Pragmatic Replication Trial of Health

Chronic pain is the most common reason U.S. adults seek medical care. Acupuncture and yoga show effectiveness, and a recent study assessed the feasibility of these two modalities for chronic pain at federally qualified health centers. Yoga research is rarely individualized, which is important for chronic pain treatments. Six experienced yoga professionals drew on research and clinical experience to co-create a yoga therapy protocol standardized for replication with flexibility for individual care. Yoga therapy was to be combined with a previously developed flexible acupuncture intervention in a feasibility trial...

BACKGROUND: About half of people living with dementia have not received a diagnosis, delaying access to treatment, education, and support. We previously developed a tool, eRADAR, which uses information in the electronic health record (EHR) to identify patients who may have undiagnosed dementia. This paper provides the protocol for an embedded, pragmatic clinical trial (ePCT) implementing eRADAR in two healthcare systems to determine whether an intervention using eRADAR increases dementia diagnosis rates and to examine the benefits and harms experienced by patients and other stakeholders...

Introduction: Cannabis use is associated with brain functional changes in regions implicated in prominent neuroscientific theories of addiction. Emerging evidence suggests that cannabidiol (CBD) is neuroprotective and may reverse structural brain changes associated with prolonged heavy cannabis use. In this study, we examine how an ∼10-week exposure of CBD in cannabis users affected resting-state functional connectivity in brain regions functionally altered by cannabis use. Materials and Methods: Eighteen people who use cannabis took part in a ∼10 weeks open-label pragmatic trial of self-administered daily 200 mg CBD in capsules...

BACKGROUND: Family caregiver training decreases caregiver psychological burden and improves caregiver depressive symptoms and health-related quality of life. Caregivers FIRST is an evidence-based group skills training curriculum for family caregivers and was announced for national dissemination in partnership with the Veterans Health Administration (VHA) National Caregiver Support Program (CSP). Previous evaluations of Caregivers FIRST implementation highlighted that varying support was needed to successfully implement the program, ranging from minimal technical assistance to intensive assistance and support...

OBJECTIVE:  This study aimed to determine whether clinically integrated Breastfeeding Peer Counseling (ci-BPC) added to usual lactation care reduces disparities in breastfeeding intensity and duration for Black and Hispanic/Latine participants. STUDY DESIGN:  This study is a pragmatic, randomized control trial (RCT) of ci-BPC care at two ci-BPC-naïve obstetrical hospital facilities in the greater Chicago area. Participants will include 720 patients delivering at Hospital Site 1 and Hospital Site 2 who will be recruited from eight prenatal care sites during midpregnancy...

IMPORTANCE: Randomized clinical trials have found that antenatal lifestyle interventions optimize gestational weight gain (GWG) and pregnancy outcomes. However, key components of successful interventions for implementation have not been systematically identified. OBJECTIVE: To evaluate intervention components using the Template for Intervention Description and Replication (TIDieR) framework to inform implementation of antenatal lifestyle interventions in routine antenatal care...

BACKGROUND: Central nervous system (CNS) active medications have been consistently linked to falls in older people. However, few randomized trials have evaluated whether CNS-active medication reduction reduces falls and fall-related injuries. The objective of the Reducing CNS-active Medications to Prevent Falls and Injuries in Older Adults (STOP-FALLS) trial is to test the effectiveness of a health-system-embedded deprescribing intervention focused on CNS-active medications on the incidence of medically treated falls among community-dwelling older adults...

BACKGROUND: This economic evaluation supplements a pragmatic randomized controlled trial conducted in community care settings, which showed superior improvement in the symptoms of adults with anxiety disorders who received 12 sessions of transdiagnostic cognitive-behavioural group therapy in addition to treatment as usual (tCBT + TAU) compared to TAU alone. METHODS: This study evaluates the cost-utility and cost-effectiveness of tCBT + TAU over an 8-month time horizon...

INTRODUCTION: A task-sharing collaborative care model for integrated depression care for South Africa's burgeoning primary health care population with chronic conditions was developed and tested through two pragmatic cluster randomized controlled trials. One trial focused on patients with hypertension and was located in one district where a collaborative care model was co-designed with district stakeholders. The other trial, focused on patients on antiretroviral treatment, was located in the same district site, with the addition of a second neighbouring district, without adaptation of the original model...

BACKGROUND: Assessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant follow-up to assess effectiveness and use patient-reported outcomes that require large sample sizes. Consequently the RCTs are often perceived as being expensive and time-consuming, particularly if the results show the test intervention is not effective. Adaptive, and particularly group sequential, designs have great potential to improve the efficiency and cost of testing new and existing surgical interventions...

Background: Depression symptoms are prevalent in the general population, and their onset and continuation may be related to biological and psychosocial factors, many of which are related to lifestyle aspects. Health promotion and lifestyle modification programmes (LMPs) may be effective on reducing the symptoms. The objective of this study was to analyse the clinical effectiveness of a LMP and a LMP plus Information and Communication Technologies, when compared to Treatment as Usual (TAU) over 6 months...

BACKGROUND: Chronic pain is prevalent and costly; cost-effective nonpharmacological approaches that reduce pain and improve patient functioning are needed. OBJECTIVE: Report the incremental cost-effectiveness ratio (ICER), compared with usual care, of cognitive behavioral therapy aimed at improving functioning and pain among patients with chronic pain on long-term opioid treatment. DESIGN: Economic evaluation conducted alongside a pragmatic cluster randomized trial...

BACKGROUND: Many people living with epilepsy (PLWE) reside in rural communities, and epilepsy self-management may help address some of the gaps in epilepsy care for these communities. A prior randomized control trial of a remotely delivered, Web-based group format 12-week self-management program (SMART) conducted in Northeast Ohio, a primarily urban and suburban community, demonstrated improved outcomes in negative health events such as depression symptoms and quality of life. However, there is a paucity of research addressing the needs of PLWE in rural settings...

BACKGROUND: There is no strong evidence that any drug is beneficial either for the treatment of SARS-CoV-2 disease or for post-exposure prophylaxis. Therefore, clinical research is crucial to generate results and evaluate strategies against COVID-19. Primary care (PC) centers, the first level of care in the health system, are in a favorable position to carry out clinical trials (CD), as they work with a large volume of patients with varied profiles (from acute to chronic pathologies)...

INTRODUCTION: Community clinics often face pragmatic barriers, hindering program initiation and replication of controlled research trial results. Mentoring is a potential strategy to overcome these barriers. We piloted an in-person and telehealth mentoring strategy to implement the T elehealth-supported, I ntegrated Community Health Workers (CHWs), M edication-access, group visit E ducation (TIME) program in a community clinic. RESEARCH DESIGN AND METHODS: Participants (n=55) were low-income Latino(a)s with type 2 diabetes...

INTRODUCTION: The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) delivered in a group format could facilitate the implementation of evidence-based psychological treatments. OBJECTIVE: This study compared the efficacy of group UP and diagnosis-specific cognitive behavioral therapy (dCBT) for anxiety and depression in outpatient mental health services. METHODS: In this pragmatic, multi-center, single-blinded, non-inferiority, randomized controlled trial (RCT), we assigned 291 patients with major depressive disorder, social anxiety disorder, panic disorder, or agoraphobia to 14 weekly sessions in mixed-diagnosis UP or single-diagnosis dCBT groups...

Genomic testing has the potential to improve patient outcomes and reduce patient care costs by personalizing medication selection. Commercial pharmacogenetic (PGx) testing for psychotropic and other medications is widely available and promoted as a means to implement "precision medicine." Despite evidence that genetic variation affects the metabolism of psychotropic medications, the clinical utility of these test results has not been established. Moreover, implementing such testing in routine clinical care is complex, requiring informatics support and a systematic approach to patient and provider education...

BACKGROUND: Although comprehensive reporting guidelines for implementation strategy use within implementation research exist, they are rarely used by clinical (i.e., efficacy and effectiveness) researchers. In this debate, we argue that the lack of comprehensive reporting of implementation strategy use and alignment of those strategies with implementation outcomes within clinical research is a missed opportunity to efficiently narrow research-to-practice gaps. MAIN BODY: We review ways that comprehensively specifying implementation strategy use can advance science, including enhancing replicability of clinical trials and reducing the time from clinical research to public health impact...

INTRODUCTION: Complex behavioral interventions such as diabetes shared medical appointments (SMAs) should be tested in pragmatic trials. Partnerships between dissemination and implementation scientists and practice-based research networks can support adaptation and implementation to ensure such interventions fit the context. This article describes adaptations to and implementation of the Targeted Training in Illness Management (TTIM) intervention to fit the primary care diabetes context...

BACKGROUND: There is a need to develop interventions to reduce the risk of dementia in the community by addressing lifestyle factors and chronic diseases over the adult life course. OBJECTIVE: This study aims to evaluate a multidomain dementia risk reduction intervention, Body Brain Life in General Practice (BBL-GP), targeting at-risk adults in primary care. METHODS: A pragmatic, parallel, three-arm randomized trial involving 125 adults aged 18 years or older (86/125, 68...