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| ID | Type | Description | Link |
|---|---|---|---|
| 5U54MD012530-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| National Institutes of Health (NIH) | NIH |
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This is a pilot study to assess the feasibility of using Surescripts refill data during the clinical encounter to improve medication adherence in patients with systemic lupus erythematosus
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Lupus clinic providers will use Surescripts refill information to assess adherence level and address adherence barriers. We will assess the feasibility and acceptability of the intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention | Behavioral | Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as Measured by Number of Participants With EMR (Electronic Medical Record) Documentation of Adherence | Feasibility as measured by documentation of adherence assessment made by provider. | 12 weeks |
| Acceptability as Measured by Provider Survey | Acceptability as measured by provider survey, score range 1-5, with a higher score indicating that the intervention was more acceptable. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence as Determined by Self Report | 12 weeks | |
| Percentage of Adherent Participants as Determined by Medication Possession Ratio (MPR) | Medication Possession Ratio (MPR) = days with medication/total days. This will be determined by pharmacy refill data and calculated for 3 months (90 days). An MPR > or = 80% indicates adherence. |
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Inclusion Criteria
- All followup patients seen at the Duke Lupus clinic
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kai Sun | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34739191 | Derived | Sun K, Eudy AM, Rogers JL, Criscione-Schreiber LG, Sadun RE, Doss J, Maheswaranathan M, Barr AC, Eder L, Corneli AL, Bosworth HB, Clowse MEB. Pilot Intervention to Improve Medication Adherence Among Patients With Systemic Lupus Erythematosus Using Pharmacy Refill Data. Arthritis Care Res (Hoboken). 2023 Mar;75(3):550-558. doi: 10.1002/acr.24806. Epub 2022 Nov 11. |
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Patients were recruited over 12 clinic sessions between 9/25/19-1/25/20 from an academic lupus clinic, which takes place 1 half-day a week.
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Intervention | Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter. Behavioral Intervention: Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter. |
| FG001 | Lupus Clinic Providers | Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Intervention | Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter. Behavioral Intervention: Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility as Measured by Number of Participants With EMR (Electronic Medical Record) Documentation of Adherence | Feasibility as measured by documentation of adherence assessment made by provider. | Data for this outcome measure collected on the Behavioral Intervention group only. | Posted | Count of Participants | Participants | 12 weeks |
|
12 weeks
Collected via chart review of clinic visit during which the intervention was performed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Intervention | Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter. Behavioral Intervention: Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kai Sun, M.D. | Duke University | 919-681-7417 | kai.sun@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2018 | May 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Baseline, 12 weeks |
| BG001 | Lupus Clinic Providers | Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Lupus Clinic Providers |
Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter. |
|
|
| Primary | Acceptability as Measured by Provider Survey | Acceptability as measured by provider survey, score range 1-5, with a higher score indicating that the intervention was more acceptable. | Data for this outcome measure collected on the Lupus Clinic Providers group only. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | Medication Adherence as Determined by Self Report | Data not collected. | Posted | 12 weeks |
|
|
| Secondary | Percentage of Adherent Participants as Determined by Medication Possession Ratio (MPR) | Medication Possession Ratio (MPR) = days with medication/total days. This will be determined by pharmacy refill data and calculated for 3 months (90 days). An MPR > or = 80% indicates adherence. | Data for this outcome measure collected on the Behavioral Intervention group only. | Posted | Number | percentage of participants | Baseline, 12 weeks |
|
|
|
| 0 |
| 130 |
| 0 |
| 130 |
| 0 |
| 130 |
| EG001 | Lupus Clinic Providers | Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |