Trial Outcomes & Findings for Pragmatic Trial of Messaging to Providers About Treatment of Hyperlipidemia (PROMPT-LIPID) (NCT NCT04394715)

Last Updated: 2024-09-03

Results Overview

Intensification of lipid lowering therapy is defined as an increase in statin dose, an addition of ezetimibe, or addition of PCSK9. Any one of the three will be sufficient to meet this endpoint. Proportion of patients who meet this endpoint will be compared between study arms.

Recruitment status

COMPLETED

Study phase

Target enrollment

2596 participants

Primary outcome timeframe

90 days from first alert for any given patient

Results posted on

2024-09-03

Participant Flow

One hundred providers who prescribed the highest volume of PCSK9i in 2020 were retrospectively identified and then consented into the study, followed by randomization into alert group versus usual care group. Patients were automatically enrolled as trial participants if they were seen by a consented provider and met the inclusion criteria as determined by the best practice alert algorithm.

Four of the 100 providers were excluded from the study before randomization, as recruitment finished before these four providers saw an eligible patient. All 2500 patient subjects were randomized, with zero loss to follow up.

Participant milestones

Participant milestones
Measure	Intervention Providers will see an electronic alert for eligible patients who are at very high risk for future ASCVD events upon opening of the patient's order entry screen in the medical record. Electronic Alert: Providers will see an automated electronic alert for each eligible hyperlipidemia patient at high risk for future atherosclerotic CVD events. This alert will appear when the provider enters the order entry screen in the patient's medical record during the patient's first eligible outpatient visit. The alert consists of a "pop up" that notifies the physician that the patient is at very high risk for ASCVD events, displays the most recent cholesterol values and the patient's current lipid lowering therapy. It also includes a link to full treatment guidelines for hyperlipidemia, which includes a continuing medical education (CME) option to obtain CME credits.	Control Providers will not see an electronic alert for any patients and will provide usual care. Silent alerts will be generated that will be sent to study team members.
Overall Study STARTED	1179	1417
Overall Study Participants Enrolled	1130	1370
Overall Study Providers Enrolled	49	47
Overall Study COMPLETED	1179	1417
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pragmatic Trial of Messaging to Providers About Treatment of Hyperlipidemia (PROMPT-LIPID)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=1130 Participants Providers will see an electronic alert for eligible patients who are at very high risk for future ASCVD events upon opening of the patient's order entry screen in the medical record. Electronic Alert: Providers will see an automated electronic alert for each eligible hyperlipidemia patient at high risk for future atherosclerotic CVD events. This alert will appear when the provider enters the order entry screen in the patient's medical record during the patient's first eligible outpatient visit. The alert consists of a "pop up" that notifies the physician that the patient is at very high risk for ASCVD events, displays the most recent cholesterol values and the patient's current lipid lowering therapy. It also includes a link to full treatment guidelines for hyperlipidemia, which includes a continuing medical education (CME) option to obtain CME credits.	Control n=1370 Participants Providers will not see an electronic alert for any patients and will provide usual care. Silent alerts will be generated that will be sent to study team members.	Total n=2500 Participants Total of all reporting groups
Age, Continuous	72 years n=99 Participants	71 years n=107 Participants	72 years n=206 Participants
Sex: Female, Male Female	531 Participants n=99 Participants	687 Participants n=107 Participants	1218 Participants n=206 Participants
Sex: Female, Male Male	599 Participants n=99 Participants	683 Participants n=107 Participants	1282 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	109 Participants n=99 Participants	132 Participants n=107 Participants	241 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	995 Participants n=99 Participants	1212 Participants n=107 Participants	2207 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	26 Participants n=99 Participants	26 Participants n=107 Participants	52 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants
Race (NIH/OMB) Asian	16 Participants n=99 Participants	15 Participants n=107 Participants	31 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Black or African American	114 Participants n=99 Participants	212 Participants n=107 Participants	326 Participants n=206 Participants
Race (NIH/OMB) White	890 Participants n=99 Participants	1054 Participants n=107 Participants	1944 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	104 Participants n=99 Participants	86 Participants n=107 Participants	190 Participants n=206 Participants
Insurance Type Medicare	814 Participants n=99 Participants	974 Participants n=107 Participants	1788 Participants n=206 Participants
Insurance Type Medicaid	294 Participants n=99 Participants	398 Participants n=107 Participants	692 Participants n=206 Participants
Insurance Type Commercial	505 Participants n=99 Participants	582 Participants n=107 Participants	1087 Participants n=206 Participants
Insurance Type Other	254 Participants n=99 Participants	315 Participants n=107 Participants	569 Participants n=206 Participants
Medical History Atrial Arrythmias	548 Participants n=99 Participants	711 Participants n=107 Participants	1259 Participants n=206 Participants
Medical History Cerebrovascular Disease	727 Participants n=99 Participants	1002 Participants n=107 Participants	1729 Participants n=206 Participants
Medical History Myocardial Infarction	868 Participants n=99 Participants	1008 Participants n=107 Participants	1876 Participants n=206 Participants
Medical History Peripheral Artery Disease	413 Participants n=99 Participants	562 Participants n=107 Participants	975 Participants n=206 Participants
Medical History Stroke	555 Participants n=99 Participants	766 Participants n=107 Participants	1321 Participants n=206 Participants
Medical History Renal Failure	230 Participants n=99 Participants	299 Participants n=107 Participants	529 Participants n=206 Participants
Medical History Depression	246 Participants n=99 Participants	320 Participants n=107 Participants	566 Participants n=206 Participants
Medical History Diabetes	353 Participants n=99 Participants	466 Participants n=107 Participants	819 Participants n=206 Participants
Medical History Hypertension	988 Participants n=99 Participants	1205 Participants n=107 Participants	2193 Participants n=206 Participants
Medical History Obesity	244 Participants n=99 Participants	329 Participants n=107 Participants	573 Participants n=206 Participants
Medical History Chronic Pulmonary Disorder	345 Participants n=99 Participants	423 Participants n=107 Participants	768 Participants n=206 Participants
Baseline Elixhauser Score	5 units on a scale n=99 Participants	5 units on a scale n=107 Participants	5 units on a scale n=206 Participants
Cholesterol	169 mg/dL n=99 Participants	172 mg/dL n=107 Participants	170 mg/dL n=206 Participants
HDL	50 mg/dL n=99 Participants	50 mg/dL n=107 Participants	50 mg/dL n=206 Participants
LDL	91 mg/dL n=99 Participants	93 mg/dL n=107 Participants	92 mg/dL n=206 Participants
Triglycerides	112 mg/dL n=99 Participants	112 mg/dL n=107 Participants	112 mg/dL n=206 Participants
AST	21 U/L n=99 Participants	21 U/L n=107 Participants	21 U/L n=206 Participants
ALT	20 U/L n=99 Participants	21 U/L n=107 Participants	21 U/L n=206 Participants
Creatinine	1 mg/dL n=99 Participants	.96 mg/dL n=107 Participants	1 mg/dL n=206 Participants
Baseline Blood Pressure Systolic BP	130 mmHg n=99 Participants	129 mmHg n=107 Participants	129 mmHg n=206 Participants
Baseline Blood Pressure Diastolic BP	74 mmHg n=99 Participants	74 mmHg n=107 Participants	74 mmHg n=206 Participants
Baseline Heart Rate	72 beats/minute n=99 Participants	72 beats/minute n=107 Participants	72 beats/minute n=206 Participants
Baseline Number of Lipid Lowering Therapy (LLT) Medications	1 Number of medications n=99 Participants	1 Number of medications n=107 Participants	1 Number of medications n=206 Participants
Number of subjects on Lipid Lowering Therapy Medications Any statin	803 Participants n=99 Participants	982 Participants n=107 Participants	1785 Participants n=206 Participants
Number of subjects on Lipid Lowering Therapy Medications Low intensity statin	37 Participants n=99 Participants	52 Participants n=107 Participants	89 Participants n=206 Participants
Number of subjects on Lipid Lowering Therapy Medications Moderate intensity statin	278 Participants n=99 Participants	330 Participants n=107 Participants	608 Participants n=206 Participants
Number of subjects on Lipid Lowering Therapy Medications High intensity statin	488 Participants n=99 Participants	600 Participants n=107 Participants	1088 Participants n=206 Participants
Number of subjects on Lipid Lowering Therapy Medications Ezetimibe	85 Participants n=99 Participants	134 Participants n=107 Participants	219 Participants n=206 Participants
Number of subjects on Lipid Lowering Therapy Medications PCSK9i	28 Participants n=99 Participants	38 Participants n=107 Participants	66 Participants n=206 Participants
Patients per Provider Type Cardiology Physician	730 Participants n=99 Participants	785 Participants n=107 Participants	1515 Participants n=206 Participants
Patients per Provider Type Cardiology Advanced Practice Provider	68 Participants n=99 Participants	118 Participants n=107 Participants	186 Participants n=206 Participants
Patients per Provider Type Internal Medicine Physician	280 Participants n=99 Participants	280 Participants n=107 Participants	560 Participants n=206 Participants
Patients per Provider Type Internal Medicine Advanced Practice Provider	52 Participants n=99 Participants	187 Participants n=107 Participants	239 Participants n=206 Participants

PRIMARY outcome

Timeframe: 90 days from first alert for any given patient

Outcome measures

Outcome measures
Measure	Intervention n=1130 Participants Providers will see an electronic alert for eligible patients who are at very high risk for future ASCVD events upon opening of the patient's order entry screen in the medical record. Electronic Alert: Providers will see an automated electronic alert for each eligible hyperlipidemia patient at high risk for future atherosclerotic CVD events. This alert will appear when the provider enters the order entry screen in the patient's medical record during the patient's first eligible outpatient visit. The alert consists of a "pop up" that notifies the physician that the patient is at very high risk for ASCVD events, displays the most recent cholesterol values and the patient's current lipid lowering therapy. It also includes a link to full treatment guidelines for hyperlipidemia, which includes a continuing medical education (CME) option to obtain CME credits.	Control n=1370 Participants Providers will not see an electronic alert for any patients and will provide usual care. Silent alerts will be generated that will be sent to study team members.
Proportion of Patients With Intensification of Lipid Lowering Therapy	159 Participants	142 Participants

SECONDARY outcome

Timeframe: 6 months from first alert for any given patient

Population: This outcome was only observed in 824 patient subjects in which data for LDL-C at 6 months was available. 368 patient subjects in the intervention arm and 456 patient subjects in the control arm received 6 month LDL-C measurements that were placed in the medical record, thus this is the population analyzed for this outcome.

LDL-C at 6 months as measured by medical record review

Outcome measures

Outcome measures
Measure	Intervention n=368 Participants Providers will see an electronic alert for eligible patients who are at very high risk for future ASCVD events upon opening of the patient's order entry screen in the medical record. Electronic Alert: Providers will see an automated electronic alert for each eligible hyperlipidemia patient at high risk for future atherosclerotic CVD events. This alert will appear when the provider enters the order entry screen in the patient's medical record during the patient's first eligible outpatient visit. The alert consists of a "pop up" that notifies the physician that the patient is at very high risk for ASCVD events, displays the most recent cholesterol values and the patient's current lipid lowering therapy. It also includes a link to full treatment guidelines for hyperlipidemia, which includes a continuing medical education (CME) option to obtain CME credits.	Control n=456 Participants Providers will not see an electronic alert for any patients and will provide usual care. Silent alerts will be generated that will be sent to study team members.
Achieved LDL-C at 6 Months	83 mg/dL Interval 66.5 to 102.0	83 mg/dL Interval 68.0 to 107.0

SECONDARY outcome

Timeframe: 6 months from first alert for any given patient

Number of patients with LDL-C levels less than 70 mg/dL based on medical record review. Number of patients who meet this endpoint will be compared between study arms.

Outcome measures

Outcome measures
Measure	Intervention n=368 Participants Providers will see an electronic alert for eligible patients who are at very high risk for future ASCVD events upon opening of the patient's order entry screen in the medical record. Electronic Alert: Providers will see an automated electronic alert for each eligible hyperlipidemia patient at high risk for future atherosclerotic CVD events. This alert will appear when the provider enters the order entry screen in the patient's medical record during the patient's first eligible outpatient visit. The alert consists of a "pop up" that notifies the physician that the patient is at very high risk for ASCVD events, displays the most recent cholesterol values and the patient's current lipid lowering therapy. It also includes a link to full treatment guidelines for hyperlipidemia, which includes a continuing medical education (CME) option to obtain CME credits.	Control n=456 Participants Providers will not see an electronic alert for any patients and will provide usual care. Silent alerts will be generated that will be sent to study team members.
Proportion of Patients With an LDL-C of Less Than 70 mg/dL	115 Participants	133 Participants

SECONDARY outcome

Timeframe: 6 months from first alert for any given patient

Number of patients with LDL-C levels less than 55 mg/dL based on medical record review. Number of patients who meet this endpoint will be compared between study arms.

Outcome measures

Outcome measures
Measure	Intervention n=368 Participants Providers will see an electronic alert for eligible patients who are at very high risk for future ASCVD events upon opening of the patient's order entry screen in the medical record. Electronic Alert: Providers will see an automated electronic alert for each eligible hyperlipidemia patient at high risk for future atherosclerotic CVD events. This alert will appear when the provider enters the order entry screen in the patient's medical record during the patient's first eligible outpatient visit. The alert consists of a "pop up" that notifies the physician that the patient is at very high risk for ASCVD events, displays the most recent cholesterol values and the patient's current lipid lowering therapy. It also includes a link to full treatment guidelines for hyperlipidemia, which includes a continuing medical education (CME) option to obtain CME credits.	Control n=456 Participants Providers will not see an electronic alert for any patients and will provide usual care. Silent alerts will be generated that will be sent to study team members.
Proportion of Patients With an LDL-C of Less Than 55 mg/dL	45 Participants	53 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 18 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 29 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nihar Desai

Yale University

Phone: 203-767-6399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place