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| ID | Type | Description | Link |
|---|---|---|---|
| 1R18DK114701-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| OCHIN, Inc. | OTHER |
| Oregon Health and Science University | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This work will test a set of strategies for helping community health centers (CHCs) routinely identify and take action on the SDH-related needs of patients with / at risk for DM using a stakeholder-driven process to develop EHR-based SDH data collection / summary tools for CHCs.
This work will test a set of strategies for helping community health centers(CHCs) routinely identify and take action on the SDH-related needs of patients with / at risk for DM. The work will specifically study: (a) EHR-based SDH data collection / action in CHCs, and (b) the impact of a set of scalable implementation strategies known to support clinical practice changes (the 'SDH Action Plan'), on CHCs' adoption of SDH data collection and action. Focusing on DM risk management and obesity prevention outcomes in adult patients, the investigators will conduct a mixed methods formative evaluation of SDH data collection uptake among CHCs that had SDH data tools activated in their EHR in June 2016. (Quantitative data will come from all 440 CHCs' shared EHR, qualitative data from 10-12 CHCs purposively recruited from this pool). Identify patterns of SDH data collection in these diverse CHCs, and clinic-level factors associated with variation in SDH data collection rates. Use results to fine-tune the SDH Action Plan intervention's strategies for helping CHCs systematically: (i) collect SDH data in standard workflows, and (ii) integrate SDH data into care plans (e.g., making referrals to social services; adapting treatment plans) for adults with / at risk for DM.
Through a pragmatic, stepped-wedge, cluster-randomized trial in 30 CHCs, the CHCs will be randomized to one of five 6-month wedges, with staggered timing. CHCs in each wedge will receive intensive implementation support (the SDH Action Plan). This scalable intervention includes both comprehensive technical assistance and training materials designed to help CHCs plan for and implement SDH data collection / action, and six months of remote access to an 'SDH Implementation Team' that will tailor implementation support to each CHC's needs, with an emphasis on the Building Blocks of Primary Care.45 To test this approach, the investigators will conduct a realist evaluation of whether and how the SDH Action Plan intervention improves: (i) SDH data collection in CHC workflows; (ii) integration of SDH data into DM risk management care; and (iii) clinical measures associated with effective DM risk management (controlled blood pressure, HbA1c, BMI, lipids, etc.; up-to-date preventive care). H3a: Intervention CHCs will have significantly greater increases in (i) SDH data collection, and (ii) actions taken to address SDH needs, compared to control CHCs. H3b: Patients at intervention CHCs for whom SDH data are collected will have significant improvements in DM / obesity risk management / receipt of related preventive care, compared to those at control CHCs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wedge 1 | 4 randomized clinics will implement SDH tool. |
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| Wedge 2 | 5 randomized clinics implement SDH tool 24 weeks following prior wedge implementation. |
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| Wedge 3 | 5 randomized clinics implement SDH tool 24 weeks following prior wedge implementation. |
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| Wedge 4 | 5 randomized clinics implement SDH tool 24 weeks following prior wedge implementation. |
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| Wedge 5 | 6 randomized clinics implement SDH tool 24 weeks following prior wedge implementation. |
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| Wedge 6 | 6 randomized clinics implement SDH tool 24 weeks following prior wedge implementation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SDH Tool | Other | The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Social Risk Screening | 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. | During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021) |
| Measure | Description | Time Frame |
|---|---|---|
| Social Risk Referral | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Note: The investigators are not enrolling patients for this clinic-randomized study, but rather studying the uptake and impact of a set of EHR-based clinical decision support tools into regular care at the participating clinics. In this clinic-randomized trial, the intervention / randomization are clinic level. The intervention targets clinic processes that are part of the regular care patients receive, and will not require special visits.
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Any persons who are at risk for type 2 diabetes seen at the participating study CHC.
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Gold, PhD, MPH | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Center for Health Research | Portland | Oregon | 97227 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35523696 | Derived | Gold R, Kaufmann J, Gottlieb LM, Weiner SJ, Hoopes M, Gemelas JC, Torres CH, Cottrell EK, Hessler D, Marino M, Sheppler CR, Berkowitz SA. Cross-Sectional Associations: Social Risks and Diabetes Care Quality, Outcomes. Am J Prev Med. 2022 Sep;63(3):392-402. doi: 10.1016/j.amepre.2022.03.011. Epub 2022 May 4. | |
| 34174834 | Derived | Haley AD, Powell BJ, Walsh-Bailey C, Krancari M, Gruss I, Shea CM, Bunce A, Marino M, Frerichs L, Lich KH, Gold R. Strengthening methods for tracking adaptations and modifications to implementation strategies. BMC Med Res Methodol. 2021 Jun 26;21(1):133. doi: 10.1186/s12874-021-01326-6. |
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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.
| ID | Title | Description |
|---|---|---|
| FG000 | Wedge 1 | 1) 6 months pre-intervention, 2) 6 months SDH intervention, 3) 36 months post-intervention monitoring |
| FG001 | Wedge 2 | 1) 12 months pre-intervention, 2) 6 months SDH intervention, 3) 30 months post-intervention monitoring |
| FG002 | Wedge 3 | 1) 18 months pre-intervention, 2) 6 months SDH intervention, 3) 24 months post-intervention monitoring |
| FG003 | Wedge 4 | 1) 24 months pre-intervention, 2) 6 months SDH intervention, 3) 18 months post-intervention monitoring |
| FG004 | Wedge 5 | 1) 30 months pre-intervention, 2) 6 months SDH intervention, 3) 12 months post-intervention monitoring |
| FG005 | Wedge 6 | 1) 36 months pre-intervention, 2) 6 months SDH intervention, 3) 6 months post-intervention monitoring |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Number of patients at the participating clinics for each wedge. If a patient was in more than one wedge (many patients had visits at different clinics), the patient will be counted more than once in the "Total" column. Note: the "Baseline Analysis Population" Total column is a calculated field that cannot be revised. 358,818 patients were analyzed (after duplicates removed).
| ID | Title | Description |
|---|---|---|
| BG000 | Wedge 1 | 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. |
| BG001 | Wedge 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age by Wedge. If a patient was in more than one wedge (many patients had visits at different clinics), the patient will be counted more than once in the "Total analyzed" column. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Social Risk Screening | 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. | Posted | Number | 95% Confidence Interval | Rate Ratio (RR) | During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021) |
|
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Adverse events were not monitored or assessed. ASCEND is a minimal risk study because it tests whether an implementation support intervention (6 months of technical assistance and coaching) to clinics improves the adoption of social risk activities as part of standards of care. Therefore, there were no adverse risks to patients involved in this study beyond data management risks (e.g. breach of confidentiality).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wedge 1 | 1) 6 months pre-intervention, 2) 6 months SDH intervention, 3) 36 months post-intervention monitoring |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Gold, PhD, MPH | Kaiser Permanente Center for Health Research | 503-528-3902 | rachel.gold@kpchr.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 30, 2021 | Jan 24, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 18, 2022 | Jan 24, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021) |
| Control of DM Risk Management Biomarkers: Blood Pressure (BP) | 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). | During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021) |
| Control of DM Risk Management Biomarkers: HbA1c | 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). | During 6-month intervention and postintervention (6-months or more, all months from the intervention period's end through December 2021) |
| Control of DM Risk Management Biomarkers: LDL | 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). | During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021) |
| DM Key Tests (Screening, Percent up to Date) | 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). | During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021) |
| 30691480 | Derived | Gold R, Bunce A, Cottrell E, Marino M, Middendorf M, Cowburn S, Wright D, Mossman N, Dambrun K, Powell BJ, Gruss I, Gottlieb L, Dearing M, Scott J, Yosuf N, Krancari M. Study protocol: a pragmatic, stepped-wedge trial of tailored support for implementing social determinants of health documentation/action in community health centers, with realist evaluation. Implement Sci. 2019 Jan 28;14(1):9. doi: 10.1186/s13012-019-0855-9. |
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.
| BG002 | Wedge 3 | 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. |
| BG003 | Wedge 4 | 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. |
| BG004 | Wedge 5 | 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. |
| BG005 | Wedge 6 | 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. |
| BG006 | Total | Total of all reporting groups |
| Clinics |
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| Median |
| Full Range |
| years |
| Participants |
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| Sex/Gender, Customized | Sex/Gender by Wedge. If a patient was in more than one wedge (many patients had visits at different clinics), the patient will be counted more than once in the "Total analyzed" column. | Count of Participants | Participants | Participants |
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| Race/Ethnicity, Customized | Race/Ethnicity by Wedge. If a patient was in more than one wedge (many patients had visits at different clinics), the patient will be counted more than once in the "Total" column. | Number | Percent | Participants |
|
| During 6-month Intervention |
Added effects of intervention compared with preintervention, RR (95% CI) |
| OG001 | Postintervention | Added effects of intervention compared with preintervention, RR (95% CI) |
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| Secondary | Social Risk Referral | 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. | Posted | Number | 95% Confidence Interval | Rate Ratio (RR) | During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021) |
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| Secondary | Control of DM Risk Management Biomarkers: Blood Pressure (BP) | 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). | 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). | Posted | Number | 95% Confidence Interval | Percent controlled | During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021) |
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| Secondary | Control of DM Risk Management Biomarkers: HbA1c | 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). | 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). | Posted | Number | 95% Confidence Interval | Percent controlled | During 6-month intervention and postintervention (6-months or more, all months from the intervention period's end through December 2021) |
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| Secondary | Control of DM Risk Management Biomarkers: LDL | 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). | 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). | Posted | Number | 95% Confidence Interval | Percent controlled | During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021) |
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| Secondary | DM Key Tests (Screening, Percent up to Date) | 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). | 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). | Posted | Number | 95% Confidence Interval | screen, % up to date | During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Wedge 2 | 1) 12 months pre-intervention, 2) 6 months SDH intervention, 3) 30 months post-intervention monitoring | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Wedge 3 | 1) 18 months pre-intervention, 2) 6 months SDH intervention, 3) 24 months post-intervention monitoring | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Wedge 4 | 1) 24 months pre-intervention, 2) 6 months SDH intervention, 3) 18 months post-intervention monitoring | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Wedge 5 | 1) 30 months pre-intervention, 2) 6 months SDH intervention, 3) 12 months post-intervention monitoring | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Wedge 6 | 1) 36 months pre-intervention, 2) 6 months SDH intervention, 3) 6 months post-intervention monitoring | 0 | 0 | 0 | 0 | 0 | 0 |
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| All patients with diabetes |
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| All patients with diabetes |
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| All patients with diabetes |
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| HbA1c (all patients with diabetes) |
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| LDL (patients with diabetes screened for social risks (subset)) |
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| LDL (all patients with diabetes) |
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