Messaging and advance directive distribution. All arms receive physician advance care planning education at the clinic level.

Messaging and advance directive distribution plus introduction to the Prepare For Your Care website. All arms receive physician advance care planning education at the clinic level.

Messaging and advance directive distribution, introduction to the Prepare For Your Care website, plus patient engagement from a trained facilitator who also can interact with the primary care physician. All arms receive physician advance care planning education at the clinic level.

Patient receives a health system-specific advance directive along with a message crafted with input from a broad group of stakeholders at the clinical sites and external advisors. Messaging introduces advance care planning, the purpose of the advance directive and contains instructions for completing it and turning it in, as well as a prompt to discuss the document with the patient's primary care physician.

Advance directive

Patient invited to use the Prepare For Your Care website (www.prepareforyourcare.org) that will introduce and facilitate advance care planning and guide completion of an advance directive.

Prepare

Facilitator engages patient to activate advance care planning and to carry out navigation and facilitation aspects of advance care planning. Facilitator can tee up advance care planning activities with the primary care physician.

Facilitator

Neil S Wenger, MD

Using a cluster randomized design at the clinic level, this project will implement and test three real-world, scalable advance care planning interventions among primary care clinics across three University of California health systems. Seriously ill patients identified using data from the electronic health record will receive (1) an advance directive with targeted messaging, (2) intervention 1 plus prompting to engage with the Prepare For Your Care website, or (3) intervention 2 plus engagement from a clinic-based facilitator. A Research cohort of patients will provide complete surveys at baseline, 12 and 24 months. The main outcomes are advance directive completion among the population cohort and goal concordant care among the Research cohort at 12 months.

The goal of the project is to test, implement, and disseminate real-world, scalable advance care planning (ACP) interventions among busy, primary care clinics across three UC Health systems. The study aims are as follows:

Aim 1: With the input of primary care stakeholders (i.e., adults with serious illness, caregivers and clinical staff) at each site, determine the barriers, facilitators and best workflow plans to implement the three ACP interventions.

Aim 2: Implement the three ACP interventions across primary care clinics using a cluster randomized design across three UC Health systems: distribution of an advance directive (AD) (arm 1), distribution of the AD plus prompting the patient to engage with the Prepare For Your Care website (arm 2), and the AD plus engagement with the Prepare For Your Care website plus a Care coordinator intervention to engage clinicians (arm 3).

Aim 3: Compare the effectiveness of the three interventions on documentation of ACP (represented by an AD, POLST or out-of-hospital DNR form available in the medical record) on a population-based primary care cohort of seriously ill patients across three UC Health systems, and assess ACP engagement, quality of communication and goal-concordant care among a Research cohort subset of these patients.

The investigators hypothesize that there will be a dose response of additive improvement from arm 1 to arm 2 to arm 3 on AD completion (primary outcome) at the population level and receipt of goal-concordant treatment at the Research cohort level.

Seriously ill patients commonly receive treatments at the end of life that are inconsistent with or not guided by their values and goals. People with serious illness bear a considerable burden of suffering, and complexity of illness is strongly associated with increased hospitalization and healthcare utilization. Families of patients with serious illness who die often sustain substantial financial and emotional injury. Yet, this is not an irremediable result of advanced technology and an enlarging older population: ACP - the process of discussion of end of life care, clarification of values and goals, and embodiment of preferences through written documents and medical orders - is associated with less aggressive medical care near death and earlier hospice referral, which is then associated with better quality of life for patients and better bereavement adjustment for loved ones.

Experimental evidence supports the premise that ACP improves the treatment choices made by and for people with serious illness. A systematic review concluded that ACP interventions increase completion of ADs, increase the frequency of discussions about care preferences and increase concordance between patient's preferences and end-of-life care received. An earlier review found that multicomponent interventions were more likely to result in AD completion, yet much of this work focused on hospitalized patients and patients with cancer. A systematic review of the effects of 113 ACP interventions found decreased use of life-sustaining treatment and increased hospice and palliative care, but concluded that more experimental designs and community studies are needed. Many of these reviews noted a lack of head-to-head comparison of ACP interventions and a need for structures to implement ACP in standard care. The Institute of Medicine IOM critiqued studied ACP interventions for being targeted as one-time decisions rather than being conceptualized as incorporated into the routine of care.

A fundamental gap exists in whether and how ACP interventions can be implemented at a healthcare system level. Although ACP has shown the potential to help patients and clinicians achieve the "triple aim" of improving quality of care and patient satisfaction, improving population health and lowering costs by honoring patients' wishes, it has been slow to be prioritized in healthcare systems. Even among seriously ill patients, ACP remains uncommon. Although quality and efficiency are increasingly emphasized and several health systems are in early phases of adopting programs to improve ACP, few programs have successfully implemented ACP across their healthcare system. Implementing a system-wide program among a diverse patient population with primary care physicians (PCPs) who are already overburdened with the complex management of seriously ill patients remains a challenge.

This project will implement three system-wide advance care planning interventions and compare their effect. This quality improvement project will be implemented at the level of the health system with no direct patient contact and collection of only deidentified data for evaluation of the effect of the interventions. A second project nested in the population-based quality improvement project will enroll and evaluate a Research cohort that will provide patient and caregiver level information about the effect of the three ACP interventions. These components will be conducted in an identical fashion at UCLA, UCSF and UCI.

Using a computer algorithm developed and validated for this project, data from the electronic health record will be used to delineate a group of seriously ill patients cared for in primary care that require ACP and also identify whether these patients have ADs in the electronic health record in the past 3 years. All patients receiving primary care in the health system are eligible to be identified as seriously ill patients.

The project will implement 3 real-world ACP intervention comparators using a clustered randomized trial design. The interventions are: (arm 1) distribution of an AD with a tailored message via MyChart in the electronic health record and/or postal mail, (arm 2) arm 1 plus access to the Prepare For Your Care website that is a publicly available decision support tool for ACP, and (arm 3) arm 2 plus patient engagement by a clinic-based facilitator who will tee up AD completion, Prepare website use and coordinate patient ACP interactions with primary care physicians. The interventions will continue over a 24-month period, with an evaluation at 12 and 24 months.

Comparison of the 3 intervention arms will occur at the population level by collecting deidentified data from the electronic health record reflecting AD completion (existence of an AD or POLST or outpatient DNR order and the date of the document), vital status, and healthcare utilization (hospitalization, ICU use, ED use, and location of death).

A Research cohort will be enrolled from the seriously ill population-based cohort that do not have an AD or POLST within the past three years by asking patients via mail, telephone, or in person whether they are willing to participate in an observational survey study. Interested patients will be asked to provide written informed consent to participate in up to 3 surveys: baseline, 12 months and 24 months. The surveys may be completed on a paper-and-pencil hard copy, completed by interview over the telephone, completed in person or completed over a secure web link, depending on patient preference. The surveys will ask about experience with and readiness for ACP, health status, preferences for healthcare and decision making, and demographics. If a patient is unable to be surveyed at month 12 or month 24, a caregiver will be approached for survey. If the patient dies, a caregiver will be asked to complete a survey about goal-concordant treatment, perceptions about care and satisfaction with care and communication. Patients will also be asked to consent to medical record review to evaluate documentation about ACP and measure goal concordant care. The principle outcome is AD completion at the population level using administrative data from the electronic health record.

Cluster randomized trial at the primary care clinic level

UC Health Care Planning Study

Population-based Comparison of Evidence-based, Patient-centered Advance Care Planning Interventions on Advance Directive Completion, Goal Concordant Care and Caregiver Outcomes for Patients With Advanced Illness

Hospitalization, ICU care and ER visits within 30 days of death will be compared among decedents of the three study arms using regression models to account for patients clustered within clinics including covariates of patient age, gender, race/ethnicity, serious illness category, clinic baseline advance directive completion rate, study site, time, study arm, and study arm-time interaction.

Advance care planning level of engagement and conversations based on survey (Sudore RL, Stewart AL, Knight SJ, McMahan RD, Feuz M, Miao Y, Barnes DE. Development and validation of a questionnaire to detect behavior change in multiple advance care planning behaviors. PLoS One. 2013;8(9):e72465).

Advance care planning level of engagement and conversations based on validated survey (Sudore RL, Stewart AL, Knight SJ, McMahan RD, Feuz M, Miao Y, Barnes DE. Development and validation of a questionnaire to detect behavior change in multiple advance care planning behaviors. PLoS One. 2013;8(9):e72465).

Proportion of patients that have advance care planning documentation (enduring advance directive, POLST or out-of-hospital DNR form in the electronic health record) at 12 months (or death) compared to baseline. Baseline date defined as the clinic intervention start date. Intention to treat analysis will use logistic regression models to account for patients clustered within clinics including covariates of patient age, gender, race/ethnicity, serious illness category, clinic baseline advance directive completion rate, study site, time, study arm, and study arm-time interaction.

Goal concordant care measured by patient/caregiver reports of receipt of preference concordant care based on questions from SUPPORT (Teno JM, Fisher ES, Hamel MB, Coppola K, Dawson NV. Medical Care Inconsistent with Patients' Treatment Goals: Association with 1-Year Medicare Resource Use and Survival. J Am Geriatr Soc. 2002;50(3):496-500. doi:10.1046/j.1532-5415.2002.50116.)

Advance care planning documentation (enduring advance directive, POLST or out-of-hospital DNR form in the electronic health record) among patients with no advance care planning documentation in the past three years. Baseline date defined as receipt of intervention. "As treated" analysis will use logistic regression models to account for patients clustered within clinics including covariates of patient age, gender, race/ethnicity, serious illness category, clinic baseline advance directive completion rate, study site, time, study arm, and study arm-time interaction.

Caregiver report of quality of end of life care among decedents based on the modified Bereaved Family Survey

Proportion of patients that have advance care planning documentation

Goal concordant care measured as match of care receipt to future care preference based on survey

Goal concordant care measured as caregiver post-mortem report goal concordant care (Teno JM, Freedman VA, Kasper JD, Gozalo P, Mor V. Is care for the dying improving in the United States? J Palliat Med. 2015;18(8):662-6).

University of California, San Francisco

University of California, Irvine

University of California, Los Angeles

Professor

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Rare Diseases

Chronic Disease

Chronic Pain

Pain

Neurologic Manifestations

Disease Attributes

Chronic Graft Versus Host Disease

Michelle Speaks, MBA

Sunil K Aggarwal, MD, PhD

Therry Eparwa, DNP

Leanna J Standish, ND, PhD

Therry Eparwa, DNP, FNP-BC

Leanna J Standish, ND, PhD, LAc

This epidemiologic research is being conducted as an observational prospective case series outcomes study of the use of advanced integrative specialty medical care and its effect on adult and pediatric patients with chronic or serious illnesses or mental health disorders.

There is growing interest in providing integrative medical care in conjunction with specialty medical care to expand the reach of integrative care to more chronically and seriously ill patient populations. At the AIMS Institute, the core specialties are naturopathy, palliative care, psychiatry, physiatry, and naturopathic oncology practiced via coordinated, team-based care by allopathic medical and psychiatric specialists, psychotherapists, specialized naturopathic physicians, advanced practice nurses, and targeted health educators, with the majority of care covered by insurance. Additionally incorporated are novel 'advanced' approaches, such as drug-assisted psychotherapy, medical cannabis education, sympathetic blocks, and some intravenous therapies.

This is an uncontrolled, prospective case series outcomes study of health-related quality of life outcomes in patients who receive care at AIMS Institute. A clinic-wide chart audit of patient characteristics and outcomes will be conducted prior to the start of enrollment.

AIMS Medical Outcomes Study

Measure quality of life using GAD-7, PHQ-9, and short form questionnaire.

Describe treatments prescribed and provided by AIMS Institute physicians abstracted from chart review.

Advanced Integrative Medical Science Institute

Behaviors and Mental Disorders

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Digestive System Diseases

Dementia

Kidney Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Kidney Failure, Chronic

Heart Failure

End Stage Liver Disease

Lung Diseases

Liver Diseases

Lung Diseases, Interstitial

Renal Insufficiency

Respiratory Tract Diseases

Gastrointestinal Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Renal Insufficiency, Chronic

Liver Failure

Hepatic Insufficiency

First stage: No patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training.

Second stage (non-responders only): High patient engagement and high intensity clinician training.

First stage: No patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training.

Second stage (non-responders only): Low intensity patient engagement and high intensity clinician training.

First stage: Low intensity patient engagement. Low intensity clinician training.

Second stage (responders only): No patient engagement and high intensity clinician training.

Second stage (non-responders only): High patient engagement and high intensity clinician training.

First stage: Low patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training.

Second stage (non-responders only): Low intensity patient engagement and high intensity clinician training.

A "booster" of the established LSTDI implementation strategy. Clinicians will be presented with summary written/electronic materials on the LSTDI developed for the study. Online training options and when and how to complete goals of care conversations and documentation will be highlighted.

Clinician Implementation Strategy Stage 1: low intensity clinician training

This includes two components:

1. Team facilitation to help the primary care team (advance practice provider, nurse, social worker) work together to create roles and responsibilities for accomplishing goals of care conversations with patients
2. A patient list "trigger" of patients potentially eligible for goals of care conversations (the patient study population) will be sent to the primary care clinicians.

Clinician Implementation Strategy Stage 2: high intensity clinician training

Patients will be sent information about goals of care conversations, including the PREPARE website.

Low patient engagement

Patients will be sent information about goals of care conversations, including the PREPARE website. Follow-up phone calls to discuss goals of care conversations and the PREPARE website will be made.

High patient engagement

David Bekelman, MD MPH

Anne M Walling, MD PhD

The long term goal is to improve quality of care in Veterans with serious illnesses by aligning medical care with Veterans' goals and values. The objective of this study is to use a sequentially randomized trial to determine what implementation strategies are effective to increase early, outpatient goals of care conversations. The study will use interviews with and surveys of medical providers, patients, and caregivers, along with medical record data. This work is significant because it tests ways Veterans can express their goals and preferences for life sustaining treatments and have them honored.

The aims of this study are as follows:

Aim 1. Use a clinician-level SMART in three VA health systems to determine the effectiveness of clinician and patient implementation strategies to improve the occurrence of documented goals of care conversations in Veterans with serious medical illness. Hypothesis 1 (first stage of the SMART): Compared to a low intensity clinician strategy alone, a low intensity clinician and patient strategy will lead to increased documentation of goals of care conversations. Hypothesis 2. Among those who do not respond to low intensity strategies, compared to a high intensity clinician strategy paired with a low intensity patient strategy, a high intensity clinician and patient strategy will lead to increased documentation of goals of care conversations.

Aim 2a. Identify the sequence of implementation strategies that leads to the overall greatest increase in documentation of goals of care conversations. Aim 2b (exploratory). Identify patient and clinician characteristics that modify the effect of sequences of implementation strategies on documentation of goals of care conversations.

Aim 3. Understand clinician and patient implementation strategy success or failure using a mixed method evaluation involving clinicians, leaders, patients, and caregivers.

Sequential multiple-assignment randomized clinical trial (SMART)

The primary outcome of goals of care conversation notes is determined by whether notes are entered into the electronic health record. The data manager queries the VA corporate data warehouse to determine if these notes are completed. Because the data manager can see who wrote the notes, the data manager is not blinded. However, the investigators do not expect the data manager to judge whether the notes were completed.

Goals of Care Conversations Study

Improving Implementation of Outpatient Goals of Care Conversations for Veterans With Serious Illness

Amongst patients attributed to a clinician who was randomized in Stage 2, whether or not a goals of care conversation note was written during Stage 2.

Amongst all patients in the study, whether or not a goals of care conversation note was written during the study.

Amongst all patients in the study, whether or not a goals of care conversation note was written during stage 1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
UC Health Care Planning Study	NCT04012749	Advance Care Pl... Advance Directi... Advanced Cancer	Advance directi... Prepare Facilitator	18 Years -	University of California, Los Angeles
AIMS Medical Outcomes Study	NCT04512755	Mental Health I... PTSD Pain Chronic Pain Chronic Disease		-	Advanced Integrative Medical Science Institute
UC Health Care Planning Study	NCT04012749	Advance Care Pl... Advance Directi... Advanced Cancer	Advance directi... Prepare Facilitator	18 Years -	University of California, Los Angeles
AIMS Medical Outcomes Study	NCT04512755	Mental Health I... PTSD Pain Chronic Pain Chronic Disease		-	Advanced Integrative Medical Science Institute
Goals of Care Conversations Study	NCT05001009	Seriously Ill P... Cancer Heart Failure Interstitial Lu... Chronic Obstruc... End-stage Renal... End-stage Liver... Dementia	Clinician Imple... Clinician Imple... Low patient eng... High patient en...	18 Years -	VA Office of Research and Development

Spots Global Cancer Trial Database for serious illness