PneumoniaPhase 2NCT00120068
Improving Care for Nursing Home Pneumonia in NHCUs and Veterans' Homes
A Phase 2 study testing Nursing inservices and Academic detailing to MDs; concurrent review and feedback in people with Pneumonia, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Nursing Home Acquired Pneumonia (NHAP) causes excessive morbidity, mortality, hospitalization, and loss of function. At any given time, 1.1-2.5% of veterans who reside at nursing home care units (NHCUs) and State Veterans Homes (SVHs) are ill 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?
- Nursing inservices and Academic detailing to MDs; concurrent review and feedback
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Jul 2005
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residents of Florence and Walsenburg, Colorado State Veterans Homes
Who cannot join
- Residents within 48 hours of death or if in facility < 5 days
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Eastern Colorado Health Care System, Denver, CO
Denver, District of Columbia, 80220
About this study
Nursing Home Acquired Pneumonia (NHAP) causes excessive morbidity, mortality, hospitalization, and loss of function. At any given time, 1.1-2.5% of veterans who reside at nursing home care units (NHCUs) and State Veterans Homes (SVHs) are ill with pneumonia. Multi-faceted implementation of evidence-based guidelines has been shown to be feasible in the private sector. Retrospective studies demonstrate an association between guideline adherence and improved survival.
Read the detailed description
Background:
Nursing Home Acquired Pneumonia (NHAP) causes excessive morbidity, mortality, hospitalization, and loss of function. At any given time, 1.1-2.5% of veterans who reside at nursing home care units (NHCUs) and State Veterans Homes (SVHs) are ill with pneumonia. Multi-faceted implementation of evidence-based guidelines has been shown to be feasible in the private sector. Retrospective studies demonstrate an association between guideline adherence and improved survival.
Objectives:
Assess the feasibility of a QUERI-like strategy to translate the guidelines into practice at VA-affiliated nursing homes through focus groups, interviews, and a small intervention trial.
Methods:
Nursing staff focus groups, key informant interviews, and tests of academic detailing (educational outreach) scripts were conducted at five facilities. Based on the information gathered, the QUERI-like intervention was modified and tested at the Florence, Colorado SVH during one influenza season compared to no intervention at a nearby SVH. Forty random SVH nursing staff took an anonymous telephone survey of knowledge and attitudes about NHAP twice prior to the intervention. A second randomly selected group of CNAs and nurses took the survey after the intervention. Research assistants enrolled residents with NHAP, interviewed them and their nurses about their quality of life, assessed their function and reviewed their medical records. The intervention was multifaceted, including (1) a formative phase to tailor implementation and foster staff investment in process and outcomes, (2) institutional level change to facilitate immunization and use of appropriate antibiotics and tests; (3) interactive educational sessions to improve nursing assessment; and (4) academic detailing to physicians to impact diagnostic and prescribing practices. Data were analyzed by Template Analysis Technique for qualitative data; test-retest reliability of the knowledge and attitude survey; exploratory bivariate comparison of intervention delivery and uptake, process of care and outcomes between the intervention and control facilities.
Status:
Project work is ongoing.
- Conditions
- Pneumonia
- Being tested
- Nursing inservices, Academic detailing to MDs; concurrent review and feedback
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing inservicesBehavioural
Academic detailing to MDs; concurrent review and feedbackProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Nursing inservices; Procedure: Academic detailing to MDs; concurrent review and feedback |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startNov 2004
- Primary completionMar 2005
- Study completionJul 2005
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 PneumoniaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Evelyn A. Hutt, MD, Principal investigator, VA Eastern Colorado Health Care System, Denver, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120068
- Sponsor's protocol ID
- IIR 03-123
- Status last verified
- Feb 2007
- First submitted
- 1 Jul 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Levy C, Hutt E, Pointer L. Site of death among veterans living in Veterans Affairs nursing homes. J Am Med Dir Assoc. 2012 Mar;13(3):199-201. doi: 10.1016/j.jamda.2011.08.004. Epub 2011 Sep 25.
PubMed 21945536Hutt E, Ruscin JM, Corbett K, Radcliff TA, Kramer AM, Williams EM, Liebrecht D, Klenke W, Hartmann S. A multifaceted intervention to implement guidelines improved treatment of nursing home-acquired pneumonia in a state veterans home. J Am Geriatr Soc. 2006 Nov;54(11):1694-700. doi: 10.1111/j.1532-5415.2006.00937.x.
PubMed 17087696
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care for Nursing Home Pneumonia in NHCUs and Veterans' Homes
- ClinicalTrials.gov ID
- NCT00120068
- Acronym / sponsor ID
- IIR 03-123
- Conditions
- Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 14 Jul 2005 (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.
Nursing Home Acquired Pneumonia (NHAP) causes excessive morbidity, mortality, hospitalization, and loss of function. At any given time, 1.1-2.5% of veterans who reside at nursing home care units (NHCUs) and State Veterans Homes (SVHs) are ill with pneumonia. Multi-faceted implementation of evidence-based guidelines has been shown to be feasible in the private sector. Retrospective studies demonstrate an association between guideline adherence and improved survival.
Detailed description
Background:
Nursing Home Acquired Pneumonia (NHAP) causes excessive morbidity, mortality, hospitalization, and loss of function. At any given time, 1.1-2.5% of veterans who reside at nursing home care units (NHCUs) and State Veterans Homes (SVHs) are ill with pneumonia. Multi-faceted implementation of evidence-based guidelines has been shown to be feasible in the private sector. Retrospective studies demonstrate an association between guideline adherence and improved survival.
Objectives:
Assess the feasibility of a QUERI-like strategy to translate the guidelines into practice at VA-affiliated nursing homes through focus groups, interviews, and a small intervention trial.
Methods:
Nursing staff focus groups, key informant interviews, and tests of academic detailing (educational outreach) scripts were conducted at five facilities. Based on the information gathered, the QUERI-like intervention was modified and tested at the Florence, Colorado SVH during one influenza season compared to no intervention at a nearby SVH. Forty random SVH nursing staff took an anonymous telephone survey of knowledge and attitudes about NHAP twice prior to the intervention. A second randomly selected group of CNAs and nurses took the survey after the intervention. Research assistants enrolled residents with NHAP, interviewed them and their nurses about their quality of life, assessed their function and reviewed their medical records. The intervention was multifaceted, including (1) a formative phase to tailor implementation and foster staff investment in process and outcomes, (2) institutional level change to facilitate immunization and use of appropriate antibiotics and tests; (3) interactive educational sessions to improve nursing assessment; and (4) academic detailing to physicians to impact diagnostic and prescribing practices. Data were analyzed by Template Analysis Technique for qualitative data; test-retest reliability of the knowledge and attitude survey; exploratory bivariate comparison of intervention delivery and uptake, process of care and outcomes between the intervention and control facilities.
Status:
Project work is ongoing.
Study design
- Primary purpose
- Prevention
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Nursing inservices, Procedure: Academic detailing to MDs; concurrent review and feedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Residents of Florence and Walsenburg, Colorado State Veterans Homes
Key exclusion criteria (1 listed)
- Residents within 48 hours of death or if in facility < 5 days
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 |
|---|---|---|
| Nursing inservices | Behavioural | Arm 1 |
| Academic detailing to MDs; concurrent review and feedback | Procedure or surgery | Arm 1 |
Primary outcome
Not reported in the source record.
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 7 Apr 2015.
- Results publication: PubMed 21945536Levy C, Hutt E, Pointer L. Site of death among veterans living in Veterans Affairs nursing homes. J Am Med Dir Assoc. 2012 Mar;13(3):199-201. doi: 10.1016/j.jamda.2011.08.004. Epub 2011 Sep 25.
- Results publication: PubMed 17087696Hutt E, Ruscin JM, Corbett K, Radcliff TA, Kramer AM, Williams EM, Liebrecht D, Klenke W, Hartmann S. A multifaceted intervention to implement guidelines improved treatment of nursing home-acquired pneumonia in a state veterans home. J Am Geriatr Soc. 2006 Nov;54(11):1694-700. doi: 10.1111/j.1532-5415.2006.00937.x.
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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.
Evelyn A. Hutt, MD principal investigator
VA Eastern Colorado Health Care System, Denver, CO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nursing inservices and Academic detailing to MDs; concurrent review and feedback in people with Pneumonia, run by US Department of Veterans Affairs 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 7 Apr 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00120068, 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 7 Apr 2015.