Cluster-randomized trials (CRTs) are increasingly common in pragmatic trials of interventions for older adults, where staff of existing clinics or service agencies deliver interventions. The Adult Day Service (ADS) Plus intervention is delivered by trained staff at adult day service facilities to assist older adults with cognitive impairments and their family caregivers. Because sizable imbalances on important site characteristics might emerge from a simple randomization, we implemented a 3-stage constrained randomization approach to limit imbalance between intervention and usual care control conditions on 5 site characteristics: capacity; % of minority clients; % of clients with dementia; urban, rural or suburban location; and private or public ownership. In stage 1, the Balance Match Weighted (BMW) re-randomization procedure was used to assign 30 sites to ADS Plus or control arms based on the best randomization out of 20 total randomizations for minimizing site imbalance. In stage 2, propensity scores from the BMW logistic regression analysis for reserve sites were used to determine substitutions for randomized sites that opted out of the CRT prior to implementation. In stage 3, a minimization approach was used to add 20 more sites to the trial. A standardized metric based on the half-normal distribution of the absolute value of mean differences was used to assess site imbalance. After stage 3, the remaining imbalance for the 49 enrolled sites was reduced by 75% from what would have been expected from a simple randomization. Optimized randomization procedures with similar imbalance metrics should be used more routinely in pragmatic CRTs.
Bibliographical noteFunding Information:
This work was supported by a grant R01 AG049692 from the National Institute on Aging (NIA) . This work was also supported in part by the NIA of the National Institutes of Health under Award Number U54AG063546 , which funds the NIA Imbedded Pragmatic Alzheimer’s Disease and AD-Related Dementias Clinical Trials Collaboratory (NIA IMPACT Collaboratory) . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Drs. Gitlin and Gaugler co-lead the Dissemination and Implementation (D&I) Core of the NIA Impact Collaboratory.
- Cluster-randomized trials
- Covariate-constrained randomization
- Family caregiving
- Half-normal distribution
- Pragmatic trials
PubMed: MeSH publication types
- Journal Article