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

NCT03607617 | Completed Results

• 1 other identifier: 1R18DK114701-01
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus

Keywords

social determinants of health; community health clinic; primary care; electronic medical record

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• Social Risk Referral

  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)

  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

  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

  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)

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

Study Arms (6)

Wedge 1

4 randomized clinics will implement SDH tool.

Other: SDH Tool

Wedge 2

5 randomized clinics implement SDH tool 24 weeks following prior wedge implementation.

Other: SDH Tool

Wedge 3

5 randomized clinics implement SDH tool 24 weeks following prior wedge implementation.

Other: SDH Tool

Wedge 4

5 randomized clinics implement SDH tool 24 weeks following prior wedge implementation.

Other: SDH Tool

Wedge 5

6 randomized clinics implement SDH tool 24 weeks following prior wedge implementation.

Other: SDH Tool

Wedge 6

6 randomized clinics implement SDH tool 24 weeks following prior wedge implementation.

Other: SDH Tool

Interventions

SDH Tool OTHER

The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.

Wedge 1; Wedge 2; Wedge 3; Wedge 4; Wedge 5; Wedge 6

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any persons who are at risk for type 2 diabetes seen at the participating study CHC.

You may qualify if:

• Any persons who are at risk for type 2 diabetes
• May include some subjects with mental health conditions of various types; however, it is important to systematically address high DM /obesity risk in this population, because such patients may be at risk for elevated high DM /obesity risk and have often been excluded or underrepresented in previous research studies.
• Decisionally/cognitively impaired
• Economically/educationally disadvantaged
• Non-English Speakers
• Elderly

You may not qualify if:

• Neonates of uncertain viability or nonviable neonates (up to 28 days post birth)
• Prisoners
• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead
• OCHIN, Inc.: collaborator
• Oregon Health and Science University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Related Publications (3)

• 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.

  PMID: 35523696 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.

  PMID: 34174834 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.

  PMID: 30691480 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Rachel Gold, PhD, MPH
• Organization: Kaiser Permanente Center for Health Research

rachel.gold@kpchr.org

503-528-3902

Study Officials

• Rachel Gold, PhD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: July 31, 2018
• Study Start: September 3, 2018
• Primary Completion: January 15, 2022
• Study Completion: July 31, 2023
• Last Updated: January 22, 2026
• Results First Posted: January 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)