Photographic Email Correspondence for Pediatric Urology Post-Operative Patients

NCT02406963 | Completed

• 1 other identifier: 15-169
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Operative Complication; Pediatric Urology

Keywords

telemedicine

Outcome Measures

Primary Outcomes (3)

• Feasibility Data- Recruitment Rate

  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

  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

  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 Outcomes (3)

• Number of ED/ unplanned clinic visits in the PEC group compared to those in TTC group

  One Year

• Number of follow up phone calls received from each group

  One Year

• Comparing family experience of both groups

  One Year

Study Arms (2)

TTC

ACTIVE COMPARATOR

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

PEC

EXPERIMENTAL

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: Digital Photograph; Other: Telephone Call

Interventions

Digital Photograph OTHER

A digital photograph sent by the family of the surgical site

PEC

Telephone Call OTHER

Standard telephone call with the nurse practitioner

PEC; TTC

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster Children's Hospital: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

Location

Study Officials

• Mandy Rickard, MN-NP

  McMaster Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Practitioner

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: April 2, 2015
• Study Start: June 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

CA (1)