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108 Implementation Trials Near You
Power is an online platform that helps thousands of Implementation patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerThe overarching goal of this study is to support the "real world" assessment of strategies used to foster adoption of several highly efficacious evidence-based practices in healthcare systems that provide care to critically ill adults with known health disparities. Investigators will specifically evaluate two discrete strategies grounded in behavioral economic and implementation science theory (i.e., real-time audit and feedback and registered nurse implementation facilitation) to increase adoption of the ABCDEF bundle in critically ill adults.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:19+
Key Eligibility Criteria
Disqualifiers:Chronic Ventilation, Prisoners
8100 Participants Needed
Educational and Feedback Interventions for Bronchiolitis
Columbus, Ohio
The purpose of this study is to identify the optimal deimplementation strategies for an overused practice: continuous pulse oximetry monitoring of children hospitalized with bronchiolitis who are not receiving supplemental oxygen.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:2+
Key Eligibility Criteria
Disqualifiers:Apnea, Cardiac Disease, Cancer, Others
32357 Participants Needed
I-STROM Implementation for Stroke Rehabilitation
Columbus, Ohio
The primary objective of this study is to tailor and test implementation strategies to support the adoption of two upper extremity motor outcome measures for stroke: the Fugl-Meyer Assessment and the Action Research Arm Test. The study's interdisciplinary team will address this objective through the following specific aims: (a) Tailor a package of implementation strategies (referred to as I-STROM-Implementation STRategies for Outcome Measurement) to promote outcome measure use across the care continuum, (b) Determine the effectiveness of I-STROM on outcome measure adoption and (c) Evaluate the appropriateness, acceptability, and feasibility of I-STROM in rehabilitation settings across the country. The mixed-methods study design is informed by implementation science methodologies, and the tailoring of I-STROM will be guided by input from stakeholders, including occupational therapy practitioners and administrators. The investigators will collect robust quantitative and qualitative data by means of retrospective chart reviews, electronic surveys, and stakeholder focus groups. This study, "Strategies to Promote the Implementation of Outcome Measures in Stroke Rehabilitation," will address core barriers to outcome measure use through a package of implementation strategies, thus laying the groundwork for I-STROM scale-up in health systems nationwide.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-therapists, Non-Ohio License, Others
3500 Participants Needed
Jaspr App for Suicide Prevention
Columbus, Ohio
This Study will evaluate the implementation of a multi-component suicide prevention technology (Jaspr Health) that facilitates delivery of suicided-related evidence-based practices (EBPs) while replacing wasted waiting time with productive time in the Emergency Departments (EDs). The EBPs satisfy several key performance elements for systems adopting Zero Suicide.
A Complementary Randomized Controlled Trial and Real-World Study for Efficacy, Effectiveness, and Implementation Study Design (CREID) will be used
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Cognitive, Emotional Incapability
27908 Participants Needed
Emergency Care Action Plan for Infant Health
Cincinnati, Ohio
Infants with medical complexity (IMC) are a challenging population with more emergency department visits, inpatient stays, and higher healthcare costs than other children. IMC also experience lower quality emergency health care. The PI and team propose to adapt and put into place an emergency care action plan (ECAP) for IMC across four US hospitals, working directly with medical providers and families in each setting. After the tool is made available to providers and families, the PI and team will measure if the ECAP tool helps decrease the number of hospitalizations (primary research outcome) for IMC, as well as if the ECAP is feasible, acceptable, and useable for those using the ECAP over a one-year period.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:0 - 6
Key Eligibility Criteria
Disqualifiers:No Caregiver Consent, Others
500 Participants Needed
HI-SPEED Protocol for Stroke
Cincinnati, Ohio
Most stroke patients are initially evaluated at the closest hospital but some need to be transferred to a hospital that can provide more advanced care. The "Door-In-Door-Out" (DIDO) process at the first hospital can take time making transferred patients no longer able to get the advanced treatments. This study will help hospitals across the US "stand up" new ways to evaluate stroke patients, decide who needs to be transferred, and transfer them quickly for advanced treatment.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:TIA, Stroke NOS, Comfort Care, Others
900 Participants Needed
Coping Skills Program for Lupus
Cincinnati, Ohio
This study aims to investigate the feasibility and effectiveness of a cognitive behavioral coping skills program, Treatment and Education Approach for Childhood-onset Lupus (TEACH), for youth with cSLE when integrated into medical care. This TEACH program aims to teach participants skills in order to cope with fatigue, pain, and depressive symptoms--symptoms that commonly affect adolescents and young adults with lupus.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:12 - 22
Key Eligibility Criteria
Disqualifiers:Juvenile Arthritis, Developmental Delay, Others
196 Participants Needed
Telehealth Rehabilitation for Ankle Sprains
Lexington, Kentucky
A vast majority (75-85%) of ankle sprain patients treated in emergency departments (ED) receive pain medication and are not referred for physical rehabilitation. Therefore, purpose of this study is to increase access to the standard of care for an ankle sprain by provide patients with physical rehabilitation delivered through telehealth. The purpose of this study includes compare a 2-week telehealth intervention to the usual care for treating 1) subjective function; 2) physical impairments; 3) medication consumption; and 4) patient-perceived barriers. The central hypothesis is participants receiving the 2-week telehealth intervention will 1) have less pain and disability; 2) improve balance and ankle range of motion; 3) consume less medication; and 4) reports positive feedback compared to the usual care group.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:15 - 35
Key Eligibility Criteria
Disqualifiers:Concomitant Injury, Lower Extremity Surgery, Others
70 Participants Needed
Blood Culture Reduction Approaches for Sepsis
Indianapolis, Indiana
This study will compare two strategies that target distinct determinants of blood culture overuse in an exploratory, hybrid, pilot trial in 8 PICUs. It aims to determine if there is any association between specific strategies used to reduce blood culture overuse on unit-wide blood culture rates, patient safety, and concurrently explore aspects of the implementation process (acceptability, feasibility, appropriateness).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-English Speaking, Reports To Investigator
8 Participants Needed
Allocation Method for Advanced Heart Failure
Indianapolis, Indiana
This trial aims to test SOCIAL HF, a set of guidelines to ensure fair allocation of advanced heart failure treatments. It targets patients needing heart transplants or special heart pumps. SOCIAL HF works by reducing bias, using objective criteria, and improving decision-making processes.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Inactive Centers, Others
1463 Participants Needed
Novel Healthcare Approaches for Delirium in Elders
Pittsburg, Pennsylvania
The goal of this clinical trial is to compare the Hospital Elder Life Program (HELP) with a family-augmented version of HELP (FAM-HELP), that includes family members and care partners, for the prevention of delirium in older patients during hospital admission. The main objectives of the trial are the following:
1. To compare the effectiveness of FAM-HELP and HELP in reducing both the incidence of delirium and its severity.
2. To compare the effectiveness of FAM-HELP and HELP in improving patient- and family-reported outcomes.
3. To explore the implementation context, process, and outcomes of the FAM-HELP program in diverse hospital settings.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:70+
Key Eligibility Criteria
Disqualifiers:Delirium, Coma, Advanced Dementia, Others
3000 Participants Needed
Cancer Screening Methods for Colorectal and Liver Cancer
Pittsburgh, Pennsylvania
Gastrointestinal cancers such as colon cancer and liver cancer cause many deaths in the US. Testing could catch these cancers early, helping people live longer. The goal of this study is to compare two different ways of getting more people tested for these cancers: 1) by directly reaching out to the people who need testing or 2) by helping providers fix issues that hold up testing.
The main question it aims to answer is: how should healthcare systems go about choosing one or the other?
Researchers will look at cancer testing rates over time at sites that are trying these different approaches. They will also survey and interview participants from these sites.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Under 18, Not In VA, Hospice
30300 Participants Needed
Implementation Strategy Training for Liver Cancer
Pittsburgh, Pennsylvania
This trial tests a new decision aid tool that uses machine learning to help healthcare providers choose the best strategies for implementing effective medical practices. The focus is on Veterans with cirrhosis who need cancer screenings. The tool aims to improve screening rates by identifying and overcoming barriers specific to each medical center.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Post-transplant, Hepatocellular Carcinoma
8020 Participants Needed
NIATx Coaching for HIV, Hepatitis C, and Opioid Use Disorder Management
Morgantown, West Virginia
The goal of this clinical trial is to evaluate an intervention strategy in introducing screen/evaluate/treat (SET) procedures for HIV/ hepatitis C/ and Opioid Use Disorder in Primary Care Clinics in West Virginia.
The main questions it aims to answer are:
* What are the barriers and facilitators to integrating evidence based practices for screening and treatment of HIV, hepatitis C, and Opioid Use Disorder into primary care clinics in West Virginia?
* To assess the extent to which our SET processes are achieved through enhanced EHR tools, NIATx (formerly known as Network for the Improvement of Addiction Treatment) facilitation and Extension for Community Healthcare Outcomes (ECHO)-supported collaborative learning?
* Does implementing these services improve primary and secondary health outcomes for patients? Primary Care Clinics will participate in training and process improvement coaching to integrate these services. Using a step-wise design, 20 Primary Care Clinics will undergo the training and coaching in four groups of five clinics.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Private Clinics, Specialty Clinics, Others
20 Participants Needed
APRETUDE for HIV Prevention
Detroit, Michigan
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP). The study objectives are also to identify barriers and facilitators to implementation. The first of two participant types in the study are the Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available CAB PrEP via prescription from the PrEP provider. The second are Staff Study Participants (SSPs) who are site staff involved in the administrative and clinical aspects of offering and administering PrEP to PSPs at the clinical site.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Sex:Female
Key Eligibility Criteria
Disqualifiers:HIV Positive, Male, Others
Must Be Taking:PrEP
156 Participants Needed
Physician-focused Behavioral Intervention for Prostate Cancer Imaging
Pittsburgh, Pennsylvania
The primary aim of this study is to determine whether a multi-modal, physician-focused behavioral intervention can improve facility-level guideline-concordant utilization of prostate cancer staging imaging. Other aims of this study include to use mixed methods to explore physician influence on guideline-concordant imaging and to determine the cost and cost impact of a physician-focused behavioral intervention to improve guideline-concordant prostate cancer imaging.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Prior Malignancy, Age Over 85, Others
58 Participants Needed
Team-Focused Approach for Mental Health Support
Pittsburgh, Pennsylvania
Child Advocacy Centers (CACs) are well-positioned to identify children at risk for mental health problems and to facilitate access to evidence-based treatments. Implementation of standardized mental health screening and referral protocols may improve recognition of mental health needs and facilitate treatment engagement. Implementation strategies that improve teamwork may enhance implementation outcomes in team-based settings like CACs. In this study, CACs will implement the Care Process Model for Pediatric Traumatic Stress (CPM-PTS) and be randomized to either team-focused implementation or standard implementation. The study aims are to evaluate the feasibility of team-focused implementation and the effect of the CPM-PTS on caregiver understanding of mental health needs and intentions to initiate treatment.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Under 18 Years
140 Participants Needed
Electronic Health Record Prompts for Childhood Obesity
Indianapolis, Indiana
The purpose of this study is to evaluate the dissemination and implementation of electronic health record-based clinical decision support tools for the management of pediatric overweight and obesity in primary care.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:2+
240772 Participants Needed
Improved Practices for Pregnancy Complications
Flint, Michigan
This study works with prenatal and postnatal care providers in 12 Michigan counties to scale up best practices for maternal health equity.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
600 Participants Needed
Psychotherapy for Depression and Anxiety Disorders
Roanoke, Virginia
Although measurement-based care (MBC) is an evidence-based practice with known benefits, it is not always systematically implemented with fidelity. Questions remain regarding MBC's unique added value compared to usual care.
Thus, the goal of this clinical trial is to investigate the implementation outcome, effectiveness, and mechanisms of change of measurement-based care in adult behavioral health. This study implemented MBC in adult ambulatory behavioral health and will test outcomes using a pragmatic randomized control trial within the RE-AIM (Reach, Efficacy, Adoption, Implementation, and Maintenance) framework.
Researchers will compare three groups: 1) the Measurement-based care group, 2) the treatment-as-usual group, and 3) the waitlist control group. Participants will participate in weekly individual psychotherapy sessions for 12 sessions in total.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Acute Psychosis, Intellectual Disability, Neurocognitive Disorders, Others
90 Participants Needed
Why Other Patients Applied
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
BH-Works Suicide Prevention Program for Youth Suicide Risk
Roanoke, Virginia
Youth suicide is a serious public health concern. Compared to their heterosexual and cisgender peers, sexual and gender minority (SGM) adolescents report higher rates of suicidal ideation and suicide attempts. Unfortunately, many barriers complicate the implementation of suicide prevention in SGM communities. SGM youth often report feeling unwelcome in traditional behavioral health service organizations. Consequently, treatment attendance and retention remain low. Instead, this population generally seeks mental health services in community organizations for lesbian, gay, bisexual, transgender, and queer (LGBTQ) youth. These organizations are often unprepared for this clinical challenge. The Behavioral Health-Works (BH-Works) suicide risk management system may offer a potential solution to this problem. BH-Works is an evidence-based, comprehensive youth suicide prevention program. It offers support for policy development, staff training, suicide and behavioral health screening, technology-assisted safety planning, an electronic patient referral system, real-time data analytics for program monitoring, and a learning collaborative structure to support sustainability. All functions are supported on a web-based software platform that facilitates cross-system communication, implementation, adoption, and expansion. In this project, the investigators will adapt this program for LGBTQ organizations and test feasibility, acceptability and preliminary effectiveness. This project builds upon robust partnerships with two diverse LGBTQ organizations in Philadelphia, Pennsylvania and rural Southwest, Virginia) and their respective behavioral health (BH) partnering sites. To facilitate BH-Works adaptation for SGM adolescents, the investigators will employ the Enhancing Engagement trajectory from Lau's cultural adaptation framework. To pilot the program within LGBTQ organizations and their partners, the investigators will use an Effectiveness-Implementation Hybrid Type 2 design with a historical comparison group. Informed by the Consolidated Framework for Implementation Research, the investigators will also pilot test a sequenced implementation strategy. This strategy focuses on promoting engagement, building partnerships, and creating sustainability. In Years 1 and 2, the investigators will collect treatment as usual data, and work with their partners to adapt BH-Works policy, content, practices, and workflow. The investigators will also train staff/providers in suicide risk management, family engagement and affirmative care. In Years 3 and 4, the investigators will test the adapted SGM BH-Works Program and examine several essential program targets (training impact, partnership development, software usability) and outcomes (successful referral, program satisfaction, caregiver involvement, suicide identification).
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:14 - 19
Key Eligibility Criteria
Disqualifiers:Limited English Proficiency, Comprehension Issues
260 Participants Needed
Contingency Management for Stimulant Use Disorder
Chicago, Illinois
Stimulants constitute a new and deadly fourth wave of the opioid epidemic. Contingency management is the most effective intervention for stimulant use and is an evidence-based adjunct to medication for opioid use disorder. Yet, uptake of contingency management in opioid treatment programs that provide medication for opioid use disorder remains low; in fact, access to contingency management is arguably one of the greatest research-to-practice gaps in the addiction treatment services field. The goal of this study is to conduct a type III hybrid effectiveness-implementation trial to evaluate a multi-level implementation strategy, the Science of Service Laboratory, to install contingency management for stimulant use in opioid treatment programs. The Science of Service Laboratory has three core components: didactic training, performance feedback, and external facilitation.
Utilizing a stepped wedge design, a regional cohort of 10 public sector opioid treatment programs will be randomized to receive Science of Service Laboratory at five distinct time points. At six intervals, each of the 10 opioid treatment programs will provide de-identified electronic medical record data from all available patient charts on contingency management delivery and patient outcomes. Staff from each opioid treatment program will provide feedback on contextual determinants influencing implementation. This study will rigorously evaluate whether a multi-level implementation strategy developed by one of the longest-standing national intermediary purveyor organizations-the SAMHSA Technology Transfer Centers, will improve both implementation and patient outcomes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Under 18, No Electronic Records
Must Be Taking:Opioid Use Disorder Medications
76 Participants Needed
Comprehensive Diabetes Management for Diabetes
Chicago, Illinois
The goal of this randomized trial is to determine the optimal combination and sequence of three enhancements for a team-based care model for patients living with diabetes in Chicago. The study aim is to determine optimization of intervention components. Participants will be randomly assigned to diabetes self-management training or remote glucose monitoring. After 6 months, participants will be rerandomized to a subsequent study arm (including a CHW support program) depending on a tailoring variable of change in A1c. Researchers will compare the final 6 study arms to see which combination and sequence of enhancements produces the most improvement in A1c.
No Placebo Group
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Gestational Diabetes, Stage-V Renal, Severe Cardiovascular, Others
270 Participants Needed
Preschool and Me for Developmental Delay
Chicago, Illinois
This proposal aims to test whether a proposed community-clinical linkage (CCL), an educational-medical linkage model, improves access to school-based services and subsequent child, parent, family and health service outcomes and offers a promising strategy to address longstanding racial, ethnic and income health care disparities among families with preschool children with developmental delays and disabilities. The investigators designed an educational-clinical linkage model, Preschool and Me (PreM) which incorporates key components of a CCL. It also utilizes a personalized medical-education care plan with remote lay navigator support to increase access to school-based services.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:36+
320 Participants Needed
Measurement-Based Care for Opioid Use Disorder
Chicago, Illinois
The goal of this clinical trial is to evaluate the effectiveness and implementation of measurement-based care, which involves the systematic use of client self-report data to inform and enhance treatment, in opioid treatment programs using a pilot hybrid effectiveness-implementation study design. The main questions this study aims to answer are: 1) is measurement based care effective for improving patient treatment attendance and opioid abstinence, and 2) can measurement based care be implemented with fidelity in opioid treatment programs? Participants in this study will be opioid treatment program leaders and treatment providers. Leaders and treatment providers will participate in measurement-based care implementation strategies such as training and consultation to help them use measurement-based care with their patients. There is no comparison group for this study, however researchers will compare effectiveness outcomes prior to and post measurement-based care implementation and will evaluate changes in measurement-based care use with fidelity post implementation.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-English Speakers, Under 18, Others
40 Participants Needed
Mi Quit Care for Quitting Smoking
Chicago, Illinois
The over-arching research question is: Does message (Advise) and referral approach (Refer) influence a patient's willingness to "opt-in" to receive a call from an Illinois Tobacco Quitline (ITQL) smoking cessation coach in patients at MSHC.
Primary UH3 study aim: Compare the effect of the portal-delivered Choice message (Arm 1) to the Information-only message (Arm 3) on linkage to the Illinois Tobacco Quitline (i.e., spoke to a Quitline coach).
Secondary UH3 aims are to:
Examine the reach of the patient portal for delivering "Advise" and "Refer" at 4 weeks. Reach is defined as a patient opening the portal-delivered provider message across all three Arms.
Compare the effect of the Quit message (Quit, Arm 2) to Information-only (Arm 3) on linkage to ITQL.
Compare the effect of the Facilitated-referral messages (opt-in link in the message: Arm 1 \& 2) vs. Self-referral (Information-only, Arm 3) on linkage to the ITQL (speaking to an ITQL coach) at four weeks.
Compare the effect of the portal-message content of the Choice message (Arm 1) vs. the Quit message (Arm 2) on linkage acceptance (opting in to be called by the ITQL) at 4 weeks.
Compare the effectiveness of re-engagement message 1 to message 2 for linkage to the ITQL among patients who opted-in to an ITQL call but who were not reached after 3 attempts.
Evaluate the cost-effectiveness of using a patient portal to advise patients to change their smoking behavior and refer them to the ITQL. We will compare the costs associated with our project to the costs associated with advising and referring patients during clinical appointments.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Under 18, Non-smoker, Others
3000 Participants Needed
Genetic Counseling Chatbot for Kidney Donors
Chicago, Illinois
Living donor (LD) kidney transplantation is the optimal treatment for patients with end-stage kidney disease (ESKD). However, LDs take on a higher risk of future ESKD themselves. African American (AA) LDs have an even greater, 3.3-fold, risk of ESKD than white LDs post-donation. Because evidence suggests that Apolipoprotein L1 (APOL1) risk variants contribute to this greater risk, transplant nephrologists are increasingly using APOL1 testing to evaluate LD candidates of African ancestry. However, nephrologists do not consistently perform genetic counseling with LD candidates about APOL1 due to a lack of knowledge and skill in counseling about APOL1. Without proper counseling, APOL1 testing will magnify LD candidates' decisional conflict about donating, jeopardizing their informed consent. Given their elevated risk of ESRD post-donation, and AAs' widely-held cultural concerns about genetic testing, it is ethically critical to protect AA LD candidates' safety through APOL1 testing in a culturally competent manner to improve informed decisions about donating.
No transplant programs have integrated APOL1 testing into LD evaluation in a culturally competent manner. Clinical "chatbots," mobile apps that use artificial intelligence to provide genetic information to patients and relieve constraints on clinicians' time, can improve informed treatment decisions and reduce decisional conflict. The chatbot "Gia," created by a medical genetics company, can be adapted to any condition. However, no chatbot on APOL1is currently available. No counseling training programs are available for nephrologists to counsel AA LDs about APOL1 and donation in a culturally competent manner. Given the shortage of genetic counselors, increasing nephrologists' genetic literacy is critical to integrating genetic testing into practice.
The objective of this study is to culturally adapt and evaluate the effectiveness of an APOL1testing program for AA LDs at two transplant centers serving large AA LD populations (Chicago, IL, and Washington, DC). The APOL1 testing program will evaluate the effect of the culturally competent testing, chatbot, and counseling on AA LD candidates' decisional conflict about donating, preparedness for decision-making, willingness to donate, and satisfaction with informed consent. The specific aims are to:
1. Adapt Gia and transplant counseling to APOL1 for use in routine clinical practice
2. Evaluate the effectiveness of this intervention on decisional conflict, preparedness, and willingness to donate in a pre-post design
3. Evaluate the implementation of this intervention into clinical practice by using the RE-AIM framework to longitudinally evaluate nephrologist counseling practices and LDs' satisfaction with informed consent.
The impact of this study will be the creation of a model for APOL1 testing of AA LDs, which can then be implemented nationally via implementation science approaches. APOL1 will serve as a model for integrating culturally competent genetic testing into transplant and other practices to improve patient informed consent.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Key Eligibility Criteria
Disqualifiers:Not Listed
12 Participants Needed
APOL1 Genetic Testing for Kidney Disease
Chicago, Illinois
Living donor (LD) kidney transplantation is the optimal treatment for patients with end-stage kidney disease (ESKD). However, LDs take on a higher risk of future ESKD themselves. African American (AA) LDs have an even greater, 3.3-fold, risk of ESKD than white LDs post-donation. Because evidence suggests that Apolipoprotein L1 (APOL1) risk variants contribute to this greater risk, transplant nephrologists are increasingly using APOL1 testing to evaluate LD candidates of African ancestry. However, nephrologists do not consistently perform genetic counseling with LD candidates about APOL1 due to a lack of knowledge and skill in counseling about APOL1. Without proper counseling, APOL1 testing will magnify LD candidates' decisional conflict about donating, jeopardizing their informed consent. Given their elevated risk of ESRD post-donation, and AAs' widely-held cultural concerns about genetic testing, it is ethically critical to protect AA LD candidates' safety through APOL1 testing in a culturally competent manner to improve informed decisions about donating.
No transplant programs have integrated APOL1 testing into LD evaluation in a culturally competent manner. Clinical "chatbots," mobile apps that use artificial intelligence to provide genetic information to patients and relieve constraints on clinicians' time, can improve informed treatment decisions and reduce decisional conflict. The chatbot "Gia," created by a medical genetics company, can be adapted to any condition. However, no chatbot on APOL1 is currently available. No counseling training programs are available for nephrologists to counsel AA LDs about APOL1 and donation in a culturally competent manner. Given the shortage of genetic counselors, increasing nephrologists' genetic literacy is critical to integrating genetic testing into practice.
The objective of this study is to culturally adapt and evaluate the effectiveness of an APOL1 testing program for AA LDs at two transplant centers serving large AA LD populations (Chicago, IL, and Washington, DC). The APOL1 testing program will evaluate the effect of the culturally competent testing, chatbot, and counseling on AA LD candidates' decisional conflict about donating, preparedness for decision-making, willingness to donate, and satisfaction with informed consent. The specific aims are to:
1. Adapt Gia and transplant counseling to APOL1 for use in routine clinical practice
2. Evaluate the effectiveness of this intervention on decisional conflict, preparedness, and willingness to donate in a pre-post design
3. Evaluate the implementation of this intervention into clinical practice by using the RE-AIM framework to longitudinally evaluate nephrologist counseling practices and LDs' satisfaction with informed consent.
The impact of this study will be the creation of a model for APOL1 testing of AA LDs, which can then be implemented nationally via implementation science approaches. APOL1 will serve as a model for integrating culturally competent genetic testing into transplant and other practices to improve patient informed consent.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-African Ancestry, Pregnancy, Others
390 Participants Needed
Modified PEST Screening for Psoriatic Arthritis
Stoney Creek, Ontario
The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:PsA, Rheumatoid Arthritis, Others
Must Not Be Taking:BDMARDs
502 Participants Needed
Take a Break + NRT for Smoking Cessation
Winston-Salem, North Carolina
The study team proposes a multi-level trial to test 1) novel implementation programs in rural counties designed to increase access to 2) recent advances in tobacco control services for people who are not-yet-ready-to-quit smoking. In this field, most trials have focused only on those already ready-to-quit. Thus, the proposed trial addresses an important knowledge gap critical to advance tobacco control in rural areas.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Actively Quitting, Prisoners, NRT Contraindications, Others
800 Participants Needed
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Frequently Asked Questions
How much do Implementation clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Implementation clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Implementation trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Implementation is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Implementation medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Implementation clinical trials?
Most recently, we added Emergency Care Action Plan for Infant Health, Preoperative Geriatric Assessment for Surgery and System-Level Intervention for Visual Impairment to the Power online platform.
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