Implementing Evidence Based Treatment of Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00265538
First received: December 12, 2005
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

This study examines the use of patient initiated discussions of blood pressure medication in the primary care setting. Additionally, this study examines different levels of patient incentive(s) to initiate discussions with providers including information only, information plus 20$ incentive and reimbursement for 6 months of copay, and information/monetary incentive plus a reminder call prior to the index visit. Patient opinions about doctor/patient relationships will be assessed. Provider attitudes and prescribing behaviors will be analyzed as well.


Condition Intervention
Hypertension
Behavioral: Patient education to engage provider in hypertension treatment discussion
Behavioral: Financial incentive and health educator phone call

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Implementing Evidence-based Treatment of Hypertension

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The percent of patients taking thiazide diuretics at their index visit and at 6 and 12 months; The percent of patients at blood pressure treatment goal at 6 and 12 months; and Mean blood pressure at 6 and 12 months [ Time Frame: 1-3 months after enrollment, at first opportunity for regularly scheduled primary care visit. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • % of Patients who talked to their providers about meds at the 1st visit, $ & # of anti-HTN meds, AE's, HTN med compliance, O/P lab tests used during primary care visits, # of visits to clinics & ER's, PT knowledge of their blood pressure meds. [ Time Frame: 1-3 months after enrollment, at first opportunity for a regularly scheduled primary care visit. ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: July 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Patient Intervention arms: pure control (no intervention letter); intervention control (patient does not receive intervention letter, but provider sees other patients who may bring in letter); group a (intervention letter only); group b (intervention, + 20$ incentive for discussion w/ provider and 6 month copay reimbursement); group c (intervention letter, 20$ incentive for discussion w/ provider + copay reimbursement, plus reminder phone call 1-3 days prior to primary care visit)
Behavioral: Patient education to engage provider in hypertension treatment discussion
Patients will receive a customized/tailored letter including most recent clinic blood pressure, current blood pressure medications and suggested htn medication(s)
Behavioral: Financial incentive and health educator phone call
Patients may receive 20$ for discussing the intervention letter with their provider and 6 months copay reimbursement and/or the 20$ discussion incentive, 6 months copay reimbursement as well as a phone call reminder 1-2 days prior to their primary care appt.

Detailed Description:

Patients will be randomized to Pure control, intervention control, intervention group a, intervention group b or intervention group c. Pure control patients will not receive any study information about diuretics and their providers will not see any patients who receive our study intervention letter. Patients in the intervention control group will not receive the intervention but will see providers who have other patients in the intervention groups. Patients in intervention group a will receive a customized letter prior to their next primary care appointment with information regarding the patient's specific blood pressure, current blood pressure medication and recommendation for switching or adding a thiazide. Patients in group b will receive the customized intervention letter as well as a 20$ incentive for discussing the information with their provider and a copay reimbursement for 6 months if a prescription is written for a thiazide. Patients in group c will receive the intervention letter, 20$ discussion incentive, copay reimbursement as well as a phone call reminder 1-2 days prior to their primary care visit.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The eligible population includes patients less than 80 years of age enrolled in primary care clinics at the study sites that meet the following additional inclusion criteria:

  • No active prescription for a thiazide diuretic (or a medication that combines a thiazide and another agent (e.g., hydrochlorothiazide and triamterene)
  • Prior diagnosis of hypertension, as documented in VA outpatient administrative files
  • Two or more visits to a primary care clinic in the prior 12 months;
  • Blood pressure above treatment goal at the two most recent VA outpatient clinic visits Above goal is defined as a systolic pressure >140 mmHg or diastolic pressure >90 mmHg. For diabetics above goal is defined as systolic pressure >130 mmHg or diastolic pressure >80 mmHg
  • Blood pressure at goal (as defined above) during one of the last two outpatient clinic visits, but the patient is receiving a prescription for a calcium channel blocker (CCB)

Exclusion Criteria:

Patients meeting the above inclusion criteria will be excluded for the following reasons:

  • Documented allergy to thiazides or to sulfa agents
  • Previously documented intolerance or adverse drug reaction to thiazide diuretics
  • Active prescription for a loop diuretic agent (e.g. furosemide)
  • Renal insufficiency, defined by a glomerular filtration rate less than 30 ml/min
  • No serum creatinine in the past year (to permit calculation of a creatinine clearance)
  • Prior history of hypokalemia or serum potassium less than 3.5 meq/l in the prior year
  • Diagnosis of gout or active prescription for allopurinol
  • Congestive heart failure (CHF) due to systolic dysfunction with a documented left ventricular ejection fraction < 35% by echocardiography, nuclear medicine study, or ventriculography
  • Residence in a long-term care facility
  • No telephone for follow-up calls
  • Life-expectancy < 6 months
  • Inability to give informed consent or impaired cognitive function (defined as > 4 errors on the 10-item Pfeiffer Portable Mental Status Questionnaire82, administered during study intake)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265538

Locations
United States, Iowa
VA Medical Center, Iowa City
Iowa City, Iowa, United States, 52246-2208
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Investigators
Principal Investigator: Peter J. Kaboli, MD MS VA Medical Center, Iowa City
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00265538     History of Changes
Other Study ID Numbers: IMV 04-066
Study First Received: December 12, 2005
Last Updated: August 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Hypertension
Diuretics
Drug Therapy
Anti-Hypertensive Agents
Patient Intervention

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014