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

Improving Posthospital Medication Management of Older Adults Through Health IT

This study has been completed.
Sponsor:
Collaborators:
Fallon Clinic
Information provided by (Responsible Party):
Jerry Gurwitz, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00611091
First received: January 25, 2008
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Adverse Outcomes Post-hospital Discharge
Other: Electronic delivery of enhanced discharge information to the ambulatory physician

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Improving Posthospital Medication Management of Older Adults Through Health IT

Resource links provided by NLM:


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

Primary Outcome Measures:
  • rate of follow-up to an outpatient provider within 14 days of hospital 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 hospital 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 hospital readmission and emergency department (ED) within 30 days of discharge. [ Time Frame: 1 year 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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: 5077
Study Start Date: August 2010
Study Completion Date: September 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
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.
Other: Electronic delivery of enhanced discharge information to the ambulatory physician
Follow-up appointment needs/plans
Other Name: HIT
Other: Electronic delivery of enhanced discharge information to the ambulatory physician
Laboratory follow-up needs
Other Name: HIT
Other: Electronic delivery of enhanced discharge information to the ambulatory physician
New medications
Other Name: HIT
No Intervention: C
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.

  Eligibility

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

Inclusion Criteria:

  • 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

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: NCT00611091

Locations
United States, Massachusetts
St Vincent's Hospital
Worcester, Massachusetts, United States, 01608
Sponsors and Collaborators
University of Massachusetts, Worcester
Fallon Clinic
Investigators
Principal Investigator: Jerry H Gurwitz, MD Meyers Primary Care Institute/University of Massachusetts Medical School
  More Information

No publications provided

Responsible Party: Jerry Gurwitz, Chief, Division of Geriatric Medicine, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00611091     History of Changes
Other Study ID Numbers: 12603, 1R18HS017203
Study First Received: January 25, 2008
Last Updated: September 12, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 25, 2014