PneumoniaNCT01068548
Reducing Length of Stay for Veterans Hospitalized With Pneumonia
A study testing reminder in people with Pneumonia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This is a pilot study to implement a computer based intervention to safely reduce length of hospital stay and time to conversion to oral antibiotics for patients with pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- reminder
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient hospitalized with outpatient-acquired pneumonia at South Texas Veterans Health Care System during study period.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229
About this study
This is a pilot study to implement a computer based intervention to safely reduce length of hospital stay and time to conversion to oral antibiotics for patients with pneumonia.
Read the detailed description
Pneumonia is the 3rd leading medical discharge diagnosis in the VA, and although significant attention has been focused improving pneumonia process of care measures less attention has been paid to resource use, specifically length of hospital stay (LOS). Based on our preliminary analyses LOS is considerably higher in the VA versus other non-federal hospitals. Major causes of this increased length of stay are delayed conversion from intravenous (IV) to oral therapy upon reaching clinical stability, and not discharging on the same day as the conversion to oral antibiotics. Therefore additional interventions are needed to decrease the LOS for veterans hospitalized with pneumonia in the VA system.
The long-term goal of this research is to develop sustainable approaches to reduce LOS and thereby improve efficiency of care in veterans admitted with pneumonia to VA Medical Centers through the implementation of computerized clinical stability reminders. Although prior research, including our own, has demonstrated moderate effectiveness of resource intense methods to implement this criteria (e.g., utilization management nurses) new, more effective and less resource intense, strategies are needed to accomplish this long-term goal. The design of the computerized clinical stability reminder, the likely range in magnitude of response to implementation of the intervention, logistics of data collection, data management, and development of study instruments are needed prior to commencement of a more definitive, multi-center study. Hence, we are seeking funding to conduct the necessary pilot work needed to successfully design and implement a large multi-center randomized intervention study to reduce LOS for veterans with pneumonia.
Our objectives include: 1) Develop and perform a local pilot implementation of an inpatient clinical reminder within Computerized Patient Record System to identify when veterans hospitalized with pneumonia are clinically stable and ready for conversion form IV to oral antibiotic therapy and hospital discharge. 2) Test measures of the constructs of the Theory of Planned Behavior (TPB) in VA medicine ward physicians and determine if they correlate with intention and discharge behavior. 3) Establish a collaborative of VA Medical Centers for the purpose of developing a larger scale implementation study to use evidence-based criteria to reduce LOS for patients hospitalized with pneumonia. 4) Prepare a VA HSR\&D IIR grant proposal for a cluster randomized controlled trial of a clinical reminder intervention to reduce length of hospital stay among veterans hospitalized with pneumonia.
The proposed pilot study will develop and implement a computerized-based inpatient clinical reminder to assist physicians with appropriate conversion from IV to oral antibiotics and discharge on the same day for veterans hospitalized with pneumonia. In addition to creating and implementing the clinical reminder at single tertiary care VA teaching hospital, we will examine physician attitudes and potential barriers/facilitators to the introduction of inpatient clinical reminders using the theoretical model of TPB. We will also assemble a cohort of VA medical centers with investigators and chiefs of medical staff willing to participate in a multi-center randomized control trial of this intervention. The results from this pilot study will be used to plan a larger, more definitive multi-center trial of this inpatient clinical reminder with the goal of significantly reducing LOS for veterans hospitalized with pneumonia in the VA health care system.
- Conditions
- Pneumonia
- Being tested
- reminder
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reminderOther
computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | No intervention | pre-implementation of computer based intervention |
| Arm 2 | Experimental | post-implementation of computer based length of stay clinical reminder Receives: Other: reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay
Measured: 1 month
Secondary outcomes (1)
Time to Change to Oral Antibiotics
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study startFeb 2011
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Eric Michael Mortensen, MD MSc BA, Principal investigator, South Texas Health Care System, San Antonio, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068548
- Sponsor's protocol ID
- PPO 09-288
- Status last verified
- Jan 2019
- First submitted
- 8 Feb 2010
- Last updated
- 9 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Length of Stay for Veterans Hospitalized With Pneumonia
- ClinicalTrials.gov ID
- NCT01068548
- Acronym / sponsor ID
- PPO 09-288
- Conditions
- Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Feb 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 15 Feb 2010 (estimated)
- Results
- Posted 17 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to implement a computer based intervention to safely reduce length of hospital stay and time to conversion to oral antibiotics for patients with pneumonia.
Detailed description
Pneumonia is the 3rd leading medical discharge diagnosis in the VA, and although significant attention has been focused improving pneumonia process of care measures less attention has been paid to resource use, specifically length of hospital stay (LOS). Based on our preliminary analyses LOS is considerably higher in the VA versus other non-federal hospitals. Major causes of this increased length of stay are delayed conversion from intravenous (IV) to oral therapy upon reaching clinical stability, and not discharging on the same day as the conversion to oral antibiotics. Therefore additional interventions are needed to decrease the LOS for veterans hospitalized with pneumonia in the VA system.
The long-term goal of this research is to develop sustainable approaches to reduce LOS and thereby improve efficiency of care in veterans admitted with pneumonia to VA Medical Centers through the implementation of computerized clinical stability reminders. Although prior research, including our own, has demonstrated moderate effectiveness of resource intense methods to implement this criteria (e.g., utilization management nurses) new, more effective and less resource intense, strategies are needed to accomplish this long-term goal. The design of the computerized clinical stability reminder, the likely range in magnitude of response to implementation of the intervention, logistics of data collection, data management, and development of study instruments are needed prior to commencement of a more definitive, multi-center study. Hence, we are seeking funding to conduct the necessary pilot work needed to successfully design and implement a large multi-center randomized intervention study to reduce LOS for veterans with pneumonia.
Our objectives include: 1) Develop and perform a local pilot implementation of an inpatient clinical reminder within Computerized Patient Record System to identify when veterans hospitalized with pneumonia are clinically stable and ready for conversion form IV to oral antibiotic therapy and hospital discharge. 2) Test measures of the constructs of the Theory of Planned Behavior (TPB) in VA medicine ward physicians and determine if they correlate with intention and discharge behavior. 3) Establish a collaborative of VA Medical Centers for the purpose of developing a larger scale implementation study to use evidence-based criteria to reduce LOS for patients hospitalized with pneumonia. 4) Prepare a VA HSR\&D IIR grant proposal for a cluster randomized controlled trial of a clinical reminder intervention to reduce length of hospital stay among veterans hospitalized with pneumonia.
The proposed pilot study will develop and implement a computerized-based inpatient clinical reminder to assist physicians with appropriate conversion from IV to oral antibiotics and discharge on the same day for veterans hospitalized with pneumonia. In addition to creating and implementing the clinical reminder at single tertiary care VA teaching hospital, we will examine physician attitudes and potential barriers/facilitators to the introduction of inpatient clinical reminders using the theoretical model of TPB. We will also assemble a cohort of VA medical centers with investigators and chiefs of medical staff willing to participate in a multi-center randomized control trial of this intervention. The results from this pilot study will be used to plan a larger, more definitive multi-center trial of this inpatient clinical reminder with the goal of significantly reducing LOS for veterans hospitalized with pneumonia in the VA health care system.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | No intervention | –pre-implementation of computer based intervention |
| Arm 2 | Experimental | Other: reminderpost-implementation of computer based length of stay clinical reminder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient hospitalized with outpatient-acquired pneumonia at South Texas Veterans Health Care System during study period.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| remindercomputer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines | Other | Arm 2 |
Primary outcome
Length of Hospital Stay
Time frame: 1 month
1 secondary outcome
Time to Change to Oral Antibiotics
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Eric Michael Mortensen, MD MSc BA principal investigator
South Texas Health Care System, San Antonio, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reminder in people with Pneumonia, run by VA Office of Research and Development 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 9 Jan 2019. 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?
Yes. Results are posted in the registry (first posted 17 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Length of Hospital Stay (time frame: 1 month). 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 9 Jan 2019.