Treatment Trials

193 Clinical Trials for Various Conditions

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ENROLLING_BY_INVITATION
Venous Leg Ulcer and Lymphedema Registry
Description

This is an observational, longitudinal real world registry of venous leg ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR.

RECRUITING
The Diabetic Foot Ulcer Registry
Description

This is an observational, longitudinal real world registry of diabetic foot ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR.

COMPLETED
Can Tailored Patient Letters Improve The Quality Of Diabetic Patient Care?
Description

The purpose of this study is to determine if tailored letters sent to diabetic patients will improve care of diabetes.

COMPLETED
Spiritual Care in Improving Quality of Life of Patients, Caregivers, and Hospital Staff
Description

This clinical trial studies spiritual care in improving quality of life of patients, caregivers, and hospital staff. Spiritual care may help understand the impact cancer and its treatment has on patients, caregivers and hospital staff.

COMPLETED
Reverse Innovation and Patient Engagement to Improve Quality of Care and Patient Outcomes
Description

Project CONNECT ("Community-based Organizations Neighborhood Network: Enhancing Capacity Together") is a randomized controlled trial that involves 22 community-based organizations (CBOs) located in Baltimore, MD. Half of these organizations were randomly assigned to the intervention group using a constrained cluster randomization process. The remaining 11 are a part of the control intervention group. The intervention is a co-developed set of IT tools hypothesized to improve the connections among intervention CBOs, Johns Hopkins health care facilities and CBO clients.

RECRUITING
Assessment of Supportive Care and Educational Needs to Guide Quality Care Improvements for Patients With Locally Advanced and Metastatic Bladder Cancer
Description

The overall goal of this study is to facilitate care improvements for bladder cancer patients with locally advanced or metastatic disease by designing and evaluating a patient need assessment screening tool to be used, in the future, as standard screening measure. Adult individuals diagnosed with Stage 4 incurable locally advanced or metastatic bladder cancer will be included in this study and asked to participate in a focus group, complete a screening tool, or complete a survey. All data collected will be linked to a study ID number and HIPAA identifiers will not be linked to study data. Identifying information (ie: name, mrn, email, phone number) will be utilized for study recruitment and identifying eligible patients. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.

RECRUITING
Impact of Project ECHO on Improving the Quality of Palliative Care in Patients With Advanced Cancer and Their Caregivers in Underserved Areas of Kenya, Nigeria, Ghana, South Africa, India, and Ethiopia
Description

This trial investigates the experience and satisfaction of care in patients with cancer that has spread to other places in the body (advanced) and their caregivers living in underserved areas of Kenya, Nigeria, Ghana, South Africa, India and Ethiopia as part of Project Extension for Community Healthcare Outcomes (ECHO). Project ECHO is a model of medical education and care management that empowers clinicians to provide better care to more people where they live. Understanding the experiences and satisfaction of patients and caregivers may help improve healthcare workforce capacity and increase access to specialty care for the world's rural and underserved populations.

COMPLETED
Study to Determine Therapeutic Massage Dosing to Improve Quality of Life in Hospitalized Patients Receiving Palliative Care
Description

Therapeutic massage is the most common non-traditional treatment option offered to improve quality of life, provide comfort and decrease pain in hospice and palliative care settings outside the hospital. Three systematic reviews of data in general pain, surgical and cancer populations found massage to be effective for treating pain versus active comparators. Given the remarkable negative impact on QOL experienced by patients hospitalized with a serious progressive illness, a nationwide opioid crisis in the setting of public concern for untreated pain, and patient demand for integrative therapies, we wish to investigate non-traditional methods of supporting patients in pain and providing clinicians with viable alternatives. Unfortunately, very little is known about optimal delivery of massage interventions in the hospital setting, including dosing parameters such as time and frequency We conducted a single center comparative effectiveness study to evaluate therapeutic massage "dosing" to improve self-reported quality-of-life in hospitalized patients receiving palliative care consultation.

COMPLETED
Care Coordination in Oncology, Quality Among Patients With Lung Cancer and Their Caregivers
Description

The Oncology Care Coordination study is designed to evaluate use of a care coordination tool for lung cancer patients and their caregiver on quality of care and performance outcomes. Eligible patients need to be receiving treatment at Geisinger. Participation in the study involves completion of surveys, permission to review information from the patient's electronic health record, and for some enrollment in the care coordination tool called Harmonized Care. Geisinger oncology care providers who have patients enrolled the study will be invited for interviews.

Conditions
COMPLETED
Improving Quality of Osteoporosis Care Through Patient Storytelling
Description

The purpose of this exploratory study is to test novel, mailed, low-cost, direct-to-patient intervention materials (i.e., a personalized letter and osteoporosis information pamphlet) designed to increase rates of dual energy X-ray absorptiometry (DXA) utilization and improve osteoporosis quality of care.

Conditions
COMPLETED
Improving Quality of Primary Care for Patients With Anxiety and/or Panic Disorders
Description

The purpose of this study is to determine if primary care patients with panic and/or generalized anxiety disorder can benefit from a telephone-based collaborative care intervention.

TERMINATED
Needs Assessment Evaluating Quality of Life Issues for Gastroparesis Patients and Caregivers
Description

The project will involve conducting a Needs Assessment for Gastroparesis patients and their caregivers with the goal of identifying quality of life issues associated with this disease. Identifying these issues will ameliorate management and support systems for gastroparesis currently existent in the community and, hopefully, provide information for the establishment of more resources to assist the patients and their families.

Conditions
RECRUITING
Large Language Models To Improve the Quality of Care of Cardiology Patients
Description

This study evaluates the impact of large language models (LLMs) versus traditional decision support tools on clinical decision-making in cardiology. General cardiologists will be randomized to manage real patient cases from a cardiovascular genetic cardiomyopathy clinic, with or without AI assistance. Each case will be assessed by two cardiologists, and their responses will be graded by blinded subspecialty experts using a standardized evaluation rubric.

NOT_YET_RECRUITING
Improving the Quality of Care for Asthma Patients at Risk of Exacerbations
Description

The goal of this trial test two known effective asthma strategies. Treatment guidelines recommend combination therapy of inhaled corticosteroids (ICS) with a long-acting beta-agonist (LABA) inhaled medications. This strategy is known as MART (maintenance and reliever therapy). The second strategy is PARTICS (patient activated reliever triggered ICS) strategy instructs patients to use an ICS metered dose inhaler (ICS) each time they use their rescue inhaler. In addition, they are instructed to take 5 puffs of the ICS after each rescue nebulizer use. PARTICS has been shown to reduce exacerbations, increase asthma control and quality of life, however, the question remains if PARTICS is as effective as MART and therefore be an alternative to MART. This trial will test PARTICS and MART head-to-head. The trial will include adults with moderate-to-severe asthma at risk for an asthma exacerbation, currently using a combination ICS. The main questions aim to answer: * Is PARTICS as effective as SMART? * Might PARTICS be more effective than SMART? Is the relative effectiveness of PARTICS versus SMART affected by frequent nebulizer use for asthma relief? * Do PARTICS and SMART diverge in terms of their effectiveness on differing asthma outcomes important to patients? * Do socioeconomic factors affect the relative effectiveness of PARTICS and SMART? Researchers will compare non frequent nebulizer (NFN) users - less than once a week to frequent nebulizer users - once a week or more, to assess whether the PARTICS strategy is ono-inferior (or superior to the MART strategy in reducing exacerbations, (primary outcome), increasing asthma control and quality of life and decrease days lost from work/school or usual activities. Most participants will be consented, enrolled, and randomized virtually, others will be consented, enrolled and randomized in person. Once randomized they will be instructed on how to use the prescribed medication: * Participants randomized to MART will be instructed to use the prescribed ICS/LABA for maintenance and as needed for rescue. * Participants randomized to PARTICS will be instructed to use the prescribed ICS each time they use their rescue inhaler and take 5 puffs of the newly prescribed ICS after each rescue nebulizer use. * Participants will be followed for 16 months by monthly survey.

RECRUITING
Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy
Description

The primary objective is to demonstrate the feasibility of incorporating VR distraction into the brachytherapy and radiotherapy clinical workflow. The secondary objective is to determine if VR distraction during brachytherapy treatment for cervical cancer improves subjects' satisfaction, procedural/acute pain, and need for analgesics or anxiolytics.

ACTIVE_NOT_RECRUITING
Understanding Quality of Life Among Patients with Cancer Receiving Palliative Care
Description

This randomized controlled trial will assess the effects on quality of life of two approaches to symptom management among new patients referred to a palliative care oncology clinic.

Conditions
RECRUITING
Patient Perceptions Around Quality of Care Through Telemedicine in Neuro-Oncology
Description

This study evaluates patient perceptions around quality of care through telemedicine in neuro-oncology. Studying questionnaires related to perceptions quality of care through telemedicine in patients with brain cancer may help doctors to improve the delivery of care through this modality.

COMPLETED
We Experience: Perspectives on a Quality Abortion Care Experience: A Patient Centered Approach
Description

The purpose of this study is to determine aspects of abortion care most important to the patient in creating a "high quality" abortion experience, to investigate patients' expectations of abortion care, and to explore provider perceptions of patients' abortion experiences and assess concordance with patients' perspectives.

COMPLETED
Development and Validation of a Tool to Measure Hand-off Quality
Description

The aim of this project is to develop and validate a simple, flexible, reliable, real-time observation tool to evaluate hand-off practices. The Hand-off CEX is a paper-based instrument that can be used to evaluate either the sender or the receiver of hand-off communication. This tool is based on a previously-validated, widely-used, real-time educational evaluation tool (the Mini-CEX); published expert opinion; and our prior research . The investigators' tool incorporates unique role-based anchors for both senders and receivers that refer to verbal communication, professionalism and environment, hand-off domains informed by preliminary work and expert opinion. The Hand-off CEX(Clinical Evaluation Exercise) will be used by academic hospitalists and house-staff physicians to assess feasibility. We, the investigators, will also assess the construct validity and inter-rater reliability of the tool through the use of standardized, videotaped hand-off scenarios depicting various levels of performance of a hand-off scenario. We hypothesize that the Hand-off CEX will arm educators with an innovative, necessary, valid and feasible method for training health professionals to conduct safe and effective hand-offs. Finally, the Hand-off CEX will be a useful tool to assist hospitals in improving patient safety.

COMPLETED
The Impact of Pharmacist Recommendations on Quality of Care in Diabetic Patients
Description

The goal of this study is to investigate a comprehensive provider-focused intervention to improve the quality of care for diabetic patients in a large primary care practice at Brigham and Women's Hospital. This will be accomplished through pharmacist recommendations provided to primary care providers prior to routine scheduled office visits for diabetic patients.

ACTIVE_NOT_RECRUITING
Improving Quality of Life for Colon Cancer Patients and Their Caregivers
Description

By joining this study, participants, including patients and their caregivers, will be provided useful information about colon cancer that may help alleviate anxiety surrounding treatment, improve communications with the medical team, and identify practical ways to support each other. Participating in this study will have no impact on your cancer care that participants receive from your provider. It is expected that the resources provided to participants and participants caregiver will help improve participants overall care. The study team will provide computer tablets for patients and their caregivers to use as part of the study to access information about colon cancer and how to help manage participants therapeutic care. The study team will check-in each week to provide assistance with the use of the tablets and ask the patient and their caregiver, to complete an assessment survey. As part of the surveys the study team will collect participants full name, address and phone number and some basic information about participants (e.g., age, gender and race). The study team will also collect some personal or medical information, including the stage of colon cancer and treatment received (if the participant) or your relationship to the patient if participants caregiver. The study team will also collect some information on your emotional health and views about the medical care that has been provided to date from the questionnaire. All this information will be held confidential and not forwarded to anyone outside of the study personnel. There are no activities required, except that the study team will encourage caregivers and patients to discuss and use the information provided in computer tablets to enhance their cancer care. Whether or not the participants use this information will not affect their ability to receive high-quality care from their providers. There is a slight burden of responding to the survey questions used to help us understand the useful features of this program. For this reason, the investigator has included small incentives to support the time and effort needed to complete these survey assessments. The study team hopes that this study, one of the first of its kind, will help identify the resources and methods that can be used to help patients and caregivers have a better understanding of their cancer care and provide resources that they can use to enhance the effectiveness of their therapy.

Conditions
COMPLETED
Development of a Sign-Out Tool to Improve Handoffs in Care
Description

The purpose of this grant is to fund the research necessary to fully understand the impact of this sign-out tool on clinician workflow, quality of sign-out, and continuity of care. This information will inform exactly how Partners will move ahead with tools to improve handoffs in care (i.e., whether the prototype will be adapted further, adopted Partners wide, or abandoned in favor of other solutions). The investigators hypothesize that a web-based handoff tool improves provider satisfaction, the quality of written sign-outs, and measures of continuity of care compared with current handoff tools.

RECRUITING
Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers
Description

The goal of this clinical trial is to improve communication among clinicians, patients with memory problems, and their family members. We are testing a way to help clinicians have better conversations to address patients' goals for their healthcare. To do this, we created a simple, short guide called the "Jumpstart Guide." The goal of this research study is to show that using this kind of guide is possible and can be helpful for patients and their families. Patients' clinicians may receive a Jumpstart Guide before the patient's clinic visit. Researchers will compare patients whose clinician received a Jumpstart Guide to patients whose clinician did not receive a guide to see if more patients in the Jumpstart Guide group had conversations about the patient's goals for their healthcare. Patients and their family members will also be asked to complete surveys after the visit with their clinician.

COMPLETED
Project to Improve Communication About Serious Illness--Hospital Study: Pragmatic Trial (Trial 1)
Description

The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients 55 years or older with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are: 1. To evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion in the period between randomization and 30 days following randomization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 7 and 30-day hospital readmissions. 2. To conduct a mixed-methods evaluation of the implementation of the intervention, guided by the RE-AIM framework for implementation science, incorporating quantitative evaluation of the intervention's reach and adoption, as well as qualitative analyses of interviews with participants, to explore barriers and facilitators to future implementation and dissemination.

COMPLETED
Facilitating Communication Study
Description

This study is a randomized clinical trial of an intervention to improve outcomes for patients and their family by using ICU nurse facilitators to support, model, and teach communication strategies that enable patients and their families to secure care in line with patients' goals of care over an illness trajectory, beginning in the ICU and continuing to care in the community.

COMPLETED
Improving Care for Children With Complex Needs
Description

Seattle Children's Hospital (SCH), in collaboration with several health plans and Washington State Department of Social and Health Services developed the Comprehensive Case Management (CCM) program with the goal to reduce costs of care for medically complex children cared for at SCH as well as improve their health status and the quality of care they receive. The CCM program aims to develop and facilitate a reliable and standardized process that empowers the child's primary care provider and provides him/her with the resources s/he needs to avoid unnecessary emergency department visits and admissions. Our study will include children who had a hospitalization or emergency department visit at Seattle Children's between 2009-2012 and, at that time, had multiple active chronic medical issues but had no specialty service at Seattle Children's to help their primary care providers manage them.

ACTIVE_NOT_RECRUITING
Project to Improve Communication About Serious Illness--Hospital Study: Comparative Effectiveness Trial (Trial 2)
Description

The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study is particularly interested in understanding the effect of the intervention to improve quality of palliative care for patients with Alzheimer's disease and related dementias (ADRD) but will also include other common chronic, life-limiting illnesses. The specific aims are: 1. To evaluate the efficacy of the EHR-based clinician-facing Jumpstart, drawn from the electronic medical record (EHR), the survey-based bi-directional Jumpstart, drawn from patient or family completed surveys, and usual care for improving quality of care provided to patients with chronic illness experiencing a hospitalization. The primary outcome is EHR documentation of a goals-of-care discussion, assessed from randomization through 30 days. Secondary outcomes include: a) intensity of care outcomes (e.g., ICU use, ICU and hospital free days, hospital readmissions, costs of hospital care); and b) patient- and family-reported outcomes assessed by surveys at 3-5 days and 4-6 weeks after randomization, including occurrence and quality of goals-of-care discussions in the hospital, goal-concordant care, psychological symptoms, and quality of life. 2. To conduct a mixed-methods evaluation of the implementation of the interventions, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative evaluation of the interventions' reach and adoption, as well as qualitative analyses of interviews with participants, to explore barriers and facilitators to future implementation and dissemination.

COMPLETED
Caregiver Burden Within the Ambulatory Extended Recovery (AXR) Patient Population
Description

The purpose of this study is to understand the level of caregiver burden related to caring for a patient who goes home within the first 24 hours following surgery. As the caregiver they are providing care to a family member, friend, or neighbor. Even when not formally trained, the care they provide is important to the patient's recovery. Providing care in this manner can be stressful. This study will help us understand what aspects of the patient's recovery are most difficult for the caregiver.

COMPLETED
Primary Care Clinician Commitments to Choosing Wisely®
Description

This pragmatic trial examines the uptake and effects of primary care clinician commitments to follow 3 Choosing Wisely® recommendations. The investigators hypothesize that pre-encounter invitations to clinicians to commit to the recommendations will decrease ordering of: (1) imaging tests for low back pain, (2) antibiotics for acute sinusitis, and (3) imaging tests for headaches. The study is a mixed-methods, stepped wedge cluster randomized trial in which the intervention will be sequentially introduced to 6 clinics in southeastern Michigan in a randomly assigned order.

COMPLETED
Evaluating the Impact of Patient-Centered Oncology Care
Description

The National Committee for Quality Assurance has worked with the National Coalition for Cancer Survivorship, the American Society of Clinical Oncology, Oncology Management Services, Independence Blue Cross, and RAND, as well as a broader multi-stakeholder advisory group, to define the Patient-Centered Oncology Care model. The purpose of this project was to pilot and evaluate this model. Specific research questions were: 1. Does Patient-Centered Oncology Care improve patient experiences and quality of care? Does it reduce undesirable events like emergency department visits and hospital stays? 2. How does adoption of Patient-Centered Oncology Care vary across a variety of practices and what factors affect adoption? The demonstration occurred in oncology practices in southeastern Pennsylvania. Practices received implementation support during the 24-month demonstration period. They were evaluated using patient surveys, quality measures, and measures of emergency department and hospital use. Results from these practices were compared in two ways: 1) with their performance before they became oncology medical homes and 2) with other similar practices.

Conditions