Physical DisordersNCT01324687
Study Of Telemedicine Consultation at Home For Older Adults
An observational study of Physical Disorders and Telemedicine, run by University of Rochester at 1 site in United States.
Trial summary
The system of medical care for older adults with acute illnesses often serves them poorly. Many factors limit these patients' access to safe, patient-centered, efficient, high-quality, acute care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Physical Disorders, Telemedicine
- What is being tested?
- Telemedicine care
- How many people
- 1,537 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults residing in senior living communities.
Who may be able to join
- Member of the Strong Health Geriatrics Group practice
- Consent to participate
- Resident of facility with telemedicine established
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The system of medical care for older adults with acute illnesses often serves them poorly. Many factors limit these patients' access to safe, patient-centered, efficient, high-quality, acute care. These factors include a shortage of geriatricians and primary care physicians; limited availability of timely, acute-illness, patient appointments; emergency department (ED) crowding; interruptions to the continuity of care when patients use the ED; and poor transitions of care from the ambulatory setting to the ED. These conditions foster unnecessary ED use, adverse events in the ED for which older adults are particularly at-risk, and unnecessary medical costs. As the population ages, the magnitude of these problems will only increase.
The overarching study goals are to develop and evaluate a telemedicine-enhanced care model that improves access to safe, high-quality, acute illness care for older adults; fosters appropriate use of health services; and reduces unnecessary expenditures. Specifically, this study aims to:
- Expand the existing pediatric HeA telemedicine network to older adults by providing senior living communities (SLC) with an alternative on-site care option for individuals with an acute illness episode. Hypothesis 1: 90% of requested telemedicine visits will be successfully completed.
- Evaluate the impact of the HeA telemedicine model on utilization, quality of care, and patient safety. Hypothesis 2: The rate of ED use will be lower at SLCs with access to care via telemedicine, as compared to SLCs without such access to care. Hypothesis 3: Quality of care and patient safety measures will be better for SLC residents with access to telemedicine-enhanced care than for residents without this form of access.
- Evaluate the economic benefit of the care delivered through the telemedicine network. Hypothesis 4: The net cost of healthcare per patient-month will be less for SLC residents with access to telemedicine-enhanced care than for those without this form of access.
- Use qualitative methods to identify strategies and assets that promote and conditions that impede the implementation, acceptance, and success of the HeA telemedicine network in SLCs. This knowledge will inform efforts to develop a toolkit to be used to disseminate this technology broadly.
Read the detailed description
Telemedicine is a potential solution with demonstrated effectiveness in other vulnerable populations. Previous work by members of this research team has shown that telemedicine is an effective health information technology solution to address similar challenges in multiple vulnerable populations, demonstrating both improved access to care and reduced ED visits. The existing telemedicine program in Rochester, Health-e-Access (HeA), has been both successful and sustained, and well accepted by all key stakeholders including patients, families, clinicians, and insurers. This existing program, combined with the experience and multidisciplinary expertise of the investigators research team, creates a unique opportunity to (1) develop a model of care that leverages this technology to improve geriatric acute care, (2) evaluate this model through a prospective cohort study, and (3) identify key barriers and drivers of implementation to promote dissemination.
- Conditions
- Physical Disorders, Telemedicine
- Being tested
- Telemedicine care
- Keywords
- Telemedicine, Geriatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine careOther
Also called Telemedicine
Availability of telemedicine
| Study group | Role | What they receive |
|---|---|---|
| Control | Group without access to telemedicine in the home for acute care issues. | |
| Telemedicine care | Cohort with access to telemedicine in the home for acute care issues. Receives: Other: Telemedicine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Department Use
Use of emergency department by individuals with access to care via telemedicine as compared to those without such access to care.
Measured: Up to 42 months
Secondary outcomes (1)
Cost of Care
Comparison of cost of care between intervention and control groups.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Physical DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,537 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Manish Shah, University of Rochester
- Investigators
- Manish N. Shah, MD, Principal investigator, University of RochesterKenneth McConnochie, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324687
- Sponsor's protocol ID
- 31563
- Other IDs
- R01HS018047
- Status last verified
- Apr 2017
- First submitted
- 19 Nov 2010
- Last updated
- 9 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Of Telemedicine Consultation at Home For Older Adults
- ClinicalTrials.gov ID
- NCT01324687
- Acronym / sponsor ID
- 31563
- Conditions
- Physical Disorders, Telemedicine
- Keywords
- Telemedicine, Geriatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,537 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Oct 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Posted 21 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The system of medical care for older adults with acute illnesses often serves them poorly. Many factors limit these patients' access to safe, patient-centered, efficient, high-quality, acute care. These factors include a shortage of geriatricians and primary care physicians; limited availability of timely, acute-illness, patient appointments; emergency department (ED) crowding; interruptions to the continuity of care when patients use the ED; and poor transitions of care from the ambulatory setting to the ED. These conditions foster unnecessary ED use, adverse events in the ED for which older adults are particularly at-risk, and unnecessary medical costs. As the population ages, the magnitude of these problems will only increase.
The overarching study goals are to develop and evaluate a telemedicine-enhanced care model that improves access to safe, high-quality, acute illness care for older adults; fosters appropriate use of health services; and reduces unnecessary expenditures. Specifically, this study aims to:
- Expand the existing pediatric HeA telemedicine network to older adults by providing senior living communities (SLC) with an alternative on-site care option for individuals with an acute illness episode. Hypothesis 1: 90% of requested telemedicine visits will be successfully completed.
- Evaluate the impact of the HeA telemedicine model on utilization, quality of care, and patient safety. Hypothesis 2: The rate of ED use will be lower at SLCs with access to care via telemedicine, as compared to SLCs without such access to care. Hypothesis 3: Quality of care and patient safety measures will be better for SLC residents with access to telemedicine-enhanced care than for residents without this form of access.
- Evaluate the economic benefit of the care delivered through the telemedicine network. Hypothesis 4: The net cost of healthcare per patient-month will be less for SLC residents with access to telemedicine-enhanced care than for those without this form of access.
- Use qualitative methods to identify strategies and assets that promote and conditions that impede the implementation, acceptance, and success of the HeA telemedicine network in SLCs. This knowledge will inform efforts to develop a toolkit to be used to disseminate this technology broadly.
Detailed description
Telemedicine is a potential solution with demonstrated effectiveness in other vulnerable populations. Previous work by members of this research team has shown that telemedicine is an effective health information technology solution to address similar challenges in multiple vulnerable populations, demonstrating both improved access to care and reduced ED visits. The existing telemedicine program in Rochester, Health-e-Access (HeA), has been both successful and sustained, and well accepted by all key stakeholders including patients, families, clinicians, and insurers. This existing program, combined with the experience and multidisciplinary expertise of the investigators research team, creates a unique opportunity to (1) develop a model of care that leverages this technology to improve geriatric acute care, (2) evaluate this model through a prospective cohort study, and (3) identify key barriers and drivers of implementation to promote dissemination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Group without access to telemedicine in the home for acute care issues. |
| Telemedicine care | – | Other: Telemedicine careCohort with access to telemedicine in the home for acute care issues. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults residing in senior living communities.
Key inclusion criteria (3 listed)
- Member of the Strong Health Geriatrics Group practice
- Consent to participate
- Resident of facility with telemedicine established
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Telemedicine careAlso: TelemedicineAvailability of telemedicine | Other | Telemedicine care |
Primary outcome
Emergency Department Use
Time frame: Up to 42 months
Use of emergency department by individuals with access to care via telemedicine as compared to those without such access to care.
1 secondary outcome
Cost of Care
Time frame: Up to 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Manish N. Shah, MD principal investigator
University of Rochester
Kenneth McConnochie, MD 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?
An observational study of Physical Disorders and Telemedicine, 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 3 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 9 Jun 2017. 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. 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?
Yes. Results are posted in the registry (first posted 21 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Emergency Department Use (time frame: Up to 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2017.