27 Clinical Trials for Various Conditions
This study will test a physical activity intervention for Latina teenagers. Investigators will recruit 200 Latina adolescents who are currently under-active to participate in this 12-month study. Participants will be referred to the study by their primary care provider. Half of the participants will be randomly selected for the Intervention group, and will receive an individual counseling session and access to a personalized website. These participants will also receive a Fitbit activity tracker to help with goal setting and monitoring, plus weekly text messages and access to the study Instagram account to remind participants to be physically active. Those assigned to the control group will receive the Fitbit activity tracker.
The purposes of this study is to evaluate the feasibility of providing a community based referral to Mayo Clinic Employee and Community Health patients for weight loss.
Child and adolescent behavioral health problems are related to the leading causes of youth morbidity and mortality. Parent-focused preventive interventions, such as GenerationPMTO (GenPMTO), effectively prevent behavioral health problems such as depression and conduct disorders. Unfortunately, parenting programs are not widely available nor well-attended. Pediatric primary care (PC) is a non-stigmatizing setting with nearly universal reach and, therefore, an ideal access point to increase availability. However, PC personnel are not trained to address behavioral health topics. Also, typical referral practices are inadequate. There is a need to develop effective referral practices in conjunction with increasing availability. There are also logistical barriers to attending in-person parenting programs, like the need for childcare and a large time-commitment. There is a need to overcome these logistical barriers with more accessible programs. The long-term goal is to prevent significant behavioral health problems by increasing access to GenPMTO.
Busy Primary Care providers (PCPs) have complex practices with many competing demands, making it difficult to improve their HL identification rates. Little research has been conducted to identify effective approaches to address the poor PCP knowledge and provide tools for them to better identify/refer patients with HL for appropriate intervention. Current data suggests there is a critical need to redesign how PCPs deliver hearing health care (HHC) by developing focused educational programs and simple clinical management tools to help them integrate HHC into their practices. To address this need, this study will educate providers on hearing loss (HL) screening/treatment as well as create a Best Practice Alert (BPA), or clinical prompt, that is configured for maximal effectiveness in reminding PCPs to ask their patients if they think they have a HL. This combination of education for providers and clinical reminder could help increase HL screening rates but how much is not clear. This 5 year R21/R33 study funded by National Institute of Deafness and Communicative Disorders seeks to provide detailed understanding of both how educating providers on HL and the use of an effective BPA affects HL screening rates and identification for people with mild to moderate hearing loss.
Veterans presenting for treatment of substance use disorders (SUDs) often have multiple and serious comorbid medical conditions that affect functional health status and health care costs. Prior studies show higher rates of medical follow-up when onsite primary health care was provided to patients with SUDs within an addictions clinic (onsite care). However, no data are available on differences between onsite versus referral models of primary care delivery in terms of clinical outcomes and total health care costs.
This add-on study of providing tobacco, alcohol and other drug screening, brief intervention and referral for treatment to a primary care high risk diabetic population leverages the existing research resources of a funded parent project "Duke University CMS Innovation Award Southeastern Diabetes initiative (PI: Robert M. Califf, MD)" to explore the feasibility of implementing Screening for substance use, Brief Intervention, and Referral to Treatment services in Primary Care (SBIRT-PC) and to examine the effects of substance use status on diabetes health care outcomes. This pilot study also examines the feasibility of the CTN's common data element algorithms of SBIRT for illicit and nonmedical drug use in the primary care setting.
This is a randomized, controlled clinical trial to evaluate the effect of a computerized screening, assessment, and brief intervention on substance use in patients recruited from a primary care clinic. Study participants will be assigned to one of the following 4 study groups: computerized health screening alone (standard care) (SC); computerized assessment-only intervention (CA); computerized assessment followed by a computer-directed motivational intervention (CACI); or computerized assessment followed by a therapist-delivered motivational intervention (CATI). Data regarding substance use, medical and psychosocial functioning, and economic outcomes will be collected. The investigators hypothesize that patients randomized to CACI and CATI will be more likely to report drug abstinence at the 3-month follow-up visit and will show greater reductions in drug use at 1, 3 and 6 months follow-up than patients assigned to CA or SC. Similarly, patients in the CACI and CATI groups will report greater reductions in HIV risk behaviors, lower rates of medical and psychosocial problems, and increased economic gains at the 6-month follow-up. In addition, patients in the assessment only intervention (CA) will have outcomes superior to those found for SC patients. A cost-effectiveness analysis will also be done comparing economic costs associated with CA, CACI and CATI and their relationship to substance use reductions and related improvements in medical and psychosocial outcomes at the 6 month follow-up.
This study is a Stage III cRCT to test the efficacy of multi-level interventions at the practice- and provider-level to address low dental utilization (attendance) among Medicaid-enrolled older adults 55 years or older attending non-urgent primary care visits (PCV) in MetroHealth practice settings. Twelve practices will be randomized into two arms: A) Intervention arm will receive the multi-level intervention that includes: 1. Practice-level: EHR changes to include: ask, advise, assess, and connect (AAAC) strategies; 2. Provider-level: Medical staff (MA, nurse): Training in the AAAC process and complete AAAC for enrolled older adults; Clinicians (physician/nurse practitioner): CSM-based education (didactic), skills training (video training with standardized patients), and view completed AAAC in EHR to deliver core oral health (OH) facts to older adults, reinforce importance of dental visits, and document in EHR that OH facts were delivered. B) Control arm will receive, at the provider-level only (clinicians), non-theory-based information about retaining a healthy mouth using the ADA Mouth Healthy Series and deliver standard OH care for patients. Older Adults will be followed at 12 months and 24 months to determine if the participant had any dental attendance. The primary objective is to test the efficacy of the practice level EHR strategy to ask \[OH risk assessment\], advise \[going to dentist\], assess \[willingness for referral\], and connect \[eReferral, resources\] together with clinician theory-based education to communicate OH facts versus clinician alone (standard oral health care) in increasing dental attendance in primary care settings. The secondary objectives are to assess oral hygiene behavior, Geriatric Oral Health Quality of life, biometric measures (BP, serum cholesterol, blood glucose, hbA1c) abstracted from EHR data, potential mediators and moderators to investigate pathways that affect the primary and secondary outcomes, and assess implementation strategies: adoption, reach, fidelity, and maintenance of providers and practices that affect older adult primary and secondary outcomes. The hypothesis is that medical staff completing the AAAC strategy and clinicians with improved OH knowledge (chronicity, systemic effects) will deliver consistent oral health messaging to older adults at PCVs that will result in increased preventive and restorative dental utilization compared to those providers delivering standard care.
The goal of this research is to leverage technology in primary care clinics to improve screening, brief intervention and referral to Substance Use Disorder (SUD) treatment, and treatment attendance by comparing 1. a text message-based screening, phone-based brief intervention, and referral to treatment by a remote care coordinator (m-SBIRT; intervention arm), versus 2. evidence-based, in-person Screening, Brief Intervention, and Referral to Treatment (SBIRT; Treatment As Usual (TAU); control arm). Primary Aim is to compare the efficacy of m-SBIRT to TAU in positive screens for substance use. Secondary Aim is to compare m-SBIRT to TAU on Substance Use Treatment Attendance.
The goal of this clinical trial is to evaluate efficacy of our enhanced version of the CHESS Health eIntervention in a clinical setting for those with moderate risk drug or alcohol use and those at high risk or with Substance Use Disorder (SUD) as measured by the ASSIST and the AUDIT assessment tools. The clinical trial is designed to determine whether SBIRT/eIntervention is significantly more effective than SBIRT/Treatment as usual (TAU) as delivered in a primary care setting. While it is not feasible or practical to individually test all components and features of the planned eIntervention, this design will permit testing of efficacy for reduction of substance use in both risk groups and increased enrollment in treatment for the high risk/SUD group in the SBIRT/eIntervention cohorts compared to the SBIRT/TAU cohorts. Note that the investigators are not including a screening/assessment only or other control condition, as the purpose of this clinical trial is not to test the efficacy of SBIRT itself, but rather to test whether SBIRT/eIntervention improves outcomes and successful referral relative to SBIRT/TAU delivery alone.
The burden of urinary incontinence (UI) on American women is immense in both human and financial terms, and continues to rise with the aging US population. Although numerous non-surgical management strategies have proven efficacy for both stress and urge urinary incontinence, there remains a lack of appropriate UI management in the primary care setting. The goal of this multi-site cluster randomized comparative effectiveness trial is to compare the effects of two methods of nonsurgical UI care delivery - electronic consult vs. advanced practice provider (APP) co-management. These two evidence-based, practice-changing strategies are designed to improve the quality of care for an ethnically diverse population of women with UI, and, by reducing deficits in care, obtain better patient-reported outcomes. Both arms of the study will include basic physician education (academic detailing) and electronic clinical decision support. In Arm 1, the investigators will implement an electronic referral system (electronic referral), in which specialists will electronically review referrals and make additional recommendations if appropriate primary UI care was not provided. In Arm 2, Advanced Practice Provider (APP) co-management will reduce the burden of care on the PCPs by providing UI care, patient education, and assisting with patient self-management through dedicated televisits (APP co-management).
This pilot study will determine the feasibility, acceptability, and efficacy of Strengths-based Linkage to Alcohol Care (SLAC; a behavioral intervention) to link Veterans, identified as hazardous drinkers in VHA primary care, to alcohol care. Participants screening positive in VA primary care for hazardous drinking and posttraumatic stress disorders (PTSD) and/or depression in the past year will be recruited. Participants will be randomly assigned to one of two study conditions - SLAC plus usual care or usual care only. The investigators will determine the feasibility of conducting a larger scale study to evaluate SLAC in primary care and SLAC's acceptability among key stakeholders (e.g., Veterans, primary care providers). Other outcomes will include exploring whether SLAC improves linkage to an alcohol care or help option and/or reduces alcohol use and mental health (PTSD, depression) symptoms.
Autism Access Link for Early Referral and Treatment \[ALERT\], the intervention proposed in this application, is a novel state-wide referral and case management platform that PCPs can activate to ensure that a child with suspected ASD receives all necessary ASD diagnosis and treatment resources in a single referral, radically simplifying a complex diagnostic and treatment process. We hypothesize that Autism ALERT will have strong acceptability and high rates of use among primary care providers as well as among diverse low-income patients of children at risk for ASD, and that we will see higher rates of child ASD educational evaluations within six months, and shorter time between referral and ASD treatment, compared with our control.
The overall goal of this three-year study is to adapt and test a brief, feasible intervention using a communication tool and brief parent coaching to increase the capability of parents of children and youth with special health care needs to exchange and use medical information in partnership with their child's physicians when their children require sub-specialty referral. We hypothesize that the use of tools to coordinate referrals between physicians and parents will facilitate increased communication between primary care physicians(PCPs) and specialists, and that parents trained in information exchange and care planning will experience increased self-efficacy in interacting with their child's physicians. There are two primary aims of the study. The first aim is to adapt a joint parent-provider referral communication and care planning intervention (i.e., the 'referral care plan') for use with ethnically diverse populations in an electronic communication environment, and optimize its usability in the practice setting. The second aim is to test the referral care plan in nine pediatric primary care and subspecialty practices in two states, using a stepped wedge cluster randomized trial, to evaluate its effect on communication, parent self-efficacy, and patient outcomes.
This proposed study tests the effectiveness and examines the implementation of screening and brief intervention techniques to delay initiation and reduce substance use among adolescents accessing medical care in Federally Qualified Health Care settings with a computer-facilitated intervention. The primary hypothesis is that participants in the intervention groups will be more likely to cease or reduce substance use at follow-up compared to clients in the treatment as usual condition.
The primary purpose of this research is to develop and evaluate the short-term efficacy of an innovative multiple behavior screening, brief intervention and referral to treatment (MB-SBIRT) model using social images and future self-images to simultaneously link and reduce prescription and other co-occurring drug use behaviors among emerging adults in a primary care setting serving a racially and economically diverse community. The long term objective of this research is to cost-effectively reduce prescription and illicit drug abuse, along with alcohol and tobacco consumption, and improve health-related quality of life among high-risk emerging adults often ignored in intervention research and services.
This project seeks to develop a comprehensive, computer-based education program for primary care physicians that will improve their skills in structured substance abuse screening, brief interventions, and referral and treatment (SBIRT). The investigators will develop two online education programs based on virtual patient (VP) technology. One program will include five typical, interactive, problem-solving VPs and the second will include five identical VPs except that two VPs will have been "worked" by substance abuse experts and presented as case studies. The remaining three VPs will be "unworked" (typical VPs). The investigators hypothesize that both education programs will significantly improve educational outcomes, compared to no training, as measured by a validated survey tool. A secondary hypothesis is that physicians using the "worked" (guided learning) program will achieve similar educational results as those using the typical VP approach, but will require less training time.
Underdiagnosis and undertreatment of elderly persons remains a widespread problem. While many innovative geriatric care programs exist within VHA, we still lack a systematic process for identifying at-risk elders from the larger VA population who are likely to benefit from specialized geriatric services.
This study seeks to evaluate and document the processes of outreach consultation through joint-clinics via teleconferencing as an intervention for system improvement in care delivery and management of diabetes mellitus (DM) at a Community Based Outpatient Center (CBOCs).
The goal of this study is to evaluate the feasibility of new implementation strategies designed to increase the number of Primary Care Providers (PCPs) referrals to chiropractic care for lower back pain (LBP) in underserved populations. The investigators plan to pilot the strategies in three qualified community health centers (CHCs) and compare the number of LBP patients who receive referrals before and after implementation. The implementation strategies involve PCP, patient, and organizational interventions. Patients presenting with LBP will be provided educational materials that focus on the safety and effectiveness of chiropractic care as an evidence-based treatment for LBP. Materials will be available in CHC common areas and may be sent to patients by their PCP via patient portal. PCPs will participate in interactive lunch seminars to allow for inter-professional learning for PCPs. They will also participate in a survey regarding their attitudes and beliefs relating to chiropractic care. Currently, many PCPs cannot make chiropractic care referrals in the electronic health record (EHR). The investigators plan to add this option, or make it easier if the referral is already available. This multi-level, multi-component approach will last two months, and will be rolled out sequentially in three clinics using a stepped-wedge design. The ordering of clinics will be random. The primary outcome is the proportion of patients with LBP who received a referral to chiropractic care before and after the intervention. Secondary outcomes include referral to any non-pharmacologic treatment, use of imaging, and prescribed medications.
The goal of this clinical trial is to compare a standard adolescent-only approach to substance use screening, brief intervention, and referral to treatment to a in primary care settings. Primary outcomes (AOD use, co-occurring behavior problems, parent-youth communication about AOD use) and secondary outcomes (adolescent quality of life, therapy attendance) are assessed at screen/initial and 3, 6, 9, and 12 months follow-up.
The purpose of this study is to determine whether seeing a physical therapist first compared with seeing a physician first is more clinically and cost effective in an occupational setting for acute musculoskeletal conditions.
Sleep disorders are prevalent health problems that reduce quality of life, increase risks for medical disease, and enhance healthcare costs/utilization. Only a small proportion of these cases are diagnosed in primary care. Pilot data from this VA suggest that sleep disorders are not adequately managed in a primary care setting: 33% of veterans with an insomnia complaint had an undiagnosed primary sleep disorder (e.g., sleep apnea), and 50% of these patients were prescribed pharmacologic treatment for insomnia by their primary care providers.
The purpose of this study is to determine the impact of primary care referrals to community physical activity programs for overweight and obese youth aged 6-18 years on objectively measured physical activity and cardiorespiratory fitness, as well as other cardiovascular health indicators. We hypothesize that physical activity referrals will result in higher levels of physical activity and fitness.
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.
The purpose of this study is to evaluate Fax to Quit (F2Q) - a strategy that links state quitlines to health care delivery systems. FQ capitalizes upon the healthcare visit as an opportunity for intervention, consistent with the finding that approximately 70% of smokers visit a primary care physician each year. Successful integration of quitlines into healthcare delivery will transform regular healthcare visits into easily implemented, cost-beneficial avenues via which smokers all across America will be routinely inducted into effective cessation intervention. F2Q will be evaluated as follows: 1. Does F2Q increase contacts and "quality contacts," between the quitline and patients who smoke and receive health care at a participating clinic? A "quality contact" is defined as a quitline referral that results in the individual enrolling in the quitline counseling services. This aim will be assessed by measuring the rates of quitline referrals in 49 clinics before and after F2Q has been implemented. 2. Are contact rates and enrollment rates of F2Q increased by "Enhanced Academic Detailing" at clinic sites (with enhanced academic detailing comprising ongoing training/technical assistance as well as performance feedback)? 3. What are the features of the Fax to Quit (F2Q) and Fax to Quit plus Enhanced Academic Detailing (F2Q + EAD) interventions that key clinic personnel found helpful and easy to implement, as well as features that were unhelpful and difficult? This information will be gathered in qualitative assessments that also will identify clinic strategies and organizational features that facilitated successful implementation. 4. What are the incremental costs of instating and sustaining F2Q and F2Q + EAD and how do these costs compare to other quitline promotional strategies (e.g., paid media, medication give-away programs)?
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).