Photographic Email Correspondence for Pediatric Urology Post-Operative Patients
Primary Purpose
Post-Operative Complication, Pediatric Urology
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Digital Photograph
Telephone Call
Sponsored by

About this trial
This is an interventional health services research trial for Post-Operative Complication focused on measuring telemedicine
Eligibility Criteria
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
Sites / Locations
- McMaster Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TTC
PEC
Arm Description
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
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
Outcomes
Primary Outcome Measures
Feasibility Data- Recruitment Rate
Recruitment rate over 7 month enrollment period to help determine whether recruitment for a larger scale trial will be feasible
Feasibility Data- Survey Completion
Participants compliance with completing the patient experience questionnaire after discussion with the NP.
Feasibility Data- Engagement rate of participants in sending photos via email
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
Secondary Outcome Measures
Number of ED/ unplanned clinic visits in the PEC group compared to those in TTC group
Number of follow up phone calls received from each group
Comparing family experience of both groups
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.
Full Information
NCT ID
NCT02406963
First Posted
March 23, 2015
Last Updated
March 21, 2016
Sponsor
McMaster Children's Hospital
Collaborators
Hamilton Health Sciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02406963
Brief Title
Photographic Email Correspondence for Pediatric Urology Post-Operative Patients
Official Title
Photographic Email Correspondence for Pediatric Urology Post-Operative Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster Children's Hospital
Collaborators
Hamilton Health Sciences Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A pilot research study is planned to occur within the pediatric urology service the spring of 2015. All pediatric urology patients in the immediate post-operative period of 0-14 days will be eligible for this study. This study will compare the current standard of care for managing post-operative complications (a telephone conversation with the NP) versus an experimental intervention (telephone call and an electronic photograph of the surgical site). Before the surgical patient is discharged from the hospital, consent will be obtained for participation. Once a family initiates contact with the NP with a post-operative concern they will be randomized to either the control or the experimental group. Those in the control group will receive the current standard of care, which is telephone advice only. Those in the experimental group will speak to the NP on the telephone and will be requested to send an electronic photograph of their child's surgical site to the NP for assessment and advice. Photographs will be assessed using a standardized tool by both NPs and this information will be entered into a database. The investigators will be measuring the number of emergency department (ED) and/or unplanned clinic visits in both groups. An unplanned clinic visit is defined as a visit that is required due to an unexpected complication or concern before the original scheduled post-operative follow-up as determined by the surgeon. The investigators will be tracking the number of follow-up phone calls for both groups, as well as requiring participants to complete a family/patient experience survey after speaking to the NP.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Complication, Pediatric Urology
Keywords
telemedicine
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TTC
Arm Type
Active Comparator
Arm Description
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
Arm Title
PEC
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Digital Photograph
Intervention Description
A digital photograph sent by the family of the surgical site
Intervention Type
Other
Intervention Name(s)
Telephone Call
Intervention Description
Standard telephone call with the nurse practitioner
Primary Outcome Measure Information:
Title
Feasibility Data- Recruitment Rate
Description
Recruitment rate over 7 month enrollment period to help determine whether recruitment for a larger scale trial will be feasible
Time Frame
7 Months
Title
Feasibility Data- Survey Completion
Description
Participants compliance with completing the patient experience questionnaire after discussion with the NP.
Time Frame
One Year
Title
Feasibility Data- Engagement rate of participants in sending photos via email
Description
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
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Number of ED/ unplanned clinic visits in the PEC group compared to those in TTC group
Time Frame
One Year
Title
Number of follow up phone calls received from each group
Time Frame
One Year
Title
Comparing family experience of both groups
Description
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.
Time Frame
One Year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandy Rickard, MN-NP
Organizational Affiliation
McMaster Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Photographic Email Correspondence for Pediatric Urology Post-Operative Patients
We'll reach out to this number within 24 hrs