Primary CareNCT00914485
Using Multimedia Patient Feedback to Reduce Disparities in VA Healthcare
A study testing Provider Communication Skills Training in people with Primary Care, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
The proposed research will provide important insight into two serious problems for veterans' healthcare: 1) mixed effectiveness of communication improvement interventions in the VA to date, and 2) persistence of racial/ethnic disparities in VA healthcare. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Care
- What is being tested?
- Provider Communication Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2009to Mar 2013
- 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
- Any patient included in the regular panel of a participating physician at either study site who is a returning patient for that physician. Since 2 of the patient perceptual measures included require the pre-existence of a relationship with a specific physician, we will only enroll patients who have been seen by their physician before.
Who cannot join
- Physical disabilities that prohibit unassisted participation in research protocol:
- legal blindness
- dementia
- severe post-traumatic stress disorder
- schizophrenic disorder
- Alzheimer's disease
Show all 9Show fewer
- bipolar disorder
- and severe anxiety and/or mood disorders (must be documented in patient's medical record or attested to by patient, physician or charge nurse).
- Also, no patients new to VA primary care or to a given participating physician will be enrolled.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
Southeast Louisiana Veterans Health Care System, New Orleans, LA
New Orleans, Louisiana, 70112
About this study
The proposed research will provide important insight into two serious problems for veterans' healthcare: 1) mixed effectiveness of communication improvement interventions in the VA to date, and 2) persistence of racial/ethnic disparities in VA healthcare.
Read the detailed description
The proposed research will provide important insight into two serious problems for veterans' healthcare: 1) mixed effectiveness of communication improvement interventions in the VA to date, and 2) persistence of racial/ethnic disparities in VA healthcare. We have identified 4 "best acts" of physician communication that patients believe to be most important in a clinical interaction. We propose to develop and evaluate a physician communication intervention that focuses specifically on these acts. In addition, our abundance of pilot study data from patients of various races/ethnicities enables us to create an intervention applicable to communication that spans patient race/ethnicity. Evaluating this intervention with physicians and patients in 2 independent VA primary care settings will help determine whether a patient-driven communication focus that incorporates input from patients of varied race/ethnicity can help "close the gap" in health outcomes between white and minority veterans.
We aim to (1) demonstrate the efficacy of using "best acts" of physician communication as content for an intervention to improve physician communication skills overall and reduce variation in communication with white versus racial/ethnic minority patients, and (2) assess the impact of patient experiences of "best acts" on patients' perceptual and behavioral outcomes.
We have collected data from over 200 primary care patients as they viewed a video of themselves and their physician interacting during a clinic visit. From these data, we are developing an educational intervention for physicians that focuses specifically on the 4 "best acts" we have identified. Scripts of the 4 "best acts" will be developed, and standardized patients at Baylor College of Medicine will perform the acts, which will be video recorded. We will then conduct a 2-site longitudinal observational study of 16 primary care physicians (8 at each site) and 36 patients of each physician. At the first site at 3-month intervals, physicians will attend an instruction session consisting of viewing a video of one best act and participating in group discussion, role-playing re-enactment of the act, and formulation of bulleted "take-away" points to facilitate subsequent recall. Once completed, the sequence of sessions will occur at the second site. At both sites, clinical interactions of participating physicians and patients will be audio recorded, and audio recordings will be analyzed for frequency of occurrence of the 4 "best acts." After each study visit, each patient will complete validated surveys measuring patients' perceptions of their physician on 4 affective dimensions known to impact patients' subsequent perceptual and behavioral outcomes. Efficacy will be assessed across patient demographics.
- Conditions
- Primary Care
- Being tested
- Provider Communication Skills Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider Communication Skills TrainingBehavioural
Consists of 4 separate 1-hour sessions, 1 per "best act," in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity.
| Study group | Role | What they receive |
|---|---|---|
| Provider Communication Skills Training | Other | Provider clinical communication training intervention Receives: Behavioral: Provider Communication Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Provider Use of Best Acts From Baseline to Post-Intervention
Mean per-patient use of "best acts" learned during provider communication skills intervention, post-intervention minus baseline.
Measured: Baseline, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2013
- Study completionMar 2013
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 Primary CareStudies 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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- P. Adam Kelly, PhD MBA BS, Principal investigator, Southeast Louisiana Veterans Health Care System, New Orleans, LA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914485
- Sponsor's protocol ID
- IIR 07-194
- Status last verified
- Apr 2015
- First submitted
- 3 Jun 2009
- Last updated
- 27 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Multimedia Patient Feedback to Reduce Disparities in VA Healthcare
- ClinicalTrials.gov ID
- NCT00914485
- Acronym / sponsor ID
- IIR 07-194
- Conditions
- Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Dec 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 5 Jun 2009 (estimated)
- Results
- Posted 9 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed research will provide important insight into two serious problems for veterans' healthcare: 1) mixed effectiveness of communication improvement interventions in the VA to date, and 2) persistence of racial/ethnic disparities in VA healthcare.
Detailed description
The proposed research will provide important insight into two serious problems for veterans' healthcare: 1) mixed effectiveness of communication improvement interventions in the VA to date, and 2) persistence of racial/ethnic disparities in VA healthcare. We have identified 4 "best acts" of physician communication that patients believe to be most important in a clinical interaction. We propose to develop and evaluate a physician communication intervention that focuses specifically on these acts. In addition, our abundance of pilot study data from patients of various races/ethnicities enables us to create an intervention applicable to communication that spans patient race/ethnicity. Evaluating this intervention with physicians and patients in 2 independent VA primary care settings will help determine whether a patient-driven communication focus that incorporates input from patients of varied race/ethnicity can help "close the gap" in health outcomes between white and minority veterans.
We aim to (1) demonstrate the efficacy of using "best acts" of physician communication as content for an intervention to improve physician communication skills overall and reduce variation in communication with white versus racial/ethnic minority patients, and (2) assess the impact of patient experiences of "best acts" on patients' perceptual and behavioral outcomes.
We have collected data from over 200 primary care patients as they viewed a video of themselves and their physician interacting during a clinic visit. From these data, we are developing an educational intervention for physicians that focuses specifically on the 4 "best acts" we have identified. Scripts of the 4 "best acts" will be developed, and standardized patients at Baylor College of Medicine will perform the acts, which will be video recorded. We will then conduct a 2-site longitudinal observational study of 16 primary care physicians (8 at each site) and 36 patients of each physician. At the first site at 3-month intervals, physicians will attend an instruction session consisting of viewing a video of one best act and participating in group discussion, role-playing re-enactment of the act, and formulation of bulleted "take-away" points to facilitate subsequent recall. Once completed, the sequence of sessions will occur at the second site. At both sites, clinical interactions of participating physicians and patients will be audio recorded, and audio recordings will be analyzed for frequency of occurrence of the 4 "best acts." After each study visit, each patient will complete validated surveys measuring patients' perceptions of their physician on 4 affective dimensions known to impact patients' subsequent perceptual and behavioral outcomes. Efficacy will be assessed across patient demographics.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Provider Communication Skills Training | Other | Behavioral: Provider Communication Skills TrainingProvider clinical communication training intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient included in the regular panel of a participating physician at either study site who is a returning patient for that physician. Since 2 of the patient perceptual measures included require the pre-existence of a relationship with a specific physician, we will only enroll patients who have been seen by their physician before.
Key exclusion criteria (9 listed)
- Physical disabilities that prohibit unassisted participation in research protocol:
- Also, no patients new to VA primary care or to a given participating physician will be enrolled.
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 |
|---|---|---|
| Provider Communication Skills TrainingConsists of 4 separate 1-hour sessions, 1 per "best act," in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity. | Behavioural | Provider Communication Skills Training |
Primary outcome
Change in Provider Use of Best Acts From Baseline to Post-Intervention
Time frame: Baseline, 18 months
Mean per-patient use of "best acts" learned during provider communication skills intervention, post-intervention minus baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
- 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.
P. Adam Kelly, PhD MBA BS principal investigator
Southeast Louisiana Veterans Health Care System, New Orleans, LA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider Communication Skills Training in people with Primary Care, run by US Department of Veterans Affairs at 2 sites 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 9 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 27 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 2 sites 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 9 Mar 2015). 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?
Change in Provider Use of Best Acts From Baseline to Post-Intervention (time frame: Baseline, 18 months). 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 27 Apr 2015.