- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02406963
Photographic Email Correspondence for Pediatric Urology Post-Operative Patients
연구 개요
상세 설명
This study design will be a pilot randomized controlled trial. Consent for this study will be obtained within the circle of care immediately before the patient is discharged home following surgery. The families will be instructed to contact the NP by telephone with any post-operative questions or concerns they have about their child. Once the family initiates contact with the NP, they will be randomized into either the experimental (PEC) group or the control (TTC) group.
Once randomization has occurred, the NP will obtain all necessary information from the parent by addressing all points in expertise based script developed by the Pediatric Urology Team for both groups. Those randomized to the control group (TTC) will be provided recommendations based on information obtained during the standard telephone call. Families who are randomized into the PEC (experimental) group will be required to send a digital photograph of the child's surgical site to the professional email address of NP. Should they agree to send digital photographs they will be required to give consent for email correspondence, which will be emailed to them by the NP. Once they have consented they may send digital photographs to the NP of their child's surgical site, which will be assessed by both NPs using an expertise-based assessment tool. This information will be entered into REDCap. The NPs will come to a unanimous decision regarding advice to be provided and this will be communicated to the parents. Upon completion of the interaction with the NP the RA will contact the family to complete the family/patient experience survey over the telephone. Family/patient experience will be measured using an adapted validated tool "Nurse Practitioner Satisfaction Survey" consisting of 10 questions directly related to telephone interaction with the NP. This survey consists of a Likert Scale with scores ranging from 1-5 with 5 being the most positive response. Follow up telephone calls for both groups will be logged in MediTech as well as the RedCAP database. All telephone calls will be documented within the MediTech system and included in patient's chart in order to maintain current standard of care. All digital photos will be printed and placed in the patient's chart and deleted from the email server, which is the current process for those engaging in PEC.
Recruitment for this study will occur for 7 months with the aim of recruiting 40 patients per arm in order to obtain the feasibility data. However, a sample size calculation has been carried out and assuming 75% power and an alpha error of 5% using a one sided test, the required sample size to answer the definitive research question is 114 patients per group.
Data will be analyzed by comparing the number of ED and unplanned clinic visits for both groups, as well as the number of follow up phone calls received. This will be done using descriptive statistics and a t-test for independent means. Family/patient experience will also be measured between the two groups (PEC and TTC) using descriptive statistics and a t-test for independent means. Subgroup analysis will be done to determine which subgroup of post-operative patients benefit most from PEC (i.e., penile surgeries).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Hamilton, Ontario, 캐나다, L8S 4K1
- McMaster Children's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Children aged 0-17 years who have undergone urological surgery.
- Children within the immediate post-operative period (0-14 days).
- Children with concerns directly related to operative site including, but not limited to catheters, stents, rashes and urine output.
Exclusion Criteria:
- Surgical patients outside the immediate post-operative period.
- Those families who are unwilling or unable to email digital photographs.
- Concerns related to issues other than the operative site (medications, follow up appointments, return to activities).
- Inability to understand written consent due to language barrier
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: TTC
Current standard of care- a telephone call with the NP in the event of a post-operative concern where advice/interventions/reassurance is provided based on information provided by family
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Standard telephone call with the nurse practitioner
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실험적: PEC
Experimental arm, the standard telephone call with the NP and the addition of a digital photograph of the surgical site for assessment prior to the administration of advice
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Standard telephone call with the nurse practitioner
A digital photograph sent by the family of the surgical site
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Feasibility Data- Recruitment Rate
기간: 7 Months
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Recruitment rate over 7 month enrollment period to help determine whether recruitment for a larger scale trial will be feasible
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7 Months
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Feasibility Data- Survey Completion
기간: One Year
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Participants compliance with completing the patient experience questionnaire after discussion with the NP.
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One Year
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Feasibility Data- Engagement rate of participants in sending photos via email
기간: One Year
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Measuring the compliance and willingness of participants to send digital photos of surgical site to NP in order to determine if larger scale trial is feasible
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One Year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of ED/ unplanned clinic visits in the PEC group compared to those in TTC group
기간: One Year
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One Year
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Number of follow up phone calls received from each group
기간: One Year
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One Year
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Comparing family experience of both groups
기간: One Year
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Families will complete validated questionnaire after speaking to the NP on teh phone to evaluate experience.
Both groups will complete this questionnaire and responses compared.
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One Year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mandy Rickard, MN-NP, McMaster Children's Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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