Trial reportImplementation science : IS2019
A method to reduce imbalance for site-level randomized stepped wedge implementation trial designs.
Trial report in Implementation science : IS, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02543840 (Hybrid Controlled Trial to Implement Collaborative Care in General Mental Health), which is not on this map. Cited by 14 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Hybrid Controlled Trial to Implement Collaborative Care in General Mental Health
Who cites it
14 citing papers in PubMed.
- Integrating Intimate Partner Violence Screening Programs in Primary Care: Results from a Hybrid-II Implementation-Effectiveness RCT.American journal of preventive medicine · 2023Trial
- Implementing the collaborative chronic care model for mental health: a nonrandomized clinical trial.Implementation science communications · 2026Article
- Article
- A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials.Clinical trials (London, England) · 2025Review
- Article
- Comparing analytical strategies for balancing site-level characteristics in stepped-wedge cluster randomized trials: a simulation study.BMC medical research methodology · 2023Article
- A scoping review described diversity in methods of randomization and reporting of baseline balance in stepped-wedge cluster randomized trials.Journal of clinical epidemiology · 2023Article
- Article
- Collaborative chronic care model implementation within outpatient behavioral health care teams: qualitative results from a multisite trial using implementation facilitation.Implementation science communications · 2021Article
- Mixed-effects models for the design and analysis of stepped wedge cluster randomized trials: An overview.Statistical methods in medical research · 2021Review
- Article
- An Economic Analysis of the Implementation of Team-based Collaborative Care in Outpatient General Mental Health Clinics.Medical care · 2020Article
- Assessing the Veterans Health Administration's response to intimate partner violence among women: protocol for a randomized hybrid type 2 implementation-effectiveness trial.Implementation science : IS · 2020Article
- Experimental and quasi-experimental designs in implementation research.Psychiatry research · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
backgroundControlled implementation trials often randomize the intervention at the site level, enrolling relatively few sites (e.g., 6-20) compared to trials that randomize by subject. Trials with few sites carry a substantial risk of an imbalance between intervened (cases) and non-intervened (control) sites in important site characteristics, thereby threatening the internal validity of the primary comparison. A stepped wedge design (SWD) staggers the intervention at sites over a sequence of times or time waves until all sites eventually receive the intervention. We propose a new randomization method, sequential balance, to control time trend in site allocation by minimizing sequential imbalance across multiple characteristics. We illustrate the new method by applying it to a SWD implementation trial.
methodsThe trial investigated the impact of blended internal-external facilitation on the establishment of evidence-based teams in general mental health clinics in nine US Department of Veterans Affairs medical centers. Prior to randomization to start time, an expert panel of implementation researchers and health system program leaders identified by consensus a series of eight facility-level characteristics judged relevant to the success of implementation. We characterized each of the nine sites according to these consensus features. Using a weighted sum of these characteristics, we calculated imbalance scores for each of 1680 possible site assignments to identify the most sequentially balanced assignment schemes.
resultsFrom 1680 possible site assignments, we identified 34 assignments with minimal imbalance scores, and then randomly selected one assignment by which to randomize start time. Initially, the mean imbalance score was 3.10, but restricted to the 34 assignments, it declined to 0.99.
conclusionsSequential balancing of site characteristics across groups of sites in the time waves of a SWD strengthens the internal validity of study conclusions by minimizing potential confounding.
trial registrationRegistered at ClinicalTrials.gov as clinical trials # NCT02543840 ; entered 9/4/2015.
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