EHR Integrated Remote Patient Monitoring to Reduce Readmission for Patients With Bladder Cancer Undergoing Cystectomy
CLEAR Cystectomy: A Pilot Randomized Trial Assessing Remote Patient Monitoring in Bladder Cancer Patients
This clinical trial tests the feasibility of an electronic health record (EHR) integrated remote patient monitoring intervention to reduce readmission for patients with bladder cancer undergoing cystectomy. Cystectomy is the preferred treatment for locally advanced bladder cancer and involves removal of the bladder, prostate or uterus and part of vagina, and pelvic lymph nodes along with reconstruction of the urinary tract using a segment of bowel. Hospital readmission rates following cystectomy exceed 25% and are among the highest of any surgery. A significant barrier to identifying complications early arises from our inability to monitor patients once they are discharged from the hospital. The EHR integrated remove patient monitoring intervention helps with monitoring of symptoms after a patient's discharge from a cystectomy procedure and provides a direct line of communication between patients and their care team when concerning symptoms arise. This may reduce readmission rate for patients with bladder cancer undergoing cystectomy.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Michigan
-
Ann Arbor、Michigan、アメリカ、48109
- University of Michigan Rogel Cancer Center
-
コンタクト：
- Tudor Borza
- 電話番号：734-936-7030
- メール：tborza@med.umich.edu
-
主任研究者：
- Tudor Borza
-
-
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
説明
Inclusion Criteria:
- Adults age 18 and older
- English speaking
- Patient currently inpatient at the University of Michigan (Michigan Medicine) who has undergone a radical cystectomy with reconstruction for bladder cancer
- Personal access or access via a caregiver to a compatible device where notifications from the Michigan Medicine MyUofMHealth account can be enabled
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
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm I (EHR integrated remote monitoring app)
Patients receive access to the MyUofMHealth App and, starting at discharge, receive notifications, up to 3 times per day with frequency decreasing to daily, then less frequently over time, prompting them to complete medication and pain assessments, record food and fluid intake and exercise and triage/symptom tracking, and provide a direct line of communication to their care team if concerning symptoms arise, up to day 35 post discharge. |
Ancillary studies Ancillary studies Communicate with care team Receive access to the MyUofMHealth App
他の名前：
Receive notifications
他の名前：
Complete assessments
他の名前：
|
|
実験的：Arm II (Standard care)
Patients receive access to the MyUofMHealth App and undergo standard post-operative care. |
Ancillary studies Ancillary studies Receive access to the MyUofMHealth App
他の名前：
Receive notifications
他の名前：
Undergo standard post-operative care
他の名前：
|
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 |
|---|---|---|
|
Trial randomization meeting goal of 50 patients (feasibility)
時間枠：Up to 6 months
|
Will be reported as number of participants accrued and randomized. |
Up to 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Intervention deployment in > 90% of patients randomized to intervention arm (feasibility)
時間枠：Up to 6 months
|
Will be reported as proportions with the associated 95% binomial confidence intervals. |
Up to 6 months
|
|
Trial enrollment of ≥ 50% of eligible patients (acceptability)
時間枠：Up to 6 months
|
Will be reported as proportions with the associated 95% binomial confidence intervals. |
Up to 6 months
|
|
Hospital free days
時間枠：Up to 90 days from discharge
|
A hospital day will be a day that includes an emergency department visit or acute care hospital or hospitalization within 90 days from discharge. A hospital-free day will be any day that is not a hospital day and when a patient is alive. Will be reported by arm using a median or mean, and effect sizes will be calculated and their associated confidence intervals. |
Up to 90 days from discharge
|
協力者と研究者
捜査官
- 主任研究者：Tudor Borza、University of Michigan Rogel Cancer Center
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- UMCC 2026.050
- NCI-2026-07233 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- UMCC 2026.050 (その他の識別子：University of Michigan Rogel Cancer Center)
- R34CA297281 (米国 NIH グラント/契約)
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?
IPD プランの説明
we will share a de-identified version of the quantitative data, including the data output from the application (e.g., frequency of patient engagement, patient symptoms, pain medications, etc.) and the responses to both the PROMIS and satisfaction questionnaires.
IPD 共有時間枠
for up to 10 years
IPD 共有アクセス基準
For interested researchers
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。