NCT01004328

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
626

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2009

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 29, 2009

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

1.2 years

First QC Date

July 22, 2009

Last Update Submit

April 23, 2014

Conditions

Keywords

patient safetycare transitionstherapeutic monitoringskilled nursing facilitiesAdverse outcomes after discharge from a SNF to home

Outcome Measures

Primary Outcomes (4)

  • Rate of follow-up to an outpatient provider within 21 days of SNF discharge.

    1 year 3 months

  • Prevalence of appropriate monitoring for selected high risk medications at 30 days from the time of SNF discharge.

    1 year 3 months

  • Incidence of adverse drug events (ADEs) 45 days after discharge.

    1 year 3 months

  • Rate of SNF readmission and emergency department (ED) within 30 days of discharge.

    1 year 3 months

Secondary Outcomes (1)

  • Determine costs directly related to the development and installation of the HIT-based transitional care intervention

    3 years

Study Arms (1)

Intervention Group 1

EXPERIMENTAL

All participants

Other: Intervention 1: Electronic medical record (EMR)-based transitional care intervention

Interventions

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

Intervention Group 1

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fallon Clinic

Worcester, Massachusetts, 01605, United States

Location

Study Officials

  • Terry S Field, DSc

    University of Massachusetts Medical School/Meyers Primary Care Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Meyers Primary Care Institute/University of Massachusetts Medical School.

Study Record Dates

First Submitted

July 22, 2009

First Posted

October 29, 2009

Study Start

April 1, 2011

Primary Completion

June 1, 2012

Study Completion

January 1, 2013

Last Updated

April 24, 2014

Record last verified: 2014-04

Locations