NCT02591628

Brief Summary

This proposed pilot study will test methods and feasibility for a large pragmatic clinical trial comparing two inexpensive, first-line drugs for treating high blood pressure to determine if one is superior in preventing serious cardiovascular events and death. It will develop and test novel approaches to conducting trials that will be faster, less expensive, and more realistic by being embedded in a typical practice setting and using advanced health information technology.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,027

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 11, 2017

Status Verified

January 1, 2017

Enrollment Period

1.9 years

First QC Date

September 25, 2015

Last Update Submit

October 10, 2017

Conditions

Hypertension

Keywords

HypertensionThiazide diuretics

Outcome Measures

Primary Outcomes (2)

  • Conversion to chlorthalidone, number of patients with primary fills

    We will observe pharmacy claims to assess whether intervention patients filled their first prescription for chlorthalidone (primary adherence)

    3 months

  • Conversion to chlorthalidone, number of participants with secondary fills

    We will observe pharmacy claims to assess whether intervention patients who filled their first chlorthalidone prescription also filled their subsequent prescription (secondary adherence)

    9 months

Secondary Outcomes (5)

  • Blood pressure

    9 months

  • Hypertension drugs

    9 months

  • Electrolyte levels

    9 months

  • Renal function

    9 months

  • Safety outcomes

    9 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Intervention is HCTZ prescription conversion to chlorthalidone. Intervention patients are defined as patients of physicians randomized to "intervention." All these patients will have their current prescription of hydrochlorothiazide (HCTZ) switched to an equipotent dose of Chlorthalidone. These patients can choose to decline this intervention, and will be followed for 9 months with no other intervention to observe primary and secondary outcomes.

Behavioral: HCTZ prescription conversion to chlorthalidone

Usual Care

NO INTERVENTION

Usual care patients are defined as patients of physicians randomized to "usual care." All these patients will keep their current prescription for HCTZ and work with their physician like normal. These patients will be followed for 9 months with no intervention to compare primary and secondary outcomes to the intervention group.

Interventions

HCTZ prescription conversion to chlorthalidoneBEHAVIORAL

The intervention is simply a prescription conversion and the main outcome is whether or not patients accept the conversion and treatment with chlorthalidone.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 years and older
  • Hypertension diagnosis (ICD-9 401.x)
  • Current prescription for hydrochlorothiazide (HCTZ), 12.5-50 mg/day as a single-agent (not part of a fixed-dose combination drug)
  • No history of intolerance to chlorthalidone (CTD)
  • No known low levels of sodium (\<135 mEg/L (milliequivalents per liter)) or potassium (\<3.5 mEg/L)
  • English speaking

You may not qualify if:

  • Physician deems patient inappropriate for switching HCTZ to CTD
  • Patient refuses the switch prior to intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

HealthPartners Institute for Education and Research

Bloomington, Minnesota, 55105, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Karen L Margolis, MD, MPH

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

  • Stephen P Fortmann, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2015

First Posted

October 29, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

October 11, 2017

Record last verified: 2017-01

Locations

US(2)