Designing provider-focused implementation trials with purpose and intent: introducing the PRECIS-2-PS tool

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Abstract

Background

First articulated by Schwartz and Lellouch (1967), randomized controlled trials (RCTs) can be conceptualized along a continuum from more explanatory to more pragmatic. The purpose and intent of the former is to test interventions under ideal contexts, and the purpose and intent of the latter is to test interventions in real-world contexts. The PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) is a validated tool that helps researchers make decisions about the elements of the trial to match the overall purpose and intent of the trial along the continuum. The PRECIS-2 tool has guided the design of hundreds of RCTs. However, a few aspects of the tool would benefit from greater clarity, including its application to provider-focused implementation trials rather than patient-focused intervention trials.

Main text

We describe the newly developed PRECIS-2-Provider Strategies (PRECIS-2-PS) tool, an extension of the PRECIS-2 tool, which has been adapted for trials testing provider-focused strategies. We elaborate on nine domains that can make a provider-focused trial more explanatory or more pragmatic, including eligibility, recruitment, setting, implementation resources, flexibility of provider strategies, flexibility of intervention, data collection, primary outcome, and primary analysis. We detail the complementary roles that researchers and stakeholders play in the trial design phase, with implications for generalizability of trial results to the contexts in which they are intended to be applied.

Conclusions

The PRECIS-2-PS tool is designed to help research and practice teams plan for provider-focused trials that reflect the overall intent and purpose of the trial. The tool has potential to help advance the science of provider-focused strategies across a range of trials, with the ultimate goal of facilitating the adoption, integration, and sustainability of provider-focused strategies outside the context of trials.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13012-020-01075-y.

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Most cited references 27

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The PRECIS-2 tool: designing trials that are fit for purpose.

Kirsty Loudon, Shaun Treweek, Frank Sullivan … (2015)

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Intention-to-treat concept: A review

Sandeep Gupta (2011)

Randomized controlled trials often suffer from two major complications, i.e., noncompliance and missing outcomes. One potential solution to this problem is a statistical concept called intention-to-treat (ITT) analysis. ITT analysis includes every subject who is randomized according to randomized treatment assignment. It ignores noncompliance, protocol deviations, withdrawal, and anything that happens after randomization. ITT analysis maintains prognostic balance generated from the original random treatment allocation. In ITT analysis, estimate of treatment effect is generally conservative. A better application of the ITT approach is possible if complete outcome data are available for all randomized subjects. Per-protocol population is defined as a subset of the ITT population who completed the study without any major protocol violations.

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Choosing implementation strategies to address contextual barriers: diversity in recommendations and future directions

Thomas Waltz, Byron J. Powell, Maria E Fernández … (2019)

Background A fundamental challenge of implementation is identifying contextual determinants (i.e., barriers and facilitators) and determining which implementation strategies will address them. Numerous conceptual frameworks (e.g., the Consolidated Framework for Implementation Research; CFIR) have been developed to guide the identification of contextual determinants, and compilations of implementation strategies (e.g., the Expert Recommendations for Implementing Change compilation; ERIC) have been developed which can support selection and reporting of implementation strategies. The aim of this study was to identify which ERIC implementation strategies would best address specific CFIR-based contextual barriers. Methods Implementation researchers and practitioners were recruited to participate in an online series of tasks involving matching specific ERIC implementation strategies to specific implementation barriers. Participants were presented with brief descriptions of barriers based on CFIR construct definitions. They were asked to rank up to seven implementation strategies that would best address each barrier. Barriers were presented in a random order, and participants had the option to respond to the barrier or skip to another barrier. Participants were also asked about considerations that most influenced their choices. Results Four hundred thirty-five invitations were emailed and 169 (39%) individuals participated. Respondents had considerable heterogeneity in opinions regarding which ERIC strategies best addressed each CFIR barrier. Across the 39 CFIR barriers, an average of 47 different ERIC strategies (SD = 4.8, range 35 to 55) was endorsed at least once for each, as being one of seven strategies that would best address the barrier. A tool was developed that allows users to specify high-priority CFIR-based barriers and receive a prioritized list of strategies based on endorsements provided by participants. Conclusions The wide heterogeneity of endorsements obtained in this study’s task suggests that there are relatively few consistent relationships between CFIR-based barriers and ERIC implementation strategies. Despite this heterogeneity, a tool aggregating endorsements across multiple barriers can support taking a structured approach to consider a broad range of strategies given those barriers. This study’s results point to the need for a more detailed evaluation of the underlying determinants of barriers and how these determinants are addressed by strategies as part of the implementation planning process. Electronic supplementary material The online version of this article (10.1186/s13012-019-0892-4) contains supplementary material, which is available to authorized users.

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Author and article information

Contributors

Wynne E. Norton: wynne.norton@nih.gov

Journal

Journal ID (nlm-ta): Implement Sci

Journal ID (iso-abbrev): Implement Sci

Title: Implementation Science : IS

Publisher: BioMed Central (London )

ISSN (Electronic): 1748-5908

Publication date (Electronic): 7 January 2021

Publication date PMC-release: 7 January 2021

Publication date Collection: 2021

Volume: 16

Electronic Location Identifier: 7

Affiliations

[1 ]GRID grid.48336.3a, ISNI 0000 0004 1936 8075, Division of Cancer Control and Population Sciences, , National Cancer Institute, ; 9609 Medical Center Drive, #3E424, Bethesda, MD 20850 USA

[2 ]Independent Contractor, Edinburgh, Scotland

[3 ]GRID grid.39381.30, ISNI 0000 0004 1936 8884, Centre for Studies in Family Medicine, Department of Family Medicine, , Western University, ; London, Ontario Canada

Article

Publisher ID: 1075

DOI: 10.1186/s13012-020-01075-y

PMC ID: 7791810

PubMed ID: 33413489

SO-VID: 43832014-d412-4e49-8b70-20c99829603d

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 1 September 2020

Date accepted : 10 December 2020

Funding

Funded by: ICF International Inc

Award ID: 18BBCA0022

Award ID: 18BBCA0025

Award Recipient : Kirsty Loudon Merrick Zwarenstein

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: pragmatic trials,explanatory trials,implementation science,randomized controlled trials,precis,implementation strategies,multi-level trials,healthcare delivery research

Data availability:

ScienceOpen disciplines: Medicine

Keywords: pragmatic trials, explanatory trials, implementation science, randomized controlled trials, precis, implementation strategies, multi-level trials, healthcare delivery research

Designing provider-focused implementation trials with purpose and intent: introducing the PRECIS-2-PS tool

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Abstract

Background

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Supplementary Information

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Karger: Digital Health

Most cited references 27

The PRECIS-2 tool: designing trials that are fit for purpose.

Intention-to-treat concept: A review

Choosing implementation strategies to address contextual barriers: diversity in recommendations and future directions

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