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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01004328
Other study ID # 1R18HS017817
Secondary ID 13001
Status Completed
Phase N/A
First received July 22, 2009
Last updated April 23, 2014
Start date April 2011
Est. completion date January 2013

Study information

Verified date April 2014
Source University of Massachusetts, Worcester
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The incidence of drug-induced injury is high in the ambulatory geriatric population, especially for elders with complex healthcare needs during high risk transitions to the ambulatory setting. In a previous study funded by the National Institute on Aging and the Agency for Healthcare Research and Quality [AHRQ] (AG 15979), the investigators determined that drug-related injuries occur at a rate of more than 50 per 1000-patient years in older adults in the ambulatory setting and that 28% are preventable. Independent risk factors for adverse drug events among older adults in the ambulatory setting included advanced age, multiple comorbid conditions, and the use of medications requiring close monitoring. In this project, Using HIT to Improve Transitions of Complex Elderly Patients from SNF to Home (1 R18 HS017817), the investigators are testing the use of an electronic medical record (EMR)-based transitional care intervention for complex elderly patients transitioning from subacute care in a skilled nursing facility (SNF) to the ambulatory setting. The growing trend for physicians and other healthcare providers to restrict their practices to single settings and not follow complex patients as they move between settings leaves older patients discharged from subacute care particularly vulnerable. This transition is uniquely challenging because of the complex healthcare needs of this population, who often require outpatient primary care physicians to coordinate with visiting nurses in order to manage complex medication regimens and fluctuating clinical status. To facilitate high-quality transitions from the subacute to the ambulatory setting and support interdisciplinary communication, the investigators will use the EMR to assure that physicians in the ambulatory setting receive key health information and alerts.


Recruitment information / eligibility

Status Completed
Enrollment 626
Est. completion date January 2013
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- 65 years and older,

- Member of the study site health plan,

- Received care from one of the study site's geriatricians during a SNF stay,

- Discharged from SNF to home.

Exclusion Criteria:

- Does not meet inclusion criteria.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
Intervention 1: Electronic medical record (EMR)-based transitional care intervention
Electronic delivery of enhanced discharge information to the ambulatory physician with plans for follow-up appointment, notice of any new medications, and recommendations for laboratory monitoring

Locations

Country Name City State
United States Fallon Clinic Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of follow-up to an outpatient provider within 21 days of SNF discharge. 1 year 3 months Yes
Primary Prevalence of appropriate monitoring for selected high risk medications at 30 days from the time of SNF discharge. 1 year 3 months Yes
Primary Incidence of adverse drug events (ADEs) 45 days after discharge. 1 year 3 months Yes
Primary Rate of SNF readmission and emergency department (ED) within 30 days of discharge. 1 year 3 months Yes
Secondary Determine costs directly related to the development and installation of the HIT-based transitional care intervention 3 years No
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