Trial · NCT04394715
Pragmatic Trial of Messaging to Providers About Treatment of Hyperlipidemia (PROMPT-LIPID)
NCT04394715, Not applicable, Completed, Yale University; results first posted 2024-09-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pragmatic Trial of Messaging to Providers About Treatment of Hyperlipidemia (PROMPT-LIPID). Trials, record NCT04394715. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04394715
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pragmatic Trial of Messaging to Providers About Treatment of Hyperlipidemia (PROMPT-LIPID)
- NCT number
- NCT04394715
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,596 participants, actual
- Lead sponsor
- Yale University
- Conditions
- High Risk Atherosclerotic Cardiovascular Disease
- Interventions
- Electronic Alert
- First posted
- 2020-05-19
- Last updated
- 2024-09-03
- Results first posted
- 2024-09-03
- Limitations and caveats
All study sites were in a single academic health system, and the alert was developed within this site's EHR, reducing generalizability. The study relied on accurately documented ASCVD ICD-10 codes. Contamination between providers at shared sites was possible, biasing the outcome toward the null. Finally, many providers chose to defer the alert, suggesting responsibility of LLT intensification belonged to primary care providers or cardiologists.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With Intensification of Lipid Lowering Therapy | 90 days from first alert for any given patient | 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. |
| Secondary | Achieved LDL-C at 6 Months | 6 months from first alert for any given patient | LDL-C at 6 months as measured by medical record review |
| Secondary | Proportion of Patients With an LDL-C of Less Than 70 mg/dL | 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. |
| Secondary | Proportion of Patients With an LDL-C of Less Than 55 mg/dL | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients With Intensification of Lipid Lowering Therapy | 90 days from first alert for any given patient | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Achieved LDL-C at 6 Months | 6 months from first alert for any given patient | 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. | mg/dL | MEDIAN |
| SECONDARY | Proportion of Patients With an LDL-C of Less Than 70 mg/dL | 6 months from first alert for any given patient | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With an LDL-C of Less Than 55 mg/dL | 6 months from first alert for any given patient | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With Intensification of Lipid Lowering Therapy | Intervention | 159 | Participants | ||
| Proportion of Patients With Intensification of Lipid Lowering Therapy | Control | 142 | Participants | ||
| Achieved LDL-C at 6 Months | Intervention | 83 | Inter-Quartile Range 66.5 to 102 | mg/dL | |
| Achieved LDL-C at 6 Months | Control | 83 | Inter-Quartile Range 68 to 107 | mg/dL | |
| Proportion of Patients With an LDL-C of Less Than 70 mg/dL | Intervention | 115 | Participants | ||
| Proportion of Patients With an LDL-C of Less Than 70 mg/dL | Control | 133 | Participants | ||
| Proportion of Patients With an LDL-C of Less Than 55 mg/dL | Intervention | 45 | Participants | ||
| Proportion of Patients With an LDL-C of Less Than 55 mg/dL | Control | 53 | Participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention | 1,179 | |
| Overall Study | STARTED | Control | 1,417 | |
| Overall Study | Participants Enrolled | Intervention | 1,130 | |
| Overall Study | Participants Enrolled | Control | 1,370 | |
| Overall Study | Providers Enrolled | Intervention | 49 | |
| Overall Study | Providers Enrolled | Control | 47 | |
| Overall Study | COMPLETED | Intervention | 1,179 | |
| Overall Study | COMPLETED | Control | 1,417 | |
| Overall Study | NOT COMPLETED | Intervention | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention | 18 | 1,130 |
| Total, all-cause mortality | Control | 29 | 1,370 |
| Total, other adverse events | Intervention | 0 | 1,130 |
| Total, other adverse events | Control | 0 | 1,370 |
| Total, serious adverse events | Intervention | 0 | 1,130 |
| Total, serious adverse events | Control | 0 | 1,370 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention vs Control: Proportion of Patients With Intensification of Lipid Lowering Therapy | Trial comparisons |
| Intervention vs Control: Proportion of Patients With an LDL-C of Less Than 55 mg/dL | Trial comparisons |
| Intervention vs Control: Proportion of Patients With an LDL-C of Less Than 70 mg/dL | Trial comparisons |
| Intervention vs Control: deaths from any cause | Trial comparisons |
| Intervention vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04394715
GET https://conductscience.org/api/trials/v1/NCT04394715/registered