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Evidence from real primary care visits.

Studied under IRB-approved protocols in independent primary care practices. The first study is complete, and the second is underway. Four physicians at two practices have opened a Brief for more than seventy patients.

Study design.

A feasibility study with its threshold and its question fixed before the first patient enrolled.

Design

An IRB-approved feasibility study of the Care Companion in primary care, with the principal investigator reviewing every Brief before it reached the physician.

Setting

A single primary care practice for the first study. A second independent primary care practice is running the same protocol now.

Participants

Consented adult patients attending scheduled primary care visits. Fifty patients completed the intake in the first practice, and each one’s physician received a Brief.

Pre-specified threshold

A PHQ-9 of 10 or higher, a GAD-7 of 10 or higher, or documented current or historical suicidality.

Primary question

Whether each patient above the threshold had a documented clinical action at the visit, verified against the physician’s contemporaneous notes.

Computation check

Independent recomputation of every case from the patient’s submitted responses.

Every patient above the pre-specified threshold had a documented clinical action.

The first practice’s study, now complete.

Fifty patients

Consented adult patients completed the intake, and their physician received a Brief, nearly always before the visit.

Documented clinical action

Every patient above the pre-specified threshold had a clinical action recorded in the physician’s notes from that visit.

Zero computation errors

Independent recomputation of all fifty cases found none.

The study measured documented clinical actions at the visit. It did not measure patient outcomes or diagnostic accuracy, and it had no control arm.

Three more physicians, at a second independent practice.

Running since September 2026 under the same IRB-approved protocol. The principal investigator reviews every Brief before it reaches the physician, and findings will be shared here when the study closes.

Sources

1
Singula Health. Care Companion feasibility study, first practice: study protocol, institutional review board approval, and study report. Available on request.
2
Singula Health. Care Companion feasibility study, second practice: study protocol and institutional review board approval. Study in progress.
3
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606-613. PMID 11556941.
4
Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092-1097. PMID 16717171.

Want the full detail?

The full study record is available on request.