NCT00599209

Brief Summary

The magnitude and intensity of medication use among our nation's 1.6 million nursing home residents matches or exceeds that of hospitalized patients. The residents of nursing homes are among the most frail patients in the population; the challenges of using medications in this setting are great, not only because of the physiologic declines and pharmacologic changes that occur with aging, but also because of the special clinical and social circumstances that often characterize nursing home care. In our previous research, we have determined that medication errors resulting in adverse drug events occur most often at the ordering and monitoring stages of pharmaceutical care. Clinical decision-support systems are clinical consultation systems that combine individual patient information with population statistics and scientific evidence to offer real-time information to health care providers. These systems have been found to improve the quality of medication prescribing in the hospital setting. In this study, we intend to determine the extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring for residents in the long-term care setting through a randomized trial. We will track the costs associated with this system and the system's impact on the productivity of providers. We will also assess the culture of U.S. nursing homes and the organization of the nursing home setting with respect to readiness to incorporate computerized provider order-entry with computer-based clinical decision support. Our project addresses specific areas that are of particular interest to AHRQ with special relevance to the delivery of high-quality care to a priority population--the frail elderly patient population residing in nursing homes. The project will assess the economic implications of health information technology in the nursing home environment that will be of interest to key stakeholders, including physicians, pharmacists, nurses, payers, policymakers, the nursing home industry, and pharmaceutical vendors to long-term care institutions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

August 4, 2011

Status Verified

August 1, 2011

Enrollment Period

4 years

First QC Date

January 11, 2008

Last Update Submit

August 2, 2011

Conditions

Patient SafetyPrescribing PracticesLaboratory Monitoring Practices

Outcome Measures

Primary Outcomes (1)

  • extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring

    two years

Secondary Outcomes (1)

  • costs associated with this system and the system's impact on the productivity of providers

    two years

Study Arms (2)

A - coded unit ID

EXPERIMENTAL

Nursing home units provided the CDS intervention

Other: clinical decision support

B - coded unit ID

NO INTERVENTION

Nursing home units not provided the CDS intervention

Interventions

clinical decision supportOTHER

CDS is provided to prescribers on intervention units upon ordering medication which offers advice on prescribing and monitoring practices

A - coded unit ID

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • prescriber at the study facility

You may not qualify if:

  • not a prescriber at the study facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meyers Primary Care Institute

Worcester, Massachusetts, 01605, United States

Location

Related Publications (2)

  • Subramanian S, Hoover S, Gilman B, Field TS, Mutter R, Gurwitz JH. Computerized physician order entry with clinical decision support in long-term care facilities: costs and benefits to stakeholders. J Am Geriatr Soc. 2007 Sep;55(9):1451-7. doi: 10.1111/j.1532-5415.2007.01304.x.

    PMID: 17915344BACKGROUND

  • Field TS, Rochon P, Lee M, Gavendo L, Baril JL, Gurwitz JH. Computerized clinical decision support during medication ordering for long-term care residents with renal insufficiency. J Am Med Inform Assoc. 2009 Jul-Aug;16(4):480-5. doi: 10.1197/jamia.M2981. Epub 2009 Apr 23.

    PMID: 19390107DERIVED

Study Officials

  • Jerry H Gurwitz, MD

    Meyers Primary Care Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2008

First Posted

January 23, 2008

Study Start

September 1, 2004

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

August 4, 2011

Record last verified: 2011-08

Locations

US(1)