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VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions
AIDS Malignancy Consortium
Anal Intraepithelial Neoplasia
High Grade Squamous Intraepithelial Neoplasia
HIV Positivity
Human Papillomavirus-16 Positive
Human Papillomavirus-18 Positive
This phase II trial studies the use of human papillomavirus (HPV) deoxyribonucleic acid
(DNA) plasmids therapeutic vaccine VGX-3100 (VGX-3100) and electroporation in treating
patients with human immunodeficiency virus (HIV)-positive high-grade anal lesions.
Vaccines made from DNA may help the body... expand
This phase II trial studies the use of human papillomavirus (HPV) deoxyribonucleic acid (DNA) plasmids therapeutic vaccine VGX-3100 (VGX-3100) and electroporation in treating patients with human immunodeficiency virus (HIV)-positive high-grade anal lesions. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells. Electroporation helps pores in your body's cells take in the drug to strengthen your immune system's response. Giving VGX-3100 and electroporation together may work better in treating patients with high-grade anal lesions. Type: Interventional Start Date: Sep 2018 |
Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy...
National Cancer Institute (NCI)
Oropharyngeal p16INK4a-Negative Squamous Cell Carcinoma
Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7
Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
This phase II/III trial studies how well radiation therapy works when given together with
cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients
with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells
(squamous cell). Specialized radiation... expand
This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab. Type: Interventional Start Date: Mar 2013 |
Ti-Mesh Frame Comparison for Alveolar Bone Augmentation
Boston University
Tooth Loss
This research compares a chairside Titanium Mesh frame fabrication used during bone
grafting procedures with the use of a computer-aided design/computer-assisted manufacture
(CAD-CAM) Titanium Mesh frame. In addition, a novel method of measuring soft tissue
thickness will be tested using an Optical... expand
This research compares a chairside Titanium Mesh frame fabrication used during bone grafting procedures with the use of a computer-aided design/computer-assisted manufacture (CAD-CAM) Titanium Mesh frame. In addition, a novel method of measuring soft tissue thickness will be tested using an Optical scanner at various times during the sequence of surgeries. The device used for shaping is a very thin, perforated titanium metal sheet with numerous small perforations (referred to as Micromesh). The construction of this device is usually accomplished chairside at the time of the surgery with custom cutting and shaping done using cues from the geometry of the surgical defect. An alternative approach will be tested where the mesh is pre-designed using digital information provided by a special xray and an optical scan device which takes a digital impression of the tooth and soft tissue surface. A digitally designed frame can then be printed using CAD-CAM software prior to surgery. This should reduce surgical time. A randomized control trial of 30 patients needing 3-D bone augmentation will be conducted comparing chairside fabrication of Ti-MESH or TEST- CAD-CAM designed and preprinted Ti-MESH to investigate these objectives: 1. Compare the operative times required for placement and removal of two different Ti-MESH frame fabrications 2. Compare post-op wound healing -Ti MESH exposure rates, bone production (volume, contour, and quality) and soft tissue thickness changes during the 1-year study period. Type: Interventional Start Date: Jan 2024 |
Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung...
SWOG Cancer Research Network
Recurrent Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
This phase III trial compares the effect of the combination of ramucirumab and
pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell
lung cancer that is stage IV or that has come back after a period of improvement
(recurrent). Ramucirumab is a monoclonal antibody that... expand
This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy. Type: Interventional Start Date: Mar 2023 |
Full-Time Occlusion Therapy for Intermittent Exotropia in Children
Jaeb Center for Health Research
Intermittent Exotropia
Determine whether full-time patching is more effective than observation for improving
distance control of IXT after 3 months of treatment (on-treatment outcome). expand
Determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome). Type: Interventional Start Date: Nov 2022 |
Cognitive Processing Therapy (CPT) Memory Support (MS) Study
Boston University
PTSD
The efficacy of psychological interventions for posttraumatic stress disorder (PTSD) is
likely limited by the difficulty participants have learning and remembering important
therapy content. Accordingly, the present study will examine the utility of integrating a
Memory Support (MS) intervention into... expand
The efficacy of psychological interventions for posttraumatic stress disorder (PTSD) is likely limited by the difficulty participants have learning and remembering important therapy content. Accordingly, the present study will examine the utility of integrating a Memory Support (MS) intervention into Cognitive Processing Therapy (CPT), an empirically supported and widely disseminated treatment for PTSD. MS was designed to integrate techniques aimed at facilitating encoding, consolidation, and retrieval of new learning into existing treatments, and has been shown to improve outcomes when integrated into cognitive therapy for depression. A pilot randomized controlled trial (n=52) comparing CPT with Memory Support (CPT+MS) to CPT-alone will be conducted. Study participants will be adults diagnosed with PTSD. The primary aim of the trial will be to determine if CPT+MS will lead to greater memory and learning of therapy content relative to CPT-alone, and to establish the acceptability and feasibility of integrating MS into CPT. Secondary aims include a preliminary examination of treatment efficacy, as indicated by the magnitude of changes in PTSD symptoms between conditions, and target validation, as indicated by associations between memory and learning of therapy content and treatment response. Exploratory analyses will examine several indicators of baseline memory-related cognitive functioning as predictors of memory and learning of therapy content, providing preliminary data to inform future research on personalized application of MS. Results of the trial will advance scientific knowledge about methods for optimizing memory and learning as a mechanism for improving PTSD treatment outcomes. Type: Interventional Start Date: Jan 2023 |
Conversation Group Treatment for Aphasia: Does it Work?
Boston University Charles River Campus
Aphasia, Acquired
The proposed research will test the efficacy of group conversation treatment for people
with aphasia and explore whether the effects of treatment differ as a result of the
following factors:
1. Group size: Do large groups of 6-8 people with aphasia or dyads of 2 people with
aphasia demonstrate... expand
The proposed research will test the efficacy of group conversation treatment for people with aphasia and explore whether the effects of treatment differ as a result of the following factors: 1. Group size: Do large groups of 6-8 people with aphasia or dyads of 2 people with aphasia demonstrate different levels of improvement with this treatment? 2. Group composition: Do effects of conversation group treatment differ if the groups include members with similar or different types of aphasia? 3. Aphasia severity: Do effects of conversation group treatment differ if the individuals within the group have mild-moderate or moderate-severe profiles of aphasia? Treatment sessions will occur in groups of 6-8 people with aphasia or with 2 people with aphasia. During treatment sessions, discourse will be facilitated on a focused set of every day topics, such as current events or travel. Linguistic and multi modal cueing hierarchies will be tailored to individual client goals and used to maximize communication success. The prediction is that conversation treatment is an effective method for improving communication in people with aphasia, but that specific benefits may differ based on variables such as group size, group composition, and aphasia severity. The results will help inform best practices for aphasia treatment and refine a hypothesized model about the mechanisms underlying conversation treatment. Type: Interventional Start Date: Apr 2022 |
Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II
Butler Hospital
Opioid Use
Chronic Pain
Phase 2 - Multiphase Optimization Strategy (MOST) Optimization Phase:
1. To conduct a factorial experiment that will allow us to evaluate the impact of each
of the 4 intervention components on yoga dosage received. We will enroll a total
n=192. All participants will receive the core... expand
Phase 2 - Multiphase Optimization Strategy (MOST) Optimization Phase: 1. To conduct a factorial experiment that will allow us to evaluate the impact of each of the 4 intervention components on yoga dosage received. We will enroll a total n=192. All participants will receive the core yoga intervention, with random assignment to the four intervention components outlined above. 2. Use results from Phase 2 to choose an efficient combination of intervention components that, together with standard yoga classes, maximizes yoga dosage. 3. Examine mechanisms by which components are hypothesized to work. Type: Interventional Start Date: Feb 2022 |
Social Media and Risk Reduction Teaching-Enhanced Reach
Boston University
Breastfeeding
SUID
SIDS
This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS)
recommendations and improve rates of initiation and duration of partial and exclusive
breastfeeding (BF) through direct education of mothers using Mobile Health (mHealth)
technologies (ex. text messaging). expand
This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF) through direct education of mothers using Mobile Health (mHealth) technologies (ex. text messaging). Type: Interventional Start Date: Jan 2022 |
A Randomized Trial to Evaluate Sequential vs Simultaneous Patching
Jaeb Center for Health Research
Amblyopia
A randomized trial to determine whether simultaneous treatment with spectacles and
patching has an equivalent VA outcome compared with sequential treatment, first with
spectacles alone followed by patching (if needed), for previously untreated amblyopia in
children 3 to <13 years of age. expand
A randomized trial to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to <13 years of age. Type: Interventional Start Date: Dec 2020 |
Improving Medical Decision Making for Older Patients With End Stage Renal Disease
Tufts Medical Center
Renal Disease, End Stage
Palliative Care
Decision Aids
The overall objective of this study is to reduce the burden of chronic kidney disease
(CKD) and its consequences for an aging U.S. population. To accomplish this, the
investigators propose to conduct a multi-center randomized trial of an advance care
planning (ACP) video intervention (vs. usual care)... expand
The overall objective of this study is to reduce the burden of chronic kidney disease (CKD) and its consequences for an aging U.S. population. To accomplish this, the investigators propose to conduct a multi-center randomized trial of an advance care planning (ACP) video intervention (vs. usual care) among older patients with CKD. Type: Interventional Start Date: Jun 2021 |
Leadership, Engagement, and Youth Activism Program With Mindfulness (LEAP)
Boston University Charles River Campus
Adolescent Behavior
Mental Health Wellness 1
The current study tests the feasibility and effectiveness of a youth intervention
designed to provide meaningful leadership opportunities and to address barriers to
equity, through the acquisition of civic leadership and development skills as well as
mindfulness practice, LEAP-M: Leadership, Engagement,... expand
The current study tests the feasibility and effectiveness of a youth intervention designed to provide meaningful leadership opportunities and to address barriers to equity, through the acquisition of civic leadership and development skills as well as mindfulness practice, LEAP-M: Leadership, Engagement, and youth Activism Program with Mindfulness. The goal of our proposal is to determine whether the Leadership, Engagement, and youth Activism Program with Mindfulness.(LEAP-M) curriculum, which was developed with youth of color, is a feasible and effective intervention for fostering civic leadership, civic development, and wellbeing. We seek to understand whether LEAP-M can support wellbeing for youth of color as a strategy to combat structural racism at the school- and neighborhood-levels, increase youth mental, emotional, and behavioral (MEB) health and decrease health disparities in youth of color. Type: Interventional Start Date: Dec 2023 |
Validating Gulf War Illness Blood Biomarkers
Roskamp Institute Inc.
Gulf War Syndrome
Gulf War Illness
The investigators goals are to identify blood lipids/metabolites that correlate with
cognitive decline in the presence of the APOE ε4 allele among veterans with GWI. To
determine the effect of dietary, medical and biological factors that influence lipid and
metabolites in blood from GW veterans. To... expand
The investigators goals are to identify blood lipids/metabolites that correlate with cognitive decline in the presence of the APOE ε4 allele among veterans with GWI. To determine the effect of dietary, medical and biological factors that influence lipid and metabolites in blood from GW veterans. To identify blood lipid/metabolite profiles that correlate with bioenergetics deficits and glial activation in the brains of GWI. To validate blood biomarker signatures of GWI using APOE genotyping and blood lipids/metabolites that correlate with the CNS dysfunction in GWI. Type: Observational Start Date: Jun 2022 |
Physical Activity for PLWH and Unhealthy Drinking
Boston University
HIV
Physical Inactivity
Unhealthy Alcohol Use
Brief Summary: Alcohol use disorder (AUD) is a significant and costly public health
problem that affects one-third of the U.S. population in their lifetime. Specifically,
unhealthy alcohol use is common among persons living with HIV (PLWH) and increases the
risk of developing negative outcomes. Antiretroviral... expand
Brief Summary: Alcohol use disorder (AUD) is a significant and costly public health problem that affects one-third of the U.S. population in their lifetime. Specifically, unhealthy alcohol use is common among persons living with HIV (PLWH) and increases the risk of developing negative outcomes. Antiretroviral therapy (ART) has shown increasing life expectancy and decreased HIV-related deaths, leading to a growing older adult HIV population. Yet, HIV accelerates the aging process and increases the risk for numerous chronic health conditions that compromise physical and mental health functioning and quality of life. Thus, PLWH continue to have shorter life expectancies relative to the general population and these multimorbidities explain this increased risk. In this context, unhealthy alcohol use among PLWH can further increase the risk for negative outcomes. Physical activity (PA) interventions can be used as an effective way to address unhealthy alcohol use among PLWH. Previous PA interventions have shown low generalizability and high loss to follow-up. Therefore, an intervention that is home-based, including lifestyle physical activity (LPA) with mobile health-delivered components is designed following the physical activity (PA) paradigm. Participants in this randomized controlled trial will be assigned to one of two study arms -- either the LPA or Fitbit Only intervention - both lasting 12-weeks. Both study arms will utilize a Fitbit to track daily step counts. In addition to utilizing a Fitbit, the LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine. The Fitbit only arm will receive only brief check-in phone calls and only related to assisting with any Fitbit functioning issues. Follow-up assessments will take place at 3 and 6 months. Type: Interventional Start Date: Feb 2023 |
Telehealth for Pain and Unhealthy Drinking Among PLWH
Boston University
HIV
Chronic Pain
Unhealthy Alcohol Use
This randomized controlled trial is a between-groups design to compare the Motivational
and Cognitive Behavioral Management for Alcohol and Pain (MCBMAP) Intervention to a Brief
Advice and Information Control condition.
Two-hundred and fifty participants who have HIV with moderate or greater chronic... expand
This randomized controlled trial is a between-groups design to compare the Motivational and Cognitive Behavioral Management for Alcohol and Pain (MCBMAP) Intervention to a Brief Advice and Information Control condition. Two-hundred and fifty participants who have HIV with moderate or greater chronic pain will be randomized for the trial. Recruitment will take place through digital media. A unique feature of this intervention trial is that most of the procedures will be conducted remotely which will minimize barriers of transportation and time for participants. Consent and baseline assessment will be completed remotely. Following baseline assessment, participants will complete two weeks of ecological momentary assessment (EMA) to assess alcohol use, chronic pain, physical function and mechanisms of behavior change for alcohol and pain management. Following the two-week phase, participants will be randomly assigned to either the intervention or control condition and meet the interventionist through videoconferencing. Participants will complete outcome assessment measures at 3- and 6-months post-baseline. Following the 3-month outcome assessment, participants will complete another two weeks of EMA. Type: Interventional Start Date: Mar 2023 |
5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer
Boston University
Superficial Basal Cell Carcinoma
Squamous Cell Carcinoma in Situ
The investigators will compare the application of two different creams for the treatment
of low-risk skin cancers-superficial basal cell carcinoma (sBCC) and squamous cell
carcinoma in situ (SCCis). 5-Fluorouracil cream is currently FDA approved for the
treatment of superficial basal cell carcinoma... expand
The investigators will compare the application of two different creams for the treatment of low-risk skin cancers-superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). 5-Fluorouracil cream is currently FDA approved for the treatment of superficial basal cell carcinoma and is routinely used by dermatologists across the country and at Boston Medical Center (BMC) for SCCis. The normal treatment regimen is 4 weeks of the 5-fluorouracil cream for both skin cancers. The application of a compounded cream consisting of 1:1 ratio 5-fluorouracil with calcipotriene will be tested. This combination cream has been shown to clear pre-skin cancers called actinic keratoses and prevent future skin cancers from developing. This combination cream for 7-14 days to see if this shorter treatment course provides clearance of the 2 types of skin cancer. This combination cream is successfully used in this manner to treat other subtypes of related skin cancers. This will be a pilot study with The primary endpoint for this pilot randomized single blinded clinical trial will be the response to treatment (yes versus no). The lesions will be assessed clinically for clearance of cancer, as would normally be done and is consistent with how comparable studies have assessed clearance. Participants will be followed closely afterwards for three years with visits at 6 months, which does not vary from standard practice. If the lesions are not clear of cancer or equivocal clinically, the lesions will be re-biopsied and normal standard of care procedure will take place. Type: Interventional Start Date: Oct 2022 |
Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric...
Vertex Pharmaceuticals Incorporated
Proteinuric Kidney Disease
The purpose of this study is to evaluate the efficacy, safety, tolerability, and
pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein
L1 (APOL1)-mediated proteinuric kidney disease. expand
The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease. Type: Interventional Start Date: Mar 2022 |
Cannabidiol (CBD) in Adults With ASD
Johns Hopkins University
Autism Spectrum Disorder
There are no FDA approved treatments for use in adults with autism spectrum disorder
(ASD), many of whom have distressing anxiety, mood disturbances, sleep problems, and
agitation. Some researchers and individuals with ASD have noted that cannabidiol (CBD) is
beneficial for those psychiatric problems.... expand
There are no FDA approved treatments for use in adults with autism spectrum disorder (ASD), many of whom have distressing anxiety, mood disturbances, sleep problems, and agitation. Some researchers and individuals with ASD have noted that cannabidiol (CBD) is beneficial for those psychiatric problems. This study is to learn more about the effectiveness and safety of CBD in the treatment of psychiatric problems in adults with ASD. The study will last 14 weeks total, during which six weeks participants will receive a pill containing CBD, two weeks where participants will receive no drug/placebo, and six weeks where participants will receive the placebo, an inactive pill. As part of the study, participants will have regular visits and be asked questions about anxiety, challenging behaviors, daily functioning, cognition, and physical symptoms, on standard assessments. Type: Interventional Start Date: Apr 2023 |
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension...
Inventiva Pharma
NASH - Nonalcoholic Steatohepatitis
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver
fibrosis histological stage F2 or F3 expand
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3 Type: Interventional Start Date: Aug 2021 |
Multimodal Outcome CHAracterization in Comatose Cardiac Arrest Patients Registry and Tissue Repository
Boston Medical Center
Cardiac Arrest
Cardiovascular disease remains the leading cause of death in the United States. Mortality
rates of cardiac arrest range from 60-85%, and approximately 80% of survivors are
initially comatose. Of those who survive, 50% are left with a permanent neurological
disability, and only 10% are able to resume... expand
Cardiovascular disease remains the leading cause of death in the United States. Mortality rates of cardiac arrest range from 60-85%, and approximately 80% of survivors are initially comatose. Of those who survive, 50% are left with a permanent neurological disability, and only 10% are able to resume their former lifestyle. Early prognosis of comatose patients after cardiac arrest is critical for management of these patients, yet predicting outcome for these patients remains quite challenging. The primary study objective of MOCHA is to develop an accurate and reliable assessment algorithm for determining neurologic prognosis in patients initially unconscious (no eye opening, GCS-M<6 and not following commands) post-cardiac arrest, using multiple prognostic modalities at standardized time points. Type: Observational [Patient Registry] Start Date: Aug 2017 |
Collection of Samples and Clinical Data From Patients With Amyloid Diseases
Boston Medical Center
Multiple Myeloma
RATIONALE: Collecting and storing samples of blood, urine, tissue and data from patients
with amyloid diseases to test in the laboratory may help the study of this disease in the
future.
PURPOSE: This research study is collecting samples from patients with amyloid diseases expand
RATIONALE: Collecting and storing samples of blood, urine, tissue and data from patients with amyloid diseases to test in the laboratory may help the study of this disease in the future. PURPOSE: This research study is collecting samples from patients with amyloid diseases Type: Observational Start Date: Jan 2000 |
Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India
Boston University
Influenza
COVID-19
SARS-COV-2 Infection
Other Respiratory Viruses
Perinatal Morbidity
This study will be conducted as a prospective cohort study, enrolling all eligible women
in their first trimester of pregnancy during a baseline visit during week 6-13 of
pregnancy at Government Medical College Hospital, Nagpur. The Hospital provides primary,
secondary, and tertiary care and the obstetric... expand
This study will be conducted as a prospective cohort study, enrolling all eligible women in their first trimester of pregnancy during a baseline visit during week 6-13 of pregnancy at Government Medical College Hospital, Nagpur. The Hospital provides primary, secondary, and tertiary care and the obstetric department delivers about 10,000 babies a year. The hypothesis is that co-infection of other respiratory viruses (ORV), particularly COVID-19 and Influenza increases the risk of adverse pregnancy outcomes in mothers and babies and could address the current standard of care in India to not vaccinate pregnant women during pregnancy, by either encouraging vaccination against both viruses before planning a pregnancy or during pregnancy based on global data supporting the safety of this strategy. Type: Observational Start Date: Dec 2023 |
Improving Access to Chiropractic Care in Community Health Centers
Boston Medical Center
Lower Back Pain
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... expand
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. Type: Interventional Start Date: Nov 2023 |
Tools to Improve Discharge Equity (TIDE) Pilot RCT
Boston Medical Center
Hospital Discharge
The investigators will test the impact of a package of linguistically appropriate
discharge teaching tools against current standard of care for patients with Limited
English proficiency (LEP) in an unblinded randomized controlled trial. The tools include
an expanded medication calendar in English... expand
The investigators will test the impact of a package of linguistically appropriate discharge teaching tools against current standard of care for patients with Limited English proficiency (LEP) in an unblinded randomized controlled trial. The tools include an expanded medication calendar in English and the patients' preferred language, pictographics to illustrate return precautions (what signs/symptoms require further evaluation), an audio recording of the nurse reviewing the After Visit Summary (composed by providers) to allow for review by patients and caretakers after discharge. The investigators will evaluate the effectiveness of the package of discharge teaching tools on patients' understanding/recall, key implementation outcomes, and secondary clinical outcomes via a structured interview 1-2 weeks after discharge and chart review 30 days after discharge. The objectives of this research study are: 1. test the effectiveness of a linguistically appropriate toolkit for improving patient understanding of discharge instruction content 2. Assess the feasibility and fidelity of the intervention in anticipation of a multi-site implementation trial 3. assess the feasibility and appropriateness of the linguistically appropriate toolkit to nurses and in-person interpreters 4. to assess the acceptability of the intervention to patients and their satisfaction with it 5. to collect data on implementation context in anticipation for a multi-site trial 6. to collect preliminary data on the toolkit's impact on clinical outcomes including medication adherence and hospital re-utilization. Type: Interventional Start Date: Dec 2023 |
Transitioning Together Boston
Boston Medical Center
Autism or Autistic Traits
Family Relations
A randomized controlled trial will be conducted to determine the effects of an adapted
family-centered autism transition intervention called Transitioning Together/Juntos en la
Transición on meaningful outcomes for families. The study will occur in a safety net
hospital setting. The adapted version... expand
A randomized controlled trial will be conducted to determine the effects of an adapted family-centered autism transition intervention called Transitioning Together/Juntos en la Transición on meaningful outcomes for families. The study will occur in a safety net hospital setting. The adapted version of this multi-family group psychoeducation intervention is delivered across one individual family joining session and four 2.5 hour multi-family group sessions. The parent and youth groups are held in separately, at the same time. Type: Interventional Start Date: Feb 2023 |
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