Adverse Outcomes Post-hospital DischargeNCT00611091
Improving Posthospital Medication Management of Older Adults Through Health IT
A study testing Electronic delivery of enhanced discharge information to the ambulatory physician in people with Adverse Outcomes Post-hospital Discharge, 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 and is increased for elders upon transition from the hospital to the ambulatory setting. In this application, we describe an effort to build on our extensive experience in medication safety and HIT-based medication management to… 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 Post-hospital Discharge
- What is being tested?
- Electronic delivery of enhanced discharge information to the ambulatory physician
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,077 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Sep 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 old, member of the study site health plan, hospitalized at the study site hospital, discharged to an outpatient provider at the study site health plan clinic
Who cannot join
- does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
St Vincent's Hospital
Worcester, Massachusetts, 01608
About this study
The incidence of drug-induced injury is high in the ambulatory geriatric population and is increased for elders upon transition from the hospital to the ambulatory setting. In this application, we describe an effort to build on our extensive experience in medication safety and HIT-based medication management to respond to the AHRQ RFA entitled Ambulatory Safety and Quality Program: Improving Quality through Clinician Use of Health IT (RFA-HS-07-006). In this study, we propose to develop and evaluate the value of an enhanced, HIT-based transitional care intervention superimposed on the ambulatory electronic medical record (EMR) to improve the quality and safety of medication management, focusing particularly on the transition from the inpatient to the ambulatory setting for older adults with multiple comorbid conditions who are prescribed high risk medications. We propose a randomized controlled trial of a HIT-based transitional care intervention with enhanced medication and therapeutic monitoring alerts to improve the quality and safety of patient monitoring and medication management. We postulate that the efficient and coordinated delivery of actionable health information to the clinician via use of HIT in the ambulatory setting can improve medication safety for the growing geriatric population. The specific aims for this study are to evaluate, among a population of older adults discharged from the hospital, the impact of an enhanced discharge information system initiated upon transition to the ambulatory setting: (1) on the rate of follow-up by an outpatient provider within 14 days of hospital discharge; (2) on the prevalence of appropriate monitoring for selected high risk medications at 30 days from the time of hospital discharge; (3) on the incidence of adverse drug events (ADEs) 30 days after discharge; and (4) on the rate of emergency department visits and hospital readmission within 30 days of discharge. A secondary aim for this study is to determine costs directly related to the development and installation of the HIT-based transitional care intervention. This research allows for the examination of an integrated HIT intervention on the quality of follow-up, outpatient clinician workflow, occurrence of ADEs, and health care utilization to gain insights into the effective use of clinical alerts and coordinated delivery of actionable information to outpatient clinicians in the management of ambulatory elderly patients subsequent to hospital discharge.
- Conditions
- Adverse Outcomes Post-hospital Discharge
- Being tested
- Electronic delivery of enhanced discharge information to the ambulatory physician
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic delivery of enhanced discharge information to the ambulatory physicianOther
Also called HIT
Follow-up appointment needs/plans
Electronic delivery of enhanced discharge information to the ambulatory physicianOther
Also called HIT
Laboratory follow-up needs
Electronic delivery of enhanced discharge information to the ambulatory physicianOther
Also called HIT
New medications
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Intervention Group - (receive intervention) randomized at patient level - includes all health plan members, aged 65+, hospitalized at the study site hospital and discharged to an outpatient health plan clinic provider. Receives: Other: Electronic delivery of enhanced discharge information to the ambulatory physician |
| C | No intervention | Control Group - (do not receive intervention) randomized at patient level - includes all health plan members, aged 65+, hospitalized at the study site hospital and discharged to an outpatient health plan clinic provider. |
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 14 days of hospital discharge.
Measured: 1 year 3 months
prevalence of appropriate monitoring for selected high risk medications at 30 days from the time of hospital discharge.
Measured: 1 year 3 months
incidence of adverse drug events (ADEs) 45 days after discharge.
Measured: 1 year 3 months
rate of hospital readmission and emergency department (ED) within 30 days of discharge.
Measured: 1 year 3 months
Secondary outcomes (2)
assess whether a HIT-based transitional care intervention is more effective in subgroups of patients (by level of comorbidity, number of medications, and use of specific high risk medications)
Measured: 1 year 3 months
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 posted8 Feb 2008 (estimated)
- Study startAug 2010
- Primary completionJun 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Outcomes Post-hospital DischargeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,077 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Fallon Clinic, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Jerry Gurwitz, University of Massachusetts, Worcester
- Investigators
- Jerry H Gurwitz, MD, Principal investigator, Meyers Primary Care Institute/University of Massachusetts Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611091
- Sponsor's protocol ID
- 12603
- Other IDs
- 1R18HS017203
- Status last verified
- Sep 2013
- First submitted
- 25 Jan 2008
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Posthospital Medication Management of Older Adults Through Health IT
- ClinicalTrials.gov ID
- NCT00611091
- Acronym / sponsor ID
- 12603
- Conditions
- Adverse Outcomes Post-hospital Discharge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,077 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Fallon Clinic, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Aug 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 Feb 2008 (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 and is increased for elders upon transition from the hospital to the ambulatory setting. In this application, we describe an effort to build on our extensive experience in medication safety and HIT-based medication management to respond to the AHRQ RFA entitled Ambulatory Safety and Quality Program: Improving Quality through Clinician Use of Health IT (RFA-HS-07-006). In this study, we propose to develop and evaluate the value of an enhanced, HIT-based transitional care intervention superimposed on the ambulatory electronic medical record (EMR) to improve the quality and safety of medication management, focusing particularly on the transition from the inpatient to the ambulatory setting for older adults with multiple comorbid conditions who are prescribed high risk medications. We propose a randomized controlled trial of a HIT-based transitional care intervention with enhanced medication and therapeutic monitoring alerts to improve the quality and safety of patient monitoring and medication management. We postulate that the efficient and coordinated delivery of actionable health information to the clinician via use of HIT in the ambulatory setting can improve medication safety for the growing geriatric population. The specific aims for this study are to evaluate, among a population of older adults discharged from the hospital, the impact of an enhanced discharge information system initiated upon transition to the ambulatory setting: (1) on the rate of follow-up by an outpatient provider within 14 days of hospital discharge; (2) on the prevalence of appropriate monitoring for selected high risk medications at 30 days from the time of hospital discharge; (3) on the incidence of adverse drug events (ADEs) 30 days after discharge; and (4) on the rate of emergency department visits and hospital readmission within 30 days of discharge. A secondary aim for this study is to determine costs directly related to the development and installation of the HIT-based transitional care intervention. This research allows for the examination of an integrated HIT intervention on the quality of follow-up, outpatient clinician workflow, occurrence of ADEs, and health care utilization to gain insights into the effective use of clinical alerts and coordinated delivery of actionable information to outpatient clinicians in the management of ambulatory elderly patients subsequent to hospital discharge.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Other: Electronic delivery of enhanced discharge information to the ambulatory physicianIntervention Group - (receive intervention) randomized at patient level - includes all health plan members, aged 65+, hospitalized at the study site hospital and discharged to an outpatient health plan clinic provider. |
| C | No intervention | –Control Group - (do not receive intervention) randomized at patient level - includes all health plan members, aged 65+, hospitalized at the study site hospital and discharged to an outpatient health plan clinic provider. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65+ years old, member of the study site health plan, hospitalized at the study site hospital, discharged to an outpatient provider at the study site health plan clinic
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 |
|---|---|---|
| Electronic delivery of enhanced discharge information to the ambulatory physicianAlso: HITFollow-up appointment needs/plans | Other | I |
| Electronic delivery of enhanced discharge information to the ambulatory physicianAlso: HITLaboratory follow-up needs | Other | I |
| Electronic delivery of enhanced discharge information to the ambulatory physicianAlso: HITNew medications | Other | I |
Primary outcome
rate of follow-up to an outpatient provider within 14 days of hospital discharge.
Time frame: 1 year 3 months
prevalence of appropriate monitoring for selected high risk medications at 30 days from the time of hospital 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 hospital readmission and emergency department (ED) within 30 days of discharge.
Time frame: 1 year 3 months
2 secondary outcomes
assess whether a HIT-based transitional care intervention is more effective in subgroups of patients (by level of comorbidity, number of medications, and use of specific high risk medications)
Time frame: 1 year 3 months
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 16 Sep 2013.
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.
Jerry H Gurwitz, MD principal investigator
Meyers Primary Care Institute/University of Massachusetts Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic delivery of enhanced discharge information to the ambulatory physician in people with Adverse Outcomes Post-hospital Discharge, 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 1 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 16 Sep 2013. 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 14 days of hospital 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 16 Sep 2013.