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HypertensionNCT00439816

Veteran Preference For Group Visits and Its Effect on Hypertension Outcomes

A study testing Group Visits in people with Hypertension and Blood Pressure, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine racial/ethnic differences in preference for group visits in veterans with poorly controlled hypertension (State 2 hypertension) and determine the effect of group visits on health outcomes among veterans with poorly controlled hypertension. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Hypertension, Blood Pressure
What is being tested?
Group Visits
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteUnited States
Study dates
Feb 2005to Sep 2007
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Caucasian and African American men and women, age 21 and older with stage 2 hypertension presently seen in the RHJ VAMC Primary Care.

Who cannot join

  • Primary diagnosis of substance abuse or dependence, current pregnancy, dementia, inability to speak English, or controlled psychiatric diagnoses.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Ralph H. Johnson VA Medical Center, Charleston, SC

    Charleston, South Carolina, 29401-5799

Other trials in United States

About this study

To determine racial/ethnic differences in preference for group visits in veterans with poorly controlled hypertension (State 2 hypertension) and determine the effect of group visits on health outcomes among veterans with poorly controlled hypertension.

Read the detailed description

Research Design: Randomized clinical trial to assess veterans� preference for group visits and the effect of group visits on hypertension outcomes. Hypertension affects close to 50 million persons in the U.S., with prevalence, severity, and impact being increased in non-white Americans 1.Despite recent clinical trials associating successful antihypertensive therapy with reductions in stroke incidence, myocardial infarction, and heart failure, control rates remain below the Healthy People 2010 goal of 50%. The importance of blood pressure control is recognized within the VA as two of the conditions selected for QUERI include ischemic heart disease and congestive heart disease, and blood pressure control is a performance measure for every VAMC 2. Clinical trials have shown that blood pressure control can be achieved in most patients with hypertension 3. When physicians fail to prescribe lifestyle modification, adequate doses of antihypertensive medications, or appropriate drugs, blood pressure control may not be achieved.1 In the course of a 15-30 minute visit with a primary care physician, lifestyle modifications may not be addressed and inertia may prevent rapid adjustments in medication dosages or changes in drug combinations. 4. The outpatient group visit model is an intervention developed by managed care organizations to capitalize on economy of scale. It has significant points of departure from the existing health care delivery system design, which focuses on acute care. The outpatient group visit model also fosters a more collaborative effort between the physician and patient, introduces nurses as knowledgeable team members who can be trusted to communicate important information to patients and between patients and physicians, and promotes peer support among the participating patients. Group visits have proven successful in high health services utilizing elderly patients with one or more chronic illnesses. A one-year study of monthly 2-hour group visits led by a physician and nurse showed significant improvements in care delivery as measured by decreases in emergency room visits, specialty care visits, and hospital readmissions though no change in self-reported health and functional status were realized. 5. Also, patients with type 2 diabetes attending group visits were shown to have increases in quality of life measures, knowledge of type 2 diabetes, and improved metabolic control as compared to patients in usual care. 6. Group visits offer providers more time per visit to address process-of-care indicators and provide patients more time per visit with their primary care physician. The monthly schedule allows for more frequent contacts between the patients and physicians. Providers caring for patients in groups can deliver consistent messages to multiple patients at once. Though monthly primary care visits (in groups) would be an increase from the 4 primary care visits per year presently realized by veterans with hypertension at the Ralph H. Johnson VAMC, the frequency is more consistent with JNC 7 guidelines for monthly visits for follow-up and monitoring after the initiation of antihypertensive therapy. Presently, the average primary care physician at the Charleston VA is scheduled to see 2 patients per hour. Group visits would allow the physician to see 20 patients over 2 hours. While demonstrated feasible and acceptable to elderly, chronically ill managed care populations, and uninsured and underinsured patients with type 2 diabetes, group visits have not been systematically tested in the Veteran�s Health Administration system. Additionally, previous studies have not evaluated patients� acceptance of group visits or their responses to groups according to race/ethnicity. This study seeks to inform whether group visits are acceptable to veterans as a method of health care delivery, regardless of race/ethnicity.

Methods: The study will assess the effect of group visits on hypertension outcomes. Veterans with stage 2 hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg) will be identified during routine office visits. The primary care physician will explain what group visits are using a standard script then patients will be asked if they are willing to be seen in a group setting. Patients who indicate a willingness to receive care in a group setting will be randomly assigned to either group visits or usual care. Randomization will occur in blocks to insure equal number of subjects by race/ethnicity in each of the two groups (group setting vs. usual care). We will recruit up to 8 VA primary care physicians to participate in this study. Several have already indicated an interest in conducting group visits.

Patient Visit Protocol: Group visits will be co-led by the patients� primary care internal medicine physician and a clinic nurse. Each group visit session will be scheduled for two hours consisting of: 15 minutes for "warm-up" and socialization, 30 minutes for presentation of a health- related topic (facilitated by the physician or another team member with special expertise), 15 minutes for break, during which time the nurse and physician will circulate, attending to individual needs, immunizations, appointment scheduling, and other issues, 15 minutes for questions and answers, 15 minutes for planning the next session, and 30 minutes for one-on-one consultations with the physician. Upon conclusion of the group portion of the visit, patients will have the opportunity to see the physician individually if required. While the group visits are intended to be the main source of medical care, patients who need care in between scheduled group visits, or who have specific medical needs that cannot be accommodated in the group visit (i.e. PAP smears, DRE), will be able to schedule a one-on-one visit with their primary care provider.

Being tested
Group Visits
Keywords
Hypertension Outcomes, Health Outcomes, Outpatient, Racial Preference, Blood Pressure Control, Clinical Trial, Intervention, Lifestyle modifications, Ethnic Differences, Randomized
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group VisitsBehavioural

Study groups in NCT00439816
Study groupRoleWhat they receive
Arm 1OtherNot described
Receives: Behavioral: Group Visits

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood pressure control. Medication compliance (as measured by refill histories). Health services utilization patterns (as defined by days in hospital, outpatient visits and urgent care visits).

Secondary outcomes (1)
  1. Acceptability of group visits to White and African American veterans, measured by comparing proportion of those who agreed to participate in groups to those who didn't. The attendance rates by patient race/ethnicity among those assigned to group visits.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2007 (estimated)
  2. Study startFeb 2005
  3. Study completionSep 2007

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00439816
Sponsor's protocol ID
LIP 82-003
Other IDs
HR 11260
Status last verified
Nov 2007
First submitted
22 Feb 2007
Last updated
7 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Wager KA, Ward DM, Lee FW, White AW, Davis KS, Clancy DE. Physicians, Patients, and EHRs. When it comes to a consultation, is three a crowd? J AHIMA. 2005 Apr;76(4):38-41. No abstract available.

    PubMed 15871467
  • Davis KS, Magruder KM, Lin Y, Powell CK, Clancy DE. Brief report: Trainee provider perceptions of group visits. J Gen Intern Med. 2006 Apr;21(4):357-9. doi: 10.1111/j.1525-1497.2006.00350.x.

    PubMed 16686812

Questions about this trial

What is this clinical trial studying?

A study testing Group Visits in people with Hypertension and Blood Pressure, 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.

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.

What does the primary outcome measure?

Blood pressure control. Medication compliance (as measured by refill histories). Health services utilization patterns (as defined by days in hospital, outpatient visits and urgent care visits).. 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 NCT00439816, 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.

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