- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00265538
Implementing Evidence Based Treatment of Hypertension
March 18, 2020 updated by: VA Office of Research and Development
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.
Study Overview
Status
Completed
Conditions
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 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.
Study Type
Interventional
Enrollment (Actual)
834
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Iowa
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Iowa City, Iowa, United States, 52246-2208
- VA Medical Center, Iowa City
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Minneapolis VA Health Care System, Minneapolis, MN
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Arm 1 (Pure Control Group)
Pure control (no intervention letter);
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No Intervention: Arm 2 (Contaminated Control Group)
Intervention control (patient does not receive intervention letter, but provider sees other patients who may bring in letter);
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Experimental: Arm 3 (Intervention Group A)
Intervention group A (the intervention is a letter only mailed to the subject); This intervention group receives an educational letter, which is the intervention.
It is an educational intervention only.
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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.
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Experimental: Arm 4 (Intervention Group B)
Intervention group B (intervention letter A + financial incentive for discussion w/ provider and 6 month copay reimbursement); This group receives the same educational intervention as Group A, but also receives the Financial incentive, which is an added intervention.
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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.
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Experimental: Arm 5 (Intervention Group C)
Intervention group C (intervention letter A, financial incentive for discussion w/ provider + copay reimbursement, PLUS reminder phone call 1-3 days prior to primary care visit).
This group receives the same intervention as Group B, but with the added intervention of a reminder phone call to test whether additional prompting is needed to make the intervention more effective.
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months
Time Frame: index visit and 6 months
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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).
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index visit and 6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Patients Taking a Thiazide at Baseline (Subgroup 2 at BP Goal and Taking a Calcium Channel Blocker)
Time Frame: At index visit
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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).
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At index visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Peter J. Kaboli, MD MS, VA Medical Center, Iowa City
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kaboli PJ, Shivapour DM, Henderson MS, Barnett MJ, Ishani A, Carter BL. Patient and provider perceptions of hypertension treatment: do they agree? J Clin Hypertens (Greenwich). 2007 Jun;9(6):416-23. doi: 10.1111/j.1524-6175.2007.06492.x.
- Pilling SA, Williams MB, Brackett RH, Gourley R, Weg MW, Christensen AJ, Kaboli PJ, Reisinger HS. Part I, patient perspective: activating patients to engage their providers in the use of evidence-based medicine: a qualitative evaluation of the VA Project to Implement Diuretics (VAPID). Implement Sci. 2010 Mar 18;5:23. doi: 10.1186/1748-5908-5-23.
- Buzza CD, Williams MB, Vander Weg MW, Christensen AJ, Kaboli PJ, Reisinger HS. Part II, provider perspectives: should patients be activated to request evidence-based medicine? A qualitative study of the VA project to implement diuretics (VAPID). Implement Sci. 2010 Mar 18;5:24. doi: 10.1186/1748-5908-5-24.
- Sutton E, Wilson H, Kaboli PJ, Carter BL. Why physicians do not prescribe a thiazide diuretic. J Clin Hypertens (Greenwich). 2010 Jul 1;12(7):502-7. doi: 10.1111/j.1751-7176.2010.00299.x.
- Reisinger HS, Brackett RH, Buzza CD, Paez MB, Gourley R, Weg MW, Christensen AJ, Kaboli PJ. "All the money in the world ..." patient perspectives regarding the influence of financial incentives. Health Serv Res. 2011 Dec;46(6pt1):1986-2004. doi: 10.1111/j.1475-6773.2011.01287.x. Epub 2011 Jun 20.
- Kaboli PJ, Baldwin AS, Henderson MS, Ishani A, Cvengros JA, Christensen AJ. Measuring preferred role orientations for patients and providers in veterans administration and university general medicine clinics. Patient. 2009 Mar 1;2(1):33-8. doi: 10.2165/01312067-200902010-00004.
- Lund BC, Charlton ME, Steinman MA, Kaboli PJ. Regional differences in prescribing quality among elder veterans and the impact of rural residence. J Rural Health. 2013 Spring;29(2):172-9. doi: 10.1111/j.1748-0361.2012.00428.x. Epub 2012 Aug 27.
- Howren MB, Vander Weg MW, Christensen AJ, Kaboli PJ. Association of patient preferences on medication discussion in hypertension: Results from a randomized clinical trial. Soc Sci Med. 2020 Oct;262:113244. doi: 10.1016/j.socscimed.2020.113244. Epub 2020 Jul 29.
- Kaboli PJ, Howren MB, Ishani A, Carter B, Christensen AJ, Vander Weg MW. Efficacy of Patient Activation Interventions With or Without Financial Incentives to Promote Prescribing of Thiazides and Hypertension Control: A Randomized Clinical Trial. JAMA Netw Open. 2018 Dec 7;1(8):e185017. doi: 10.1001/jamanetworkopen.2018.5017.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
December 12, 2005
First Submitted That Met QC Criteria
December 12, 2005
First Posted (Estimate)
December 14, 2005
Study Record Updates
Last Update Posted (Actual)
March 20, 2020
Last Update Submitted That Met QC Criteria
March 18, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMV 04-066
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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