Treatment Trials

37 Clinical Trials for Various Conditions

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COMPLETED
Telehealth Nursing Intervention for Children With Complex Health Care Needs (CCHCN)
Description

The overall objective of this study is to evaluate the effectiveness of a telehealth care coordination and case management nursing intervention for children with complex special health care needs.

COMPLETED
Randomized Controlled Trial of Routine Screening for IPV
Description

This is a randomized controlled trial with three arms to establish the impact of screening and referral to services for women disclosing exposure to IPV.

COMPLETED
Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy
Description

The purpose of this study is to examine deficits in activation and motor patterns, as well as central drive in patients with rotator cuff tendinopathy. There are three specific aims: (1) determine the effect of acute pain relief on rotator cuff muscle activation in patients with rotator cuff tendinopathy, (2) determine the effect of exercise on rotator cuff muscle activation in patients with rotator cuff tendinopathy, and (3) compare rotator cuff muscle activation between patients with rotator cuff tendinopathy and healthy controls.

UNKNOWN
Lifestyle Interventions for Long Term Diabetes Control
Description

Lifestyle interventions have been shown to reduce heart disease risk and improve blood sugar control in clinical trials. This project will investigate whether those lifestyle interventions can be implemented long-term, in usual practice settings, by using dietitian case managers to coordinate lifestyle change in cooperation with fitness instructors and primary care clinicians.

Conditions
COMPLETED
Improving Hepatitis C Treatment in Injection Drug Users
Description

The overall goal of the research project is to improve the outcome of medical care for injection drug users (IDUs) with Hepatitis C viral (HCV) infection. Hypothesis: An intervention designed to improve the rate of HCV treatment completion and sustained virologic response (SVR) in IDUs will increase access by integrating HCV medical care into a substance abuse treatment program.

COMPLETED
Hearing Health Care Service Access and Use
Description

Hearing loss screening rates in for older persons in primary care clinics are very low even though hearing loss is relatively common for older persons. When diagnosed with hearing loss older persons are often reluctant to follow through. This study involves a prospective controlled trial comparing the effectiveness of three primary care based protocols for older adults ≥ 60 who screen positive for possible hearing loss in promoting subsequent access to and use of hearing health care services. The protocols will compare: 1) screening only (standard care control); 2) screening plus an illustrated educational brochure; and 3) screening plus an in-person educational intervention and an illustrated educational brochure. Screening will be done by primary care personnel. Participants will be tracked for 8 months to assess outcomes.

Conditions
NOT_YET_RECRUITING
A Multi-Site Hybrid Type I Effectiveness-Implementation Randomized Trial of an Emergency Care Action Plan for Infants With Medical Complexity
Description

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.

RECRUITING
UCSD RELINK: Connecting Adults To Supportive Services
Description

The goal of this randomized intervention study is to learn about effective health literacy teaching methods in Justice Involved Adults (JIA). Researchers will compare coach-guided health literacy or self-study design to see if there is a difference in the access and use of healthcare in this population. The main questions it aims to answer are: * Will this improve access and use of heath services? * Will this improve health insurance coverage and long term use of health services? Participants will: * Meet with a health coach and service navigator during 12 sessions or meet with service navigator and complete online training over 12 weeks. * Complete surveys at different time (6months, 1 year)

COMPLETED
Engagement in HIV Primary Care Services
Description

This study is to look at things that may affect whether or not people who are HIV-infected get into medical care and stay in medical care. some of the things that will be examined include how drug use, HIV disease severity, mental health, housing, trust, feelings of discrimination, social support, relationship with provider, and patient's race and provider's race are linked with whether or not people get health care. People who are enrolled in the study will be interviewed once, and their medical records will be examined.

COMPLETED
Padres Efectivos (Parent Activation): Skills Latina Mothers Use to Get Healthcare for Their Children
Description

The goal of this study is to develop an intervention to teach activation skills to Latino parents who bring children for mental health services.

COMPLETED
Evaluation of Emails Promoting Mail-order Pharmacy
Description

In this evaluation, four versions of emails will be sent to eligible health plan members who are not currently enrolled in the health system's mail-order pharmacy. A control group will not receive any communication. The researchers hypothesize that the use of content informed by behavioral nudge theory in the emails should lead to increased enrollment in the health system's mail-order pharmacy.

COMPLETED
THRIVE+ Pharmacy Liaison-Patient Navigation Intervention
Description

This is a pragmatic comparative effectiveness trial (n=364) to compare two screening and referral program models to address health-related social needs (HRSN) among the intermediate risk population of Boston Accountable Care Organization (BACO), a Medicaid ACO. The first study arm is THRIVE-Basic, the low-touch usual care model already implemented in all primary care clinics at Boston Medical Center (BMC) where patients are screened for HRSN and receive a printed paper resource referral guide. The second study arm is THRIVE+, which enhances the THRIVE-Basic model by engaging a pharmacy liaison-patient navigator to provide targeted navigation services and motivational interviewing to ensure connection to hospital- and community-based resources. The patient navigators will also interface directly with a partner community organization, Action for Boston Community Development (ABCD), to further help connect patients receiving THRIVE+ to community resources for HRSN. All patients in our study will receive pharmacy services via an existing Pharmacy Care Program. Patients in study arm 1 will be connected to a pharmacy liaison, which is standard clinical practice for intermediate risk ACO members in the BMC General Internal Medicine clinics. Patients in study arm 2 will receive systematic screening for and addressing of HRSN (THRIVE+) via a pharmacy liaison-patient navigator (a pharmacy technician trained as a patient navigator to deploy both pharmacy services and the THRIVE+ intervention), thereby avoiding duplication of services and multiple touches. Assignment to the study arms will be linked to existing Pharmacy Care Program enrollment activities and will be based on medical record number. The investigators' rationale for the study is that if patients' HRSN are addressed, patients will be better positioned to manage chronic conditions, adhere to preventive care plans, and less likely to use the emergency department (a conduit to inpatient care) for ambulatory care-sensitive conditions. The effectiveness of these two models will be compared with respect to alleviating HRSN and reducing acute health care utilization over a 12-month follow-up period.

COMPLETED
Extended-release Naltrexone and Care Management for Alcohol Dependent Frequent Emergency Department Users
Description

Our primary aim is to assess the feasibility of initiating treatment in the ED with extended-release naltrexone (XR-NTX) plus care management (CM) vs. standard care and continuing care in cooperation with clinic providers as well as how best to assess outcomes. Secondarily, the investigators will explore its effect on various health outcomes (healthcare utilization and engagement, expenditures, drinking and consequences, quality of life) as well as the association of patient-level characteristics (e.g. sex, race, baseline drinking, health and psychosocial factors, mu opioid receptor genotype) with effectiveness. Determining both how to implement XR-NTX+CM and rigorously test its effects in the ED (phase 1) is essential before planning a large-scale effectiveness trial (phase 2).

COMPLETED
Health Coach Program to Improve Chronic Disease Outcomes Following an Emergency Department Visit
Description

The purpose of this study is to determine whether health coaching initiated in the emergency department (ED) reduces subsequent ED visits, increases primary care visits, and positively impacts health outcomes in patients with diabetes and/or hypertension.

ACTIVE_NOT_RECRUITING
Development of STEPPT
Description

This 6-month pilot study aims to assess the feasibility, acceptability, and estimate effect sizes of the pilot STEPPT intervention for addressing ethnic disparities in physical therapy referrals and adherence between Hispanic and Non-Hispanic White patients with spine pain. Feasibility and acceptability will be assessed based on the extent to which the pilot clinic implements all components of the intervention appropriately, feedback from clinic staff during implementation of the intervention, and feedback from patients during post-intervention interviews. The investigators anticipate that the intervention will be both feasible and acceptable. Feedback from patients and clinic staff will be used to inform intervention modifications for a larger clinical trial. Effect sizes for the pilot STEPPT intervention (intervention) in comparison to standard care (control) will be assessed by evaluating changes in ethnic disparities (Hispanic vs. Non-Hispanic White) in physician referral to physical therapy and patient adherence to physical therapy referral for the treatment of spine pain before and after implementation of the pilot STEPPT intervention. In comparison to standard care, the investigators expect STEPPT to reduce ethnic disparities in referral and adherence outcomes.

NOT_YET_RECRUITING
Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years
Description

The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic. The main questions it aims to answer are: * Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing? * Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity? * Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)? Participants will receive in-person and telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months. Researchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.

RECRUITING
Homeless Veterans and Peer Whole Health Coaching
Description

Use of acute care services (e.g., hospitalizations, Emergency Department visits) contributes substantially to the cost of healthcare for Veterans. Homelessness is a robust social determinant of super utilization of acute care. The goal of this project is to test if Peer Specialists trained in Whole Health Coaching can reduce homeless Veterans' frequent use of acute care.

COMPLETED
Online and Shared Decision-Making Interventions to Engage Service Men and Women in Post-Deployment Mental Health Care
Description

OEF/OIF/OND war Veterans have unique post-deployment care needs that the VA is striving to understand and address. Unfortunately, there is a significant disparity in utilization of mental health (MH) care and VA access as most war Veterans don't seek needed care. New interventions are urgently needed to address disparities in post-deployment MH treatment engagement for war Veterans and to support VA's efforts to provide them with optimal access and care. Online health interventions have been shown to be preferred by OEF/OIF combat Veterans and have the potential to promote access to VA MH care. The investigators' research team has developed a web-based interface (WEB-ED) evolved by feedback from Veterans that screens for common post-deployment MH and readjustment concerns, provides tailored education about positive screens, and facilitates linkage to VA resources. Data from the investigators' prior studies demonstrate WEB-ED can be successfully implemented within VA and activate Veterans to seek needed care. Furthermore, emerging evidence indicates that when patients are educated about their health conditions and treatment alternatives using shared decision-making (SDM), increased treatment participation and adherence, and better health outcomes result. Next steps include: linking Veteran WEB-ED screening results to a VA secure network so that a provider can access the results; and integrating a SDM interface to promote Veteran-Provider partnerships in patient-centered care. This study will improve the investigators' understanding of the most effective methods to reduce barriers to enrollment in VA/MHV and transferring important medical information using My HealtheVet (MHV). Furthermore, it will provide important information regarding how WEB-ED results can enhance the capability of VA providers and transition patient advocates to use Veterans' screening results to triage and engage Veterans in patient-centered MH care and promote VA provider adoption of WEB-ED+ to facilitate patient engagement. Online screening, tailored education, and links to geographically accessible VA resources has been shown to be preferred by Veterans, providing recognition of treatable post-deployment MH concerns, and education that reduces stigma. This study builds upon and augments this prior work with research to understand and evaluate the processes needed to integrate WEB-ED+ into current VHA systems to support efficient care delivery, facilitate patient-centered care, and address unmet need for MH care while also resolving disparities in VA and VA MH care access and engagement for war Veterans. WEB-ED+'s use of shared decision making is a key component for promoting these benefits. WEB-ED+ represents a readily implementable and cost-effective intervention that, with partner collaboration, can be integrated into VA systems through MHV. Findings have important policy implications for several operational partners heavily invested in the improved access and delivery of evidence-based mental health care for war Veterans.

COMPLETED
A Statewide Intervention to Reduce Use of Unproven or Ineffective Breast Cancer Care
Description

The goal of this project is to examine the effectiveness and potential cost savings of two organizational interventions aimed at reducing the use of ineffective or unproven care among women with incident breast cancer.

Conditions
COMPLETED
Combination Primary Care and Prevention Services for Women Who Inject Drugs and Exchange Sex in Seattle, Washington
Description

The investigators will implement a non-randomized observational clinical trial that will include a pop-up clinic for women who inject drugs (WWID) near venues for exchange sex and drug use in north Seattle. The pop-up clinic will be housed within a van and serve as a research extension of the SHE Clinic, a Harborview Medical Center run clinic for women who exchange sex and use drugs in north Seattle. Through the implementation of the pop-up clinic, the investigators will aim to assess: 1. The impact of the pop-up clinic on uptake and sustained use of HIV pre-exposure prophylaxis (PrEP) and medications for opioid use disorder (MOUD) among WWID. 2. The impact of point of care (POC) sexually transmitted infection (STI) testing on STI treatment completion rates. 3. The acceptability and feasibility of providing HIV prevention care for WWID and exchange sex in a pop-up van clinic.

COMPLETED
Improving Antibiotic Use in Acute Care Treatment
Description

Purpose The emergence and rapid rise in antibiotic resistance among common bacteria are adversely affecting the clinical course and health care costs of community-acquired infections. Because antibiotic resistance rates are strongly correlated with antibiotic use patterns, multiple organizations have declared reductions in unnecessary antibiotic use to be critical components of efforts to combat antibiotic resistance. Among humans, the vast majority of unnecessary antibiotic prescriptions are used to treat acute respiratory tract infections (ARIs) that have a viral etiology. Although the rate of antibiotic prescribing for ARIs by office-based physicians in the US has decreased about 16% from its peak in 1997, the rate of antibiotic prescribing in acute care settings (eg, emergency departments and urgent care centers), which account for 1 in 5 ambulatory antibiotic prescriptions in the US, has shown only a modest decline (6%) during this period. Translation of lessons from intervention studies in office-based practices is needed to improve antibiotic use in acute care settings.

NOT_YET_RECRUITING
Hormonal Contraception Access Through Pharmacist Prescribing Implementation
Description

The goal of this clinical trial is to learn if use of the HAPPI software can improve pharmacist-provided birth control services. The main questions it aims to answer are: 1. Does the HAPPI software make it easier for pharmacists to provide birth control services in their pharmacy? 2. Does the HAPPI software make it easier for patients to access birth control? Researchers will compare pharmacists' implementation and patients' access when using the HAPPI software and when not using the HAPPI software to see if the software improves implementation and access. Participants will include pharmacists and patients. Pharmacists will be asked to provide birth control services as normal while using the HAPPI software. Patients will be asked to receive birth control services from a pharmacist as normal, while using the HAPPI software.

COMPLETED
Community and Clinician Partnership for Prevention
Description

The purpose of this study is to evaluate the impact of strategies to develop and foster the relationship between primary care practices and community resources to address specific unhealthy behaviors (tobacco use, poor nutrition, and lack of physical activity).

COMPLETED
Post Affordable Care Act Evaluation
Description

This innovative study will measure the impact of Affordable Care Act-sponsored Medicaid expansions on access to and utilization of community health center (CHC) services. Building on the investigators prior work that developed a robust community-based research infrastructure within the OCHIN community health information network, the investigator will utilize linked electronic health record data from the OCHIN network of \>400 CHC clinics in 8 states that expanded Medicaid coverage and 8 states that did not expand.

Conditions
COMPLETED
Impact of the CommunityRx Program on Health, Service Utilization and Costs
Description

The CommunityRx system generates patient-centered e-prescriptions for community services (HealtheRx) via an interface between the electronic health records (EHR) and a comprehensive community resource database. Based on a patient's diagnoses, a HealtheRx will be printed automatically at the end of the ambulatory care visit and will provide patients with a customized map and/or list of places in their community that provide health and social services as well as contact information for a local community health worker who can provide limited case management support. The CommunityRx program aims to promote: 1) better healthcare, 2) better health, and 3) lower cost. The purpose of this research is to systematically evaluate the impact of CommunityRx on health outcomes as well as health care service utilization and total cost of care for Medicaid, Medicare and other beneficiaries. The investigators hypothesize that beneficiaries who participate in the CommunityRx intervention will experience better healthcare, better health and lower total cost of care.

WITHDRAWN
Symptom Management, Quality of Life and Satisfaction With Care for Advanced Stage Cancers - Control Arm
Description

Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent Control Study). The primary aim of the study is to compare the proportion of advanced cancer patients who have a hospitalization or emergency department visit in the last 6 months of life before and after implementation of a new care model that provides more comprehensive symptom management and supportive care, including earlier referral to palliative care. The secondary comparative aim is to assess measures of quality of life and satisfaction in both groups. This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase).

COMPLETED
Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care
Description

The purpose of this study is to determine whether, for individuals in inpatient opioid detoxification, linking to outpatient Suboxone treatment increases treatment adherence and reduces relapse to illicit opioid use.

COMPLETED
Adolescents' Use of Complementary and Alternative Medicine
Description

The purpose of this study is to help improve our understanding of when and why adolescents decide to use alternative and complimentary medicines, and to understand factors that lead to better communication between youth and their clinicians.

Conditions
COMPLETED
Improving Delivery of Mental Health Services for Patients With Drug Use and Other Behavioral and Emotional Problems
Description

This research is being done to: * identify any emotional, behavioral or other troubling psychological problems that some people have who are seeking and receiving treatment for heroin or other drug use problems, * learn if providing additional psychiatric treatment services in the ATS drug abuse treatment program is as beneficial for and acceptable to patients as referring them to the Bayview Community Psychiatry Program to get help for their emotional, behavioral and other psychological problems.

RECRUITING
A Systems Analysis and Improvement Approach for Optimizing HIV Service Delivery in Syringe Services Programs
Description

The goal of this clinical trial is to assess the effectiveness of an evidence-based, organizational-level implementation strategy, the Systems Analysis and Improvement Approach, in improving HIV service delivery (SAIA-SSP-HIV) in U.S. syringe services programs (SSPs). The main questions it aims to answer are: * Does SAIA-SSP-HIV improve delivery of HIV services (including the proportion of SSP participants receiving HIV testing) compared to implementation as usual (IAU)? * Does SAIA-SSP-HIV result in sustained improvement of HIV service delivery cascades (including the proportion of SSP participants receiving HIV testing) compared to IAU? * What are the costs associated with SAIA-SSP-HIV and how cost-effective is the strategy? The trial will take place over 21 months and consist of a 3-month lead-in period, a 12-month active period, and a 6-month sustainment period. During the 12-month active period a SAIA specialist will meet with SSPs randomized to the SAIA-SSP-HIV arm to help them optimize their HIV service delivery cascades. Researchers will compare the SAIA-SSP-HIV and IAU arms to see if HIV service delivery and costs and cost-effectiveness differ by group.

Conditions