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Sexually Transmitted Diseases, Viral

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Immunologic Deficiency Syndromes

Lori Wiener, Ph.D.

Background:

* Few resources exist for helping adolescents and young adults with cancer or HIV disease understand their changing physical, emotional and social needs when treatment is no longer effective.
* An advance directive document called Five Wishes has had particular success with the adult population because of the consideration of personal, emotional and spiritual needs in addition to medical and legal concerns.

Objectives:

-To learn which questions in Five Wishes are useful for adolescents and young adults and to then create a new document that reflects the issues they feel are most appropriate for people with cancer or HIV disease.

Eligibility:

-Adolescents and young adults 16 to 30 years of age with advanced cancer or HIV disease acquired perinatally or early in life and enrolled in an active NIH treatment protocol.

Design:

* Stage 1: Participants go through each question in Five Wishes and respond to whether they feel the questions are useful.
* Stage 2: Participants are asked to compare each question from Five Wishes to a newly developed document based on the feedback received during first stage of the study.
* Participants are enrolled for either Stage 1 or Stage 2 depending on the date they enter the study.

Background:

* Discussing end of life (EoL) care with adolescents and young adults can be one of the most difficult aspects of living with a life threatening disease.
* Few established resources exist to aid this population in accepting and understanding their changing physical, emotional and social needs when treatment is no longer effective. Standards in palliative care suggest that discussion of end of life issues be routine and commence soon after diagnosis.
* While many helpful documents exist to facilitate such conversations with adults, few address the particular concerns and needs of adolescents and young adults.
* One advance directive (AD) document, Five Wishes, has had particular success with the adult population because of the consideration of 'personal, emotional and spiritual needs' in addition to medical and legal concerns.

Objective:

* To determine if adolescents and young adults living with advanced cancer or HIV disease feel that an AD document, such as Five Wishes, is useful in addressing end of life issues.
* To develop and perform a pilot evaluation of a modified age-appropriate advance care planning tool for young adults and adolescents based on Five Wishes that reflects the participants opinions on which questions they feel are most useful and additional items that might be helpful.

Eligibility:

* Age: 16 to 30 years
* Known metastatic, progressive or recurrent cancer or HIV disease acquired perinatally or early in life and enrolled in an active NIH treatment protocol.

Design:

-A descriptive study of attitudes of young adults (16-30 years) with cancer or HIV disease concerning the questions contained in the AD document Five Wishes as well as a comparison between Five Wishes and a modified version of that document.

An Exploratory Study of the Use of Five Wishes as a Tool for Advanced Care Planning in Young Adults With Metastatic, Recurrent, or Progressive Cancer or HIV Infection

National Cancer Institute (NCI)

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

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Subjects in this arm will participate in Reimagine's online Four Conversations program during the initial study period of four weeks.

Subjects in this arm will continue to receive standard care from their healthcare providers during the initial study period (i.e. no intervention). After four weeks, subjects will then participate in Reimagine's online Four Conversations program.

The online Four Conversations program consists of tutorial videos, printable documents, and live sessions with a counselor to educate subjects on shared decision making and care planning for those with advanced disease.

Four Conversations

Sophia K Smith, PhD

The purpose of this study is to see whether patients with metastatic breast cancer, their caregivers, and their healthcare providers can improve in shared decision making (SDM) and preparedness around end of life (EOL) planning through participation in Reimagine's online Four Conversations™ program. The goal is to close clinical practice gaps and enhance the quality of care for patients with metastatic breast cancer through increased competence and performance of healthcare providers and healthcare systems.

Four Conversations RCT

Four Conversations Randomized Controlled Trial

Clickstream data associated with viewing videos and other web content (e.g., social community) on the Reimagine website will be collected and analyzed through a web analytics software package. Session attendance will be collected by the Reimagine staff (specially trained counselors called Pillar Guides) and sent to the study team for analysis following each of the online meetings.

The Program Satisfaction \& Evaluation questionnaire was developed by the study team to assess perceived helpfulness of the program in terms of outcomes and patient-provider communication. Points are totaled and summed.

The Preparation for Decision Making Scale is a reliable and validated self-reported measure of the patient/caregiver or provider's perception of how useful a decision support intervention is in preparing the respondent to communicate with others making a health decision. Items are summed and scored, then divided by 10; scores can be converted to a 0-100 scale. Higher scores indicate higher perceived level of preparation for decision making.

The Decision Self-efficacy Scale is a reliable and validated instrument that measures self-confidence or belief in one's abilities in decision making, including shared decision making (SDM). Items are summed, divided by 11, and multiplied by 25. Scores range from 0 to 100 (very confident).

The Decisional Conflict scale is a reliable and validated measure of the state of uncertainty about a course of action. Items are summed, divided by 16, and multiplied by 25. Scores range from 0 to 100 (high decisional conflict).

The content of the City of Hope End of Life Knowledge Assessment was revised to reflect the program curriculum. Correctly answered questions will be awarded one point, summed, and a total score generated.

The PROMIS Global Scale is a reliable and validated measure of general perceptions of health. Items are predictive of care utilization and mortality. The scale produces two health scores: physical and mental. Items are summed and converted to t-scores.

The EOL Conversations are author-developed questionnaires incorporating items from the Survey on Advanced Care Planning Conversations. Points are totaled and summed.

Duke Cancer Institute

National Comprehensive Cancer Network

Pfizer

Pillars4Life, Inc.

Duke University

Digestive System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

This pilot study involves a two-arm parallel design comparing the effectiveness of a CPR video versus a CPR narrative script in advance directive (AD) completion over a 1 month time frame post intervention.

This pilot study involves a two-arm parallel design comparing the effectiveness of a CPR video versus a CPR narrative in advance directive (AD) completion over a 1 month timeframe post intervention.

Baseline Assessments (10 mins),Intervention:CPR video or script (5 mins) Post intervention assessments (10 mins), Longitudinal chart review follow-up (6 months)

(CPR) video and questionnaires

cardiopulmonary resuscitation (CPR) narrative script and questionnaires

Eileen O'Reilly, MD

Advance care planning involves thinking about choices if the patient becomes sick, and is important for everyone. It does not matter if the patients are ill or healthy. It is especially important for people who have diseases that cannot be cured. It allows people to make sure their wishes are respected if they become very sick or are dying. Thinking about these issues can be upsetting. But, for many people, it is helpful. This type of discussion can help the family learn what the patient may want but cannot tell them when these decisions need to be made

Cardiopulmonary Resuscitation (CPR) Video to Enhance Advance Care Planning in Advanced Upper Gastrointestinal Cancer Patients

The Use of a CPR Video to Enhance Advance Care Planning in Advanced Upper Gastrointestinal Cancer Patients: A Randomized Controlled Pilot Tria

Massachusetts General Hospital

Mount Sinai Hospital, New York

Memorial Sloan Kettering Cancer Center

Group A had watching educational module plus ACP brochure

Using vedio to assist physicians introducing advance care planning to cancer patients

For interventional module

Shao-Yi Cheng Shao-Yi

Shao-Yi Cheng, PHD

Shaoyi Cheng

Shao-Yi Cheng Shao-Yi, PHD

Evaluation of an Interventional module to assist physicians introducing ACP to cancer patients

Investigators hypothesize that compared to ACP brochure alone, educational module plus ACP brochure is effective in assisting the physicians to introduce ACP to the patients and completion of AD documentation

Shared decision making (SDM) process through Advance Care Planning (ACP) consultation with cancer patients

Evaluation of an Interventional Module to Assist Physicians Introducing ACP to Cancer Patients

National Taiwan University Hospital,Taiwan (R.O.C)

To evaluate factors that might hinder patient willingness to sign DNR / complete AD documentation by applying the The Transtheoretical Model (TTM).

After intervention cancer patients willing sing DNR

After intervention cancer patients completion of a new AD documentation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Exploratory Study of the Use of Five Wishes as a Tool for Advanced Care Planning in Young Adults With Metastatic, Recurrent, or Progressive Cancer or HIV Infection	NCT01445145	Neoplasms		16 Years - 30 Years	National Institutes of Health Clinical Center (CC)
UC Health Care Planning Study	NCT04012749	Advance Care Pl... Advance Directi... Advanced Cancer	Advance directi... Prepare Facilitator	18 Years -	University of California, Los Angeles
Four Conversations RCT	NCT02944344	Breast Cancer	Four Conversati...	18 Years -	Duke University
Cardiopulmonary Resuscitation (CPR) Video to Enhance Advance Care Planning in Advanced Upper Gastrointestinal Cancer Patients	NCT01105806	Pancreas and He...	(CPR) video and... cardiopulmonary...	18 Years -	Memorial Sloan Kettering Cancer Center
Cardiopulmonary Resuscitation (CPR) Video to Enhance Advance Care Planning in Advanced Upper Gastrointestinal Cancer Patients	NCT01105806	Pancreas and He...	(CPR) video and... cardiopulmonary...	18 Years -	Memorial Sloan Kettering Cancer Center
UC Health Care Planning Study	NCT04012749	Advance Care Pl... Advance Directi... Advanced Cancer	Advance directi... Prepare Facilitator	18 Years -	University of California, Los Angeles
Evaluation of an Interventional Module to Assist Physicians Introducing ACP to Cancer Patients	NCT04969952	Cancer Patients	For interventio...	20 Years - 85 Years	National Taiwan University Hospital
Four Conversations RCT	NCT02944344	Breast Cancer	Four Conversati...	18 Years -	Duke University

Spots Global Cancer Trial Database for advance directive