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

Kaiser Permanente logo

Kaiser Permanente

Status

Unknown

Conditions

Diabetes Mellitus

Treatments

Other: SDH Tool

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT03607617
1R18DK114701-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10,609 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

10,609 participants in 6 patient groups

Wedge 1
Description:
Five randomized clinics will implement SDH tool.
Treatment:
Other: SDH Tool
Wedge 2
Description:
Five randomized clinics implement SDH tool 24 weeks following prior wedge implementation.
Treatment:
Other: SDH Tool
Wedge 3
Description:
Five randomized clinics implement SDH tool 24 weeks following prior wedge implementation.
Treatment:
Other: SDH Tool
Wedge 4
Description:
Five randomized clinics implement SDH tool 24 weeks following prior wedge implementation.
Treatment:
Other: SDH Tool
Wedge 5
Description:
Five randomized clinics implement SDH tool 24 weeks following prior wedge implementation.
Treatment:
Other: SDH Tool
Wedge 6
Description:
Five randomized clinics implement SDH tool 24 weeks following prior wedge implementation.
Treatment:
Other: SDH Tool

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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