A Randomized Trial to Evaluate an Electronic CKD Clinical Decision Support System (CDSS) in Clinical Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 542
- 试验地点
- 1
- 主要终点
- Change in blood pressure from enrollment
研究概览
简要总结
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.
详细描述
Setting:
The investigators will conduct this study within the three General Internal Medicine (GIM) practices at UCSF. These include general internal medicine PCPs who practice primary care. This trial is specifically designed to work within the framework of the existing infrastructure of these practices.
Randomization:
The unit for randomization will be the PCP (MD and NPs with their own panel of patients); the investigators plan to include up to 105 PCPs.
Training and Pre-Trial Preparation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Clinical Decision Support System (CDSS)
PCPs get a notice the CKD Clinical Decision Support System (CDSS) is available.
CDSS overview:
- The study MDs order CKD triple marker tests
- Patients will go to the lab as per usual clinical care
- Lab results are returned to PCPs clinical results folder as per usual clinical workflow with information about CKD and link to KDIGO guidelines
- Results will also be sent to the Study MD's for monitoring
- At the patient's next visit, if the labs are completed, the full CDSS launches for the PCP
- If the labs are not completed by the next visit, a Best Practice Alert (BPA) will launch for the PCP notifying them that the labs have been ordered, but the patient hasn't done them yet
干预措施: Clinical Decision Support System (CDSS) (Other)
Clinic Decision Sup System + Pharmacist
The Clinical Decision Support System + Pharmacist follow-up call extends beyond the CDSS alone.
CDSS Plus overview:
- At the visit in which the CDSS launches, the PCP will hand a study card with pharmacist information to their patient notifying them that a pharmacist will be calling to follow-up after the visit
- The pharmacist will use MyChart and/or phone calls to schedule a follow-up call within two weeks of the visit
- On the follow-up phone call, the pharmacist will discuss understanding of CKD, medication review and adherence assessment, home BP checks, and the importance of NSAID avoidance
- A second follow-up call will only be scheduled if the patient is non-adherent with their medications and makes an active plan for adherence with the pharmacist, or if the patient requests an additional call from the pharmacist
干预措施: Clinic Decision Sup System + Pharmacist (Other)
Usual Care
Patients continue to receive usual care by their provider.
结局指标
主要结局
Change in blood pressure from enrollment
时间窗: Investigators will follow patients up to 2 years after measures
Clinical Outcome: The primary clinical outcome of the trial is change in blood pressure (mmHg) from enrollment to the end of the follow up period as a continuous outcome, ascertained from the electronic medical record. BP measures from the clinical record will be ascertained in no more than quarterly intervals in the primary care setting to avoid bias by ascertainment. Investigators will also consider the dichotomous clinical outcome "achieved sustained BP control", defined as BP \< 140/90 mmHg in ≥ two consecutive visits during the trial.
次要结局
- Feasibility(Investigators will follow patients up to 2 years after measures)
- Processes of Care(Investigators will follow patients up to 2 years after measures)
- CKD and NSAID avoidance Knowledge(Investigators will interview each participant 2 weeks after their primary care visit or clinical pharmacist phone call)