Development of a Multicomponent Implementation Strategy to Reduce Upper Gastrointestinal Bleeding Risk in Patients Using Warfarin and Antiplatelet Therapy, and Protocol for a Pragmatic Multilevel Randomized Factorial Pilot Implementation Trial

BackgroundConcomitant use of anticoagulant and antiplatelet medications increases the risk of upper gastrointestinal (GI) bleeding. Two underused evidence-based practices (EBPs) can reduce the risk: de-prescribe unnecessary antiplatelet therapy or initiate a proton pump inhibitor. We describe 1) the development of a multicomponent intervention to increase use of these EBPs in patients treated with warfarin and followed by an anticoagulation monitoring service (AMS) and 2) the design of a pilot pragmatic implementation trial.MethodsA participatory planning group iteratively used Implementation Mapping and the Multiphase Optimization Strategy to develop implementation strategies and plan the trial. Informed by qualitative interviews with patients and clinicians, we drew on several implementation science theories, as well as self-determination theory, to design interventions. For patients, we developed an activation guide to help patients discuss the EBPs with their clinicians. For clinicians, we developed two electronic health record (EHR)-based interventions: (1) Clinician notification (CN) consists of a templated message that identifies a patient as high risk, summarizes the EBPs, and links to a guidance statement on appropriate use of antiplatelet therapy. (2) Clinician notification with nurse facilitation (CN+NF) consists of a similar notification message but includes additional measures by nursing staff to support appropriate and timely decision-making: The nurse performs a chart review to identify any history of vascular disease, embeds indication-specific guidance on antiplatelet therapy in the message, and offers to assist with medication order entry and patient education. We will conduct a pilot factorial cluster- and individual-level randomized controlled trial with a primary objective of evaluating feasibility. Twelve clinicians will be randomized to receive either CN or CN+NF for all their patients managed by the AMS while 50 patients will be individually randomized to receive either the activation guide or usual care. We will explore implementation outcomes using patient and clinician interviews along with EHR review.DiscussionThis pilot study will prepare us to conduct a larger optimization study to identify the most potent and resource conscious multicomponent implementation strategy to help AMSs increase use of best practices for upper GI bleeding risk reduction.Trial RegistrationClinicalTrials.gov, NCT05085405, Registered 19 October 2021 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT05085405

The Impact of COVID-19 and Associated Restrictions on Physical Activity Among Assisted Living Residents

COVID-19 and associated restrictions significantly impacted residents in assisted living (AL) communities. This was a descriptive study of 35 AL communities that were participating in an implementation trial of Function Focused Care for Assisted Living Residents with Dementia during the COVID-19 pandemic. Within twelve months of the COVID-19 pandemic, 18% of the AL communities had at least one resident who was positive for COVID-19. Almost half of the ALs allowed health care providers into the setting. All of the ALs facilitated family visits outside and by telephone and technology, but only 11% allowed visitors inside the community. Over 50% stopped using recreational supplies to encourage physical activity and 28% reported that residents experienced more behavioral and psychological symptoms of dementia. Restrictions designed to prevent the spread of COVID-19 may have negatively impacted resident behavior and the AL staff’s engagement of residents in physical and recreational activities during the pandemic.

The Essential Network (TEN): Protocol for an implementation trial of a digital-first mental health solution for Australian healthcare workers during COVID-19 (Preprint)

BACKGROUND The COVID-19 pandemic has placed healthcare workers (HCWs) under severe stress, compounded by barriers to seeking mental health support among HCWs. The Essential Network (TEN) is a blend of digital and person-to-person (blended care) mental health support services for HCWs, funded by the Australian Federal Department of Health as part of their national COVID-19 response strategy. New blended services need to demonstrate improvements in mental health symptoms and test acceptability in their target audience, as well as review implementation strategies to improve engagement. OBJECTIVE The primary objective of this implementation trial is to design and test an implementation strategy to improve uptake of TEN. The secondary objectives are examining the acceptability of TEN among HCWs, changes in mental health outcomes associated with use of TEN, as well as reductions in mental health stigma among HCWs following use of TEN. METHODS The implementation trial contains three components: a consultation study with up to 39 stakeholders or researchers with implementation experience to design an implementation strategy; a longitudinal observational study of at least 105 healthcare workers to examine the acceptability of TEN and the effectiveness of TEN at one and six months in improving mental health (as assessed by Distress Questionnaire (DQ-5), Patient Health Questionnaire (PHQ-9), Generalised Anxiety Disorder (GAD-7), Oldenburg Burnout Inventory (OBI-16), and Work and Social Adjustment Scale (WSAS)) and reducing mental health stigma (Endorsed and Anticipated Stigma Inventory (EASI)); and an implementation study where TEN service uptake analytics will be examined for three months before and after the introduction of the implementation strategy. RESULTS The implementation strategy, designed with input from the consultation and observational studies, is expected to lead to an increased number of unique visits to the TEN Website in the three months following the introduction of the implementation strategy. The observational study is expected to observe high service acceptability. Moderate improvements to general mental health (DQ-5, WSAS) and a reduction in workplace- and treatment-related mental health stigma (EASI) between the baseline and 1-month timepoints. CONCLUSIONS TEN is a first-of-kind blended mental health service available to Australian HCWs. The results of this project have the potential to inform the implementation and development of blended care mental health services, as well as how such services can be effectively implemented during crisis. CLINICALTRIAL N/A

Centralized colorectal cancer screening outreach and patient navigation for vulnerable populations in North Carolina: study protocol for the SCORE randomized controlled trial

Background Although colorectal cancer (CRC) screening is effective in reducing CRC mortality, screening rates in vulnerable populations served by community health centers (CHCs) remain below national targets. CHCs in North Carolina are challenged to reach CRC screening targets as they tend to be under-resourced, have limited capacity to implement and sustain population health interventions, and typically operate independently from one another and from regional colonoscopy providers. The Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE) project is designed to address barriers to CRC screening in partnership with CHCs by implementing a multilevel intervention that includes centralized support infrastructure for mailed fecal immunochemical test (FIT) outreach and patient navigation to follow-up colonoscopy. This paper describes protocols for the SCORE implementation trial. Methods We will conduct a type 2 hybrid effectiveness-implementation trial that will assess effectiveness at increasing CRC screening and follow-up rates while also assessing implementation outcomes. The planned trial sample will include 4000 CHC patients who are at average CRC risk and due for screening. Participants will be randomized 1:1 to receive either usual care or a multilevel intervention that includes mailed FIT outreach and patient navigation support to follow-up colonoscopy for those with abnormal FIT. The primary effectiveness outcome is completion of any CRC screening test at six months after randomization. We will also conduct a multilevel assessment of implementation outcomes and determinants. Discussion This hybrid effectiveness-implementation trial will evaluate the effectiveness and implementation of an intervention that provides centralized infrastructure for mailed FIT screening and patient navigation for CHCs that operate independently of other healthcare facilities. Findings from this research will enhance understanding of the effectiveness of a centralized approach and factors that determine successful implementation in vulnerable patient populations. Trial registration The trial was registered on May 28, 2020, at ClinicalTrials.gov (identifier NCT04406714).