Pragmatic Trial Protocol Research Articles

Stakeholder-informed pragmatic trial protocol of the TabCAT-BHA for the detection of cognitive impairment in primary care

BackgroundCognitive impairment and dementia are frequently under-recognized. Health system strategies anchored in primary care are essential to address gaps in timely, comprehensive diagnosis. The goal of this paper is to describe the adaptation of a tablet-based brain health assessment (TabCAT-BHA) intervention and the study protocol to test its effectiveness in improving the detection of cognitive impairment, including dementia.MethodsThis mixed-methods, pragmatic, cluster randomized, hybrid effectiveness-implementation trial is being conducted in two 18-month waves with 26 Kaiser Permanente Southern California primary care clinics, with 13 serving as intervention clinics and 13 as usual care clinics. Patients 65 years and older with memory concerns (n ~ 180,000) receiving care at the 26 clinics will be included in the analyses. Primary care clinics are provided the following practice supports as part of the TabCAT-BHA intervention: brief education and training on neurocognitive disorders and study workflows; digital tools to assess cognitive function and support clinician decision making and documentation; and registered nurse support during the work-up and post-diagnosis periods for primary care providers, patients, and families. The intervention was adapted based on engagement with multiple levels of clinical and operational leaders in the healthcare system. Effectiveness outcomes include rates of cognitive impairment diagnosis in primary care and rates of completed standardized cognitive assessments and specialist referrals with incident diagnoses. Implementation outcomes include acceptability-appropriateness-feasibility, adoption, and fidelity.ResultsWe identified seven themes organized by system-, provider-, and patient-level domains that were used to adapt the TabCAT-BHA intervention. Accordingly, changes were made to the provider education, diagnostic work-up, and post-diagnostic support. Results will be reported in fall of 2027.ConclusionsOur engagement with multiple primary and specialty care clinical and operational leaders to adapt the TabCAT-BHA intervention to these primary care clinics has informed the protocol to evaluate the intervention’s effectiveness for improving the detection of cognitive impairment, including dementia, in an integrated healthcare system.Trial RegistationClinicaltrials.gov: NCT06090578 (registered 10/24/23).

Integration of serial self-testing for COVID-19 as part of contact tracing in the Brazilian public health system: A pragmatic trial protocol.

The coronavirus disease (COVID-19) pandemic has led to an unprecedented public health crisis. Insufficient testing continues to limit the effectiveness of the global response to the COVID-19 pandemic. Molecular testing methods such as reverse transcriptase polymerase chain reaction (RT-PCR) continue to be highly centralized and are a sub-optimal option for population surveillance. Rapid antigen tests (Ag-RDTs) offer multiple benefits including low costs, high flexibility to conduct tests in a wide variety of settings, and faster return of results. Self-test Ag-RDTs (STs) have gained approval in several markets and offer the possibility to expand testing, reaching at-risk populations. While STs have the potential to assist the COVID-19 response, test result integrity, reporting, and appropriate linkage to care continue to hinder the widespread implementation of self-testing programs. This protocol presents a mixed-methods pragmatic trial (ISRCTN91602092) to better understand the feasibility of self-testing as part of a contact tracing strategy within the Brazilian public health system. Approximately 604 close contacts of 150 index cases testing positive for COVID-19 will be enrolled. Index cases will be randomized for their close contacts to participate in either serial (daily) self-testing over a 10-day follow-up period or a more traditional approach to contact tracing with a professional Ag-RDT at one time point post-exposure. Usability workshops and focus group discussions will also be conducted. This study protocol presents a comprehensive plan to assess the effectiveness, operational feasibility, and stakeholder preferences of a serial self-testing strategy for contact tracing within the Brazilian public health system. Our results will contribute to better understanding of the feasibility of a self-testing strategy within the public sector. Potential risks and limitations are discussed. Our findings will have important implications as governments continue working to mitigate the impact of COVID-19, particularly in the context of where to direct limited resources for testing and healthcare infrastructure. Registration: This trial is registered at ISCTRN (ISRCTN91602092).

The Impact of Financial Incentives on Service Engagement Among Adults Experiencing Homelessness and Mental Illness: A Pragmatic Trial Protocol

Background: People experiencing homelessness and mental illness have poorer service engagement and health-related outcomes compared to the general population. Financial incentives have been associated with increased service engagement, but evidence of effectiveness is limited. This protocol evaluates the acceptability and impact of financial incentives on service engagement among adults experiencing homelessness and mental illness in Toronto, Canada.Methods: This study protocol uses a pragmatic field trial design and mixed methods (ClinicalTrials.gov Identifier: NCT03770221). Study participants were recruited from a brief multidisciplinary case management program for adults experiencing homelessness and mental illness following hospital discharge, and were randomly assigned to usual care or a financial incentives arm offering $20 for each week they attended meetings with a program provider. The primary outcome of effectiveness is service engagement, measured by the count of participant-provider health-care contacts over the 6-month period post-randomization. Secondary health, health service use, quality of life, and housing outcomes were measured at baseline and at 6-month follow-up. Quantitative data will be analyzed using descriptive statistics and inferential modeling including Poisson regression and generalized estimating equations. A subset of study participants and other key informants participated in interviews, and program staff in focus groups, to explore experiences with and perspectives regarding financial incentives. Qualitative data will be rigorously coded and thematically analyzed.Conclusions: Findings from this study will contribute high quality evidence to an underdeveloped literature base on the effectiveness and acceptability of financial incentives to improve service engagement and health-related outcomes among adults experiencing homelessness and mental illness.

PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients

IntroductionPatients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic...

Multicomponent physical activity program to prevent body changes and metabolic disturbances associated with antiretroviral therapy and improve quality of life of people living with HIV: a pragmatic trial

OBJECTIVES:Comprehensive care for people living with human immunodeficiency virus (HIV) (PLH) includes the promotion of healthier habits, including physical activity (PA). This study aimed to describe a multicomponent pragmatic trial protocol to assess the effect of PA in preventing body changes and metabolic disturbances, improving the quality of life of PLH starting antiretroviral therapy (ART) and present cohort characteristics.METHODS:PLH undergoing ART for ≤4 months were recruited for a randomized trial. The intervention comprised three cardiorespiratory and/or strength training sessions per week at the clinic or in public spaces for 6 months under on-site or remote supervision, and educational sessions. Participants’ PA levels, cardiorespiratory fitness, anthropometric measures, strength, flexibility, quality of life, and laboratory monitoring (blood glucose and lipids, CD4 counts) at baseline and post-intervention will be compared. The pragmatic design aims to enable the assessment of intervention effectiveness in real-life conditions.RESULTS:At baseline, our cohort of 38 recently diagnosed patients (mean time since HIV diagnosis and duration of ART were 3 and 2.58 months, respectively) were predominantly male, young, with high schooling and good immune status (median CD4 count=498 cells/mm3). Twenty-two (57.9%) patients reported a PA below the World Health Organization recommendations. We found baseline normal anthropometric measures and metabolic parameters: below-average trunk flexion and elbow extension strength, poor handgrip strength and flexibility, and high quality of life scores in all except the physical domain.CONCLUSIONS:Understanding how effective PA is in preventing body changes and metabolic disturbances, and in improving the quality of PLH starting ART may help establish guidelines to better incorporate PA in HIV care.

The (cost-)effectiveness and cost-utility of a novel integrative care initiative for patients with chronic musculoskeletal pain: the pragmatic trial protocol of Network Pain Rehabilitation Limburg

BackgroundRehabilitation care for patients with chronic musculoskeletal pain (CMP) is not optimally organized. The Network Pain Rehabilitation Limburg 2.0 (NPRL2.0) provides integrated care with a biopsychosocial approach and strives to improve the Quadruple Aim outcomes: pain-related disability of patients with CMP; experiences of care of patients with CMP; meaning in the work of healthcare professionals; and healthcare costs. Firstly, in this study, the effectiveness (with regard to the functioning and participation of patients) of primary care for patients with CMP will be assessed, comparing care organized following the NPRL2.0 procedure with usual care. Secondly, the cost-effectiveness and cost-utility with regard to health-related quality of life and healthcare costs will be assessed. And thirdly, the effect of duration of participation in a local network in primary care will be studied.MethodsIn this pragmatic study, it is expected that two local networks with 105 patients will participate in the prospective cohort study and six local networks with 184 patients in the stepped-wedge based design. Healthcare professionals in the local networks will recruit patients. Inclusion criteria: age ≥ 18 years; having CMP; willing to improve functioning despite pain; and adequate Dutch literacy. Exclusion criteria: pregnancy; and having a treatable medical or psychiatric disease. Patients will complete questionnaires at baseline (T1), 3 months (T2), 6 months (T3), and 9 months (T4). Questionnaires at T1 and T4 will include the Pain Disability Index and Short Form Health Survey. Questionnaires at T1, T2, T3, and T4 will include the EQ-5D-5L, and iMTA Medical Consumption and Productivity Cost Questionnaires. Outcomes will be compared using linear mixed-model analysis and costs will be compared using bootstrapping methods.DiscussionNPRL2.0 is a multidimensional, complex intervention, executed in daily practice, and therefore needing a pragmatic study design. The current study will assess NPRL2.0 with respect to the Quadruple Aim outcomes: patient health and costs. This will provide more information on the (cost-) effectiveness of the organization of care in a network structure regarding patients with CMP. The other two Quadruple Aim outcomes will be examined alongside this study.Trial registration Netherlands Trial Register: NL7643. https://www.trialregister.nl/trial/7643.

A pharmacy liaison-patient navigation intervention to reduce inpatient and emergency department utilization among primary care patients in a Medicaid accountable care organization: A pragmatic trial protocol.

ObjectiveTo determine whether employing the services of a pharmacy liaison to promote medication adherence (usual care), relative to a pharmacy liaison with training in motivational interviewing and as a patient navigator who systematically screens for health-related social needs and provides targeted navigation services to connect patients with appropriate community resources in partnership with a community-based organization (enhanced usual care), will reduce inpatient hospital admissions and emergency department visits among patients who are members of a Medicaid ACO and receive primary care at a large urban safety-net hospital. BackgroundPrior studies have demonstrated only modest effects in reducing utilization among safety-net patient populations. Interventions that address health-related social needs have the potential to reduce utilization in these populations. Design/MethodsAssignment to treatment condition is by medical record number (odd vs. even) and is unblinded (NCT03919084). Adults age 18–64 within the 3rd to 10th percentile for health care utilization and cost among Medicaid Accountable Care Organization membership attending a primary care visit in the general internal medicine practice at Boston Medical Center enrolled. DiscussionOur study will advance the field in two ways: 1) by providing evidence about the effectiveness of pharmacy liaisons who also function as patient navigators; and 2) by de-implementing patient navigators. Patients in the enhanced usual care arm will no longer receive the services of a clinic-based patient navigator. In addition, our study includes a novel collaboration with a community-based organization, and focuses on an intermediate-cost patient population, rather than the most costly patient population.

How good are GPs at adhering to a pragmatic trial protocol in primary care? Results from the ADDITION-Cambridge cluster-randomised pragmatic trial

ObjectiveTo assess the fidelity of general practitioners’ (GPs) adherence to a long-term pragmatic trial protocol.DesignRetrospective analyses of electronic primary care records of participants in the pragmatic cluster-randomised ADDITION (Anglo-Danish-Dutch Study...