Systemic Lupus Erythematosus
Conditions
Keywords
medication adherence
Brief summary
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
Interventions
BEHAVIORALBehavioral 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.
Sponsors
Duke University
National Institute on Minority Health and Health Disparities (NIMHD)
National Institutes of Health (NIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- All followup patients seen at the Duke Lupus clinic
Exclusion criteria
* Patients not seen at the Duke Lupus Clinic * New patients seen for the first time at the Duke Lupus Clinic * Patients who are not prescribed any lupus medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as Measured by Number of Participants With EMR (Electronic Medical Record) Documentation of Adherence | 12 weeks | Feasibility as measured by documentation of adherence assessment made by provider. |
| Acceptability as Measured by Provider Survey | 12 weeks | Acceptability as measured by provider survey, score range 1-5, with a higher score indicating that the intervention was more acceptable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence as Determined by Self Report | 12 weeks | — |
| Percentage of Adherent Participants as Determined by Medication Possession Ratio (MPR) | Baseline, 12 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKai Sun
Duke University
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 130 |
| 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. | 5 |
| Total | 135 |
Baseline characteristics
| Characteristic | Behavioral Intervention | Total | Lupus Clinic Providers |
|---|---|---|---|
| Age, Continuous | 44.0 years STANDARD_DEVIATION 14 | 43 years STANDARD_DEVIATION 7 | 42.0 years STANDARD_DEVIATION 4.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 127 Participants | 132 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 71 Participants | 71 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 54 Participants | 58 Participants | 4 Participants |
| Region of Enrollment United States | 130 Participants | 135 Participants | 5 Participants |
| Sex: Female, Male Female | 123 Participants | 127 Participants | 4 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 130 | 0 / 5 |
| other Total, other adverse events | 0 / 130 | 0 / 5 |
| serious Total, serious adverse events | 0 / 130 | 0 / 5 |
Outcome results
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.
Time frame: 12 weeks
Population: Data for this outcome measure collected on the Lupus Clinic Providers group only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lupus Clinic Providers | Acceptability as Measured by Provider Survey | 4.4 score on a scale | Standard Deviation 0.6 |
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.
Time frame: 12 weeks
Population: Data for this outcome measure collected on the Behavioral Intervention group only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Intervention | Feasibility as Measured by Number of Participants With EMR (Electronic Medical Record) Documentation of Adherence | 116 Participants |
Secondary
Medication Adherence as Determined by Self Report
Time frame: 12 weeks
Population: Data not collected.
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.
Time frame: Baseline, 12 weeks
Population: Data for this outcome measure collected on the Behavioral Intervention group only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Behavioral Intervention | Percentage of Adherent Participants as Determined by Medication Possession Ratio (MPR) | Baseline (prior to intervention) | 46 percentage of participants |
| Behavioral Intervention | Percentage of Adherent Participants as Determined by Medication Possession Ratio (MPR) | 12 weeks (after intervention) | 55 percentage of participants |