ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03607617
Recruitment Status : Not yet recruiting
First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Collaborators:
Ochin, Inc.
Oregon Health and Science University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Kaiser Permanente

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.

Condition or disease Intervention/treatment
Diabetes Mellitus Other: SDH Tool

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 : Observational
Estimated Enrollment : 10609 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: ASCEND: ApproacheS to CHC ImplEmeNtation of SDH Data Collection and Action
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : August 2022

Group/Cohort Intervention/treatment
Wedge 1
Five randomized clinics will implement SDH tool.
Other: SDH Tool
The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.

Wedge 2
Five randomized clinics implement SDH tool 24 weeks following prior wedge implementation.
Other: SDH Tool
The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.

Wedge 3
Five randomized clinics implement SDH tool 24 weeks following prior wedge implementation.
Other: SDH Tool
The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.

Wedge 4
Five randomized clinics implement SDH tool 24 weeks following prior wedge implementation.
Other: SDH Tool
The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.

Wedge 5
Five randomized clinics implement SDH tool 24 weeks following prior wedge implementation.
Other: SDH Tool
The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.

Wedge 6
Five randomized clinics implement SDH tool 24 weeks following prior wedge implementation.
Other: SDH Tool
The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.




Primary Outcome Measures :
  1. SDH data collection adoption [ Time Frame: Monthly, up to four years ]
    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.


Secondary Outcome Measures :
  1. SDH-related referral [ Time Frame: Monthly, up to four years ]
    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).

  2. SDH-related follow-up [ Time Frame: Monthly, up to four years ]
    % 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

  3. Control of DM risk management biomarkers: BP [ Time Frame: Monthly, up to four years ]
    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.

  4. Control of DM risk management biomarkers: BMI [ Time Frame: Monthly, up to four years ]
    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.

  5. Control of DM risk management biomarkers: A1c [ Time Frame: Monthly, up to four years ]
    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.

  6. Control of DM risk management biomarkers: LDL [ Time Frame: Monthly, up to four years ]
    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.

  7. Comorbidities: retinopathy [ Time Frame: Monthly, up to four years ]
    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.

  8. Comorbidities: nephropathy [ Time Frame: Monthly, up to four years ]
    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.

  9. Comorbidities: Neuropathy [ Time Frame: Monthly, up to four years ]
    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.

  10. DM Key tests [ Time Frame: Monthly, up to four years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any persons who are at risk for type 2 diabetes seen at the participating study CHC.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607617


Contacts
Contact: Rachel Gold, PhD, MPH 503-528-3902 rachel.gold@kpchr.org

Sponsors and Collaborators
Kaiser Permanente
Ochin, Inc.
Oregon Health and Science University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Rachel Gold, PhD, MPH Kaiser Permanente

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03607617     History of Changes
Other Study ID Numbers: 1R18DK114701-01 ( U.S. NIH Grant/Contract )
1R18DK114701-01 ( U.S. NIH Grant/Contract )
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kaiser Permanente:
social determinants of health
community health clinic
primary care
electronic medical record

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases