HealthyNCT00122148
Can Vignettes Be Used to Improve Practice & Outcome
A study testing Feedback on provision of care in people with Healthy, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This is a pilot study to first measure the cross-sectional relationship between variations in physicians� vignette scores and aggregated scores of individual physicians� patient health outcomes; and second to (longitudinally) determine whether feedback of vignette scores improves physicians� clinical performance as… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthy
- What is being tested?
- Feedback on provision of care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jun 2006
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Physician at SF VAMC with panel of primary care patients
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Vignettes be Used to Improve Practice and Outcomes?
This is a pilot study to first measure the cross-sectional relationship between variations in physicians� vignette scores and aggregated scores of individual physicians� patient health outcomes; and second to (longitudinally) determine whether feedback of vignette scores improves physicians� clinical performance as measured by vignettes
Read the detailed description
- Study Design: Physicians will complete computerized vignettes for four conditions � diabetes, coronary artery diseases (CAD), chronic obstructive pulmonary disease (COPD), and depression. We will collect retrospective outcomes data and develop composite outcome measures for on two conditions, Diabetes and CAD. For the longitudinal analysis, only vignette data will be collected and fed back to providers. Feedback will consist of specific data on vignette outcome scores for the individual physicians and for the sites overall.
- Site Selection: Primary care clinics at 2 VAMCs
- Study Population and Sampling: We will enroll primary care physicians at 2 VAMCs. 30 consenting physicians will be prospectively randomized into two groups. One group will receive feedback of their vignette scores, and the other group will serve as control, receiving no feedback.
- Variables and Measurement Instruments: Computerized vignettes measuring clinical practice completed by the physicians for diabetes, CAD, COPD, and Depression and a composite health outcome measures from the medical records of these physicians� patients with diabetes and CAD.
- Data Collection Strategy and Timeline: Vignettes will be administered to all physicians at baseline, with feedback of scores 3 months later and readministration of vignettes 9 months thereafter to measure the trend in improvement. The composite outcome data will only be collected at baseline only.
- Data Analysis: The statistical analysis will compare the effects within the context of an analysis of covariance (ANCOVA) model. The analyte is the quality of care physicians give to patients with four common conditions. The relationship between vignette scores and patient outcomes will be modeled accounting for clustering effects. The prospective experimental design will be used to quantify possible differences between the intervention and control groups. The data will be analyzed using a three-way crossed, one-way nested ANCOVA model where the covariate is the baseline vignette score. This model can be used to look at case effects, by domain, level of training, and by site.
- Conditions
- Healthy
- Being tested
- Feedback on provision of care
- Keywords
- Quality of health care, Feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback on provision of careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Behavioral: Feedback on provision of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-specific patient care indicators, comparing results at six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startSep 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Sharad Jain, MD, Principal investigator, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122148
- Sponsor's protocol ID
- IIR 01-189
- Status last verified
- Aug 2006
- First submitted
- 18 Jul 2005
- Last updated
- 8 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Peabody JW, Luck J, Jain S, Bertenthal D, Glassman P. Assessing the accuracy of administrative data in health information systems. Med Care. 2004 Nov;42(11):1066-72. doi: 10.1097/00005650-200411000-00005.
PubMed 15586833
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Vignettes be Used to Improve Practice and Outcomes?
- ClinicalTrials.gov ID
- NCT00122148
- Acronym / sponsor ID
- IIR 01-189
- Conditions
- Healthy
- Keywords
- Quality of health care, Feedback
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 21 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.
This is a pilot study to first measure the cross-sectional relationship between variations in physicians� vignette scores and aggregated scores of individual physicians� patient health outcomes; and second to (longitudinally) determine whether feedback of vignette scores improves physicians� clinical performance as measured by vignettes
Detailed description
- Study Design: Physicians will complete computerized vignettes for four conditions � diabetes, coronary artery diseases (CAD), chronic obstructive pulmonary disease (COPD), and depression. We will collect retrospective outcomes data and develop composite outcome measures for on two conditions, Diabetes and CAD. For the longitudinal analysis, only vignette data will be collected and fed back to providers. Feedback will consist of specific data on vignette outcome scores for the individual physicians and for the sites overall.
- Site Selection: Primary care clinics at 2 VAMCs
- Study Population and Sampling: We will enroll primary care physicians at 2 VAMCs. 30 consenting physicians will be prospectively randomized into two groups. One group will receive feedback of their vignette scores, and the other group will serve as control, receiving no feedback.
- Variables and Measurement Instruments: Computerized vignettes measuring clinical practice completed by the physicians for diabetes, CAD, COPD, and Depression and a composite health outcome measures from the medical records of these physicians� patients with diabetes and CAD.
- Data Collection Strategy and Timeline: Vignettes will be administered to all physicians at baseline, with feedback of scores 3 months later and readministration of vignettes 9 months thereafter to measure the trend in improvement. The composite outcome data will only be collected at baseline only.
- Data Analysis: The statistical analysis will compare the effects within the context of an analysis of covariance (ANCOVA) model. The analyte is the quality of care physicians give to patients with four common conditions. The relationship between vignette scores and patient outcomes will be modeled accounting for clustering effects. The prospective experimental design will be used to quantify possible differences between the intervention and control groups. The data will be analyzed using a three-way crossed, one-way nested ANCOVA model where the covariate is the baseline vignette score. This model can be used to look at case effects, by domain, level of training, and by site.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: Feedback on provision of care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Physician at SF VAMC with panel of primary care patients
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 |
|---|---|---|
| Feedback on provision of care | Behavioural | 1 |
Primary outcome
Disease-specific patient care indicators, comparing results at six months.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2010.
- Results publication: PubMed 15586833Peabody JW, Luck J, Jain S, Bertenthal D, Glassman P. Assessing the accuracy of administrative data in health information systems. Med Care. 2004 Nov;42(11):1066-72. doi: 10.1097/00005650-200411000-00005.
Related trials for Healthy
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy
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.
Sharad Jain, MD principal investigator
San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback on provision of care in people with Healthy, 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: stopped early, as of the sponsor's last update on 8 Feb 2010. 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 was stopped early. Results are not available in the source record.
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?
Disease-specific patient care indicators, comparing results at six months.. 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 NCT00122148, which also lists 1 linked publication.
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 8 Feb 2010.