Using the consolidated framework for implementation research to evaluate clinical trials: An example from multisite nursing research

Costa, Linda L.; Bobay, Kathleen L.; Hughes, Ronda G.; Bahr, Sarah J.; Siclovan, Danielle M.; Nuccio, Susan; Weiss, Marianne

doi:10.1016/j.outlook.2020.07.005

Cited by 8 publications

(7 citation statements)

References 16 publications

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“…medical distrust, patient knowledge). Furthermore, in alignment with other research, 15,17 we believed many individual characteristics related to study staff and PIs (e.g. knowledge, beliefs about the study) would be most appropriately aggregated to descriptions of site-level barriers.…”

Section: Methodsmentioning

confidence: 85%

“…Thus, we chose to use CFIR to categorize clinical trial recruitment barriers for a pediatric clinical SCD trial. 14,15,17 The Engaging Parents of Children with Sickle Cell Anemia and their Providers in Shared-Decision-Making for Hydroxyurea (ENGAGE-HU; NCT03442114) clinical trial is a multi-site study that compares two dissemination methods to facilitate shared decision-making with caregivers of young children with SCD about initiating a disease-modifying medication, hydroxyurea. [18][19][20][21] At the time of this article, the ENGAGE-HU trial had stopped recruiting participants having reached the study enrollment goal.…”

Section: Introductionmentioning

confidence: 99%

“…relative implementation priority, study site effectiveness) associated with low-/high implementation fidelity across settings. 15 Moreover, Varsi et al 16 found that applying CFIR constructs demonstrated a positive impact on enrollment. Thus, we chose to use CFIR to categorize clinical trial recruitment barriers for a pediatric clinical SCD trial.…”

Section: Introductionmentioning

confidence: 99%

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Using the consolidated framework for implementation research to identify recruitment barriers and targeted strategies for a shared decision-making randomized clinical trial in pediatric sickle cell disease

et al. 2023

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Background/Aims: Recruitment is often a barrier in clinical trials that include minoritized populations, such as individuals with sickle cell disease. In the United States, the majority of people with sickle cell disease identify as Black or African American. In sickle cell disease, 57% of the United States trials that ended early did so due to low enrollment. Thus, there is a need for interventions that improve trial enrollment in this population. After lower-than-expected recruitment during the first 6 months of the Engaging Parents of Children with Sickle Cell Anemia and their Providers in Shared-Decision-Making for Hydroxyurea trial, a multi-site study for young children with sickle cell disease, we collected data to understand barriers and used the Consolidated Framework for Implementation Research to categorize them and guide the development of targeted strategies. Methods: Study staff used screening logs and coordinator and principal investigator calls to identify recruitment barriers that were then mapped onto Consolidated Framework for Implementation Research constructs. Targeted strategies were implemented during Months 7–13. Recruitment and enrollment data were summarized before (Months 1–6) and during the implementation period (Months 7–13). Results: During the first 13 months, 60 caregivers ( M = 30.65 years; SD = 6.35) enrolled in the trial. Most caregivers primarily self-identified as female ( n = 54, 95%) and African American or Black ( n = 51, 90%). Recruitment barriers mapped onto three Consolidated Framework for Implementation Research constructs: (1) Process barriers (i.e. no identified “site champion” and poor recruitment planning at several sites); (2) Inner setting barriers (i.e. limited communication, low relative study priority at several sites); and (3) Outer setting barriers (i.e. poor patient attendance at clinic appointments). Targeted strategies to improve recruitment included (1) principal investigator site visits and retraining on recruitment procedures to address process barriers; (2) increased frequency of communication through all coordinator, site principal investigator, and individual site calls to address inner setting barriers; and (3) development and implementation of no-show procedures for clinic appointments to address outer setting barriers. After implementation of the recruitment strategies, the number of caregivers identified for pre-screening increased from 54 to 164, and enrollment more than tripled from 14 to 46 caregiver participants. Conclusion: Consolidated Framework for Implementation Research constructs guided the development of targeted strategies that increased enrollment. This reflective process reframes recruitment challenges as the responsibility of the research team rather than characterizing minoritized populations as “difficult” or “hard to reach.” Future trials including patients with sickle cell disease and minoritized populations may benefit from this approach.

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Section: Methodsmentioning

confidence: 85%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Using the consolidated framework for implementation research to identify recruitment barriers and targeted strategies for a shared decision-making randomized clinical trial in pediatric sickle cell disease

et al. 2023

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“…Adapting implementation frameworks to the clinical trial context can also advance science via new application of a shared vocabulary and improvement models to generate new knowledge. While some frameworks have been applied to aspects of clinical trials, a global consideration of trials as complex interventions through an implementation science lens could significantly advance both the science and practice of clinical trials and the field of implementation science [ 12 , 13 ].…”

Section: Introductionmentioning

confidence: 99%

Applying implementation frameworks to the clinical trial context

Stensland

Sales

Damschroder

et al. 2022

Implement Sci Commun

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Background Clinical trials advance science, benefit society, and provide optimal care to individuals with some conditions, such as cancer. However, clinical trials often fail to reach their endpoints, and low participant enrollment remains a critical problem with trial conduct. In these ways, clinical trials can be considered beneficial evidence-based practices suffering from poor implementation. Prior approaches to improving trials have had difficulties with reproducibility and limited impact, perhaps due to the lack of an underlying trial improvement framework. For these reasons, we propose adapting implementation science frameworks to the clinical trial context to improve the implementation of clinical trials. Main text We adapted an outcomes framework (Proctor’s Implementation Outcomes Framework) and a determinants framework (the Consolidated Framework for Implementation Research) to the trial context. We linked these frameworks to ERIC-based improvement strategies and present an inferential process model for identifying and selecting trial improvement strategies based on the Implementation Research Logic Model. We describe example applications of the framework components to the trial context and present a worked example of our model applied to a trial with poor enrollment. We then consider the implications of this approach on improving existing trials, the design of future trials, and assessing trial improvement interventions. Additionally, we consider the use of implementation science in the clinical trial context, and how clinical trials can be “test cases” for implementation research. Conclusions Clinical trials can be considered beneficial evidence-based interventions suffering from poor implementation. Adapting implementation science approaches to the clinical trial context can provide frameworks for contextual assessment, outcome measurement, targeted interventions, and a shared vocabulary for clinical trial improvement. Additionally, exploring implementation frameworks in the trial context can advance the science of implementation through both “test cases” and providing fertile ground for implementation intervention design and testing.

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“…Support from all levels of nursing management from Chief Nurse Executive to unit management teams is critical for implementation of new practice protocols. The multi‐level engagement of executive and unit‐level management was critical to the successful implementation of the discharge readiness assessment protocols over the many months of the READI study (Costa et al., 2020). Recognition from nursing leadership for the clinical nurse efforts towards successful implementation was a key factor in achieving high fidelity to the intervention (over 70% of patients received the new discharge assessment protocols (Weiss et al., 2019).…”

Section: Implications For Nursing Managementmentioning

confidence: 99%

Clinical nurses' perspectives on discharge practice changes from participating in a translational research study

et al. 2020

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Aim To describe clinical nurses' experiences with practice change associated with participation in a multi‐site nursing translational research study implementing new protocols for hospital discharge readiness assessment. Background Nurses' participation in translational research studies provides an opportunity to evaluate how implementation of new nursing interventions affects care processes within a local context. These insights can provide information that leads to successful adoption and sustainability of the intervention. Methods Semi‐structured focus groups from 30 of 33 participating study hospitals lead by team nurse researchers. Results Nurses reported improved and earlier awareness of patients' discharge needs, changes in discharge practices, greater patient/family involvement in discharge, synergy and enhanced discharge processes, and implementation challenges. Participating nurses related the benefits of participation in nursing research. Conclusion Participation in a unit‐level translational research project was a successful strategy for engaging nurses in practice change to improve hospital discharge. Implications for Nursing Management Leading unit‐based implementation of a structured discharge readiness assessment including nurse assessment and patient self‐assessment encourages earlier awareness of patients' discharge needs, improved patient assessment and greater patient/family involvement in discharge preparation. Integrating discharge readiness assessments into existing discharge care promotes communication between health team members that facilitates a timely, coordinated discharge.

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Using the consolidated framework for implementation research to evaluate clinical trials: An example from multisite nursing research

Cited by 8 publications

References 16 publications

Using the consolidated framework for implementation research to identify recruitment barriers and targeted strategies for a shared decision-making randomized clinical trial in pediatric sickle cell disease

Using the consolidated framework for implementation research to identify recruitment barriers and targeted strategies for a shared decision-making randomized clinical trial in pediatric sickle cell disease

Applying implementation frameworks to the clinical trial context

Clinical nurses' perspectives on discharge practice changes from participating in a translational research study

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