Table 3

Outcomes, potential effect modifiers and intervention engagement measures

OutcomesMeasures or sourceBaselineFollow-upFood FarmacyFood Farmacy+Behaviour PharmacyControl
Primary outcome (survey)After referral; before first delivery/visit*4 monthsXX
Fruit and vegetable consumptionDietary Screener Questionnaire (DSQ)-1026
Secondary outcomes (survey)
Physical activityExercise vital sign30
Health-related quality of lifeHealthy Days Core Module (CDC HRQOL-4)34
Social isolationUCLA loneliness 3-item31
Food insecurityHousehold food insecurity Short Form (6-item)22
Depressive symptomsNine-item Patient Health Questionnaire (PHQ-9)32
Anxiety symptomsGeneralised Anxiety Disorder 7-Item (GAD-7)33
Secondary outcomes (EHR)4 months prior to referral and 1 month after6 months and 12 months with allowable window of 3 months prior and 3 month after each time point
HbA1cEHR labXXX
Microalbumin, urineEHR labXXX
Fasting glucoseEHR lab
Fasting insulinEHR lab
HOMA-IR (calculated)EHR lab
Total cholesterolEHR labXXX
HDL cholesterolEHR labXXX
LDL cholesterolEHR labXXX
TriglyceridesEHR labXXX
Non-HDL cholesterol (calculated)EHR labXXX
BMI (calculated)EHR vital signsXXX
WeightEHR vital signsXXX
Systolic blood pressureEHR vital signsXXX
Diastolic blood pressureEHR vital signsXXX
Food insecurityEHR vital signs Hunger vital sign8XXX
Depressive symptomsNine-item Patient Health Questionnaire (PHQ-9) in EHR5XXX
Two-item Patient Health Questionnaire (PHQ-2) in EHR5XXX
Anxiety disorderGeneralised Anxiety Disorder 7-Item (GAD-7) scale in EHR6XXX
Prescribed medicationsEHR prescription12 months prior to referral12 months prior to referralXXX
Emergency department visitsEHR emergency visits12 months prior to referral12 months after referralXXX
Hospitalisation (acute and ICU)EHR inpatient visitsXXX
Potential modifiers
DemographicsAge, race/ethnicity, clinic siteNAXXX
Health status at baselineRelevant conditions from EHR such as obesity, hypertension, diabetes, pre-diabetes, depressionNAXXX
Intervention engagement
Number of food bags deliveredDDF redemption recordsOngoingXX
Session attendanceOSW attendance records (in-clinic or online)OngoingX

  • *If patient cannot be reached before the first delivery, research staff attempt to contact until the third delivery.

  • BMI, body mass index; EHR, electronic health record; HDL, high-density lipoprotein; ICU, intensive care unit; LDL, low-density lipoprotein.