Trial Outcomes & Findings for ASCEND: ApproacheS to CHC ImplEmeNtation of SDH Data Collection and Action (NCT NCT03607617)

Results Overview

Average differences are reported comparing the pre-intervention period (6 months or more) to (1) the six-month intervention period and (2) the post-intervention period (6 months or more). Numerator is measured as the number of patients with documented social risk screening results entered at a clinical encounter in the measurement period (excluding those only for COVID-19 testing/vaccination, as many people received these services at the study sites who were not otherwise patients at these clinics). Denominator is total patients seen in that period. Domains of social risk screening included child/family care insecurity, education, employment, financial strain, food insecurity, health insurance, health literacy, housing instability, inadequate physical activity, relationship safety, social isolation, stress, transportation needs, and utilities insecurity.

Recruitment status

COMPLETED

Target enrollment

31 participants

Primary outcome timeframe

During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021)

Results posted on

2026-01-22

Participant Flow

Protocol enrollment (n=31) describes the number of clinics enrolled in the study. Number of participants describes the patients of participating clinics used for analysis. The total number of patients in the completed row after duplicate records are removed is 358,818.

Unit of analysis: Number of Clinics

Participant milestones

Participant milestones
Measure	Wedge 1 1\) 6 months pre-intervention, 2) 6 months SDH intervention, 3) 36 months post-intervention monitoring	Wedge 2 1\) 12 months pre-intervention, 2) 6 months SDH intervention, 3) 30 months post-intervention monitoring	Wedge 3 1\) 18 months pre-intervention, 2) 6 months SDH intervention, 3) 24 months post-intervention monitoring	Wedge 4 1\) 24 months pre-intervention, 2) 6 months SDH intervention, 3) 18 months post-intervention monitoring	Wedge 5 1\) 30 months pre-intervention, 2) 6 months SDH intervention, 3) 12 months post-intervention monitoring	Wedge 6 1\) 36 months pre-intervention, 2) 6 months SDH intervention, 3) 6 months post-intervention monitoring
Overall Study STARTED	24650 4	108752 5	21743 5	66504 5	64082 6	122138 6
Overall Study Step 1: 1-6 Months (Wedge 1 Intervention Started 9/2018)	24650 4	0 0	0 0	0 0	0 0	0 0
Overall Study Step 2: 7-12 Months (Wedge 2 Intervention Started 3/2019)	24650 4	108752 5	0 0	0 0	0 0	0 0
Overall Study Step 3: 13-18 Months (Wedge 3 Intervention Started 9/2019)	24650 4	108752 5	21743 5	0 0	0 0	0 0
Overall Study Step 4: 19-24 Months (Wedge 4 Intervention Started 2/2020)	24650 4	108752 5	21743 5	66504 5	0 0	0 0
Overall Study Step 5: 25-30 Months (Wedge 5 Intervention Started 8/2020)	24650 4	108752 5	21743 5	66504 5	64082 6	0 0
Overall Study Step 6: 31-36 Months (Wedge 6 Intervention Started 1/2021)	24650 4	108752 5	21743 5	66504 5	64082 6	122138 6
Overall Study COMPLETED	24650 4	108752 5	21743 5	66504 5	64082 6	122138 6
Overall Study NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ASCEND: ApproacheS to CHC ImplEmeNtation of SDH Data Collection and Action

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Wedge 1 n=4 Clinics 4 randomized clinics will implement SDH tool. SDH Tool: The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.	Wedge 2 n=5 Clinics 5 randomized clinics implement SDH tool 24 weeks following prior wedge implementation. SDH Tool: The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.	Wedge 3 n=5 Clinics 5 randomized clinics implement SDH tool 24 weeks following prior wedge implementation. SDH Tool: The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.	Wedge 4 n=5 Clinics 5 randomized clinics implement SDH tool 24 weeks following prior wedge implementation. SDH Tool: The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.	Wedge 5 n=6 Clinics 6 randomized clinics implement SDH tool 24 weeks following prior wedge implementation. SDH Tool: The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.	Wedge 6 n=6 Clinics 6 randomized clinics implement SDH tool 24 weeks following prior wedge implementation. SDH Tool: The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.	Total n=31 Clinics Total of all reporting groups
Age, Continuous	36 years n=270 Participants	44 years n=4 Participants	45 years n=9 Participants	45 years n=220 Participants	44 years n=3 Participants	45 years n=18 Participants	45 years n=2259 Participants
Sex/Gender, Customized Female	11787 Participants n=270 Participants	60088 Participants n=4 Participants	11299 Participants n=9 Participants	36452 Participants n=220 Participants	32026 Participants n=3 Participants	67403 Participants n=18 Participants	219055 Participants n=2259 Participants
Sex/Gender, Customized Male	12839 Participants n=270 Participants	48627 Participants n=4 Participants	10436 Participants n=9 Participants	30011 Participants n=220 Participants	32017 Participants n=3 Participants	54675 Participants n=18 Participants	188605 Participants n=2259 Participants
Sex/Gender, Customized Unknown	24 Participants n=270 Participants	37 Participants n=4 Participants	8 Participants n=9 Participants	41 Participants n=220 Participants	39 Participants n=3 Participants	60 Participants n=18 Participants	209 Participants n=2259 Participants
Race/Ethnicity, Customized Hispanic	10 Percent n=270 Participants	35.3 Percent n=4 Participants	24.5 Percent n=9 Participants	26.8 Percent n=220 Participants	17.4 Percent n=3 Participants	44.8 Percent n=18 Participants	33 Percent n=2259 Participants
Race/Ethnicity, Customized Non-Hispanic Black	61.3 Percent n=270 Participants	6.6 Percent n=4 Participants	43 Percent n=9 Participants	7.1 Percent n=220 Participants	20.7 Percent n=3 Participants	6 Percent n=18 Participants	13.1 Percent n=2259 Participants
Race/Ethnicity, Customized Non-Hispanic, non-Black, nonwhite	9.6 Percent n=270 Participants	7.3 Percent n=4 Participants	3.2 Percent n=9 Participants	3.8 Percent n=220 Participants	3.8 Percent n=3 Participants	4.2 Percent n=18 Participants	5 Percent n=2259 Participants
Race/Ethnicity, Customized Non-Hispanic white	17.5 Percent n=270 Participants	43.9 Percent n=4 Participants	22.9 Percent n=9 Participants	49.4 Percent n=220 Participants	49.4 Percent n=3 Participants	35.9 Percent n=18 Participants	40.5 Percent n=2259 Participants
Race/Ethnicity, Customized Not documented in EHR	1.6 Percent n=270 Participants	7 Percent n=4 Participants	6.4 Percent n=9 Participants	12.9 Percent n=220 Participants	8.6 Percent n=3 Participants	9 Percent n=18 Participants	8.3 Percent n=2259 Participants

PRIMARY outcome

Timeframe: During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021)

Average differences are reported comparing the pre-intervention period (6 months or more) to (1) the six-month intervention period and (2) the post-intervention period (6 months or more). Numerator is measured as the number of patients with documented social risk screening results entered at a clinical encounter in the measurement period (excluding those only for COVID-19 testing/vaccination, as many people received these services at the study sites who were not otherwise patients at these clinics). Denominator is total patients seen in that period. Domains of social risk screening included child/family care insecurity, education, employment, financial strain, food insecurity, health insurance, health literacy, housing instability, inadequate physical activity, relationship safety, social isolation, stress, transportation needs, and utilities insecurity.

Outcome measures

Outcome measures
Measure	During 6-month Intervention n=155747 Participants Added effects associated with intervention compared with preintervention, absolute percent change (95% CI)	Postintervention n=241606 Participants Added effects associated with intervention compared with preintervention, absolute percent change (95% CI)
Social Risk Screening	2.45 Rate Ratio (RR) Interval 1.32 to 4.39	2.16 Rate Ratio (RR) Interval 0.64 to 7.27

SECONDARY outcome

Timeframe: During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021)

Average differences are reported comparing the pre-intervention period (6 months or more) to (1) the six-month intervention period and (2) the post-intervention period (6 months or more). Monthly clinic rate of provision of social risk-related referrals, measured as the number of patients with a documented referral among all patients seen in the measurement period (regardless of whether social risk screening was documented). This outcome included referrals internal (e.g., to a social worker) or external (e.g., to housing services) to the clinic. Denominator is total patients seen in that period.

Outcome measures

Outcome measures
Measure	During 6-month Intervention n=155747 Participants Added effects associated with intervention compared with preintervention, absolute percent change (95% CI)	Postintervention n=241606 Participants Added effects associated with intervention compared with preintervention, absolute percent change (95% CI)
Social Risk Referral	1.33 Rate Ratio (RR) Interval 0.73 to 2.43	0.89 Rate Ratio (RR) Interval 0.18 to 1.93

SECONDARY outcome

Timeframe: During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021)

Population: This table is a subpopulation cohort comprised of patients with an encounter during the study period and established diabetes before the second month of their clinic's baseline period (excluding pregnant women).

Average differences are reported comparing the pre-intervention period (6 months or more) to (1) the six-month intervention period and (2) the post-intervention period (6 months or more). Numerator is measured as the percent of patients with BP controlled (\<140/80 mmHg)--measured with systolic and diastolic pressure, denominator is total patients seen in that period with the needed follow-up data. This table is a subpopulation cohort comprised of patients with an encounter during the study period and established diabetes before the second month of their clinic's baseline period (excluding pregnant women).

Outcome measures

Outcome measures
Measure	During 6-month Intervention n=155747 Participants Added effects associated with intervention compared with preintervention, absolute percent change (95% CI)	Postintervention n=241606 Participants Added effects associated with intervention compared with preintervention, absolute percent change (95% CI)
Control of DM Risk Management Biomarkers: Blood Pressure (BP) Patients with diabetes screened for social risks (subset)	1.35 Percent controlled Interval -1.96 to 4.65	11.26 Percent controlled Interval 1.51 to 21.0
Control of DM Risk Management Biomarkers: Blood Pressure (BP) All patients with diabetes	-0.90 Percent controlled Interval -3.37 to 1.56	1.57 Percent controlled Interval -6.21 to 9.36

SECONDARY outcome

Timeframe: During 6-month intervention and postintervention (6-months or more, all months from the intervention period's end through December 2021)

Population: This table is a subpopulation cohort comprised of patients with an encounter during the study period and established diabetes before the second month of their clinic's baseline period (excluding pregnant women).

Average differences are reported comparing the pre-intervention period (6 months or more) to (1) the six-month intervention period and (2) the post-intervention period (6 months or more). Numerator is measured as the percent of patients with A1c controlled (\<7.0%), denominator is total patients seen in that period with the needed follow-up data. This table is a subpopulation cohort comprised of patients with an encounter during the study period and established diabetes before the second month of their clinic's baseline period (excluding pregnant women).

Outcome measures

Outcome measures
Measure	During 6-month Intervention n=155747 Participants Added effects associated with intervention compared with preintervention, absolute percent change (95% CI)	Postintervention n=241606 Participants Added effects associated with intervention compared with preintervention, absolute percent change (95% CI)
Control of DM Risk Management Biomarkers: HbA1c All patients with diabetes	-2.05 Percent controlled Interval -5.26 to 1.17	-6.46 Percent controlled Interval -13.52 to 0.61
Control of DM Risk Management Biomarkers: HbA1c Patients with diabetes screened for social risks (subset)	-2.01 Percent controlled Interval -7.5 to 3.47	-6.74 Percent controlled Interval -15.98 to 2.49

SECONDARY outcome

Timeframe: During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021)

Population: This table is a subpopulation cohort comprised of patients with an encounter during the study period and established diabetes before the second month of their clinic's baseline period (excluding pregnant women).

Average differences are reported comparing the pre-intervention period (6 months or more) to (1) the six-month intervention period and (2) the post-intervention period (6 months or more). Numerator is measured as the percent of patients with Low-density lipoprotein (LDL) controlled (l\<100 mg/dL), denominator is total patients seen in that period with the needed follow-up data. This table is a subpopulation cohort comprised of patients with an encounter during the study period and established diabetes before the second month of their clinic's baseline period (excluding pregnant women).

Outcome measures

Outcome measures
Measure	During 6-month Intervention n=155747 Participants Added effects associated with intervention compared with preintervention, absolute percent change (95% CI)	Postintervention n=241606 Participants Added effects associated with intervention compared with preintervention, absolute percent change (95% CI)
Control of DM Risk Management Biomarkers: LDL Patients with diabetes screened for social risks (subset)	4.19 Percent controlled Interval -1.86 to 10.25	7.33 Percent controlled Interval -2.61 to 17.27
Control of DM Risk Management Biomarkers: LDL All patients with diabetes	4.63 Percent controlled Interval -0.05 to 9.3	5.61 Percent controlled Interval -2.99 to 14.2

SECONDARY outcome

Timeframe: During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021)

Population: This table is a subpopulation cohort comprised of patients with an encounter during the study period and established diabetes before the second month of their clinic's baseline period (excluding pregnant women).

Average differences are reported comparing the pre-intervention period (6 months or more) to (1) the six-month intervention period and (2) the post-intervention period (6 months or more). Numerator is measured as the rate of patients with up-to-date on DM key tests (annual low-density lipoprotein (LDL), biannual hemoglobin A1C (HbA1c)), denominator is total patients seen in that period with the needed follow-up data. This table is a subpopulation cohort comprised of patients with an encounter during the study period and established diabetes before the second month of their clinic's baseline period (excluding pregnant women).