Health-e-Access Telemedicine in Primary Pediatric Care

• ClinicalTrials.gov Identifier: NCT00234806
• Recruitment Status: Completed
• First Posted: October 7, 2005
• Last Update Posted: October 22, 2015
• Sponsor: University of Rochester
• Collaborators: United States Department of Commerce; Robert Wood Johnson Foundation
• Information provided by (Responsible Party): Kenneth McConnochie, University of Rochester

Tracking Information

• First Submitted Date: October 5, 2005
• First Posted Date: October 7, 2005
• Last Update Posted Date: October 22, 2015
• Study Start Date: December 2000
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 4, 2007): Evaluation of the impact of telehealth on utilization and cost of health care
• Original Primary Outcome Measures (submitted: October 5, 2005): Evaluation of the impact of telehealth on utilization and cost of health care.
• Change History: Complete list of historical versions of study NCT00234806 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: January 4, 2007): Evaluation of the feasibility and acceptability of integrating telehealth services into 10 primary care practices
• Original Secondary Outcome Measures (submitted: October 5, 2005): Evaluate the feasibility and acceptability of integrating telehealth services into 10 primary care practices.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Health-e-Access Telemedicine in Primary Pediatric Care
• Official Title: Health-e-Access: A Study of Telemedicine in Primary Pediatric Care in Rochester, NY

Brief Summary

This study aims to take the existing model from the pilot of Telemedicine in Daycare and expand it to other suburban childcare centers and both urban and suburban elementary schools.

An assessment of the value of telehealth in the child programs will then be initiated to detail the impact of utilization and costs.

An assessment of the value of integrating telehealth into primary care practice will also be evaluated. The impact of continuity of care, well child visit rates, and immunization status will be among the various measures used in this evaluation.

Detailed Description

This involves estimating the impact of reduced absence due to illness on parents and their employers and estimating the value of a telehealth visit to these stakeholders. An interview instrument was developed to administer before experience with telehealth and again after a family has had experience with the program. In addition program attendance (childcare or school) records will be collected to document changes in absenteeism pre and post telehealth service implementation.

This study involves a before and after research design including both historical and concurrent controls comparing a detailed utilization of health services including telehealth visits, emergency department services and illness related office visits. Analyses will include center-level analyses of service utilization on a weekly basis pre and post as well as a child-level analyses including utilization before enrollment in a participating childcare center or school through program participation and, eventually, telehealth participation.

This is a descriptive observational study of the feasibility and acceptability of integrating telehealth service into 10 primary care pediatric practices. This study will document the integration process by maintaining a log of key communications relating to decision making (meeting minutes, memos, written agreements, protocols) and by interviewing key staff such as residents, nurse practitioners, attending physicians, staff nurses, and administrative leaders following the study period.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Common Childhood Illnesses
• Non-emergent Care

Intervention

Other: Health-e-Access

telemedicine intervention

Study Arms

• Experimental: Telemedicine intervention group
  Intervention: Other: Health-e-Access
• Placebo Comparator: Control group
  Intervention: Other: Health-e-Access

• Publications *: McConnochie KM, Wood NE, Kitzman HJ, Herendeen NE, Roy J, Roghmann KJ. Telemedicine reduces absence resulting from illness in urban child care: evaluation of an innovation. Pediatrics. 2005 May;115(5):1273-82.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 21, 2015): 2000
• Original Enrollment (submitted: October 5, 2005): 1000
• Actual Study Completion Date: December 2007
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• All children at participating childcare centers and elementary schools.

Exclusion Criteria:

• Foster care children, children whose parents have refused participation, or children whose parents are unable to appropriately comprehend the program for any reason.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Weeks to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00234806
• Other Study ID Numbers: 8858; AHRQ- R01 HS015165-02; MCHB- 1 R40MC03605-01-00
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Kenneth McConnochie, University of Rochester
• Study Sponsor: University of Rochester

Collaborators

• United States Department of Commerce
• Robert Wood Johnson Foundation

Investigators

• Principal Investigator: Kenneth McConnochie, MD, MPH; University of Rochester

• PRS Account: University of Rochester
• Verification Date: October 2015