Trial Outcomes & Findings for Implementing Evidence Based Treatment of Hypertension (NCT NCT00265538)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

834 participants

Primary outcome timeframe

index visit and 6 months

Results posted on

2020-03-20

Participant Flow

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.

61,019 potential subjects from the 13 clinics were screened using an automated protocol to identify 2,910 potentially eligible subjects

Participant milestones

Participant milestones
Measure	Intervention Group A Group a (intervention letter only): Patients will receive a customized/tailored letter including most recent clinic blood pressure, current blood pressure medications, and suggested blood pressure medication(s). The letter also encouraged the patient to discuss their blood pressure treatment with their provider.	Intervention Group B Group B: intervention letter from Group A + $20 financial incentive for discussion with the provider and 6 month copay reimbursement if the patient has a copay.	Intervention Group C Group C: Intervention letter from Group A + financial incentive from Group B + health educator phone call. The phone call 1-2 days prior to their primary care appointment encouraged them to talk with their provider about their blood pressure treatment.	Control Group The control group received usual care. They were given informed consent that they could either be in the intervention or control groups.
Overall Study STARTED	196	170	182	286
Overall Study COMPLETED	186	161	171	267
Overall Study NOT COMPLETED	10	9	11	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Implementing Evidence Based Treatment of Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=286 Participants No intervention (usual care)	Combined Intervention Groups n=548 Participants 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)	Total n=834 Participants Total of all reporting groups
Age, Continuous	64.1 years STANDARD_DEVIATION 9.2 • n=93 Participants	62.9 years STANDARD_DEVIATION 8.8 • n=4 Participants	63.1 years STANDARD_DEVIATION 9.0 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	9 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	282 Participants n=93 Participants	539 Participants n=4 Participants	821 Participants n=27 Participants
Region of Enrollment United States	286 participants n=93 Participants	548 participants n=4 Participants	834 participants n=27 Participants

PRIMARY outcome

Timeframe: index visit and 6 months

Population: Total number of patients prescribed a thiazide at time of enrollment (index visit).

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).

Outcome measures

Outcome measures
Measure	Intervention Group A n=143 Participants Group A (intervention letter only)	Intervention Group B n=128 Participants Intervention Letter + financial incentive	Intervention Group C n=131 Participants Intervention letter + financial incentive + phone call	Control Group n=196 Participants Usual care
Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months Taking Thiazide at Index (baseline) visit	35 Participants	33 Participants	43 Participants	19 Participants
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	31 Participants	33 Participants	45 Participants
Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months Taking Thiazide at 6 months	31 Participants	28 Participants	37 Participants	31 Participants
Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months At BP goal at 6 months	38 Participants	39 Participants	40 Participants	48 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Intervention Group A n=53 Participants Group A (intervention letter only)	Intervention Group B n=42 Participants Intervention Letter + financial incentive	Intervention Group C n=51 Participants Intervention letter + financial incentive + phone call	Control Group n=90 Participants Usual care
Percent of Patients Taking a Thiazide at Baseline (Subgroup 2 at BP Goal and Taking a Calcium Channel Blocker)	5 Participants	11 Participants	16 Participants	1 Participants

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combined Intervention Groups

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control Group n=286 participants at risk No intervention (usual care)	Combined Intervention Groups n=548 participants at risk 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)blood pressure, current blood pressure medications and suggested htn medication(s)
Blood and lymphatic system disorders	0.00% 0/286 There were not any reported Adverse Events, so there is not separate reporting of events, because there were no events. The numerator for all is zero. Because there were no events, the denominator was combined into all the Control Patients and all the Intervention Patients. It is thus not possible to separate them since there were no events.	0.00% 0/548 There were not any reported Adverse Events, so there is not separate reporting of events, because there were no events. The numerator for all is zero. Because there were no events, the denominator was combined into all the Control Patients and all the Intervention Patients. It is thus not possible to separate them since there were no events.

Additional Information

Dr. Peter Kaboli

Iowa City VA Health Care System

Phone: 319-338-0581

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place