Trial Outcomes & Findings for Tailored Communication to Reduce Cardiovascular Risk (NCT NCT01286311)

Results Overview

Significant LDL cholesterol reduction at 9 months Definition: Percentage of patients with LDL-C repeated and which is at least 30 mg/dl lower than baseline

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

464 participants

Primary outcome timeframe

9 months

Results posted on

2015-02-09

Participant Flow

Physicians were recruited at their clinic offices in January 2011. They provided written informed consent to be randomized and to have study staff mail risk messages directly to patients on their behalf if they were randomized to the intervention. Patients were included with a waiver of consent.

Participant milestones

Participant milestones
Measure	Direct-to-patient Tailored Cardiovascular Risk Message System Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.	Control Eligible patients cared for by physicians randomized to the control group will receive usual care. After 9 months, control group physicians were provided with lists of their eligible patients and their risk scores.
Overall Study STARTED	232	232
Overall Study COMPLETED	218	232
Overall Study NOT COMPLETED	14	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Direct-to-patient Tailored Cardiovascular Risk Message System Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.	Control Eligible patients cared for by physicians randomized to the control group will receive usual care. After 9 months, control group physicians were provided with lists of their eligible patients and their risk scores.
Overall Study Physician did not want outreach sent	14	0

Baseline Characteristics

Tailored Communication to Reduce Cardiovascular Risk

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Direct-to-patient Tailored Cardiovascular Risk Message System n=232 Participants Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.	Control n=232 Participants	Total n=464 Participants Total of all reporting groups
Age, Categorical <=18 years	0 patient participants n=5 Participants	0 patient participants n=7 Participants	0 patient participants n=5 Participants
Age, Categorical Between 18 and 65 years	137 patient participants n=5 Participants	147 patient participants n=7 Participants	284 patient participants n=5 Participants
Age, Categorical >=65 years	81 patient participants n=5 Participants	70 patient participants n=7 Participants	151 patient participants n=5 Participants
Age, Continuous	61.3 years STANDARD_DEVIATION 9.4 • n=5 Participants	60.1 years STANDARD_DEVIATION 9.2 • n=7 Participants	60.7 years STANDARD_DEVIATION 9.4 • n=5 Participants
Gender Female	49 participants n=5 Participants	50 participants n=7 Participants	99 participants n=5 Participants
Gender Male	169 participants n=5 Participants	167 participants n=7 Participants	336 participants n=5 Participants
Region of Enrollment United States	232 participants n=5 Participants	232 participants n=7 Participants	464 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Significant LDL cholesterol reduction at 9 months Definition: Percentage of patients with LDL-C repeated and which is at least 30 mg/dl lower than baseline

Outcome measures

Outcome measures
Measure	Direct-to-patient Tailored Cardiovascular Risk Message System n=218 Participants Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.	Control n=217 Participants Eligible patients cared for by physicians randomized to the control group will receive usual care.
Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction	11.0 % of patients with major LDL reduction	11.1 % of patients with major LDL reduction

SECONDARY outcome

Timeframe: 9 months

This will measure the difference in frequency of clinical encounters in the electronic medical record.

Outcome measures

Outcome measures
Measure	Direct-to-patient Tailored Cardiovascular Risk Message System n=218 Participants Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.	Control n=217 Participants Eligible patients cared for by physicians randomized to the control group will receive usual care.
Frequency of Clinical Encounters	61.9 % of patients with any office visit Interval 0.0 to 2.0	56.7 % of patients with any office visit Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 9 months

This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia.

Outcome measures

Outcome measures
Measure	Direct-to-patient Tailored Cardiovascular Risk Message System n=218 Participants Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.	Control n=217 Participants Eligible patients cared for by physicians randomized to the control group will receive usual care.
Medication Prescriptions for Dyslipidemia	11.9 % of patients with New Rx for LLM	6.0 % of patients with New Rx for LLM

SECONDARY outcome

Timeframe: 9 months

Population: Among patients with uncontrolled hypertension, 76 of the 218 in the intervention arm and 85 of 217 in the control arm were included.

This will measure the percentage of participants who had uncontrolled hypertension at baseline who had an increase in the number of antihypertensive medication drug classes prescribed within 9 months.

Outcome measures

Outcome measures
Measure	Direct-to-patient Tailored Cardiovascular Risk Message System n=76 Participants Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.	Control n=85 Participants Eligible patients cared for by physicians randomized to the control group will receive usual care.
Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed	11.8 percentage of participants	4.7 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: 38 patients in the intervention arm and 50 patients in the control arm had aspirin listed in their medication list in the electronic medical record as the start of the study therefore they were excluded from this analysis.

This will measure the presence of an aspirin prescriptions on the medication list in the electronic medical record.

Outcome measures

Outcome measures
Measure	Direct-to-patient Tailored Cardiovascular Risk Message System n=180 Participants Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.	Control n=167 Participants Eligible patients cared for by physicians randomized to the control group will receive usual care.
Presence of an Aspirin Prescription	3.9 % patients w/aspirin now on med list	1.8 % patients w/aspirin now on med list

Adverse Events

Direct-to-patient Tailored Cardiovascular Risk Message System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephen D. Persell, MD MPH

Northwestern University

Phone: 312-503-6464

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place