Chronic Rheumatic Diseases
Conditions
Brief summary
The investigators will pilot test a clinician-led intervention to improve medication adherence in general rheumatology clinic across a spectrum of rheumatic diseases. The study will assess feasibility, acceptability, and fidelity, and explore signal for improved medication adherence.
Interventions
BEHAVIORALClinician-led adherence intervention
The clinician will review real time pharmacy refill data during clinic and use effective communication techniques to discuss adherence with the patient
Sponsors
Duke University
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 providers at Southpoint Rheumatology All patients with a rheumatic disease diagnosis currently prescribed at least one rheumatic medication will be included in the analysis
Exclusion criteria
* new patients, those who are not prescribed any rheumatic disease medications, or do not have available pharmacy refill data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Feasibility as Measured by Number of Providers Agreeing to Participate | 4 weeks | — |
| Intervention Feasibility as Measured by the Feasibility of Intervention Measure (FIM) | 4 weeks | Provider survey based on the Feasibility of Intervention Measure, scores range from 1-5, where 5 is most feasible. |
| Intervention Feasibility as Measured by Percent of Visits With EMR Documentation of Providers Reviewing Refills | 4 weeks | Calculated for the full population, not per participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Acceptability as Measured by the Acceptability of Intervention Measure (AIM) | 4 weeks | Provider survey based on the Acceptability of Intervention Measure, scores range from 1-5, where 5 is most acceptable. |
| Intervention Acceptability as Measured by the Percentage of Patients Who Report a Positive Feeling After Having an Adherence Conversation With Their Providers | 4 weeks | Patient survey will be administered following provider visit. |
| Fidelity as Measured by the Number of Participants With Clinicians Conducting the Intervention Components of Reviewing Pharmacy Refills and Using Effective Communication Strategies | 4 weeks | This was collected using a EMR Smartphrase where clinicians documented whether they reviewed pharmacy refill data or discussed adherence with patients. |
| Fidelity as Measured by the Number of Participants With EMR Documentation of Completing the Intervention Components of Reviewing Pharmacy Refills and Using Effective Communication Strategies | 4 weeks | — |
| Change in MPR (Medication Possession Ratio) as a Percentage for the Entire Sample | Baseline to 3 months | MPR is calculated by dividing the number of days all patients were covered by medication by the total number of days in the observation period. This is multiplied by 100 to present a percent change for the entire sample. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKai Sun, MD, MS
Duke Health
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clinician-led Adherence Intervention - Clinicians Clinicians in this arm will be trained to conduct the adherence intervention in general rheumatology clinic with all follow up patients with a chronic rheumatic disease.
Patients seen by these clinicians will contribute to the outcome data collection.
Clinician-led adherence intervention: The clinician will review real time pharmacy refill data during clinic and use effective communication techniques to discuss adherence with the patient | 6 |
| Clinician-led Adherence Intervention - Patients Patients seen by these clinicians will contribute to the outcome data collection.
Clinician-led adherence intervention: The clinician will review real time pharmacy refill data during clinic and use effective communication techniques to discuss adherence with the patient | 96 |
| Total | 102 |
Baseline characteristics
| Characteristic | Clinician-led Adherence Intervention - Patients | Total | Clinician-led Adherence Intervention - Clinicians |
|---|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 17 | 54 years STANDARD_DEVIATION 17 | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 5 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 91 Participants | 97 Participants | 6 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 | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants | 31 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 | 6 Participants | 6 Participants | 0 Participants |
| Race (NIH/OMB) White | 57 Participants | 62 Participants | 5 Participants |
| Region of Enrollment United States | 96 Participants | 102 Participants | 6 Participants |
| Sex: Female, Male Female | 81 Participants | 83 Participants | 2 Participants |
| Sex: Female, Male Male | 15 Participants | 19 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 96 |
| other Total, other adverse events | 0 / 6 | 0 / 96 |
| serious Total, serious adverse events | 0 / 6 | 0 / 96 |
Outcome results
Primary
Intervention Feasibility as Measured by Number of Providers Agreeing to Participate
Time frame: 4 weeks
Population: Clinicians approached for study participation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinician-led Adherence Intervention - Clinicians | Intervention Feasibility as Measured by Number of Providers Agreeing to Participate | 6 Participants |
Primary
Intervention Feasibility as Measured by Percent of Visits With EMR Documentation of Providers Reviewing Refills
Calculated for the full population, not per participant.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clinician-led Adherence Intervention - Clinicians | Intervention Feasibility as Measured by Percent of Visits With EMR Documentation of Providers Reviewing Refills | 65.0 percentage of visits |
Primary
Intervention Feasibility as Measured by the Feasibility of Intervention Measure (FIM)
Provider survey based on the Feasibility of Intervention Measure, scores range from 1-5, where 5 is most feasible.
Time frame: 4 weeks
Population: Data not collected on patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinician-led Adherence Intervention - Clinicians | Intervention Feasibility as Measured by the Feasibility of Intervention Measure (FIM) | 4.60 score on a scale | Standard Deviation 0.58 |
Secondary
Change in MPR (Medication Possession Ratio) as a Percentage for the Entire Sample
MPR is calculated by dividing the number of days all patients were covered by medication by the total number of days in the observation period. This is multiplied by 100 to present a percent change for the entire sample.
Time frame: Baseline to 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clinician-led Adherence Intervention - Clinicians | Change in MPR (Medication Possession Ratio) as a Percentage for the Entire Sample | 11.0 percentage of change |
p-value: 0.002McNemar
Secondary
Fidelity as Measured by the Number of Participants With Clinicians Conducting the Intervention Components of Reviewing Pharmacy Refills and Using Effective Communication Strategies
This was collected using a EMR Smartphrase where clinicians documented whether they reviewed pharmacy refill data or discussed adherence with patients.
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinician-led Adherence Intervention - Clinicians | Fidelity as Measured by the Number of Participants With Clinicians Conducting the Intervention Components of Reviewing Pharmacy Refills and Using Effective Communication Strategies | 62 Participants |
Secondary
Fidelity as Measured by the Number of Participants With EMR Documentation of Completing the Intervention Components of Reviewing Pharmacy Refills and Using Effective Communication Strategies
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinician-led Adherence Intervention - Clinicians | Fidelity as Measured by the Number of Participants With EMR Documentation of Completing the Intervention Components of Reviewing Pharmacy Refills and Using Effective Communication Strategies | 62 Participants |
Secondary
Intervention Acceptability as Measured by the Acceptability of Intervention Measure (AIM)
Provider survey based on the Acceptability of Intervention Measure, scores range from 1-5, where 5 is most acceptable.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinician-led Adherence Intervention - Clinicians | Intervention Acceptability as Measured by the Acceptability of Intervention Measure (AIM) | 4.30 score on a scale | Standard Deviation 0.64 |
Secondary
Intervention Acceptability as Measured by the Percentage of Patients Who Report a Positive Feeling After Having an Adherence Conversation With Their Providers
Patient survey will be administered following provider visit.
Time frame: 4 weeks
Population: Patients who completed the survey.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clinician-led Adherence Intervention - Clinicians | Intervention Acceptability as Measured by the Percentage of Patients Who Report a Positive Feeling After Having an Adherence Conversation With Their Providers | 90.0 percentage of patients |
Other Pre-specified
Change in MPR (Medication Possession Ratio) as a Percentage
MPR is calculated by dividing the number of days a patient is covered by medication by the total number of days in the observation period. This is multiplied by 100 to present a percent change.
Time frame: Baseline to 6 months