Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Using Health Information Technology (HIT) to Improve Transitions of Complex Elderly Patients From Skilled Nursing Facility (SNF) to Home (RAMPAGEII)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Terry Field, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01004328
First received: July 22, 2009
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Using HIT to Improve Transitions of Complex Elderly Patients From SNF to Home

Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Rate of follow-up to an outpatient provider within 21 days of SNF discharge. [ Time Frame: 1 year 3 months ] [ Designated as safety issue: Yes ]
  • Prevalence of appropriate monitoring for selected high risk medications at 30 days from the time of SNF discharge. [ Time Frame: 1 year 3 months ] [ Designated as safety issue: Yes ]
  • Incidence of adverse drug events (ADEs) 45 days after discharge. [ Time Frame: 1 year 3 months ] [ Designated as safety issue: Yes ]
  • Rate of SNF readmission and emergency department (ED) within 30 days of discharge. [ Time Frame: 1 year 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine costs directly related to the development and installation of the HIT-based transitional care intervention [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 626
Study Start Date: April 2011
Study Completion Date: January 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group 1
All participants
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004328

Locations
United States, Massachusetts
Fallon Clinic
Worcester, Massachusetts, United States, 01605
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Terry S Field, DSc University of Massachusetts Medical School/Meyers Primary Care Institute
  More Information

No publications provided

Responsible Party: Terry Field, Associate Professor, Meyers Primary Care Institute/University of Massachusetts Medical School., University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01004328     History of Changes
Other Study ID Numbers: 1R18HS017817, 13001
Study First Received: July 22, 2009
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
patient safety
care transitions
therapeutic monitoring
skilled nursing facilities
Adverse outcomes after discharge from a SNF to home

ClinicalTrials.gov processed this record on November 25, 2014