At-risk and vulNerable individuals to infection with Coronavirus Disease 2019 (COVID-19) and ProActive inTervention with intEgrated health and social care (ANTICIPATE): A randomized controlled trial
Andrew D. Pinto, Parsa Balalaie, Rosemarie N. Lall, Matthew Orava, Deepti Pasricha, Ann N. Burchell, Noah Crampton, Bruno R. da Costa, Christine Fahim, Michelle Greiver, Peter Jüni, Christopher Meaney, Rahim Moineddin, Donatus R. Mutasingwa, Braden O’Neill, Navindra Persaud, Malika Sharma, Kevin Thorpe, Ross Upshur, Karen Weyman
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BSTRACT
Background:
Proactive outreach and system navigation may help primary care teams address medical and social needs among vulnerable patients, but effects on emotional distress are uncertain. We evaluated whether navigator-led outreach reduced anxiety and depression symptoms over three months versus information-only support.
Methods:
We conducted a parallel-group randomized controlled trial across three primary care organizations in Ontario, Canada (November 2021-August 2023). Adults ≥60 years with at least one vulnerability (chronic condition, serious mental illness, or social risk) were randomized 1:1 to (i) a primary care-embedded system navigator providing tailored support or (ii) an information-only control (curated resources). Primary outcomes were Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression T-scores at three months, summarized using follow-up means with 95% confidence intervals (CIs) and analyzed using linear regression adjusting for baseline values and site. Secondary outcomes included self-efficacy, loneliness, instrumental support, and physical function.
Results:
Of the target 128 participants, 78 were randomized; 61 completed the three-month follow-up (30 intervention; 31 control). Baseline characteristics were similar. At three months, there were no clear between-group differences in emotional distress. Adjusted mean differences were +1.31 T-points (95% CI −2.08 to 4.71) for anxiety and −1.69 T-points (95% CI −5.02 to 1.64) for depression. Secondary outcomes showed small between-group differences with CIs spanning the null. Self-reported coronavirus 2019 (COVID-19) test results did not differ by arm (
Conclusions:
In this underpowered trial, low-intensity navigator-led outreach in primary care did not improve anxiety or depression at three months compared with information-only support. Larger studies should assess intervention intensity, longer follow-up, or alternative outcomes.