Real-time evaluation and adaptation to facilitate rapid recruitment in a large, prospective cohort study.

BACKGROUND: Recruiting large cohorts efficiently can speed the translation of findings into care across a range of scientific disciplines and medical specialties. Recruitment can be hampered by factors such as financial barriers, logistical concerns, and lack of resources for patients and clinicians. These and other challenges can lead to underrepresentation in groups such as rural residents and racial and ethnic minorities. Here we discuss the implementation of various recruitment strategies for enrolling participants into a large, prospective cohort study, assessing the need for adaptations and making them in real-time, while maintaining high adherence to the protocol and high participant satisfaction. METHODS: While conducting a large, prospective trial of a multi-cancer early detection blood test at Geisinger, an integrated health system in central Pennsylvania, we monitored recruitment progress, adherence to the protocol, and participants' satisfaction. Tracking mechanisms such as paper records, electronic health records, research databases, dashboards, and electronic files were utilized to measure each outcome. We then reviewed study procedures and timelines to list the implementation strategies that were used to address barriers to recruitment, protocol adherence and participant satisfaction. RESULTS: Adaptations to methods that contributed to achieving the enrollment goal included offering multiple recruitment options, adopting group consenting, improving visit convenience, increasing the use of electronic capture and the tracking of data and source documents, staffing optimization via leveraging resources external to the study team when appropriate, and integrating the disclosure of study results into routine clinical care without adding unfunded work for clinicians. We maintained high protocol adherence and positive participant experience as exhibited by a very low rate of protocol deviations and participant complaints. CONCLUSION: Recruiting rapidly for large studies - and thereby facilitating clinical translation - requires a nimble, creative approach that marshals available resources and changes course according to data. Planning a rigorous assessment of a study's implementation outcomes prior to study recruitment can further ground study adaptations and facilitate translation into practice. This can be accomplished by proactively and continuously assessing and revising implementation strategies.

Factors influencing implementation of a care coordination intervention for cancer survivors with multiple comorbidities in a safety-net system: an application of the Implementation Research Logic Model.

BACKGROUND: Under- and uninsured cancer survivors have significant medical, social, and economic complexity. For these survivors, effective care coordination between oncology and primary care teams is critical for high-quality, comprehensive care. While evidence-based interventions exist to improve coordination between healthcare teams, testing implementation of these interventions for cancer survivors seen in real-world safety-net settings has been limited. This study aimed to (1) identify factors influencing implementation of a multicomponent care coordination intervention (nurse coordinator plus patient registry) focused on cancer survivors with multiple comorbidities in an integrated safety-net system and (2) identify mechanisms through which the factors impacted implementation outcomes. METHODS: We conducted semi-structured interviews (patients, providers, and system leaders), structured observations of primary care and oncology operations, and document analysis during intervention implementation between 2016 and 2020. The practice change model (PCM) guided data collection to identify barriers and facilitators of implementation; the PCM, Consolidated Framework for Implementation Research, and Implementation Research Logic Model guided four immersion/crystallization data analysis and synthesis cycles to identify mechanisms and assess outcomes. Implementation outcomes included appropriateness, acceptability, adoption, and penetration. RESULTS: The intervention was appropriate and acceptable to primary care and oncology teams based on reported patient needs and resources and the strength of the evidence supporting intervention components. Active and sustained partnership with system leaders facilitated these outcomes. There was limited adoption and penetration early in implementation because the study was narrowly focused on just breast and colorectal cancer patients. This created barriers to real-world practice where patients with all cancer types receive care. Over time, flexibility intentionally designed into intervention implementation facilitated adoption and penetration. Regular feedback from system partners and rapid cycles of implementation and evaluation led to real-time adaptations increasing adoption and penetration. DISCUSSION: Evidence-based interventions to coordinate care for underserved cancer survivors across oncology and primary care teams can be implemented successfully when system leaders are actively engaged and with flexibility in implementation embedded intentionally to continuously facilitate adoption and penetration across the health system.

Acceptability, Appropriateness and Feasibility of a Nurse-Led Integrated Care Intervention for Patients with Severe Exacerbation of COPD from the Healthcare Professional's Perspective - A Mixed Method Study.

Purpose: To improve inpatient care and self-management in patients with severe acute exacerbations of COPD, we implemented a nurse-led behavioral intervention. This study aimed to assess implementation outcomes from the perspective of the healthcare professionals (HCP) who delivered it. Methods: Using an explanatory sequential mixed method approach, we conducted an online questionnaire and two small group interviews. We applied descriptive statistics for quantitative data, a framework analysis for qualitative data, and a mixed methods matrix to integrate the results. Results: A total of 19 of 27 invited participants answered the online questionnaire; 9 of 19 participated in the group interviews. The intervention's overall acceptability, appropriateness, and feasibility was rated high to very high (median 5/5; 4/5 and 4/5). Enablers to implementation included general recognition of the need for specialized care, sufficient knowledge of the intervention by HCP, and strong interprofessional collaboration. Main barriers included the lack of resident physician's resources and difficulties in adaptability. Conclusion: While the acceptance of the intervention was very high, the perceived appropriateness and feasibility were affected by its complexity. The availability of a knowledgeable interprofessional core team is a strategy that supports the implementation of complex interventions.

The SMILe integrated care model in allogeneic SteM cell TransplantatIon faciLitated by eHealth: a protocol for a hybrid effectiveness-implementation randomised controlled trial.

BACKGROUND: While effectiveness outcomes of eHealth-facilitated integrated care models (eICMs) in transplant and oncological populations are promising, implementing and sustaining them in real-world settings remain challenging. Allogeneic stem cell transplant (alloSCT) patients could benefit from an eICM to enhance health outcomes. To combat health deterioration, integrating chronic illness management, including continuous symptom and health behaviour monitoring, can shorten reaction times. We will test the 1st-year post-alloSCT effectiveness and evaluate bundled implementation strategies to support the implementation of a newly developed and adapted eICM in allogeneic stem cell transplantation facilitated by eHealth (SMILe-ICM). SMILe-ICM has been designed by combining implementation, behavioural, and computer science methods. Adaptions were guided by FRAME and FRAME-IS. It consists of four modules: 1) monitoring & follow-up; 2) infection prevention; 3) physical activity; and 4) medication adherence, delivered via eHealth and a care coordinator (an Advanced Practice Nurse). The implementation was supported by contextually adapted implementation strategies (e.g., creating new clinical teams, informing local opinion leaders). METHODS: Using a hybrid effectiveness-implementation randomised controlled trial, we will include a consecutive sample of 80 adult alloSCT patients who were transplanted and followed by University Hospital Basel (Switzerland). Inclusion criteria are basic German proficiency; elementary computer literacy; internet access; and written informed consent. Patients will be excluded if their condition prevents the use of technology, or if they are followed up only at external centres. Patient-level (1:1) stratified randomisation into a usual care group and a SMILe-ICM group will take place 10 days pre-transplantation. To gauge the SMILe-ICM's effectiveness primary outcome (re-hospitalisation rate), secondary outcomes (healthcare utilization costs; length of inpatient re-hospitalizations, medication adherence; treatment and self-management burden; HRQoL; Graft-versus-Host Disease rate; survival; overall survival rate) and implementation outcomes (acceptability, appropriateness, feasibility, fidelity), we will use multi-method, multi-informant assessment (via questionnaires, interviews, electronic health record data, cost capture methods). DISCUSSION: The SMILe-ICM has major innovative potential for reengineering alloSCT follow-up care, particularly regarding short- and medium-term outcomes. Our dual focus on implementation and effectiveness will both inform optimization of the SMILe-ICM and provide insights regarding implementation strategies and pathway, understudied in eHealth-facilitated ICMs in chronically ill populations. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT04789863 . Registered April 01, 2021.

Adapting a skills-based stroke prevention intervention for communities in Ghana: a qualitative study.

BACKGROUND: Stroke is a major cause of death in Ghana. Evidence-based interventions for stroke prevention have been successful in the US; however, in low- and middle-income countries (LMICs), such interventions are scarce. The "Discharge Education Strategies for Reduction of Vascular Events" (DESERVE) intervention led to a 10-mmHg reduction in systolic blood pressure (SBP) among Hispanic survivors of mild/moderate stroke and transient ischemic attack (TIA) at 1-year follow-up. Our objectives were to capture the perceptions of a diverse set of stakeholders in an urban community in Ghana regarding (1) challenges to optimal hypertension management and (2) facilitators and barriers to implementation of an evidence-based, skills-based educational tool for hypertension management in this context. METHODS: This exploratory study used purposive sampling to enroll diverse stakeholders in Accra (N = 38). To identify facilitators and barriers, we conducted three focus group discussions: one each with clinical nurses (n = 5), community health nurses (n = 20), and hypertensive adults (n = 10). To further examine structural barriers, we conducted three key informant interviews with medical leadership. All interviews were audio recorded and transcribed. Thematic analysis was carried out via deductive coding based on Proctor's implementation outcomes taxonomy, which conceptualizes constructs that shape implementation, such as acceptability, adoption, appropriateness, cost, and feasibility. RESULTS: Findings highlight facilitators, such as a perceived fit (appropriateness) of the core intervention components across stakeholders. The transferable components of DESERVE include: (1) a focus on risk knowledge, medication adherence, and patient-physician communication, (2) facilitation by lay workers, (3) use of patient testimonials, (4) use of a spirituality framework, and (5) application of a community-based approach. We report potential barriers that suggest adaptations to increase appropriateness and feasibility. These include addressing spiritual etiology of disease, allaying mistrust of biomedical intervention, and tailoring for gender norms. Acceptability may be a challenge among individuals with hypertension, who perceive relative advantage of alternative therapies like herbalism. Key informant interviews highlight structural barriers (high opportunity costs) among physicians, who perceive they have neither time nor capacity to educate patients. CONCLUSIONS: Findings further support the need for theory-driven, evidence-based interventions among hypertensive adults in urban, multiethnic Ghana. Findings will inform implementation strategies and future research.

Implementation Strategies to Enhance the Implementation of eHealth Programs for Patients With Chronic Illnesses: Realist Systematic Review.

BACKGROUND: There is growing evidence of the positive effects of electronic health (eHealth) interventions for patients with chronic illness, but implementation of such interventions into practice is challenging. Implementation strategies that potentially impact implementation outcomes and implementation success have been identified. Which strategies are actually used in the implementation of eHealth interventions for patients with chronic illness and which ones are the most effective is unclear. OBJECTIVE: This systematic realist review aimed to summarize evidence from empirical studies regarding (1) which implementation strategies are used when implementing eHealth interventions for patients with chronic illnesses living at home, (2) implementation outcomes, and (3) the relationship between implementation strategies, implementation outcomes, and degree of implementation success. METHODS: A systematic literature search was performed in the electronic databases MEDLINE, Embase, PsycINFO, Scopus, Allied and Complementary Medicine Database, Cumulative Index to Nursing and Allied Health Literature, and Cochrane Library. Studies were included if they described implementation strategies used to support the integration of eHealth interventions into practice. Implementation strategies were categorized according to 9 categories defined by the Expert Recommendations for Implementing Change project: (1) engage consumers, (2) use evaluative and iterative strategies, (3) change infrastructure, (4) adapt and tailor to the context, (5) develop stakeholder interrelationships, (6) use financial strategies, (7) support clinicians, (8) provide interactive assistance, and (9) train and educate stakeholders. Implementation outcomes were extracted according to the implementation outcome framework by Proctor and colleagues: (1) acceptability, (2) adoption, (3) appropriateness, (4) cost, (5) feasibility, (6) fidelity, (7) penetration, and (8) sustainability. Implementation success was extracted according to the study authors' own evaluation of implementation success in relation to the used implementation strategies. RESULTS: The implementation strategies management support and engagement, internal and external facilitation, training, and audit and feedback were directly related to implementation success in several studies. No clear relationship was found between the number of implementation strategies used and implementation success. CONCLUSIONS: This is the first review examining implementation strategies, implementation outcomes, and implementation success of studies reporting the implementation of eHealth programs for patients with chronic illnesses living at home. The review indicates that internal and external facilitation, audit and feedback, management support, and training of clinicians are of importance for eHealth implementation. The review also points to the lack of eHealth studies that report implementation strategies in a comprehensive way and highlights the need to design robust studies focusing on implementation strategies in the future. TRIAL REGISTRATION: PROSPERO CRD42018085539; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=85539.