Patient SafetyNCT00599209
Health Information Technology in the Nursing Home
A study testing clinical decision support in people with Patient Safety and Prescribing Practices, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Patient Safety, Prescribing Practices, Laboratory Monitoring Practices
- What is being tested?
- clinical decision support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Sep 2008
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- prescriber at the study facility
Who cannot join
- not a prescriber at the study facility
Trial locations and contacts
1 site in 1 country.
United States1 site
Meyers Primary Care Institute
Worcester, Massachusetts, 01605
About this study
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.
- Being tested
- clinical decision support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical decision supportOther
CDS is provided to prescribers on intervention units upon ordering medication which offers advice on prescribing and monitoring practices
| Study group | Role | What they receive |
|---|---|---|
| A - coded unit ID | Experimental | Nursing home units provided the CDS intervention Receives: Other: clinical decision support |
| B - coded unit ID | No intervention | Nursing home units not provided the CDS intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring
Measured: two years
Secondary outcomes (1)
costs associated with this system and the system's impact on the productivity of providers
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startSep 2004
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patient SafetyStudies 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
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Baycrest Centre for Geriatric Care, Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- Jerry H Gurwitz, MD, Principal investigator, Meyers Primary Care Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599209
- Sponsor's protocol ID
- 11390
- Other IDs
- 5R01HS015430
- Status last verified
- Aug 2011
- First submitted
- 11 Jan 2008
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17915344Field 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.
PubMed 19390107
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Information Technology in the Nursing Home
- ClinicalTrials.gov ID
- NCT00599209
- Acronym / sponsor ID
- 11390
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Baycrest Centre for Geriatric Care, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Sep 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 23 Jan 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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - coded unit ID | Experimental | Other: clinical decision supportNursing home units provided the CDS intervention |
| B - coded unit ID | No intervention | –Nursing home units not provided the CDS intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- prescriber at the study facility
Key exclusion criteria (1 listed)
- not a prescriber at the study facility
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 |
|---|---|---|
| clinical decision supportCDS is provided to prescribers on intervention units upon ordering medication which offers advice on prescribing and monitoring practices | Other | A - coded unit ID |
Primary outcome
extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring
Time frame: two years
1 secondary outcome
costs associated with this system and the system's impact on the productivity of providers
Time frame: two 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 4 Aug 2011.
- Background: PubMed 17915344Subramanian 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.
- Derived from this study: PubMed 19390107Field 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.
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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.
Jerry H Gurwitz, MD principal investigator
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 clinical decision support in people with Patient Safety and Prescribing Practices, 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 4 Aug 2011. 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?
extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00599209, which also lists 2 linked publications.
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 4 Aug 2011.