Implementing Evidence Based Treatment of Hypertension

NCT00265538 | Completed Results

• 1 other identifier: IMV 04-066
• Study Type: interventional
• Target: 834
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent of Patients Taking Thiazide Diuretics and at BP Goal at 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).

  index visit and 6 months

Other Outcomes (1)

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

  At index visit

Study Arms (5)

Arm 1 (Pure Control Group)

NO INTERVENTION

Pure control (no intervention letter);

Arm 2 (Contaminated Control Group)

NO INTERVENTION

Intervention control (patient does not receive intervention letter, but provider sees other patients who may bring in letter);

Arm 3 (Intervention Group A)

EXPERIMENTAL

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

Arm 4 (Intervention Group B)

EXPERIMENTAL

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

Arm 5 (Intervention Group C)

EXPERIMENTAL

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

Interventions

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.

Arm 3 (Intervention Group A); Arm 4 (Intervention Group B); Arm 5 (Intervention Group C)

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.

Arm 5 (Intervention Group C)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Medical Center, Iowa City

Iowa City, Iowa, 52246-2208, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (9)

• 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.

  PMID: 17541326 RESULT

• 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.

  PMID: 20298563 RESULT

• 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.

  PMID: 20298564 RESULT

• 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.

  PMID: 20629812 RESULT

• 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.

  PMID: 21689098 RESULT

• 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.

  PMID: 22273057 RESULT

• 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.

  PMID: 23551647 RESULT

• 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.

  PMID: 32750626 DERIVED

• 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.

  PMID: 30646291 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Peter Kaboli
• Organization: Iowa City VA Health Care System

Peter.kaboli@va.gov

319-338-0581

Study Officials

• Peter J. Kaboli, MD MS

  VA Medical Center, Iowa City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2005
• First Posted: December 14, 2005
• Study Start: July 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 20, 2020
• Results First Posted: March 20, 2020

Record last verified: 2020-03

Locations

US (2)