Trial Outcomes & Findings for Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study (NCT NCT01235377)

Results Overview

rates of provider prescribing of the Cluster Designated drug

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

nine months

Results posted on

2014-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	Favor Chlorthalidone Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients	Favor Hydrochlorothiazide Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
Overall Study STARTED	11	9
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Favor Chlorthalidone n=77 Participants Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients	Favor Hydrochlorothiazide n=61 Participants Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients	Total n=138 Participants Total of all reporting groups
Age, Continuous	60.9 years STANDARD_DEVIATION 10.8 • n=5 Participants	60.4 years STANDARD_DEVIATION 13.1 • n=7 Participants	60.7 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	76 Participants n=5 Participants	60 Participants n=7 Participants	136 Participants n=5 Participants

PRIMARY outcome

Timeframe: nine months

Population: providers prescribing a thiazide at least once in the study period

rates of provider prescribing of the Cluster Designated drug

Outcome measures

Outcome measures
Measure	Favor Chlorthalidone n=10 Participants Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients	Favor Hydrochlorothiazide n=8 Participants Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
Prescription Rates	80 % new thiazide prescriptions Interval 54.5 to 100.0	100 % new thiazide prescriptions Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: nine months

factors (barriers and facilitators) associated with prescribing according to the Cluster Designation

Outcome measures

Outcome data not reported

Adverse Events

Favor Chlorthalidone

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Favor Hydrochlorothiazide

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	Favor Chlorthalidone n=77 participants at risk Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients	Favor Hydrochlorothiazide n=61 participants at risk Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
Endocrine disorders other abnormal glucose	2.6% 2/77	0.00% 0/61

Additional Information

Madeline McCarren, PhD

Veterans Health Administration Pharmacy Benefits Management

Phone: 7087867987

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place