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

January 5, 2026 updated by: Kaiser Permanente
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Center for Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Wedge 1
4 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
5 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
5 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
5 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
6 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
6 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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.
During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
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.
During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021)
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).
During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021)
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)
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)
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)
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)
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)
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).
During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaiser Permanente

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Oregon Health and Science University
OCHIN, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rachel Gold, PhD, MPH, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R18DK114701-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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