The Utility of Clinical Milestones Pathway in a Cardiovascular ICU
The Utility of an Electronic Based Milestone Pathway on the Care of Patients Undergoing Cardiac Valve Surgery
The economic burden of health care is becoming a greater burden from year to year. Medicare spending, which represented 20 percent of national health spending in 2013, grew 3.4 percent to $585.7 billion, a slowdown from growth of 4.0 percent in 2012. This slowdown was attributed largely to slower enrollment growth and impacts of the Affordable Care Act (ACA) and sequestration. Per-enrollee spending in 2013 grew at about the same rate as 2012.
The push to create Accountable Care Organizations (ACO) has taken these initiatives a step further. The goal would be to move away from a fee for service system and base reimbursement on quality of care. Clinical metrics, re-admissions, and patient satisfaction in categories of acute myocardial infarction, congestive heart failure, pneumonia, surgeries and healthcare associated infections will be the foci for 2013. Centers for Medicare and Medicaid Services (CMS) has also initiated a valve bundled payment system that encompasses total patient care for 90 days, including readmissions.
Leapfrog and the ACO movement along with the nonprofit group Institute for Health Care Improvement have placed quality and cost effectiveness into the spotlight for clinicians in the ICU and beyond. While clinicians have always been focused on evidence based therapies with little concern for cost, in the new era of healthcare understanding cost, value and effectiveness of therapies will be key for improved patient outcomes and institutional solvency in trying economic times.
Vanderbilt elected to enroll in the CMS valve bundle trial. The Leadership team in the heart and vascular institute identified the importance of an electronic medical record that includes display and utilization of key drivers of quality and success across the continuum of care (Preoperative assessment to discharge up to 90 days) in the bundled payment model of care. A multidisciplinary team was developed in conjunction with nurses, midlevel providers, multi-specialty physicians, case managers, informatics specialists, and performance improvement representatives to develop an electronic pathway of care using evidence based and best practices for cardiac surgery.
調査の概要
詳細な説明
A multidisciplinary team consisting of physicians, pharmacists, nutritionists, social workers, bedside nurses, physical therapists, and mid-level providers developed the structure and key elements of the milestone pathway. The Vanderbilt University Informatics Team developed the electronic version of the consensus milestones. The pathway encompasses 17 phases beginning with the pre-procedure evaluation and continuing through the perioperative period until the three-month follow-up post procedure. The nursing staff performed documentation of pathway stages during the index hospitalization, and the milestone stage was displayed on the door of the patient's room. The milestone stage was discussed on multi-disciplinary bedside rounds in the ICU, and if a patient could not progress to the next stage the nurse would document the reason for failure to progress.
In this study, the investigators compared patients who underwent valve surgery with the milestone pathway in place, to patients who underwent valve surgery without the milestone pathway in place. Patients were adjusted according to baseline characteristics such as demographics, procedure, and proceduralist collected from the electronic medical record and Society of Thoracic Surgeons (STS) database.
The investigators primary clinical outcome is mortality, and secondary clinical outcomes include the incidence of re-intubation within 48 hours, acute kidney injury as defined by Kidney Disease Improving Global Outcome (KDIGO) criteria, delirium, major adverse cardiac events (MACE), and infection rates for catheter and central line associated infections as well as sternal wound infection. In addition the investigators examined financial outcomes including variance in direct and total cost, and direct and total cost per patient.
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Underwent cardiac valve surgery at vanderbilt university medical center between 1/1/2013 and 12/31/2014
Exclusion Criteria:
- none
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
Pre intervention
This cohort consists of patients who underwent cardiac valve surgery during calender year 2013 prior to the institution of the electronic milestone pathway
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post intervention
This cohort consists of patients who underwent cardiac valve surgery during calender year 2014 after the electronic milestone pathway had been instituted
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an electronic based, clinical milestone driven pathway developed to guide the care of cardiac valve surgery patients.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
mortality
時間枠:Post operative day 0 to post operative day 7
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mortality rate for patients during index hospitalization
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Post operative day 0 to post operative day 7
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Re-intubation rate within 48 hours
時間枠:48 hours of index procedure
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re-intubation rate within 48 hours of index procedure for patients undergoing cardiac surgery
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48 hours of index procedure
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Acute Kidney Injury as defined by KDIGO (Kidney Disease Improving Global Outcomes) guidelines
時間枠:All time points occurring between post operative day 0 and Post operative day 7
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Incidence of acute Kidney Injury as defined by KDIGO (Kidney Disease Improving Global Outcomes) guidelines during index hospitalization
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All time points occurring between post operative day 0 and Post operative day 7
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Delirium
時間枠:All time points occurring between post operative day 0 and Post operative day 7
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Incidence of delirium as defined by Intensive Care Unit Confusion Assessment Method (ICU-CAM) scoring system during index hospitalization
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All time points occurring between post operative day 0 and Post operative day 7
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major adverse cardiac events
時間枠:All time points occurring between post operative day 0 and Post operative day 7
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Incidence of major adverse cardiac events defined as death, need for re-operation, myocardial infarction during index hospitalization
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All time points occurring between post operative day 0 and Post operative day 7
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Infection rates
時間枠:All time points occurring between post operative day 0 and Post operative day 7
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defined as Catheter Associated Urinary Tract Infection (CAUTI), Central Line Associated Blood Stream Infection (CLABSI), sternal wound infection during index hospitalization
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All time points occurring between post operative day 0 and Post operative day 7
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Direct cost
時間枠:All time points occurring between post operative day 0 and Post operative day 7
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summation of costs directly attributable to patient care during index hospitalization
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All time points occurring between post operative day 0 and Post operative day 7
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total cost
時間枠:All time points occurring between post operative day 0 and Post operative day 7
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summation of costs directly attributable to patient care, as well as costs to the patient which are not directly attributable to patient care (unspecified charges to patient such as OR utilization fees, laboratory staff fees, etc.)
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All time points occurring between post operative day 0 and Post operative day 7
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variance in cost
時間枠:All time points occurring between post operative day 0 and Post operative day 7
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total and direct costs attributable to each patient undergoing cardiac valve surgery will be averaged for all patients undergoing cardiac valve surgery during the study period.
Each individual patient's direct and total costs will then be compared to the averaged cost for all patients undergoing cardiac valve surgery hospitalization to obtain a variance in cost for each individual patient undergoing cardiac valve surgery.
The investigators will then compare average variance between the two cohorts.
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All time points occurring between post operative day 0 and Post operative day 7
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Lee Parmley, MD, JD、Vanderbilt University Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB #151566
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
心臓手術の臨床試験
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Dong Yangわからない腹腔鏡補助下手術 | 切開を行わない全腹腔鏡手術(Natural Orifice Transluminal Endoscopic Surgery、NOSES)中国
electronic milestone pathwayの臨床試験
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San Diego Veterans Healthcare SystemVA Palo Alto Health Care System完了
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Washington University School of MedicineInternational Headache Society募集