223 Clinical Trials for Various Conditions
Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this study is to pilot test, an optimization trial approach to develop and refine the decision partnering skills of persons with stage 4 chronic kidney disease and their caregivers. Using a 2x2x2 full factorial design, 64 dyads (patients and one identified caregiver) will be randomized to receive one or more lay coach-delivered decision partnering training components, based on Pearlin's Stress-Health Model of Family Caregiving and Rini's Social Support Effectiveness theory. The components include: 1) caregiver coaching on effective decision support (1 vs. 3 sessions); 2) caregiver decision support communication training (1 session vs. none); and 3) patient social support effectiveness psychoeducation (yes vs. no).
Develop a Metastatic Breast Cancer (MBC)-specific electronic Treatment Plans (TP). Phase 1: Aim 1a: Patient interviews along with navigator, nurse, and physician focus group discussions will be used to identify factors that influence decision-making in treatment selection and the optimal approach for sharing information about prognosis and guideline-based care. Identify decisional needs for Shared Decision Making (SDM) in MBC. Investigators will conduct semi-structured interviews/discussion groups with patients, navigators, nurses, and physicians to elements important to decision-making. Phase 2: Aim 1b: Develop MBC-specific TP. Investigators will build upon Aim1a to systematically develop the TP intervention using the Ottawa Decision Support Framework. Investigators will test the TPs with 5 patients and conduct qualitative investigations to refine the TP using an iterative process. Phase 3:Further explore decision-making related to reducing amount of chemotherapy for patients with good prognosis.
Oregon's decision makers (e.g., community service providers, public health, justice, advocacy groups, payers) are calling for comprehensive, current, and trusted data to inform how they allocate resources to improve substance use services and mitigate the growing opioid and methamphetamine epidemics in their state. Consistent with the HEAL Data2Action call for Innovation projects that drive action with data in real-world settings, this study will refine and test the impact of a novel implementation strategy to engage cross- sector decision makers and make data that they identify as relevant to their decisions available to them in easy- to-use products. The proposed study aims to not only address critical knowledge gaps regarding how and when data can inform impactful, transparent decision-making, but to provide decision makers with the data that they need to achieve community-wide substance use prevention and treatment goals, including the increased delivery of high-quality, evidence-informed, services and the prevention of overdoses.
This proposal responds to NIMH Objective 4.2.c to develop "decision-support tools and technologies that increase the effectiveness and continuous improvement of mental health interventions" by leveraging the Family First Prevention Services Act (FFPSA) policy opportunity. First, a web-based platform to host (a) a decision-support tool and (b) automated facilitation for group decisions with the tool will be developed with state partners' feedback. Next, decision makers leading their states' FFPSA quality improvement efforts will be engaged to pilot a decision-support intervention comprised of the tool and live or automated facilitation, and to evaluate the implementation quality of evidence-based programs adopted with the decision-support intervention.
The investigators will conduct a randomized control trial enrolling 366 older Veterans with multiple chronic conditions receiving primary care at the Michael E. DeBakey VA Medical Center and VA Connecticut Medical Center to determine if Patient Priorities Care reduces treatment burden, increases priorities-aligned home and community services, and sets shared health outcome goals compared with usual care. The investigators will randomize at the patient level rather than clinic or clinician level to evaluate the effect of identifying patient priorities on clinician decision making and alignment of care with identified priorities.
This is pilot quasi-experimental study of women with one or two prior cesarean deliveries who are now pregnant and eligible for a trial of labor after cesarean delivery, to assess whether a decision aid, providing knowledge about trial of labor (VBAC) and planned repeat cesarean delivery can improve the birth options decision-making process for patients. Participants are screened for eligibility through electronic health records. Once an individual is screened eligible, and email invite is sent providing information about the study and assessing the interest in participation. An on-line consent is completed and women are entered sequentially into the usual care group and then through further recruitment, another sample of women are entered into the decision aid group. The primary outcome is satisfaction with the shared decision-making process with their provider.
Investigators will conduct a randomized trial with patients, through one-on-one interviews, to evaluate their understanding of and willingness to use a decision support tool and to determine if receiving and discussing the decision support tool improves the likelihood that a patient is adherent to a new antihypertensive medication.
The goal of this study is to increase shared decision making for patients considering treatment for severe aortic stenosis. The main questions it aims to answer are: * Do patient decision aids and clinician skills training course improve the quality of decisions, and do they work well for different patient populations? * Are heart clinics able to reach the majority of patients with decision aids before their specialist visit and do the majority of clinicians complete the training course? All participating sites will start in the usual care group and then will be randomly assigned a time to switch to the intervention group. Participants will complete surveys before and after their specialist visit. Researchers will compare data from patients seen during usual care with data from those seen after the interventions are implemented to see if there are improvements in the quality of decisions.
To address the significant barriers to pre-exposure prophylaxis (PrEP) implementation for cisgender women and address racial inequities in HIV prevention in the United States (US), a novel approach that accounts for multilevel influences is necessary. This study is the second part (Aim 2) of a multi-component project and involves a patient- and clinic-level intervention in a public health family planning clinic in Duval County Florida, where most patients are women of color. The area has one of the highest HIV incidence rates among women in the US. The investigators developed 1) a tablet-based decision support tool (DST) that helps users learn about HIV vulnerabilities and HIV prevention strategies to inform how they consider options for reducing their likelihood of acquiring HIV, and 2) clinic-wide trainings regarding shared decision making and trauma informed care. In Aim 1 (previously completed), participants were randomized to viewing an HIV prevention DST in a clinic that had not received clinic-wide trainings. In Aim 2 (the present study), there will be two phases. In the first phase, participants will receive care at the clinic following training; the DST will not be used. In the second phase, in addition to being seen at a clinic-site that has experienced the training, participants will use the DST before their visit. Participants will be surveyed about experiences with HIV prevention counseling, intentions about using HIV prevention, and DST use (among those in the active arm in the second phase). A subset of participants, individuals who self-identify as Black or Latinx, will also complete a post-clinic visit interview. The investigators will assess whether participants initiated an HIV prevention method three months following their initial visit. The main outcomes will include a quantitative and qualitative assessment of PrEP or other HIV prevention use, decisional certainty, and satisfaction with information about HIV prevention options.
To address the significant barriers to PrEP implementation for those who were assigned female at birth and self-identify as a woman and address racial inequities in HIV prevention in the United States (US), a novel approach that accounts for multilevel influences is necessary. This study is one part of a multi-component project and involves a patient-level intervention in one public health family planning clinic in Duval County Florida, where the majority of patients are women of color. The area has one of the highest HIV incidence rates among women in the US. The investigators developed a tablet-based decision support tool that helps users learn about HIV vulnerabilities and HIV prevention strategies to inform how they consider options for reducing their likelihood of acquiring HIV. Participants will be randomized to use the HIV decision support tool before their visit or standard counseling (without the use of the tool) and will be surveyed about the use of the tool, experiences with HIV prevention counseling, and intentions about the use of HIV prevention. A subset of participants, all individuals who self-identify as a woman and as Black or Latina, will also complete a post-clinic visit interview. The investigators will follow-up with participants at three months following their initial visit to see if they have initiated the HIV prevention method(s) they chose at their visit. The main outcomes will include a quantitative and qualitative assessment of PrEP or other HIV prevention use, decisional certainty, and satisfaction with information about HIV prevention options. Hypotheses: 1. Women who use the HIV prevention decision support tool will be more likely to have initiated PrEP within 3 months compared to women who received standard counseling at the time of their initial appointment. 2. The HIV prevention decision support tool will increase women's knowledge of PrEP and other HIV prevention methods compared to women who received standard counseling at the time of their initial appointment. 3. The HIV prevention decision support tool will increase participants' decisional certainty in their choice of an HIV prevention method compared to women who received standard counseling at the time of their initial appointment.
PTSD is one of the most common mental health conditions affecting Veterans and is associated with significant burden. Highly effective treatments exist for PTSD, evidence-based psychotherapies, but very few Veterans receive them. Although VA has trained over 8,500 providers in evidence-based psychotherapies for PTSD over the past 10 years, only 6% of the 650,000 VHA patients with PTSD receive an evidence-based psychotherapy. It is critical to connect Veterans with the most effective PTSD treatments and done so in a way that is Veteran-centered. Shared decision making is a patient-centered approach to choosing healthcare treatment options. It has been shown to increase patients' motivation for treatment and ability to stay in treatment long enough to get benefit. It has also been shown to help providers align their practice with evidence-based guidelines. This proposal will refine and pilot test a shared decision making intervention for PTSD to be used in VA primary care clinics, where the vast majority of Veterans with PTSD are treated.
One mechanism to reduce potentially inappropriate medications is through deprescribing, a deimplementation-based approach to thoughtfully discontinue a medication a patient is currently prescribed. Many interventions to overcome deprescribing barriers target the provider, who is already overburdened. Although some believe providers have primary responsibility for deprescribing, patient-initiated discontinuation discussions can effectively facilitate deprescribing. In a single-site pilot study, the investigators successfully engaged VA Primary Care patients to facilitate deprescribing of select potentially inappropriate medications. The investigators now propose a multisite randomized controlled trial of engaging Veterans who may be deprescribing candidates. By study end, the investigators will have established the effectiveness of an innovative, low-tech, patient-focused intervention to promote deprescribing, thereby directly improving quality, safety, and value of VA care while also setting the stage for generalization of this approach to other potentially inappropriate medications.
What is the research about? Long-term pain -or pain that lasts for months or years-is one of the most common health problems in the United States. Clinicians often treat long-term pain with opioids. Opioids can help ease pain in the short term, but evidence does not support their effectiveness in the long term. For some people, long-term opioid use can lead to addiction and overdose. People need effective options and support to help improve their function and enjoy life as much as possible. What is the research team doing? This study that compared two programs for helping people living with long-term pain to improve their function while managing their pain. People with long-term pain who had been taking opioid medicines for 3 or more months could be in the study. This study was done at primary care and pain care clinics at 3 health systems in North Carolina and Tennessee. The study team assigned people by chance to one of two study programs: (1) Shared Decision Making (SDM) or (2) Cognitive Behavioral Therapy and Motivational Interviewing (CBT+MI). Both programs went by clinical guidelines for opioid prescribing. In the SDM program, the patient and clinician worked together to make decisions that were best for the patient. In the CBT+MI program, the patient learned strategies to better cope with chronic pain. The study team compared the two programs by looking at changes in opioid dose, physical functioning, and pain interference over time. They collected information on prescribed opioid dose from electronic health records. People did surveys at the start of the study and at 6 and 12 months. Study data collection is over, and the study team is analyzing data. Results are forthcoming. The study team worked with an advisory group that included patients, advocates, clinicians, and pain experts. The advisory group met with the study team two to three times per year to provide input on the study.
The investigators have designed a tablet-based decision support tool to help women learn more about their birth control options and support them in choosing a method they are happy with. The investigators will test whether the decision support tool helps women choose a birth control method they can continue using successfully by having some women use the tool before their birth control-related visit to a health care provider, and some women not use the tool before their visit. The investigators will then follow up with all the women at four months and seven months after their visit to see if they are still using the birth control method they chose at the visit and how happy they are with the method. Hypotheses: 1. Women who use the contraceptive decision support tool will be more likely to continue using their chosen method at 4 and 7 months follow-up, compared to women who receive usual care. 2. The contraceptive decision support tool will increase women's knowledge, choice of, and use of highly effective reversible contraception, compared to usual care. 3. The contraceptive decision support tool will decrease decision conflict, compared to usual care. 4. The contraceptive decision support tool will increase patient satisfaction with the clinic visit and with their method, compared to usual care. 5. Women who use the contraceptive decision support tool will have fewer unintended pregnancies during the follow-up period, compared to women who received usual care. 6. The contraceptive decision support tool will increase shared patient-provider decision making in contraceptive counseling visits, compared to usual care. 7. The contraceptive decision support tool will decrease provider frustration when providing contraceptive counseling and increase provider job satisfaction. 8. Women using the tool will be more likely to report use of any moderately or highly effective method of contraception at 4 and 7 months follow-up, compared to women not using the tool.
The purpose of this research study is to learn about how Shared Decision Making, when used to decide treatment, impacts treatment engagement, retention, and outcomes for active duty military personnel seeking treatment for posttraumatic stress disorder (PTSD). Shared Decision Making between the service member and the therapists will be used to match patients to 1 of 3 different types of therapy for PTSD: (1) Prolonged Exposure (PE) therapy, (2) Cognitive Processing Therapy (CPT), or (3) Written Exposure Therapy (WET) in 1 of 2 different frequencies: (1) massed (daily) or (2) spaced (weekly).
HIV prevalence among transgender women (TW) in the United States is high (\~14%). The best way to reduce HIV incidence in this population is to link TW to HIV pre-exposure prophylaxis (PrEP), which can reduce HIV transmission by up to 86%, with optimal adherence. The FDA approved the first long-acting form of PrEP, injectable cabotegravir (CAB-LA), in late 2021, which has the potential to decrease HIV transmission and increase PrEP adherence among TW. The addition of CAB-LA to available PrEP options necessitates TW and PrEP service providers select the best method (oral vs injectable) for each TW. However, TW have unique concerns about PrEP (e.g., interactions with gender-affirming hormones) and report that patient/provider discussions on this medication are suboptimal. Thus, to inform this shared decision process, the proposed study builds on formative work by developing and pilot-testing "WePrEP," a PrEP-focused bilingual digital shared decision-making tool (SDMT), tailored to diverse English- and Spanish-speaking TW and PrEP service providers. WePrEP will support communication between TW and PrEP service providers as they identify the ideal PrEP product for each TW and discuss associated adherence strategies by cuing conversations on TW's unique PrEP needs/concerns and presenting pertinent information that is culturally relevant and tailored to this population. To develop and test WePrEP, the investigators will partner with the Mile High Behavioral Healthcare Transgender Center of the Rockies, a Denver-based transgender-serving organization. They will use McNulty et al.'s adapted Shared Decision-Making Model for TW to guide the iterative participatory design process we will use with a group of racially/ethnically diverse TW and PrEP service providers, to develop WePrEP; we will begin this process using prototypes created from preliminary data (Aim 1a). The investigators will rigorously assess the usability of WePrEP via simulated patient/provider discussions (Aim 1b). Next, they will pilot test WePrEP in a randomized controlled trial (RCT; N=69 TW) with 2:1 randomization. In the RCT, PrEP service providers (N=4, of which n=1 is bilingual) will use WePrEP with intervention TW to select CAB-LA or oral PrEP and discuss adherence. Other providers (N=2, of which n=1 is bilingual) will give control TW a standard of care explanation of PrEP (CDC recommendations) to help them make their PrEP choice. TW will be referred to Sheridan Health Services to start PrEP. We will assess primary (feasibility; acceptability) and secondary (potential mechanisms of action of WePrEP; preliminary impact) outcome measures using validated scales and rigorous qualitative methods (Aims 2, 3). By creating a bilingual digital SDMT to enhance communication between TW and PrEP service providers as TW choose their ideal PrEP modality, this project is likely to make a widespread and lasting impact on TW's uptake and adherence to PrEP.
The objectives of this study will be to quantify, using validated scales, the effects of 3D-printed models on shared decision-making and patient anxiety during the pre-operative consent and education process.
The project will investigate the efficacy of a Veteran-peer-navigator-led decision coaching (PDC) program to promote Shared Decision Making (SDM) for prostate cancer screening among Veterans at the Veterans Health Administration (VA). Prostate cancer is commonly screen detected using PSA, a non-specific test which has led to modest population-level survival benefits at the cost of over-detection of low-risk disease. This trade off in outcomes is ideally addressed using SDM which can be challenging to implement in time constrained primary care office visits. The investigators propose the evaluation of a PDC intervention to promote SDM for PSA screening to improve both access and quality of care for Veterans. The investigators results will enhance understanding of the efficacy, cost-effectiveness, and sustainability of PDC interventions for SDM promotion across communication formats in the VA. Lessons learned through this proposal will not only improve quality of care for PSA screening but also will suggest a paradigm for dissemination of SDM across preventive services.
This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.
The goal of this clinical trial is to increase shared decision-making between dialysis providers and patients in order to increase patients' probability of transplantation and to reduce socioeconomic/racial disparities in access to kidney transplantation. Participants will receive educational material over the course of 4-6 months about different aspects of the kidney transplant and waitlisting process.
This clinical trial compares the use of a shared decision-making communication tool during a clinical encounter to standard care for improving the quality of the shared decision-making process among patients with non-small cell lung cancer. Lung cancer patients are faced with many decisions about their treatment options. Studies have found that patients are most satisfied if they perceive an effort by their physician to share decision making and are afforded sufficient time to make their decision. Shared decision-making tools can help physicians guide the conversation, offer tailored estimates of the potential benefits, harms, and practical inconveniences of the available options, and support deliberations that take into account patient biological and biographical circumstances, goals, and priorities. Incorporating a shared decision-making communication tool into standard clinical encounters may improve the shared-decision making process as well as patient satisfaction with their treatment choice.
In this pilot study, the investigators will show feasibility of the NLP-based feedback system in 20 consultations of men with newly diagnosed prostate cancer. The investigators will recruit from the practices of up to 10 physicians who typically see these patients. The investigators will report the top five sentences from each consultation across key content areas (cancer prognosis, life expectancy, erectile dysfunction, urinary incontinence, and irritative urinary symptoms) to both patients and physicians within 2 weeks of the consultation.
The goal of this pilot randomized trial is to learn about shared decision making in kidney transplant candidates. The aim of this proposal is to evaluate the Donor Plan Donor Choice tool to promote high-quality Shared Decision Making for providers and kidney transplant candidates at two transplant centers. Participants will: * Review an online education tool, Donor Plan Donor Choice. * Discuss a Kidney Offer Plan with a transplant provider. * Answer questions about willingness to consider different donor types. Researchers will compare the Shared Decision Making group to usual care to generate pilot data and implementation outcomes for a larger trial.
Investigators will conduct a pilot randomized controlled trial assessing the efficacy and feasibility of the newly developed Family Media Check-In (FMC).
This is a non randomized pilot trial aimed to: Test the feasibility of an intervention to support intensive care unit clinicians in conducting shared decision making conversations with families of patients with acute respiratory failure. The goal of this intervention is to mitigate racial disparities in shared decision making.
Aim 1: Characterize shared decision-making and unmet patient-caregiver dyads needs for patients with diabetes and Alzheimer's Disease and related dementias (ADRD) while using a continuous glucose monitoring (CGM) device. Aim 2: Develop an interactive tool to enhance shared decision-making for diabetes management.
Shared decision making is the first overarching principle for the treat to target guidelines for rheumatoid arthritis (RA) and has been proposed as a potential mechanism to reduce health disparities, however there is little evidence to inform effective ways to implement this practice in the care of Veterans with RA. The purpose of this project is to evaluate the effectiveness of a multi-component shared decision making intervention on RA disease activity, adherence to RA medications and patient knowledge of RA. The proposed research will contribute to fundamental knowledge about how to effectively foster shared decision making across varied VA rheumatology clinical settings to improve patient disease outcomes and experience; and support clinicians to engage patients in meaningful ways with the ultimate goal to improve health, reduce disability, and eliminate disparities.
Hypothesis 1a: The investigators anticipate that navigator decision coaching, compared to enhanced usual care (EUC) will result in higher quality SDM for lung cancer screening (LCS )(primary outcome), greater knowledge of lung cancer screening benefits and harms, and lower decisional conflict. Hypothesis 1b: Compared to enhanced usual care (EUC), we expect that TELESCOPE will result in more screening discussions, increased initial for lung cancer screening (LCS) with low-dose CT scan (LDCT) uptake among interested participants, increased adherence to repeat LCS and diagnostic testing, and increased smoking cessation referrals for current smokers. Hypothesis 2: The investigators expect that a "booster" coaching session will increase adherence to repeat lung cancer screening (LCS).
Given that firearm ownership is legal, common, and valued by many people in the U.S, safe storage is important to minimize the risk of unauthorized access, injury and death. Safe storage is particularly important in households with children, as they are at elevated risk of death by unintentional injury or suicide if a gun is accessible in the home. However, only 1/3 of firearm-owning parents with children in the home report consistently safe storage. Decisions about firearm storage are complex, with perceived costs and benefits of different storage options varying by individual factors (i.e., primary reasons for firearm ownership, types of firearms), family factors (i.e., age and mental and physical health of household members), and community factors (i.e., crime and norms). Storage decisions affect all household members, and prior research finds that firearm owners who discuss storage with other family members have the safest storage practices. However, a recent survey study of firearm-owning US parents of school-aged youth (n=749) found that in only 55% of parenting dyads are both parties highly involved in the decision about how firearms are stored. In this sample, investigators observed that safe storage was more likely when both members of a parenting dyad were highly involved in the storage decision (regardless of their gender and whether one or both own firearms). However, at present firearm storage interventions are directed at individuals rather than family systems. Given the prevalence of pediatric firearm injuries and the role of within-family processes in storage safety, there is a critical need to develop a feasible, self-directed, family-centered firearm safety intervention. The objective of the proposed short-term project is to develop and obtain preliminary data about acceptability and feasibility of a prototype of a brief decision aid for parenting dyads. The conceptual framework for the decision aid is the Ottawa Decision Support Framework, and then investigators will adapt the Ottawa Person Decision Guide for Two to this issue and for self-facilitation outside of the clinical setting.
This study observes conversations between non-small cell lung cancer patients and their doctors to support the development of a decision aid that can be used to inform discussions about treatment options for after surgery. Patients who have undergone surgery for their non-small cell lung cancer may have the option of completing additional treatment. Patients contemplating this additional treatment have been shown to be most satisfied with their choice if they perceive an effort by their doctor to share decision making. Shared decision making tools can help doctors guide conversations, offer tailored recommendations, and support deliberation on whether or not to pursue treatment. This study develops a shared decision making tool for patients with surgically removed non-small cell lung cancer contemplating additional treatment.