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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinician-led adherence intervention | Behavioral | The clinician will review real time pharmacy refill data during clinic and use effective communication techniques to discuss adherence with the patient |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Feasibility as Measured by Number of Providers Agreeing to Participate | 4 weeks | |
| 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. | 4 weeks |
| Intervention Feasibility as Measured by Percent of Visits With EMR Documentation of Providers Reviewing Refills | Calculated for the full population, not per participant. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Intervention Acceptability as Measured by the Percentage of Patients Who Report a Positive Feeling After Having an Adherence Conversation With Their Providers |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kai Sun, MD, MS | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data not collected on clinicians. |
| 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 | Intervention Feasibility as Measured by Number of Providers Agreeing to Participate | Clinicians approached for study participation. | Posted | Count of Participants | Participants | 4 weeks |
|
3 months
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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 | 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 |
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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 | Jun 6, 2024 | Apr 17, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 15, 2023 | Sep 6, 2024 | ICF_000.pdf |
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Patient survey will be administered following provider visit. |
| 4 weeks |
| 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. | 4 weeks |
| 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 | 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. | Baseline to 3 months |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| 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 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 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. | Data not collected on patients. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| Primary | Intervention Feasibility as Measured by Percent of Visits With EMR Documentation of Providers Reviewing Refills | Calculated for the full population, not per participant. | Posted | Number | percentage of visits | 4 weeks | Visits | Visits |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| 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. | Patients who completed the survey. | Posted | Number | percentage of patients | 4 weeks |
|
|
|
| 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. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| 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 | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| 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. | Posted | Number | percentage of change | Baseline to 3 months |
|
|
|
|
| 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. | Not Posted | Baseline to 6 months | Participants |
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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 | 0 | 96 | 0 | 96 | 0 | 96 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|