Multimedia Aid Gynecologic Counseling and Consent
2020年8月10日 更新者:UNC Lineberger Comprehensive Cancer Center
Does Multimedia Perioperative Teaching Improve Patient Experience in the Treatment of Endometrial Cancer
This is an interventional trial to introduce two short animated videos into preoperative counseling/consent and to compare patient comprehension and satisfaction with a multimedia approach compared to standard of care currently.
The investigators anticipate that patients will retain more information about their surgery and peri-operative care and will be more satisfied with a multimedia approach.
調査の概要
詳細な説明
The investigators plan a pilot study where patients will be randomized to receiving standard consent and teaching prior to their planned surgery for endometrial cancer or standard consent and multimedia video aid with targeted teaching.
This video will be an adjunct to the standard consent process and supplement the pre and post-operative teaching that is currently not formalized.
The primary outcome is patient satisfaction.
The secondary outcomes include patient understanding and physician satisfaction.
The investigators hypothesize that patients will be more satisfied when their consent for surgery is done in conjunction with this multimedia aid.
研究の種類
介入
入学 (実際)
87
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
North Carolina
-
Chapel Hill、North Carolina、アメリカ、27599
- Univeristy of North Carolina at Chapel Hill
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
説明
Inclusion Criteria:
- English-speaking
- Has diagnosis of endometrial cancer
- Planned minimally invasive surgical treatment with hysterectomy and sentinel lymph node biopsy
Exclusion Criteria:
- Non-English speaking
- Pregnant
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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:処理
- 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 |
|---|---|
|
介入なし:Control
Patients in the control arm will have pre-operative teaching from their physician and sign consent for surgery, as is the current standard of care at the investigators' institution.
|
|
|
実験的:Video arm
Patients in the intervention arm will watch two short animated video about minimally-invasive endometrial cancer surgery followed by focused pre-operative teaching from their physician.
They will then sign consent for surgery.
|
Two short animated videos - one that reviews minimally-invasive surgery and sentinel lymph node mapping and biopsy for endometrial cancer treatment.
This video as reviews possible complications.
The second video reviews peri-operative instructions.
|
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 |
|---|---|---|
|
Patient satisfaction
時間枠:1 day (assessed at first visit)
|
Patient satisfaction with the clinic visit (either new patient visit where they are consented for surgery or a pre-operative visit).
Patient satisfaction will be measured using two survey tools: a single question to assess global satisfaction with the clinic visit (on a scale from 1-10) and an 8 question validated satisfaction survey (Client Satisfaction Questionnaire-8 or CSQ-8).
Patient satisfaction will be compared between the control and intervention groups.
For the single question satisfaction question, answers are on a scale from 1-10, the higher numbers indicating higher satisfaction.
The CSQ8 survey contains 8 questions that all have answers ranging from 1 to 4, with higher numbers indicating higher satisfaction.
|
1 day (assessed at first visit)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient comprehension
時間枠:6-8 weeks (assessed at 3 time points - first clinic visit, inpatient at time of surgery, and at follow-up visit 4-6 weeks after surgery)
|
Patient comprehension (of the surgery, its complication, and peri-operative instructions) will be measured using a 9 question survey developed by the study investigators.
This survey was developed to assess patient understanding on key information reviewed either in the study videos or by physicians during pre-operative counseling.
Patient comprehension will be assessed at three different time points (using the same survey) to compare comprehension immediately after watching the video or undergoing standard physician counseling and again during the patient's hospital stay and at the follow-up visit.
Comprehension scores will be compared between the control and intervention groups.
The comprehension surveys questions will all be awarded points for correct answers, with higher answers indicating more comprehension of topics relating to the surgery.
|
6-8 weeks (assessed at 3 time points - first clinic visit, inpatient at time of surgery, and at follow-up visit 4-6 weeks after surgery)
|
|
Physician satisfaction
時間枠:1 day (assessed at first visit)
|
Physician satisfaction with new patient or pre-operative visit.
Physician satisfaction will be measured using a single question to assess global satisfaction with the clinic visit (on a scale from 1-10, with higher numbers indicating higher satisfaction).
|
1 day (assessed at first visit)
|
|
Visit length
時間枠:1 day (assessed during first visit)
|
Time of new patient or pre-operative visit.
The length of visits will be recorded (from the time the physician first enters the patient room until the visit is complete and the patient is leaving the clinic room).
Appointment times will be compared between the control and intervention group, for pre-operative visits and new patient visits.
|
1 day (assessed during first visit)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:Katherine Tucker, MD、UNC Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年10月1日
一次修了 (実際)
2020年4月1日
研究の完了 (実際)
2020年4月1日
試験登録日
最初に提出
2019年3月1日
QC基準を満たした最初の提出物
2019年3月29日
最初の投稿 (実際)
2019年4月2日
学習記録の更新
投稿された最後の更新 (実際)
2020年8月11日
QC基準を満たした最後の更新が送信されました
2020年8月10日
最終確認日
2020年8月1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。