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

Diabetes Mellitus Clinical Trial

— ASCEND  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03607617
• Other study ID #: 1R18DK114701-01
• Secondary ID: 1R18DK114701-01
• Status: Active, not recruiting
• Start date: September 3, 2018
• Est. completion date: August 2023

Study information

• Verified date: May 2022
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10609
• Est. completion date: August 2023
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	Kaiser Permanente Center for Health Research	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Kaiser Permanente	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), OCHIN, Inc., Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SDH data adoption	Monthly rate of targeted patients for whom SDH data are documented in the EHR. Tests H3ai: Intervention CHCs will have greater increases in SDH data collection vs. control CHCs. Measured by: # with SDH data documented or updated that month / # targeted patients seen at the CHC that month.	Change from baseline to up to four years
Secondary	SDH-related referral	Monthly rate of patients for whom an SDH-related referral is made (exclude if 'patient declined referral' is documented). Tests H3aii: Intervention CHCs will have significantly higher rates of actions taken to address SDH needs, vs. control CHCs). Measured by: # with SDH-related referral documented that month / # targeted patients seen at the CHC that month. (Stratified by whether patient has a documented SDH need).	Monthly, up to four years
Secondary	SDH-related follow-up	% of SDH Action Plan's decision support suggestions that are acted on (e.g., if HbA1c screening is ordered within a week of the encounter at which it is recommended). Measured by: # suggestions acted on / # SDH action 'care plan suggestions' at a given encounter	Monthly, up to four years
Secondary	Control of DM risk management biomarkers: BP	BP control (<140/80 mmHg)--measured with systolic and diastolic pressure. Tests H3b: Patients at intervention CHCs will have significant improvements in DM-related risk management vs. at control CHCs. Measured by # with a given biomarker controlled / # targeted patients seen at the CHC that month and by the rate of relative / absolute change in a given biomarker, limited to patients with >1 measure for that biomarker during follow-up.	Monthly, up to four years
Secondary	Control of DM risk management biomarkers: BMI	BMI <30--measured by height and weight. Tests H3b: Patients at intervention CHCs will have significant improvements in DM-related risk management vs. at control CHCs. Measured by # with a given biomarker controlled / # targeted patients seen at the CHC that month and by the rate of relative / absolute change in a given biomarker, limited to patients with >1 measure for that biomarker during follow-up.	Monthly, up to four years
Secondary	Control of DM risk management biomarkers: A1c	A1c control (<7.0%). Tests H3b: Patients at intervention CHCs will have significant improvements in DM-related risk management vs. at control CHCs. Measured by # with a given biomarker controlled / # targeted patients seen at the CHC that month and by the rate of relative / absolute change in a given biomarker, limited to patients with >1 measure for that biomarker during follow-up.	Monthly, up to four years
Secondary	Control of DM risk management biomarkers: LDL	LDL control (l<100 mg/dL). Tests H3b: Patients at intervention CHCs will have significant improvements in DM-related risk management vs. at control CHCs. Measured by # with a given biomarker controlled / # targeted patients seen at the CHC that month and by the rate of relative / absolute change in a given biomarker, limited to patients with >1 measure for that biomarker during follow-up.	Monthly, up to four years
Secondary	Comorbidities: retinopathy	Rates of incident of retinopathy among patients with DM. Also tests H3b. Measured by # incident cases of each morbidity / # targeted patients seen at the CHC that month.	Monthly, up to four years
Secondary	Comorbidities: nephropathy	Rates of incident of nephropathy among patients with DM. Also tests H3b. Measured by # incident cases of each morbidity / # targeted patients seen at the CHC that month.	Monthly, up to four years
Secondary	Comorbidities: Neuropathy	Rates of incident of neuropathy among patients with DM. Also tests H3b. Measured by # incident cases of each morbidity / # targeted patients seen at the CHC that month.	Monthly, up to four years
Secondary	DM Key tests	Rate of patients up-to-date on DM key tests (lipid panel annually, HbA1c within 6 months, eye / foot exams.) This will be measured as a count of patients meeting all exam criteria / count of patients with DM. Also tests H3b. Measured by # with a given test up to date / # targeted patients seen at the CHC that month.	Monthly, up to four years