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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT00611091
Study groupRoleWhat they receive
IExperimentalIntervention 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
CNo interventionControl 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.

  1. rate of follow-up to an outpatient provider within 14 days of hospital discharge.

    Measured: 1 year 3 months

  2. prevalence of appropriate monitoring for selected high risk medications at 30 days from the time of hospital discharge.

    Measured: 1 year 3 months

  3. incidence of adverse drug events (ADEs) 45 days after discharge.

    Measured: 1 year 3 months

  4. rate of hospital readmission and emergency department (ED) within 30 days of discharge.

    Measured: 1 year 3 months

Secondary outcomes (2)
  1. 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

  2. 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.

  1. First posted8 Feb 2008 (estimated)
  2. Study startAug 2010
  3. Primary completionJun 2012
  4. Study completionSep 2013

Resources

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)
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

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.

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