Hypertension
Conditions
Keywords
Hypertension, Diuretics, Drug Therapy, Anti-Hypertensive Agents, Patient Intervention
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.
Interventions
BEHAVIORALPatient 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.
BEHAVIORALFinancial 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Taking a Thiazide at Baseline (Subgroup 2 at BP Goal and Taking a Calcium Channel Blocker) | 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). |
Countries
United States
Participant flow
Recruitment details
An intervention study was implemented. Both the Iowa City VA and associated outpatient clinics as well as the Minneapolis VA and associated clinics were sites chosen for this intervention study. Subjects with a diagnosis of uncontrolled Hypertension or Hypertension controlled by a CCB were recruited.
Pre-assignment details
61,019 potential subjects from the 13 clinics were screened using an automated protocol to identify 2,910 potentially eligible subjects
Participants by arm
| Arm | Count |
|---|---|
| Control Group No intervention (usual care) | 286 |
| Combined Intervention Groups Patient Intervention Arms: Group A (intervention letter only); Group B (intervention, + financial incentive for discussion w/ provider and 6 month copay reimbursement); Group C (intervention letter, financial incentive for discussion w/ provider + copay reimbursement, plus reminder phone call 1-3 days prior to primary care visit) | 548 |
| Total | 834 |
Baseline characteristics
| Characteristic | Control Group | Combined Intervention Groups | Total |
|---|---|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 9.2 | 62.9 years STANDARD_DEVIATION 8.8 | 63.1 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 286 participants | 548 participants | 834 participants |
| Sex: Female, Male Female | 4 Participants | 9 Participants | 13 Participants |
| Sex: Female, Male Male | 282 Participants | 539 Participants | 821 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 286 | 0 / 548 |
| other Total, other adverse events | 0 / 286 | 0 / 548 |
| serious Total, serious adverse events | 0 / 286 | 0 / 548 |
Outcome results
Primary
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).
Time frame: index visit and 6 months
Population: Total number of patients prescribed a thiazide at time of enrollment (index visit).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group A | Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | Taking Thiazide at Index (baseline) visit | 35 Participants |
| Intervention Group A | Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | At BP goal at Index (baseline) visit | 29 Participants |
| Intervention Group A | Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | Taking Thiazide at 6 months | 31 Participants |
| Intervention Group A | Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | At BP goal at 6 months | 38 Participants |
| Intervention Group B | Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | At BP goal at Index (baseline) visit | 31 Participants |
| Intervention Group B | Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | Taking Thiazide at 6 months | 28 Participants |
| Intervention Group B | Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | At BP goal at 6 months | 39 Participants |
| Intervention Group B | Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | Taking Thiazide at Index (baseline) visit | 33 Participants |
| Intervention Group C | Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | Taking Thiazide at 6 months | 37 Participants |
| Intervention Group C | Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | At BP goal at Index (baseline) visit | 33 Participants |
| Intervention Group C | Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | At BP goal at 6 months | 40 Participants |
| Intervention Group C | Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | Taking Thiazide at Index (baseline) visit | 43 Participants |
| Control Group | Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | At BP goal at 6 months | 48 Participants |
| Control Group | Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | At BP goal at Index (baseline) visit | 45 Participants |
| Control Group | Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | Taking Thiazide at Index (baseline) visit | 19 Participants |
| Control Group | Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | Taking Thiazide at 6 months | 31 Participants |
Other Pre-specified
Percent of Patients Taking a Thiazide at Baseline (Subgroup 2 at BP Goal and Taking a Calcium Channel Blocker)
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).
Time frame: At index visit
Population: The number of participants analyzed represents the number of participants with available data at each time point. This was a pre-specified sub-group and there for did not have the entire study population represented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group A | Percent of Patients Taking a Thiazide at Baseline (Subgroup 2 at BP Goal and Taking a Calcium Channel Blocker) | 5 Participants |
| Intervention Group B | Percent of Patients Taking a Thiazide at Baseline (Subgroup 2 at BP Goal and Taking a Calcium Channel Blocker) | 11 Participants |
| Intervention Group C | Percent of Patients Taking a Thiazide at Baseline (Subgroup 2 at BP Goal and Taking a Calcium Channel Blocker) | 16 Participants |
| Control Group | Percent of Patients Taking a Thiazide at Baseline (Subgroup 2 at BP Goal and Taking a Calcium Channel Blocker) | 1 Participants |