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Health-e-Access Telemedicine in Primary Pediatric Care

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ClinicalTrials.gov Identifier: NCT00234806
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : October 22, 2015
Sponsor:
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  ICMJE October 5, 2005
First Posted Date  ICMJE October 7, 2005
Last Update Posted Date October 22, 2015
Study Start Date  ICMJE December 2000
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2007)
Evaluation of the impact of telehealth on utilization and cost of health care
Original Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: January 4, 2007)
Evaluation of the feasibility and acceptability of integrating telehealth services into 10 primary care practices
Original Secondary Outcome Measures  ICMJE
 (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  ICMJE Health-e-Access Telemedicine in Primary Pediatric Care
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Common Childhood Illnesses
  • Non-emergent Care
Intervention  ICMJE Other: Health-e-Access
telemedicine intervention
Study Arms  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2015)
2000
Original Enrollment  ICMJE
 (submitted: October 5, 2005)
1000
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Weeks to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00234806
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Kenneth McConnochie, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE
  • United States Department of Commerce
  • Robert Wood Johnson Foundation
Investigators  ICMJE
Principal Investigator: Kenneth McConnochie, MD, MPH University of Rochester
PRS Account University of Rochester
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP