Common Childhood IllnessesNCT00234806
Health-e-Access Telemedicine in Primary Pediatric Care
A study testing Health-e-Access in people with Common Childhood Illnesses and Non-emergent Care, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 weeks to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Childhood Illnesses, Non-emergent Care
- What is being tested?
- Health-e-Access
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2000to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All children at participating childcare centers and elementary schools.
Who cannot join
- Foster care children, children whose parents have refused participation, or children whose parents are unable to appropriately comprehend the program for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health-e-Access: A Study of Telemedicine in Primary Pediatric Care in Rochester, NY
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.
Read the 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.
- Conditions
- Common Childhood Illnesses, Non-emergent Care
- Being tested
- Health-e-Access
- Keywords
- telehealth, telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health-e-AccessOther
telemedicine intervention
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine intervention group | Experimental | Not described Receives: Other: Health-e-Access |
| Control group | Placebo comparator | Not described Receives: Other: Health-e-Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the impact of telehealth on utilization and cost of health care
Secondary outcomes (1)
Evaluation of the feasibility and acceptability of integrating telehealth services into 10 primary care practices
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startDec 2000
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Common Childhood IllnessesStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Commerce, Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Kenneth McConnochie, University of Rochester
- Investigators
- Kenneth McConnochie, MD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234806
- Sponsor's protocol ID
- 8858
- Other IDs
- AHRQ- R01 HS015165-02, MCHB- 1 R40MC03605-01-00
- Status last verified
- Oct 2015
- First submitted
- 5 Oct 2005
- Last updated
- 22 Oct 2015
- Results posted
- No
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. doi: 10.1542/peds.2004-0335.
PubMed 15867035
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-e-Access: A Study of Telemedicine in Primary Pediatric Care in Rochester, NY
- ClinicalTrials.gov ID
- NCT00234806
- Acronym / sponsor ID
- 8858
- Conditions
- Common Childhood Illnesses, Non-emergent Care
- Keywords
- telehealth, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- United States Department of Commerce, Robert Wood Johnson Foundation
- Study start
- Dec 2000
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 7 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine intervention group | Experimental | Other: Health-e-Access |
| Control group | Placebo comparator | Other: Health-e-Access |
Who may qualify
- Ages
- 6 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All children at participating childcare centers and elementary schools.
Key exclusion criteria (1 listed)
- Foster care children, children whose parents have refused participation, or children whose parents are unable to appropriately comprehend the program for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health-e-Accesstelemedicine intervention | Other | Control group, Telemedicine intervention group |
Primary outcome
Evaluation of the impact of telehealth on utilization and cost of health care
1 secondary outcome
Evaluation of the feasibility and acceptability of integrating telehealth services into 10 primary care practices
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
- Background: PubMed 15867035McConnochie 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. doi: 10.1542/peds.2004-0335.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth McConnochie, MD, MPH principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health-e-Access in people with Common Childhood Illnesses and Non-emergent Care, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the impact of telehealth on utilization and cost of health care. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00234806, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2015.