Adverse OutcomesRAMPAGEIINCT01004328
Using Health Information Technology (HIT) to Improve Transitions of Complex Elderly Patients From Skilled Nursing Facility (SNF) to Home
A study testing Intervention 1: Electronic medical record (EMR)-based transitional care intervention in people with Adverse Outcomes, run by University of Massachusetts, Worcester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adverse Outcomes
- What is being tested?
- Intervention 1: Electronic medical record (EMR)-based transitional care intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 626 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- Does not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Adverse Outcomes
- Being tested
- Intervention 1: Electronic medical record (EMR)-based transitional care intervention
- Keywords
- patient safety, care transitions, therapeutic monitoring, skilled nursing facilities, Adverse outcomes after discharge from a SNF to home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1: Electronic medical record (EMR)-based transitional care interventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group 1 | Experimental | All participants Receives: Other: Intervention 1: Electronic medical record (EMR)-based transitional care intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of follow-up to an outpatient provider within 21 days of SNF discharge.
Measured: 1 year 3 months
Prevalence of appropriate monitoring for selected high risk medications at 30 days from the time of SNF discharge.
Measured: 1 year 3 months
Incidence of adverse drug events (ADEs) 45 days after discharge.
Measured: 1 year 3 months
Rate of SNF readmission and emergency department (ED) within 30 days of discharge.
Measured: 1 year 3 months
Secondary outcomes (1)
Determine costs directly related to the development and installation of the HIT-based transitional care intervention
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startApr 2011
- Primary completionJun 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse OutcomesStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 626 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terry Field, University of Massachusetts, Worcester
- Investigators
- Terry S Field, DSc, Principal investigator, University of Massachusetts Medical School/Meyers Primary Care Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004328
- Sponsor's protocol ID
- 1R18HS017817
- Other IDs
- 13001
- Acronym
- RAMPAGEII
- Status last verified
- Apr 2014
- First submitted
- 22 Jul 2009
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using HIT to Improve Transitions of Complex Elderly Patients From SNF to Home
- ClinicalTrials.gov ID
- NCT01004328
- Acronym / sponsor ID
- RAMPAGEII / 1R18HS017817
- Conditions
- Adverse Outcomes
- Keywords
- patient safety, care transitions, therapeutic monitoring, skilled nursing facilities, Adverse outcomes after discharge from a SNF to home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 626 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 29 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group 1 | Experimental | Other: Intervention 1: Electronic medical record (EMR)-based transitional care interventionAll participants |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention 1: Electronic medical record (EMR)-based transitional care interventionElectronic 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 | Other | Intervention Group 1 |
Primary outcome
Rate of follow-up to an outpatient provider within 21 days of SNF discharge.
Time frame: 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
Incidence of adverse drug events (ADEs) 45 days after discharge.
Time frame: 1 year 3 months
Rate of SNF readmission and emergency department (ED) within 30 days of discharge.
Time frame: 1 year 3 months
1 secondary outcome
Determine costs directly related to the development and installation of the HIT-based transitional care intervention
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry S Field, DSc principal investigator
University of Massachusetts Medical School/Meyers Primary Care Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1: Electronic medical record (EMR)-based transitional care intervention in people with Adverse Outcomes, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of follow-up to an outpatient provider within 21 days of SNF discharge. (time frame: 1 year 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.