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OpenTrials
Completed

NCT Number: NCT00265538

Implementing Evidence Based Treatment of Hypertension

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 a financial 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center, Iowa City, Iowa City, Iowa, United States

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About this study

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 financial 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, financial discussion incentive, copay reimbursement as well as a phone call reminder 1-2 days prior to their primary care visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Patient educational letter to engage provider in hypertension rx discussion

Behavioral

Patients will receive a customized/tailored letter (education) including most recent clinic blood pressure, current blood pressure medications and suggested htn medication(s). All the intervention arms (A, B and C) receive the letter.

Financial incentive (Arms B and C) and health educator phone call (Arm C)

Behavioral

Patients may receive a financial incentive for discussing the intervention letter with their provider and 6 months copay reimbursement and/or the financial incentive discussion incentive, 6 months copay reimbursement as well as a phone call reminder 1-2 days prior to their primary care appt. The Financial incentive is part of both Arms B and C. The health educator phone call is only in Arm C.

Primary outcomes

  1. Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months

    Time frame: index visit and 6 months

    Reported in 2 sub-groups: Subgroup 1 not at BP goal; Subgroup 2 at BP goal but taking a calcium channel blocker (see pre-specified sub group analysis below).

Other outcomes

  1. Percent of Patients Taking a Thiazide at Baseline (Subgroup 2 at BP Goal and Taking a Calcium Channel Blocker)

    Time frame: At index visit

    This was a pre-specified sub-group of patients already at their blood pressure goal, so the primary outcome was taking a thiazide at baseline (index visit).

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Implementing Evidence-based Treatment of Hypertension

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 14, 2005
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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