- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01004328
Using Health Information Technology (HIT) to Improve Transitions of Complex Elderly Patients From Skilled Nursing Facility (SNF) to Home (RAMPAGEII)
April 23, 2014 updated by: Terry Field, University of Massachusetts, Worcester
Using HIT to Improve Transitions of Complex Elderly Patients From SNF to Home
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
626
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01605
- Fallon Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group 1
All participants
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of follow-up to an outpatient provider within 21 days of SNF discharge.
Time Frame: 1 year 3 months
|
1 year 3 months
|
|
Prevalence of appropriate monitoring for selected high risk medications at 30 days from the time of SNF discharge.
Time Frame: 1 year 3 months
|
1 year 3 months
|
|
Incidence of adverse drug events (ADEs) 45 days after discharge.
Time Frame: 1 year 3 months
|
1 year 3 months
|
|
Rate of SNF readmission and emergency department (ED) within 30 days of discharge.
Time Frame: 1 year 3 months
|
1 year 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Determine costs directly related to the development and installation of the HIT-based transitional care intervention
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Terry S Field, DSc, University of Massachusetts Medical School/Meyers Primary Care Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
July 22, 2009
First Submitted That Met QC Criteria
October 28, 2009
First Posted (Estimate)
October 29, 2009
Study Record Updates
Last Update Posted (Estimate)
April 24, 2014
Last Update Submitted That Met QC Criteria
April 23, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1R18HS017817 (U.S. AHRQ Grant/Contract)
- 13001 (Australasian Lung Trials Group)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adverse Outcomes
-
G. d'Annunzio UniversitySan Giovanni di Dio HospitalActive, not recruitingCearean Section Rate | Maternal Adverse Outcomes | Neonatal Adverse OutcomesItaly
-
First Affiliated Hospital Xi'an Jiaotong UniversityRecruitingAdverse Pregnancy OutcomesChina
-
University of MichiganWomen's Health Innovation FundCompletedPostpartum | Adverse Pregnancy OutcomesUnited States
-
Beth Israel Deaconess Medical CenterHarvard Risk Management Foundation; Dynamics Research Corporation; Armed Forces... and other collaboratorsCompletedAdverse Maternal and Neonatal OutcomesUnited States
-
University of Massachusetts, WorcesterAgency for Healthcare Research and Quality (AHRQ); Fallon ClinicCompletedAdverse Outcomes Post-hospital DischargeUnited States
-
Indiana UniversityNot yet recruitingAdverse Pregnancy Outcomes | Ovarian Aging
-
Portsmouth Hospitals NHS TrustRecruitingAdult Hospital Patients at Risk of Adverse OutcomesUnited Kingdom
-
Teachers College, Columbia UniversityColumbia UniversityRecruitingAdverse Childhood Experiences | Mental Health Outcomes | Perceived School Safety | Educational OutcomesUnited States
-
Medical College of WisconsinNot yet recruitingPregnancy | Adverse Pregnancy Outcomes | Preconception Care, Preconception Risk | Preconception EducationUnited States
-
Xiamen Innovax Biotech Co., LtdXiamen University; Xiamen Health and Medical Big Data CenterCompletedAutoimmune Diseases | Adverse Pregnancy OutcomesChina
Clinical Trials on Intervention 1: Electronic medical record (EMR)-based transitional care intervention
-
City of Hope Medical CenterNational Cancer Institute (NCI)WithdrawnHematopoietic and Lymphoid Cell Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
Nest GenomicsDana-Farber Cancer Institute; National Human Genome Research Institute (NHGRI)RecruitingHereditary Cancer Syndromes | Clinical Decision SupportUnited States
-
M.D. Anderson Cancer CenterRecruitingHematopoietic and Lymphoid Cell NeoplasmUnited States
-
University of Texas Southwestern Medical CenterEnrolling by invitationInflammatory Bowel Disease | Inflammatory Bowel Disease (IBD)United States
-
Fred Hutchinson Cancer CenterApex FoundationActive, not recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8United States
-
Mayo ClinicCompletedAdvanced Malignant Female Reproductive System NeoplasmUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingBreast Carcinoma | Congestive Heart Failure | CardiomyopathyUnited States
-
Ohio State University Comprehensive Cancer CenterRecruitingPancreatic AdenocarcinomaUnited States
-
Ohio State University Comprehensive Cancer CenterNational Comprehensive Cancer NetworkRecruitingMalignant Thoracic NeoplasmUnited States
-
Wake Forest University Health SciencesCompleted