ASCEND: ApproacheS to CHC ImplEmeNtation of SDH Data Collection and Action (NCT03607617) | Clinical Trial Compass
CompletedNot Applicable
ASCEND: ApproacheS to CHC ImplEmeNtation of SDH Data Collection and Action
United States31 participantsStarted 2018-09-03
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Social Risk Screening
Timeframe: During 6-month intervention and postintervention (6 months or more, all months from the intervention period's end through December 2021)