Ischemic Heart DiseaseNCT00013104
Implementation of Ischemic Heart Disease Clinical Practice Guidelines
An observational study of Ischemic Heart Disease, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to design and evaluate targeted implementation strategies to fully integrate the VHA clinical practice guidelines for ischemic heart disease into VHA clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Heart Disease
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Sep 2002
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- None
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
About this study
The purpose of this study is to design and evaluate targeted implementation strategies to fully integrate the VHA clinical practice guidelines for ischemic heart disease into VHA clinical practice. Effectively implementing the guideline will enhance the quality, appropriateness, timeliness, and cost effectiveness of care delivered to veterans with ischemic heart disease.
Read the detailed description
Background:
The purpose of this study is to design and evaluate targeted implementation strategies to fully integrate the VHA clinical practice guidelines for ischemic heart disease into VHA clinical practice. Effectively implementing the guideline will enhance the quality, appropriateness, timeliness, and cost effectiveness of care delivered to veterans with ischemic heart disease.
Objectives:
The long-term objective of this study is to identify the best strategies for implementing the IHD guidelines to improve guideline adherence and provider acceptance. The specific objectives of the study are to: 1) describe the temporal aspects of guideline acceptance and adherence over three periods of time: pre-implementation, post-implementation of general strategies, and post- implementation of targeted strategies; 2) assess the relative effectiveness of targeted intervention strategies on guideline adherence; 3) identify the relationships among provider beliefs, attitudes, and their intentions to use guidelines; 4) identify the costs associated with implementation of general and targeted implementation strategies; and 5) describe provider satisfaction with targeted implementation strategies.
Methods:
Qualitative (focus groups, interviews with key informants) and quantitative methods (surveys, chart reviews) are used to address study objectives. A survey will be sent to providers to measure beliefs and attitudes that predict provider acceptance to clinical practice guidelines. Patient level data will be collected from reviews of charts from each facility. Based on provider focus groups we will design targeted strategies to overcome system barriers and address needs identified by providers to support clinical practice guideline implementation. A randomized trial will be conducted to assess the relative effectiveness of the targeted intervention strategies.
Status:
Data collection has ended. We are currently evaluating adherence data at all sites following introduction of case management to determine if the intervention increases adherence to the guidelines.
- Conditions
- Ischemic Heart Disease
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Audrey L. Nelson, RN PhD FAAN, Principal investigator, James A. Haley Veterans' Hospital, Tampa, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013104
- Sponsor's protocol ID
- VCR 99-014
- Status last verified
- Jan 2005
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
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
- Implementation of Ischemic Heart Disease Clinical Practice Guidelines
- ClinicalTrials.gov ID
- NCT00013104
- Acronym / sponsor ID
- VCR 99-014
- Conditions
- Ischemic Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Sep 2002 (actual)
- First posted
- 16 Mar 2001 (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 purpose of this study is to design and evaluate targeted implementation strategies to fully integrate the VHA clinical practice guidelines for ischemic heart disease into VHA clinical practice. Effectively implementing the guideline will enhance the quality, appropriateness, timeliness, and cost effectiveness of care delivered to veterans with ischemic heart disease.
Detailed description
Background:
The purpose of this study is to design and evaluate targeted implementation strategies to fully integrate the VHA clinical practice guidelines for ischemic heart disease into VHA clinical practice. Effectively implementing the guideline will enhance the quality, appropriateness, timeliness, and cost effectiveness of care delivered to veterans with ischemic heart disease.
Objectives:
The long-term objective of this study is to identify the best strategies for implementing the IHD guidelines to improve guideline adherence and provider acceptance. The specific objectives of the study are to: 1) describe the temporal aspects of guideline acceptance and adherence over three periods of time: pre-implementation, post-implementation of general strategies, and post- implementation of targeted strategies; 2) assess the relative effectiveness of targeted intervention strategies on guideline adherence; 3) identify the relationships among provider beliefs, attitudes, and their intentions to use guidelines; 4) identify the costs associated with implementation of general and targeted implementation strategies; and 5) describe provider satisfaction with targeted implementation strategies.
Methods:
Qualitative (focus groups, interviews with key informants) and quantitative methods (surveys, chart reviews) are used to address study objectives. A survey will be sent to providers to measure beliefs and attitudes that predict provider acceptance to clinical practice guidelines. Patient level data will be collected from reviews of charts from each facility. Based on provider focus groups we will design targeted strategies to overcome system barriers and address needs identified by providers to support clinical practice guideline implementation. A randomized trial will be conducted to assess the relative effectiveness of the targeted intervention strategies.
Status:
Data collection has ended. We are currently evaluating adherence data at all sites following introduction of case management to determine if the intervention increases adherence to the guidelines.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- None
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
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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.
Audrey L. Nelson, RN PhD FAAN principal investigator
James A. Haley Veterans' Hospital, Tampa, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, 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 0 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.
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?
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.