- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03607617
ASCEND: ApproacheS to CHC ImplEmeNtation of SDH Data Collection and Action (ASCEND)
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97227
- Kaiser Permanente Center for Health Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Wedge 1
4 randomized clinics will implement SDH tool.
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The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.
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Wedge 2
5 randomized clinics implement SDH tool 24 weeks following prior wedge implementation.
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The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.
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Wedge 3
5 randomized clinics implement SDH tool 24 weeks following prior wedge implementation.
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The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.
|
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Wedge 4
5 randomized clinics implement SDH tool 24 weeks following prior wedge implementation.
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The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.
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Wedge 5
6 randomized clinics implement SDH tool 24 weeks following prior wedge implementation.
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The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.
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Wedge 6
6 randomized clinics implement SDH tool 24 weeks following prior wedge implementation.
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The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Social Risk Screening
Time Frame: 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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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.
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Risk Referral
Time Frame: 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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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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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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Control of DM Risk Management Biomarkers: Blood Pressure (BP)
Time Frame: 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 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).
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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)
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Control of DM Risk Management Biomarkers: HbA1c
Time Frame: 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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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)
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Control of DM Risk Management Biomarkers: LDL
Time Frame: 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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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)
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DM Key Tests (Screening, Percent up to Date)
Time Frame: 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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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).
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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)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rachel Gold, PhD, MPH, Kaiser Permanente
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R18DK114701-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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