Study Of Telemedicine Consultation at Home For Older Adults

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT01324687
• Collaborator: Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
• Enrollment: 1,537
• Location: 1
• Duration (Months): 62
• Patients Per Site Per Month: 24.8

Study Details

Study Description

Brief 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. 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:

1. 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.

1. 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.

1. 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.

1. 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.

Condition or Disease	Intervention/Treatment	Phase
Physical Disorders; Telemedicine	Other: Telemedicine care

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

• Study Type: Observational
• Actual Enrollment: 1537 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Study Of Telemedicine Consultation at Home For Older Adults
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Telemedicine care; Availability of telemedicine; Other Names: Telemedicine

Outcome Measures

Primary Outcome Measures

1. Emergency Department Use [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.

Secondary Outcome Measures

1. Cost of Care [Up to 36 months]

   Comparison of cost of care between intervention and control groups.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Member of the Strong Health Geriatrics Group practice

• Consent to participate

• Resident of facility with telemedicine established

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester
• Agency for Healthcare Research and Quality (AHRQ)

Investigators

• Principal Investigator: Manish N. Shah, MD, University of Rochester
• Principal Investigator: Kenneth McConnochie, MD, University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manish Shah, Associate Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT01324687
• Other Study ID Numbers: 31563; R01HS018047
• First Posted: Mar 29, 2011
• Last Update Posted: Jun 9, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Manish Shah, Associate Professor, University of Rochester: Telemedicine; Geriatrics

Study Results

Participant Flow

Pre-assignment Detail	We excluded 15 individuals from analysis because they left the facility and the study less than 1 month after starting, and they were significantly different than the rest of the population. We felt that they has been mistakenly accepted into an independent or assisted living and recognized this and moved out to an alternate level of care.

Arm/Group Title	Control	Telemedicine Care
Arm/Group Description	Group without access to telemedicine in the home for acute care issues.	Cohort with access to telemedicine in the home for acute care issues. Telemedicine care: Availability of telemedicine
Period Title: Overall Study
STARTED	1058	494
COMPLETED	1058	479
NOT COMPLETED	0	15

Baseline Characteristics

Arm/Group Title	Control	Telemedicine Care	Total
Arm/Group Description	Group without access to telemedicine in the home for acute care issues.	Cohort with access to telemedicine in the home for acute care issues. Telemedicine care: Availability of telemedicine	Total of all reporting groups
Overall Participants	1058	479	1537
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	85	85	85
Sex: Female, Male (Count of Participants)
Female	746 70.5%	347 72.4%	1093 71.1%
Male	312 29.5%	132 27.6%	444 28.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	36 3.4%	27 5.6%	63 4.1%
White	1022 96.6%	452 94.4%	1474 95.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	1058 100%	479 100%	1537 100%

Outcome Measures

1. Primary Outcome

Title	Emergency Department Use
Description	Use of emergency department by individuals with access to care via telemedicine as compared to those without such access to care.
Time Frame	Up to 42 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Telemedicine Care
Arm/Group Description	Group without access to telemedicine in the home for acute care issues.	Cohort with access to telemedicine in the home for acute care issues. Telemedicine care: Availability of telemedicine
Measure Participants	1058	479
Number [Emergency dept use rate per person-month]	0.1050	0.0885

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Telemedicine Care
	Comments	Rate ratio of ED use rate of the intervention group as compared to the control group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.017
	Comments
	Method	GEE / Poisson regression models
	Comments
Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	0.8387
	Confidence Interval	(2-Sided) 95%; 0.7261 to 0.9689
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Cost of Care
Description	Comparison of cost of care between intervention and control groups.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

The cost data was not available from the Finance Office from Rochester General Hospital or Thompson Hospital so this analysis was not performed.

Arm/Group Title	Control	Telemedicine Care
Arm/Group Description	Group without access to telemedicine in the home for acute care issues.	Cohort with access to telemedicine in the home for acute care issues. Telemedicine care: Availability of telemedicine
Measure Participants	0	0

Adverse Events

Arm/Group Title	Control		Telemedicine Care
Arm/Group Description	Group without access to telemedicine in the home for acute care issues.		Cohort with access to telemedicine in the home for acute care issues. Telemedicine care: Availability of telemedicine
All Cause Mortality
	Control		Telemedicine Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control		Telemedicine Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1058 (0%)		0/479 (0%)
Other (Not Including Serious) Adverse Events
	Control		Telemedicine Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1058 (0%)		0/479 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.