Evaluation of an Electronic CKD Clinical Decision Support System (CDSS) in Clinical Care (NCT02925962) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of an Electronic CKD Clinical Decision Support System (CDSS) in Clinical Care
United States542 participantsStarted 2017-08-14
Plain-language summary
The investigators propose a three-arm, pragmatic, cluster-randomized clinical trial based in primary care. Participating Primary Care Providers (PCPs) will be randomized to usual care or one of two intervention arms. The first intervention will evaluate the efficacy of an automated CDSS that utilizes the electronic health record (EHR) to facilitate triple marker test ordering, guideline implementation and BP management, compared with usual care, among patients with previous documentation of eGFRcreat \<60 ml/min/1.73m2. The second intervention goes a step further, and will evaluate whether a CDSS plus a follow-up telephone call from a pharmacist (CDSS PLUS) can improve BP management and patient CKD and NSAID toxicity knowledge among the patients with CKD, compared with CDSS alone. The primary clinical outcome is BP level, with secondary outcomes related to processes of care and patient knowledge.
Who can participate
Age range
18 Years – 80 Years
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:
* Have at least two outpatient, documented eGFRcreat values 30- 59 ml/min/1.72m2 that are at least ≥3 months apart
* At least one of these measurements should be within 12 months.
* Patients have seen their primary care physician at least one time within the previous 18 months
* Patient's primary care providers agree to participate
Exclusion Criteria:
* Patients actively and recently seen by nephrology clinic (at least once in the past 12 months)
* Patients with a diagnosis of end stage renal disease
* Persons aged \>80
* Persons with New York Heart Association (NYHA) class III or IV heart failure, known ejection fraction \< 25%, or documented allergy to ace/arb.
* Patients on dialysis, kidney transplant recipients and pregnant women
* Patients with prevalent dementia, impaired cognition or severe mental illness; expected life expectancy \< 6 months.
There will also be a category where the physician can opt out for specific patients in their panel due to not believing this person should be included in the study for any reason.
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
Change in blood pressure from enrollment
Timeframe: Investigators will follow patients up to 2 years after measures