Clinical Research Directory

CommunityRx-Dementia + Peer Navigation (CRxDpeer)

The CRxDpeer intervention, delivered by a trained peer navigator, in practice called a "peer mentor", includes three evidence-based components: (a) focused education about common social (e.g., food and housing insecurity) and caregiving (e.g., respite and end of life care) needs, (b) activation of personalized community resource information for social and caregiving needs through delivery of a resource list (HealtheRx) at the baseline encounter and coaching on how to communicate with service providers, coordinate services and manage social support (e.g., connect with their peer navigator, reach out to friends or relatives for support, identify support groups, etc.) and (c) ongoing navigation-focused support meant to boost the baseline intervention, including a series of proactive text messages over 12 months. During this time, the subject can respond to and communicate with the peer navigator for ongoing support.

I Kua na'u Advance Care Planning for Native Hawaiian Elders

Communication surrounding serious illness decision making is formalized in Advance Care Planning (ACP), a process involving verbal or written information designed to inform patients of possible medical options including palliative and hospice care services. Numerous studies have suggested that improved ACP rates better align health care delivery with patient preferences. Despite expansion of ACP services in the health care system, Native Hawaiians (NHs) consistently have negligible rates of ACP and low use of palliative and hospice care services. To address these shortcomings, our multi-disciplinary community and research group has partnered to create the I kua na'u "Let Me Carry Out Your Last Wishes" ACP video intervention. Our Community-Based Collaborative Approach will create, develop and test the I kua na'u comprehensive video-based ACP program honoring the history, opinions, and culture of NHs. Indeed, NH culture is primarily an oral tradition in which the spoken word permeates the life of NHs and is the normal way of interacting with neighbors, including in its most recent adaptation with the use of video media. The I kua na'u program will include videos tailored for the different settings in which older NHs live and get medical care. The videos will explain the importance of ACP, empower NHs to tell their story ('olelo Kama'ilio; "Talk Story") by allowing the recording of personal video declarations of ACP wishes, and the ability to share the personal video declaration with family, friends and clinicians. The overall objective is to conduct a five-year program that includes two years of development of the I kua na'u ACP video program with focus group testing, and then three years of implementation in the NH community. Demonstrating the effectiveness of using the video program in NHs represents an essential step to implement this tool in practice. The Specific Aim is to compare the ACP engagement, knowledge, decisional conflict, and ACP completion rates in 220 NHs over the age of 55 in: (a) a pre-post study design in 110 people living on Homestead or Assisted Living using the video intervention, and (b) a randomized trial of 110 people recruited from Ambulatory Clinics.

Chatbot-Assisted Advance Care Planning Education for Family Members

The goal of this clinical trial is to learn if a messaging and chatbot program, called ChatACP, helps family members of people living in nursing homes take part in advance care planning. The main questions this study aims to answer are: * Does ChatACP help family members feel more ready to talk about future medical and personal care with their loved one? * Does ChatACP help family members take part in advance care planning activities, such as having care discussions or completing planning documents? * Is ChatACP easy to use and acceptable for family members? Researchers will compare ChatACP to standard self-learning materials about advance care planning to see which approach works better. Participants will: * Receive short daily messages with pictures or videos about advance care planning and access to a chatbot specialized in ACP for 10 days * Complete surveys at the start of the study, after the program ends, and again 3 months later * Take part in an interview to share their experience with the program

Using a Conversation Game to Engage Native American Washoe Tribe Members in Advance Care Planning: Preparation for a Clinical Trial

The goal of this study is to learn if a culturally adapted version of the Hello game, an advance care planning (ACP) conversation tool, is feasible and acceptable for use with members of the Washoe Tribe. The main questions it aims to answer are: Can the Hello game be successfully adapted to reflect the cultural values, beliefs, and storytelling traditions of the Washoe Tribe? Does playing the adapted Hello game increase ACP engagement and advance directive (AD) completion among Washoe Tribe members within 3 months? Participants will: * Take part in talking circles at one of four Washoe reservations to share their beliefs, motivations, and experiences related to end-of-life care and advance care planning * Complete brief questionnaires about their ACP attitudes and behaviors * Play the culturally adapted Hello game in a group setting * Complete follow-up measures of ACP engagement and advance directive completion 3 months after playing the game

Resilience in East Asian Immigrants for Advance Care Planning Discussions

The purpose of the study is to develop a culturally tailored digital resilience-building intervention to help East Asian immigrants engage in advance care planning discussions with their family caregivers.

The Impact of an Advance Care Planning Game on Life-Sustaining Treatment Preferences, Depression, and Hope in Older Adults With Stroke

Stroke is the world's third leading cause of death and a major source of disability, with high rates of recurrence and mortality that often limit patients' ability to express their values and treatment preferences. This highlights the importance of Advance Care Planning (ACP) after stroke. This randomized controlled trial examined the effects of an ACP block-based game on life-sustaining treatment preferences, depression, and hope among adults aged 65-100 with subacute stroke in a regional teaching hospital. The Life Support Preferences Questionnaire (LSPQ) served as the primary outcome to assess preference changes immediately after the intervention and at four weeks, while the Hospital Anxiety and Depression Scale (HADS) and the Herth Hope Index (HHI) were secondary measures. The intervention used the "LOHAS Journey" ACP game, which applies travel-themed scenarios, blocks to express medical choices, hope-enhancing elements, and companion cards emphasizing personal resources and potential surrogate decision-makers, while also encouraging warm emotional expression. Generalized Estimating Equations (GEE) were used to analyze repeated measures and time-by-group effects. If effective, this ACP game may support broader clinical adoption of structured discussions on life-sustaining treatment preferences for older stroke patients.

Advance Care Planning With Formerly Homeless Older Adults Residing in Permanent Supportive Housing

The homeless population is aging, with an increasing proportion of individuals over age 50 who experience accelerated aging, high rates of mortality, and a high risk of not having their wishes honored at the end of life. The goal of this randomized control trial (RCT) is to test the effectiveness of adapted evidence-based advance care planning (ACP) interventions for formerly chronically homeless older adults living in permanent supportive housing (PSH).

Project Talk Trial: Engaging Underserved Communities in End-of-life Conversations

Compared to the general population, individuals from underserved communities are more likely to receive low quality end-of-life care and unwanted, costly and burdensome treatments due in part to a lack of advance care planning (ACP; the process of discussing wishes for end-of-life care with loved ones/clinicians and documenting them in advance directives). This study will use existing, trusted, and respected social networks to evaluate two conversation-based tools intended to engage underserved individuals in discussions about end-of-life issue and motivate them to carry out ACP behaviors. Through this study, investigators will learn how best to engage underserved populations in ACP so as to: 1) increase the likelihood that patients from underserved communities will receive high-quality end-of-life care; 2) address health disparities related to end-of-life treatments; and 3) reduce unnecessary suffering for patients and their families.

Effectiveness of Engaging in Advance Care Planning Talks (ENACT) Group Visits in Primary Care for Older Adults With and Without Alzheimer's Disease

The main goal of the ENACT (ENgaging in Advance Care planning Talks) Group Visit intervention is to integrate a patient-centered advance care planning process into primary care, ultimately helping patients to receive medical care that is aligned with their values. The ENACT Group Visit intervention involves two group discussions about advance care planning with 8-10 patients who meet for 2-hour sessions, one month apart, facilitated by a geriatrician and a social worker. This study will compare the ENACT Group Visit intervention to mailed advance care planning materials.

Navigating Advanced Illness Goals And Treatment With Digital Engagement (NAVIGATE)

The goal of this two-armed, parallel-design, pre-/post-intervention assessment clinical trial is to learn if a digital and interactive website helps to improve advance care planning (ACP) engagement among caregivers of patients with serious illness. The main questions it aims to answer are: Does the website increase ACP engagement of caregivers of patients with serious illness? Researchers will compare the digital and interactive website to the usual care (a digital booklet) to see if the digital intervention works to improve ACP engagement among caregivers. Participants who are caregivers will: * Be introduced to a digital website and asked to explore the site over the course of the study. * Complete four self-administered questionnaires (baseline, one-week, six-week, and six-month). Participants who are patients will not have any intervention assigned and will only have their observational data collected through four interviewer-administered questionnaires (baseline, one-week, six-week, and six-month)

Jumpstarting Advance Care Planning With ANAI People

The older Alaska Native/American Indian (ANAI) population is increasing at twice the rate of the general population with a higher burden of serious illness. Older ANAI adults with serious illness are half as likely to have advance directives (AD), indicating a need for improved access to and utilization of advance care planning (ACP) to ensure that medical care aligns with the values, goals, and preferences of ANAI patients and their families throughout the illness trajectory. The major goals of this cluster randomized trial (CRT) are to (1) evaluate the comparative effectiveness of usual care and JUMPSTART- ANAI, a culturally tailored ACP communication intervention, for prompting patient-driven ACP conversations between ANAI adults and primary care providers and to (1) identify key factors to successfully implement the intervention in health systems serving ANAI adults with serious illness.

Motivational Interviewing to Enhance Advance Care Planning for Older Adults and Caregivers After Emergency Visits

This study aims to evaluate the effectiveness of a motivational interviewing (MI) intervention in enhancing advance care planning (ACP) among older adults who have visited the Emergency Room (ER) in the past six months and their family caregivers. The main question it aims to answer is: The effectiveness of the MI-based ACP intervention implemented within six months of an ER visit on improving older adults' advance directives (AD) completion rate. Compared to participants in the control group who will only receive a self-education booklet, participants in the intervention group will receive a motivational interview educational intervention to see the effectiveness of an MI-based ACP intervention implemented within six months following an emergency room visit regarding the completion of AD for older adults.

Advanced Care Planning for the Severely Ill Home-dwelling Elderly

This study will develop and evaluate a complex intervention to implement advance care planning for severely ill home-dwelling elderly acutely admitted to hospital, by using a cluster randomized design. Twelve Norwegian acute geriatric hospital units will participate in the main study, each as one cluster. Of the twelve clusters, half will receive implementation support and training immediately, and the other half will receive similar support after the intervention period. The study includes 1) assessment of implementation outcomes (fidelity) in the participating units,2) health service and clinical outcomes including a) questionnaires to all staff in the units before and after the implementation period, questionnaires to attending clinicians and qualitative interviews with health personnel and local unit leaders b) questionnaires to patients and their relatives, patients records and data from central health registers and qualitative interviews with patients and relatives. Furthermore we will assess barriers and facilitators for advance care planning in 1) a wider health service context, and 2) at the national, regional and municipal level, and do economic analyses.

Development and Evaluation of 'My Voice': a Randomized Controlled Trial

The study aims to develop and evaluate a web-based interactive platform (called 'My Voice') that helps to educate patients with heart failure and their caregivers about heart failure, identify their goals for end-of-life care, and share these with their caregivers and doctors.

Improved Prescribing for Older Nursing Home Patients

Research aim: To investigate the effect of training health care professionals in medication assessments on the medication use of nursing home residents with a limited life expectancy (\< 1.5-2 years). The core of the training is to tailor medication use to (palliative) treatment goals of nursing home residents. Design: A cluster randomized controlled trial on long term care wards in nursing homes, with the nursing home care organisations as unit of randomisation. The investigators intent to include 6 organisations and 450 nursing home patients. The research starts in september and lasts 1 year and 3 months. Eligible patients are nursing home patients of 65 years and older with a limited life expectancy (\< 1.5-2 year) of long term care wards. Intervention: The intervention includes a method in which healthcare professionals (medical practitioner, pharmacist and care worker) are trained to tailor medication to the (palliative) treatment goals of nursing home patients with a limited life expectancy. The training consists of 2 components: 1) medication assessment, and 2) advance care planning (ACP). In the intervention group, healthcare professionals receive the training in combination with supporting tools and educational materials, in the control group care continues as normal. The allocation ratio for control and intervention groups is 1:1. A process evaluation will take place simultaneously with the intervention study. Data collection takes place before the start of the intervention (T0), after 6 months (T1) and after 12 months (T2). Outcome measures: The primary outcome measure is potential under- and over-treatment with medication. The secondary outcome measure is experienced involvement in decision-making (measured with a short questionnaire based on the revised PATD (patients' attitude towards deprescribing)). Tertiary outcome measures are: quality of life, deaths, falls, hospital admissions/acute first aid referrals and pain. Discussion: The intervention is expected to result in a decrease in chronic and preventive medication prescriptions, an increase in medication for symptom treatment and more involvement (and satisfaction) of the nursing home resident in decision-making, without adverse effects.

Advance Care Planning Training for Nurses

The aims of this study are to examine the effectiveness of a multi-media experiential training programme in advance care planning (ACP) for nursing staff in acute care settings. The main questions it aims to answer are: * can the programme enhance nurses' decision-support skills * can the programme strengthen nurses' knowledge and confidence, and improve their attitude toward ACP? Researchers will compare the participants in the intervention group (receive training programme) with those who are in the control group (receive no intervention) to evaluate the effectiveness of the programme.

Home-based Nurse Intervention in the Care of High Risk of Death Patients After Discharge From Geriatric Department

This study consists to evaluate the feasibility of a case-management intervention of Advance Care Plan (ACP) placement for elderly patients at high risk of death at twelve months discharged alive from acute geriatric medicine. Feasibility will include the following indicators: rate of patients included and randomized, rate of patients remaining in the study, ACP rates achieved at one month.

Which Health-care Professional(s) to Talk About Advance Care Planning ?

The goal of this descriptive observational study is to evaluate the preference of French adult patients followed in the context of a oncological disease, regarding the choice of the preferred healthcare professional to discuss advance care planning. To this end, voluntary participants will be asked to indicate their preferences by answering a self-questionnaire available in electronic or paper format.

Implementation of Online Advance Care Planning Tool for (Hemato-)Oncological Patients Within the Cancer Network Concord

The aim of this mixed-methods study is to describe both the implementation process and outcomes of the online module Advance Care Plan for (hemato-)oncology patients within the oncology-network CONCORD. The main question is: How is implementation and assurance of the advance care plan in daily care for (hemato-)oncological patients within CONCORD achieved, so that early integration of advance care planning in oncological care takes place and patient preferences are discussed? Healthcare providers and patients are asked to use the module and share their experiences with it.