41 Clinical Trials for Various Conditions
The purpose of the study will be to determine how participation in Family-Centered Care (FCC) compared to Child-centered care (CCC) will affect caregiver engagement in IPV-based community services, caregiver perceptions of empowerment and survivor-defined practice, and clinical outcomes for children exposed to IPV.
A Fast Healthcare Interoperability Resources (FHIR)-enabled digital personal health record mobile app has the potential to enhance care coordination for families of children and youth with special healthcare needs (CYSHCN) and to inform improvements in family-centered care coordination that will be highly impactful for populations of patients with complex health needs across the age spectrum. The purpose of this study is to evaluate the feasibility of a digital personal health record (PHR) mobile application integrated with electronic health records by FHIR data standards to enhance care coordination for families of CYSHCN. The study will enroll 40 families (adult parents/caregivers) of CYSHCN in pediatric primary care clinics to use the digital PHR mobile application as a tool for coordinating their child's care over a 6-month period. Using a single group, non-randomized study design and convergent mixed methods analyses, the study will: (a) determine the feasibility of FHIR-enabled integration of the mobile application with electronic health records for care coordination; (b) identify barriers and facilitators to implementation in real-world settings; and (c) examine associations between level of app adoption by families and family-reported outcome measures.
Comorbid depression and multiple medical conditions in older adults are a serious public health problem. As an important facilitator of health-related activities, families are already involved in various aspects of self-management of chronic disease in older adults. Despite the benefits they provide, informal caregiving activities currently are organized outside the medical system, which potentially creates redundant or misaligned efforts.The purpose of the mentored research is to examine the feasibility and acceptability of the FACE-PC, a theory-driven, multi- component, technology-assisted interdisciplinary team-based care model that systematically involves family in chronic disease management. It aims to optimize the patient and family's collective ability to self-manage chronic disease.
This is a stepped wedged randomized controlled trial comparing the PARTNER intervention with usual care in 5 Intensive Care Units. The overarching goal of this research project to ensure patient-centered decisions about the use of intensive treatments for patients with advanced critical illness. In a prior project, the investigators developed the PARTNER program (PAiring Re-engineered ICU Teams with Nurse-driven Education and OutReach), a 4-facet, team-based intervention that re-engineers how surrogates are supported in ICUs, including: 1) changing care "defaults" to ensure clinician-family meetings within 48 hours of enrollment and frequently thereafter; 2) protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings, 3) increased use of palliative care services for patients with a poor prognosis. The investigators propose to begin deployment of the PARTNER II program in the spring of 2015 enrolling 690 surrogate decision makers in 5 ICUs using a stepped wedge design. The investigators expect to achieve the following project goals: 1. To increase the patient-centeredness of end-of-life decisions, and to increase the quality of clinician-family communication. 2. To decrease the psychological burden on family members acting as surrogates. 3. To reduce total health care costs by decreasing the duration of use of burdensome, invasive treatments at the end of life.
One in five deaths in the U.S. occurs in or shortly after discharge from an intensive care unit (ICU), typically following decisions made by surrogate decision makers to forego life prolonging treatment. A large body of empirical research has identified deficiencies in care processes that contribute to three important problems: 1) family members often experience poor quality communication with ICU clinicians, leading to lasting psychological distress associated with the ICU experience; 2) patients near the end of life frequently receive invasive, expensive treatment that is inconsistent with their values and preferences, and 3) end-of-life care is a major contributor to health care costs.\[8, 9\] Although advance care planning can prevent some unwanted treatment, many patients wish for a trial of intensive treatment when the prognosis is uncertain, and therefore it seems likely that the need for interventions to improve "in-the-moment" decisions by surrogates will persist.\[10, 11\] In a pilot project, the investigators developed the PARTNER intervention (PAiring Re-engineered ICU Teams with Nurse-driven Emotional Support and Relationship-building), an interdisciplinary intervention that 1) gives new responsibilities and advanced communication skills training to existing ICU staff (local nurse leaders and social work members of the ICU team); 2) changes care "defaults" to ensure frequent clinician-family meetings; and 3) adds protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings. The objective of this proposal is to conduct a stepped wedge randomized controlled trial testing the PARTNER intervention in 5 ICUs among 1000 patients with advanced critical illness and their surrogates.
The primary objective is to conduct a randomized controlled trial (RCT) to assess the impact of an online skills training module on 1) individual providers' self-rated confidence and comfort with and current practice of family centered care (FCC) skills; and 2) assess team performance of FCC and resuscitative care skills during simulated pediatric resuscitation scenarios.
The study seeks to implement and test a novel approach to teach pediatric residents about patient and family-centered care (PFCC). The approach calls for a supervised meeting between a family member of a previously hospitalized child and a resident in the context of a pediatric residency rotation.
The goal of this project is to investigate the acceptability, feasibility and fidelity of an innovative NICU rehabilitation program that will include six multimodal, gestational age (GA) appropriate, parent-administered interventions (vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy). Using the general movement assessment (GMA) instrument, the investigators will determine the effects of this program on short-term motor outcomes (general movements (GMs), cranial nerves, posture, movements, tone, and reflexes) in premature infants (≤32 week's gestation and/or ≤1500 grams birthweight) identified as at-risk for CP. The short-term motor outcomes will be measured using the GMA, the Test of Infant Motor Performance (TIMP) and the Hammersmith Infant Neurological Examination (HINE) instruments. This novel program will be applied during the neonatal intensive care unit (NICU) hospitalization when the brain is highly plastic and actively developing with the goal to mitigate severity of brain injury and its impact on development.
This study will test if giving parents access to their child's medical notes on a bedside tablet: * helps them get more involved in their care * helps identify safety concerns Parents of hospitalized children will be randomly assigned to either use the Bedside Notes tool or follow usual care. To see if this approach improves care and safety, researchers will measure: * note access * parent-reported safety concerns * overall experiences
The goal of this clinical trial is to measure the effects of using a storybook versus standard child life intervention with parents of children newly diagnosed with leukemia on parental stress. The main questions it aims to answer are: * What effect will the storybook have on parent/legal guardian stress at three timepoints: baseline, discharge, and follow up? * Will this storybook impact parent/legal guardian comfort levels and improve their child's understanding? Participants will be asked to complete surveys at three timepoints, prior to and following child life intervention and about 3.5 months later. During child life interventions, participants will receive resources and support to explain leukemia to their school aged, 3-16-year-old, child (patient or sibling). Researchers will compare Intervention and Control Groups to see if parental stress is lower in those who received the storybook in addition to the standard child life intervention versus the standard child life intervention alone.
Admission to the pediatric intensive care unit (PICU) is well-recognized to be extremely distressing and stressful for the patient and family. As medical research and technology have advanced more and more children in the PICU are surviving, however in turn incurring new and persistent impairments across physical, cognitive, emotional, and social domains of health. This phenomenon is often referred to as post-intensive care syndrome (PICS). These impairments not only impact the patient but parents have also been found to have poor emotional health outcomes following discharge from the PICU. Consistently, parents/caregivers of children admitted to the PICU report their primary concerns to be 1) the overwhelming physical environment of the PICU, 2) uncertainty about the child's survivorship and outcomes, 3) relationships and communication with staff, and 4) feeling helpless. Additionally, research has shown that caregiver-perceived stress during the child's hospitalization positively predicts post-traumatic stress three months after discharge for parents/caregivers (Nelson et al., 2019), which may translate into higher risk and duration of post-traumatic stress in their children. Therefore, providing an in-hospital outlet such as a "PICU Journal" for patients and families to express their subjective experiences may help bridge the gap between perception and reality as a means of buffering against post-traumatic responses. Conceptually, a semi-structured journal intervention may integrate the therapeutic aspects of journaling while also providing pertinent information and serving as an advocacy and communication tool. Prior research has demonstrated the use of a "PICU Journal" is feasible for implementation and has been well-received by families of children in the PICU (Herrup et al., 2019). Therefore, the aims of this mixed-method study are to 1) examine the relationship between this journaling intervention and the perceived stress, care engagement, symptoms of anxiety, and depression, and the development of PICS in parents of children hospitalized in the PICU, and 2) examine the relationship between parent participation in this intervention and the development of PICS-p in children, and 3) assess the feasibility of this intervention from key stakeholders.
The goal of this clinical trial is to compare different strategies to communicate around potential risks and benefits related to treatment decision making in parents/adult caregivers of children with medical complexity. The objective of this study is to identify the most effective ways to communicate decision-related risks and benefits to improve the quality of caregiver decision making for children with medical complexity. Participants will view a video of a simulated clinic visit and related medical information and complete a survey about their experiences. Researchers will compare participant survey responses to see if decision quality changes based on the information reviewed by the participant.
The purpose of this study is to find out if a new training program for nurses called PACT (Partnership, Assessment, Care, and Transition) will be effective and relevant in helping nurses gain the skills needed to provide high-quality family-centered care. Family-centered care skills include engaging family caregivers as partners in patient care, and strengthening their capacity for caregiving by assessing family support needs and facilitating access to resources when needed. The study will also look at whether the quality of nurses' family-centered care skills is associated with improved outcomes for family caregivers. Both nurses and family caregivers will be enrolled in this study. Participants will be nurses/caregivers who care for advanced GI cancer patients admitted to Memorial Sloan Kettering.
Children with ultra-rare or complex rare diseases are routinely excluded from research studies because of their conditions, creating a health disparity. However, new statistical techniques make it possible to study small samples of heterogeneous populations. We propose to study the palliative care needs of family caregivers of children with ultra-rare diseases and to pilot test a palliative care needs assessment and advance care planning intervention to facilitate discussions about the future medical care choices families are likely to be asked to make for their child.
Alzheimer's disease and related dementias (ADRD) are leading causes of disability and often result in communication deficits of the person with dementia (PWD) that can complicate ADRD caregiving and clinical care. The research team will work with stakeholders to develop and design a personalized Assistive and Alternative Communication (AAC) device that relies on information technology (IT) and touchscreens to promote communication and personhood for PWD about their care preferences and experiences. This study will integrate the AAC into an existing health IT intervention that already facilitates clinical communication between caregivers and providers of PWD. A clinical trial will be conducted to evaluate outcomes of 58 dyads (PWD/caregivers) and their health care provider utilizing the My PATI (My Person Assisted Touchscreen Interface)intervention as an adjunct to care and care giving for 6 months.
Family-centered care is a best practice approach to delivering high quality early intervention (EI) services for children 0-3 years old with developmental needs. Yet, family engagement in designing and monitoring their child's EI service plan is suboptimal. Families need a valid, reliable, and useful tool to share in decisions about the scope of their child's EI service plan. The investigators will achieve a major advance in contributing occupational therapy expertise to improve family engagement when designing and monitoring their child's EI services. The investigators will test the use of an evidence-based electronic tool with families at one EI program, when the child is due for an annual review of progress in the program. The investigators will also gather input from families, practitioners, and program leadership to identify facilitators and barriers to its use in multiple EI programs. This project tries to test an innovation in how the investigators deliver family-centered and participation-focused care. Study results will yield evidence for the effectiveness of the electronic intervention on parent activation, EI service plan focus, EI service use quantity, parent perceptions of EI service quality, and child functioning.
Prompt delivery of cardiopulmonary resuscitation (CPR) is a crucial determinant of survival for many victims of sudden cardiac arrest (SCA), yet bystander CPR is provided in less than one third of witnessed SCA events. A number of barriers to bystander CPR training have been identified including time and cost of the training course. Since the large majority of arrest events occur in the home environment, studies have suggested that providing CPR training to family members of hospitalized cardiac patients may serve as a useful approach to address an environment in which bystander CPR is frequently not provided. Utilizing an existing in-hospital program to train adult family members, the investigators will assess the skills of those who learn CPR through two different educational methods: a mobile app and video self-instruction (VSI).
Children with type 1 diabetes face complex self-management regimens which make adherence challenging and ultimately result in poor blood sugar control. Several common barriers interfere with diabetes control such as limited knowledge or challenges with staying motivated. Efficacious strategies exist to improve diabetes self-management including, but not limited to, diabetes education or family therapy. Patients and families often do not access these strategies, in part due to healthcare systems-based issues such as accessibility, provider availability, or insurance coverage. A family-centered approach has been suggested to tailor diabetes care to provide improved outcomes for each child. Family-centered care engages the family in the decision-making about the child's health and well-being. In this study we will take a family-centered approach to providing diabetes self-management by identifying families' unique self-management barriers through a 10-minute survey tool called PRISM (Problem Recognition in Illness Self-Management). Based upon the results of PRISM, we will provide tailored self-management resources (interventions) to meet the family's needs. We will coordinate group-based delivery of the resources with routine diabetes clinic visits. These group-based resources will be delivered in four 75-minute sessions over a year. The primary goal of this study is to compare the effectiveness of family-centered tailoring of diabetes self-management resources with the untailored approach of usual care. We hypothesize that the family-centered model of care with tailored resources will improve the outcomes of glycemic control and quality of life among children with type 1 diabetes and their parents.
Under the auspice of 'Specially for Children and with funding from the Seton Healthcare Family, Children's Comprehensive Care (CCC) in Austin, Texas, has developed a coordinated and integrated model of care for children with medical complexity. This model serves as the patient's Medical Home (primary care provider, (PCP)), and uses extensivists (physicians who work as hospitalists and within the PCP) and nurse practitioners to provide continuous care between hospital and primary care. This model seeks to provide a system of care that more fully meets the complex needs of the child and family, while implementing innovations in care delivery, fully implementing family-centered practice, and "embedding" behavioral, psychiatric, psychosocial, and palliative care. This study is a randomized intervention trial that evaluates the effectiveness of the newly-created Children's Comprehensive Care on two outcomes: utilization and cost of care; and, evaluation of the experience of parents and their families.
Recent needs assessments suggest that difficulties exist in care coordination between emergency medical services (EMS) systems and primary care for injured adolescents with alcohol problems and post-traumatic stress disorder (PTSD). This project will implement, evaluate, and disseminate the adolescent trauma support service model program that aims to enhance coordination between EMS systems and primary care/community services.
This study will examine the efficacy of Family Centered Advance Care Planning in enhancing quality of life, integrating effective end-of-life care, and preventing depression and anxiety among HIV infected adolescents and their family members.
Our goal is to advance palliative care with persons living with AIDS (PLWA) or life-limiting co-morbidities to decrease suffering and increase quality of life (QOL). Left without advance care planning (ACP) for end-of-life decision, miscommunication and disagreements may result in families being charged with neglect or court battles over treatment choices, unmet care or delivery of unnecessary or unwanted care, and non-relative caregivers being dismissed (e.g. gay partners). We hope to increase families' understandings of their family member's wishes for end-of-life care to decrease conflict through the FAmily-CEntered Advance (FACE) Care Planning intervention. We will also study communication, quality of life, and spiritual struggle. Families will be randomized into either the Control (N=96 families) or the FACE Intervention (n=192 dyads). FACE families will meet with a trained/certified researcher for two 60-minute sessions scheduled one week apart: Session 1: The Respecting Choices Interview®; and Session 2: Completion of The Five Wishes©. Control families will also meet with a researcher for two 60-minute sessions scheduled one week apart: Session 1: Developmental History; and Session 2: Nutrition and Exercise. Questionnaires will be administered five times, Baseline and at 3, 6, 12 and 18 month post-intervention, for an average of 2 years. AIM 1. To determine the efficacy of FACE on congruence in treatment preferences between PLWA and their surrogates over time, and the effect of the pattern of congruence development trajectory on healthcare utilization (i.e., distal outcomes: number of hospitalizations, dialysis, ER visits). Hypothesis A: Development of congruence may not be homogeneous and FACE may influence the pattern of congruence development. Hypothesis B: Different patterns of congruence development may have different effects on health care utilization. Hypothesis C: Compared to Controls, FACE participants will better maintain congruence over time. AIM 2. To determine the efficacy of FACE on key components of QOL for PLWA. Hypothesis: FACE participants will increase or better maintain psychosocial QOL compared to Controls. AIM 3. To minimize health disparities in ACP between Blacks and non Blacks and identify factors associated with disparities. Hypothesis: Blacks in the FACE intervention will complete advance directives at a rate comparable to non Blacks, and at significantly greater rates compared to Controls.
Our goal is to advance palliative care to adolescents and their families. We hope our study will decrease suffering (psychological, spiritual, physical) and increase quality of life (QOL). Left unprepared for end-of-life decisions, miscommunication and disagreements may result in families being charged with neglect or court battles over treatment choices. FAmily CEntered (FACE) Advance Care Planning helps prepare adolescents with HIV/AIDS and their families for future medical decisions. We hope to increase families' understanding of their teens' wishes for end-of-life care and to decrease conflict. We will also study communication and spiritual struggle Families will be randomized into the either the Control (N=65 families) or FACE Intervention (N=65 families). FACE families will meet with a trained/certified researcher for three 60- to 90-minute sessions scheduled one week apart: Session 1: Lyon Advance Care Planning Survey© - Adolescent and Surrogate Versions: Session 2: The Respecting Choices Interview® Session 3: Completion of The Five Wishes©. Control families will also meet with a researcher for three 60-to 90-minute sessions scheduled one week apart: Session 1: Developmental History, Session 2: Safety Tips, and Session 3: Nutrition. Questionnaires will be administered five times, when first seen, at 3, 6, 12 and 18 months from the time of Session 3. Hypothesis 1: Compared to an active control, FACE will relieve psychological suffering by 1) increasing congruence in treatment preferences between teens with AIDS and their surrogates, 2) decreasing decisional conflict regarding EOL decision making for future medical treatment in adolescents with AIDS; 3) increasing quality communication about EOL care in adolescent/legal guardian or surrogate dyads; 4) and maximizing QOL. Hypothesis 2: In addition to the direct effects, FACE will also indirectly affect QOL through dimensions of threat appraisal. Hypothesis 3: FACE will have stronger effects on the QOL measures among patients who have less spiritual struggle. Hypothesis 4: Spiritual struggle has both direct and indirect effects on hospitalization/dialysis use. FACE will also affect hospitalization/dialysis use indirectly through threat appraisal and HAART adherence.
More than 41 million children, or 55 percent of all children in the United States, live more than 30 minutes away from a pediatric trauma center. The management of pediatric trauma requires medical expertise that is only available at Level I pediatric trauma centers, which are specialized pediatric referral hospitals located in large urban cities. Smaller hospitals lack pediatric trauma expertise and resources to properly care for these children. When a small hospital receives a child with trauma, the standard of care is to conduct a telephone consultation to a pediatric trauma specialist, err on the side of safety, and transfer the child to the regional Level I pediatric trauma center. A newer model of care, the Virtual Pediatric Trauma Center (VPTC), uses live video, or telemedicine, to bring the expertise of a Level I pediatric trauma center virtually to patients at any hospital emergency department. While the VPTC model is being used more frequently, the advantages and disadvantages of these two systems of care remain unknown, particularly with regard to parent/family-centered outcomes. The goal of this study is to optimize the patient and family experience and to minimize distress, healthcare utilization, and out-of-pocket costs following the injury of a child. The results of this project will help to optimize communication, confidence, and shared decision making between parents/families and clinical staff from both the transferring and receiving hospitals.
Advance Care Planning (ACP) prepares patients and their loved ones for future health care decisions, including end-of-life decisions. Yet, the needs of adolescent oncology patients for participation in ACP, despite its priority, is not well studied. Our goal is to test a model of ACP that anticipates these issues, fully empowers the family and adolescent, and keeps the key role of health care professionals central, building on our earlier work. We hypothesized FAmily CEntered (FACE) ACP, would: (1) increase congruence in treatment preferences between adolescents and surrogates; (2) decrease decisional conflict for adolescents; and (3) increase quality of communication compared with controls.
To test the efficacy of FACE-TC on key outcomes, the investigators propose using an intent-to-treat, longitudinal, prospective, multi-site, randomized controlled trial (RCT) design. Adolescents with cancer, aged 14 up to 20 years, and their families (N=130 dyads; N=260 participants) will be recruited and randomized to FACE-TC or Treatment as Usual (TAU) control. Participants will complete standardized questionnaires at baseline and 3, 6, 12, and 18 months post-intervention. Our goal is to assess the extent to which FACE-TC helps adolescents and young adults with cancer and their families: (1) reach and maintain better congruence in treatment preferences over time; (2) improve their quality of life; and (3) document goals of care and advance directives earlier in the course of their potentially life limiting illness.
The aim of this study is to evaluate the impact of virtual family-centered rounds in the neonatal intensive care unit on parental and neonatal outcomes.
This study evaluates the feasibility and efficacy of a family-centered songwriting intervention for cognitively-impaired children referred to a palliative care service.
The purpose of this randomized controlled pilot trial is to develop and test mobile app, Intensive Care Unit-Caregiver Activation Response, and Engagement (ICU-CARE). ICU-CARE provides a simulated learning environment to encourage family caregivers of mechanically ventilated patients to assess two patient symptoms, thirst and anxiety, and perform specific nonpharmacologic comfort measures to help alleviate patient symptom burden.
Severe strokes, including large artery acute ischemic stroke and intracerebral hemorrhage, continue to be the leading cause of death and disability in adults in the U.S. Due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is the most common cause of death in severe strokes, but occurs at a highly variable rate. Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. The investigators have developed a pilot DA for goals-of-care decisions for surrogates of severe, critically ill stroke patients. This was developed through qualitative research using semi-structured interviews in surrogate decision makers of traumatic brain injury patients and physicians, and adapted to severe strokes. The investigators now propose to pilot-test a DA for surrogates of critically ill severe stroke patients in a feasibility trial.