Photographic Email Correspondence for Pediatric Urology Post-Operative Patients

March 21, 2016 updated by: Mandy Rickard, McMaster Children's Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • McMaster Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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
Other: Telephone Call
Standard telephone call with the nurse practitioner
Experimental: 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
Other: Telephone Call
Standard telephone call with the nurse practitioner
Other: Digital Photograph
A digital photograph sent by the family of the surgical site

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility Data- Recruitment Rate
Time Frame: 7 Months
Recruitment rate over 7 month enrollment period to help determine whether recruitment for a larger scale trial will be feasible
7 Months
Feasibility Data- Survey Completion
Time Frame: One Year
Participants compliance with completing the patient experience questionnaire after discussion with the NP.
One Year
Feasibility Data- Engagement rate of participants in sending photos via email
Time Frame: One Year
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
One Year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of ED/ unplanned clinic visits in the PEC group compared to those in TTC group
Time Frame: One Year
One Year
Number of follow up phone calls received from each group
Time Frame: One Year
One Year
Comparing family experience of both groups
Time Frame: One Year
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.
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hamilton Health Sciences Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mandy Rickard, MN-NP, McMaster Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-169

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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