System-Wide Improvement for Transitions After Surgery: The SWIFT Post op Program (SWIFT)
調査の概要
詳細な説明
At the start of the study, inpatient and outpatient nurses, physicians and physicians assistants will be oriented to the intervention in the study and will be suggested that the intervention is standard of care based on the following study:
Nagle D, Pare T, Keenen E, Marcet K, Tizio S, Poylin V*. Ileostomy Pathway Virtually Eliminates Readmissions for Dehydration in New Ostomates. Diseases of the Colon and Rectum 2012; 55: 1266-1272.
The intervention patients will be subject to a compliance surveillance and intervention strategy (CSIS) administered by study personnel to encourage the following and persist with telephone calls if the following have not been achieved.
- Prospective audits by study personnel to check and encourage teaching in the clinic, teaching on the wards, and telephone follow up occurred.
- A self-assessment tool for patients and families to confirm understanding of the education materials.
- Coaching of inpatient nurses taking care of ileostomy patients by WOCN and/or the inpatient nurse champion
- Call from the clinic nurse practitioner or physician's assistant within 7 days of discharge to review the educational materials and administer a screening questionnaire to identify patients at risk of dehydration. In patients randomized to CSIS, study personnel will ensure this phone call is made.
The usual care arm will include no such surveillance.
The randomized study will be powered to detect a decrease in hospital readmission rates (all-cause) from 25% to 5%. Secondary outcomes include readmission due to dehydration and patient satisfaction (Surgical-CAHPS survey)
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Minnesota
-
Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota Medical Center -Fairview
-
Saint Paul、Minnesota、アメリカ、55114
- Colon and Rectal Surgery Associates
-
-
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:
- Patients who are scheduled or who undergo ileostomy alone or as part of a multiple procedure operation
- patients who have had an ileostomy in the past are eligible
- patients who have an ileostomy to address a recent surgical complication are eligible
Exclusion Criteria:
- Patients who have an ileostomy already in place immediately prior to the procedure (ie. revision, transposition, or parastomal hernia procedures
- patients on dialysis
- patients who require chronic TPN, IVF, or have short gut
- non-English speaking patients who do not have easy access to an appropriate interpreter.
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:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:compliance surveillance
|
External monitor to ensure compliance with an educational protocol.
|
介入なし:Usual Care
educational session at the start of the study
|
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 |
時間枠 |
---|---|
Readmission to the hospital
時間枠:30 days after hospital discharge
|
30 days after hospital discharge
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Patient satisfaction
時間枠:3-6 months after surgery
|
S-CAHPS
|
3-6 months after surgery
|
Index length-of-stay
時間枠:Index length-of-stay
|
Time from surgical date to hospital discharge
|
Index length-of-stay
|
Emergency room visit
時間枠:30 days after hospital discharge
|
Emergency room visits for any reason 30 days after surgery
|
30 days after hospital discharge
|
Total hospital-length-of-stay
時間枠:30 days after hospital discharge
|
Total hospital length of stay for any reason after surgery
|
30 days after hospital discharge
|
Readmission due to dehydration or acute renal failure
時間枠:30 days after hospital discharge
|
Dehydration by clinician assessment, acute renal failure defined as elevation in creatinine to >2 mg/dl, or oliguria/anuria
|
30 days after hospital discharge
|
Post-discharge follow up phone call
時間枠:30 days after hospital discharge
|
Nurse, physician, or physician-assistant documentation of phone call to the patient that describes monitoring of ileostomy output volume
|
30 days after hospital discharge
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Mary R Kwaan, MD、University of Minnesota
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
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。
大腸外科の臨床試験
-
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