NCT00129493

Brief Summary

This study investigates group medical visits as a quality improvement strategy for hypertension. It studies group visits in which patients see their own primary care provider together with other patients who have hypertension. The group visits are intended to enhance the patient's self-efficacy for self-management of their chronic disease (hypertension).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

April 7, 2015

Status Verified

May 1, 2009

Enrollment Period

2.1 years

First QC Date

August 9, 2005

Last Update Submit

April 6, 2015

Conditions

Keywords

Practice guidelinesHypertensionPrimary health carePatient-centered careHealthcare qualityOffice visitsSelf-efficacySelf careGuideline adherencePatient noncompliance

Outcome Measures

Primary Outcomes (1)

  • Change in blood pressure from baseline to endpoint (6, 12 or 18 months depending on how long patient is in study) and comparisons of study arms; change inmedication adherence from baseline to endpoint. Formative evaluation of the program.

    6, 12, 18 months

Secondary Outcomes (1)

  • Patient, provider and other staff satisfaction; organizational impact of the group visits program (health care system factors exploratory analyses of utilization)added value of visits beyond 12 months, qualitative data from interviews.

    18 months

Study Arms (1)

Arm 1

OTHER
Behavioral: Group medical visits

Interventions

Our intervention aims to develop and implement a model of group medical visits in iterative steps, to evaluate whether group medical visits improve patient adherence to prescribed antihypertensive medications and improve BP control, and to assess patient, physician, and health care system factors involved in successfully making organizational changes to encompass group medical visits.

Arm 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects include both health care professionals and their patients. The included health care professionals are primary care clinicians practicing at VA Palo Alto who have their own panels of patients for whom they provide primary care. Included patients are patients of these primary care clinicians; the patients must have a diagnosis of hypertension and at least one blood pressure in the previous year that was above guideline-target for that patient, and patient must be approved by the primary care clinician as suitable for a group medical visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

Related Links

MeSH Terms

Conditions

HypertensionPatient Compliance

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Mary K. Goldstein, MD MS

    VA Palo Alto Health Care System, Palo Alto, CA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2005

First Posted

August 11, 2005

Study Start

February 1, 2004

Primary Completion

March 1, 2006

Study Completion

August 1, 2007

Last Updated

April 7, 2015

Record last verified: 2009-05

Locations