining a Comprehensive ACP Program. The programme combines two complementary evidence-based interventions: clinician communication skills training (VitalTalk) and patient video decision aids (ACP Decisions). We will implement the programme at 36 oncology clinics across three unique US health systems. Our primary outcome is the proportion of eligible patients with ACP documentation completed in the electronic health record. Our secondary outcomes include resuscitation preferences, palliative care consultations, death, hospice use and final cancer-directed therapy. From a subset of our patient population, we will collect surveys and video-based declarations of goals and preferences. We estimate 11 000 patients from the three sites will be enrolled in the study. ETHICS AND DISSEMINATION:Regulatory and ethical aspects of this trial include Institutional Review Board (IRB) approval via single IRB of record mechanism at Dana-Farber Cancer Institute, Data Use Agreements among partners and a Data Safety and Monitoring Board. We plan to present findings at national meetings and publish the results. TRIAL REGISTRATION NUMBER:NCT03609177; Pre-results.

SUBMITTER: Lakin JR

PROVIDER: S-EPMC7365491 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer.

Lakin Joshua R JR Brannen Elise N EN Tulsky James A JA Paasche-Orlow Michael K MK Lindvall Charlotta C Chang Yuchiao Y Gundersen Daniel A DA El-Jawahri Areej A Volandes Angelo A

BMJ open 20200714 7

<h4>Introduction</h4>Advance care planning (ACP) is associated with improved health outcomes for patients with cancer, and its absence is associated with unfavourable outcomes for patients and their caregivers. However, older adults do not complete ACP at expected rates due to patient and clinician barriers. We present the original design, methods and rationale for a trial aimed at improving ACP for older patients with advanced cancer and the modified protocol in response to changes brought by t ...[more]

PMID: 32665394

Similar Datasets

Project description:IntroductionFewer than half of all people in the USA have a documented advance care plan (ACP). Hospitalisation offers an opportunity for physicians to initiate ACP conversations. Despite expert recommendations, hospital-based physicians (hospitalists) do not routinely engage in these conversations, reserving them for the critically ill.The objective of this study is to test the effect of a novel behavioural intervention on the incidence of ACP conversations by hospitalists practicing at a stratified random sample of hospitals drawn from 220 US acute care hospitals staffed by a large, nationwide acute care physician practice with an ongoing ACP quality improvement initiative.Methods and analysisWe developed Hopewell Hospitalist, a theory-based adventure video game, to modify physicians' attitudes towards ACP conversations and to increase their motivation for engaging in them. The planned study is a pragmatic stepped-wedge crossover phase III trial, testing the efficacy of Hopewell Hospitalist for increasing ACP conversations. We will randomise 40 hospitals to the month (step) in which they receive the intervention. We aim to recruit 30 hospitalists from up to eight hospitals each step to complete the intervention, playing Hopewell Hospitalist for at least 2 hours. The primary outcome is ACP billing for patients aged 65 and older managed by participating hospitalists. We hypothesise that the intervention will increase ACP billing in the quarter after dissemination, and have 80% power to detect a 1% absolute increase and 99% power to detect a 3.5% absolute increase.Ethics and disseminationDartmouth's Committee for the Protection of Human Subjects has approved the study protocol, which is registered on clinicaltrials.gov. We will disseminate the results through manuscripts and the trials website. Hopewell Hospitalist will be made available on the iOS Application Store for download, free of cost, at the conclusion of the trial.Trial registration numberNCT04557930.

Project description:Adolescent girls and young women account for a disproportionate fraction of new HIV infections in Africa and are a priority population for HIV prevention, including provision of pre-exposure prophylaxis (PrEP). Anchoring PrEP delivery to care settings like family planning (FP) services that women already access routinely may offer an efficient platform to reach HIV at-risk women. However, context-specific implementation science evaluation is needed. The Family Planning Plus Project is a prospective, pragmatic implementation evaluation, designed as a stepped wedge, cluster randomized trial, at 12 clinics in Kenya. In collaboration with the Kenya Ministry of Health and Kisumu County Department of Health, we will introduce integration of HIV risk screening and PrEP delivery in public health FP clinics. The core multifaceted implementation strategies to integrate PrEP in FP clinics will include: (1) PrEP delivery by existing FP clinic staff, (2) health provider training, (3) PrEP technical assistance to coach and mentor providers, (4) joint supervision with Kisumu County health officials, and (5) stakeholder engagement. All core components of PrEP delivery-including screening for HIV risk, HIV testing, dispensing, adherence and risk reduction counseling, assessment of side effects, and provision of refills, or safety assessment-will be conducted by existing FP clinic staff as part of a standard care service package. The goal is to catalyze sustainable scale-up within existing infrastructures beyond the project. We will rigorously evaluate implementation outcomes and impact, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, and we will use Organizational Readiness for Implementing Change (ORIC) and the Consolidated Framework for Implementation Science Research (CFIR) to assess readiness to implement and contextual enablers and barriers of implementation, including how clinics innovate efficient delivery systems. Anchoring PrEP delivery to existing FP systems and staffing has tremendous potential to address barriers that women face in accessing HIV prevention and PrEP care, including lack of time, cost, and stigma of visiting a facility solely for HIV prevention. The FP Plus Project will initiate preparation for full-scale and sustainable model of integration of comprehensive HIV prevention services, including PrEP implementation, in public health FP clinics in low-income settings. Trial registration Registered with ClinicalTrials.gov on December 14, 2020: NCT04666792.

Project description:BackgroundSepsis survivors experience high morbidity and mortality, and healthcare systems lack effective strategies to address patient needs after hospital discharge. The Sepsis Transition and Recovery (STAR) program is a navigator-led, telehealth-based multicomponent strategy to provide proactive care coordination and monitoring of high-risk patients using evidence-driven, post-sepsis care tasks. The purpose of this study is to evaluate the effectiveness of STAR to improve outcomes for sepsis patients and to examine contextual factors that influence STAR implementation.MethodsThis study uses a hybrid type I effectiveness-implementation design to concurrently test clinical effectiveness and gather implementation data. The effectiveness evaluation is a two-arm, pragmatic, stepped-wedge cluster randomized controlled trial at eight hospitals in North Carolina comparing clinical outcomes between sepsis survivors who receive Usual Care versus care delivered through STAR. Each hospital begins in a Usual Care control phase and transitions to STAR in a randomly assigned sequence (one every 4 months). During months that a hospital is allocated to Usual Care, all eligible patients will receive usual care. Once a hospital transitions to STAR, all eligible patients will receive STAR during their hospitalization and extending through 90 days from discharge. STAR includes centrally located nurse navigators using telephonic counseling and electronic health record-based support to facilitate best-practice post-sepsis care strategies including post-discharge review of medications, evaluation for new impairments or symptoms, monitoring existing comorbidities, and palliative care referral when appropriate. Adults admitted with suspected sepsis, defined by clinical criteria for infection and organ failure, are included. Planned enrollment is 4032 patients during a 36-month period. The primary effectiveness outcome is the composite of all-cause hospital readmission or mortality within 90 days of discharge. A mixed-methods implementation evaluation will be conducted before, during, and after STAR implementation.DiscussionThis pragmatic evaluation will test the effectiveness of STAR to reduce combined hospital readmissions and mortality, while identifying key implementation factors. Results will provide practical information to advance understanding of how to integrate post-sepsis management across care settings and facilitate implementation, dissemination, and sustained utilization of best-practice post-sepsis management strategies in other heterogeneous healthcare delivery systems.Trial registrationNCT04495946 . Submitted July 7, 2020; Posted August 3, 2020.

Project description:BackgroundAdvance Care Planning (ACP) helps people discuss personal values, goals and priorities regarding future care with family and professionals. It can support care coordination and guide decision-making as health deteriorates. However, uptake remains low internationally. Poor communication and information due to Covid-19 pressures exacerbated public and professional criticism and concerns. Recent recommendations highlight the importance of understanding and addressing public perceptions about ACP combined with person-centred approaches to ACP conversations.ObjectivesTo explore public perceptions of ACP to inform increased public engagement and empowerment.MethodsJoanna Briggs Institute methodology was applied in a rapid scoping review. Three databases (Embase, MEDLINE, APA PsycInfo) were searched for English language reviews and primary or secondary research studies from 2015 to 2021. Following title and abstract review, two researchers screened full-text articles and performed data extraction independently using Covidence. Charted data were analysed for themes and subthemes starting with two recent published reviews. Emerging findings were added and data synthesis reviewed by the research team, including public-patient representatives, to achieve consensus.ResultsOf 336 studies, 20 included reviews and research papers represented diverse public views, situations and contexts. Studies found poor public knowledge of ACP and widespread perceptions of confusing or accessible information. Multiple reports described little personal relevance, perceived risks of emotional distress, fears, mistrust and misconceptions about the purpose and scope of ACP. Studies identified public concerns stemming from reluctance to discuss death and dying despite this being just one aspect of ACP. Research with minority communities and marginalised groups found intensified concerns. Some studies cited people who valued maintaining autonomy by expressing their goals and preferences.ConclusionsStudies reviewed found many members of the public had negative or unclear perceptions of ACP. Improved knowledge and understanding appeared to influence perceptions of ACP but were not considered sufficient to change behaviours. The research provided valuable insights from members of the public that could inform current professional and societal debates about the future of ACP. Findings point to a need for novel approaches to ACP public information and involvement whilst bearing in mind societal norms, diverse cultures and contexts.

Dataset Information

Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer.

Publications

Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets