Clinical trial NCT00265538: Implementing Evidence Based Treatment of Hypertension
Official title: Implementing Evidence-based Treatment of Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Diuretics
Drug Therapy
Anti-Hypertensive Agents
Patient Intervention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-12-14
Enrollment: 834
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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)

Primary outcomes:
measure: Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months
timeFrame: index visit and 6 months
Secondary outcomes:
Other outcomes:
measure: Percent of Patients Taking a Thiazide at Baseline (Subgroup 2 at BP Goal and Taking a Calcium Channel Blocker)
timeFrame: At index visit
Locations:
city: Iowa City
country: United States
facility: VA Medical Center, Iowa City
state: Iowa
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: VA Medical Center, Iowa City
name: Peter J. Kaboli, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.