Clinical trial NCT03607617: ASCEND: ApproacheS to CHC ImplEmeNtation of SDH Data Collection and Action
Official title: ASCEND: ApproacheS to CHC ImplEmeNtation of SDH Data Collection and Action
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Keywords: social determinants of health
community health clinic
primary care
electronic medical record
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: OCHIN, Inc.
name: Oregon Health and Science University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-07-31
Enrollment: 10609
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any persons who are at risk for type 2 diabetes seen at the participating study CHC.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: SDH data adoption
timeFrame: Change from baseline to up to four years
Secondary outcomes:
measure: SDH-related referral
timeFrame: Monthly, up to four years
measure: SDH-related follow-up
timeFrame: Monthly, up to four years
measure: Control of DM risk management biomarkers: BP
timeFrame: Monthly, up to four years
measure: Control of DM risk management biomarkers: BMI
timeFrame: Monthly, up to four years
measure: Control of DM risk management biomarkers: A1c
timeFrame: Monthly, up to four years
measure: Control of DM risk management biomarkers: LDL
timeFrame: Monthly, up to four years
measure: Comorbidities: retinopathy
timeFrame: Monthly, up to four years
measure: Comorbidities: nephropathy
timeFrame: Monthly, up to four years
measure: Comorbidities: Neuropathy
timeFrame: Monthly, up to four years
measure: DM Key tests
timeFrame: Monthly, up to four years
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
Study officials:
affiliation: Kaiser Permanente
name: Rachel Gold, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.