Implementing Evidence Based Treatment of Hypertension

• ClinicalTrials.gov Identifier: NCT00265538
• Recruitment Status: Completed
• First Posted: December 14, 2005
• Results First Posted: March 20, 2020
• Last Update Posted: March 20, 2020
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Behavioral: Patient educational letter to engage provider in hypertension rx discussion; Behavioral: Financial incentive (Arms B and C) and health educator phone call (Arm C)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 834 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Implementing Evidence-based Treatment of Hypertension
• Study Start Date: July 2006
• Actual Primary Completion Date: August 2009
• Actual Study Completion Date: August 2009

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Arm 1 (Pure Control Group); Pure control (no intervention letter);
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);
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.	Behavioral: Patient educational letter to engage provider in hypertension rx discussion; 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.
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.	Behavioral: Patient educational letter to engage provider in hypertension rx discussion; 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.
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.	Behavioral: Patient educational letter to engage provider in hypertension rx discussion; 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.; Behavioral: Financial incentive (Arms B and C) and health educator phone call (Arm C); 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures:

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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

VA Office of Research and Development

Investigators

• Principal Investigator: Peter J. Kaboli, MD MS; VA Medical Center, Iowa City

More Information

Publications of Results:

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.

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, Páez 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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00265538
• Other Study ID Numbers: IMV 04-066
• First Posted: December 14, 2005
• Results First Posted: March 20, 2020
• Last Update Posted: March 20, 2020
• Last Verified: March 2020

Keywords provided by VA Office of Research and Development:

Hypertension; Diuretics; Drug Therapy; Anti-Hypertensive Agents; Patient Intervention

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases