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The purpose of the overall study is to improve medication use rates among veterans by looking at the risk factors of low-density lipoprotein cholesterol (LDL). It will involve patients who have high LDL-C level (<130mg/dl) and /or may have difficulty taking their medications based on how often they refilled their medications in the last 12 months.
The investigators will test an innovative adherence packaging relative to usual care. The primary hypothesis is that veterans who receive the intervention will have greater improvement in their medication adherence as measured by pill refill at 6 and 12 months of follow up as compared to the control group.
A sample of participants with elevated LDL level >130 mg/dl and/or <80% medication position ratio in the last 12 months (n=250) will be consented. The study sample will consist of both male and female subjects. Research assistants (RA's) will complete a baseline assessment and then randomly allocated participants to one of the following two groups:
The study includes the following contacts with participants.
All participants enrolled in study will be followed for 12 months.
The study includes the following contacts with providers
• Baseline consent and explanation of the adherence packaging - In person for all providers (group style visit)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adherence Packaging Intervention Group | Experimental | [MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications. |
|
| Education Only Group | No Intervention | Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed. The 6-month interval was selected to maintain contact with patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| packaging | Behavioral | Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles |
| Measure | Description | Time Frame |
|---|---|---|
| Cholesterol Medication Adherence | Pill refill obtained at 12 months to review change in cholesterol medication adherence over the 12 month period between groups | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months | obtain non-fasting lipid panel at timepoints to review change in LDL cholesterol levels over the 12 month period (at baseline, 6 and 12 months) | Baseline, 6months, 12months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hayden B Bosworth, PhD | Duke University Medical Center/Durham VA Medical Center, Health Services and Development | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VAMC | Durham | North Carolina | 27701 | United States | ||
| Raleigh Community-based Outpatient Clinic (CBOC- Raleigh) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adherence Packaging Intervention Group | [MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA (Research Assistant) on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications. packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles |
| FG001 | Education Only Group | Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adherence Packaging Intervention Group | [MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications. packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles |
| 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 | Cholesterol Medication Adherence | Pill refill obtained at 12 months to review change in cholesterol medication adherence over the 12 month period between groups | Data on pill refill could not be obtained for 2 of the education only participants. | Posted | Median | Inter-Quartile Range | adherence proportion | 12 months |
|
During 1 year study participation
Patients were asked about adverse events at each follow-up appointment and a systematic review of the medical record was completed at each follow-up as well.
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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 | Adherence Packaging Intervention Group | [MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications. packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bee Sting- Emergency Room Visit | General disorders | Systematic Assessment | Bee sting |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hayden Bosworth, PhD | Durham Veterans Affairs Medical Center | 919-286-6936 | hayden.bosworth@va.gov |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019064 | Product Packaging |
| ID | Term |
|---|---|
| D007221 | Industry |
| D013676 | Technology, Industry, and Agriculture |
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| Raleigh |
| North Carolina |
| 27701 |
| United States |
| Lost to Follow-up |
|
| No longer meets inclusion |
|
| BG001 | Education Only Group | Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Education Only Group | Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed. |
|
|
|
| Secondary | Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months | obtain non-fasting lipid panel at timepoints to review change in LDL cholesterol levels over the 12 month period (at baseline, 6 and 12 months) | Cholesterol values could not be obtained for all patients at all time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 6months, 12months |
|
|
|
|
| 33 |
| 120 |
| 0 |
| 120 |
| EG001 | Education Only Group | Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed. | 26 | 120 | 0 | 120 |
| Bleeding- Emergency Room Visit | Reproductive system and breast disorders | Systematic Assessment | Heavy bleeding accompanied by lightheadedness |
|
| Cardiac Related Hospitalization or Visit | Cardiac disorders | Systematic Assessment | Includes: chest pain, MI, heart failure, hospitalization including surgery |
|
| Bowel Obstruction- Hospitalization | Gastrointestinal disorders | Systematic Assessment | Hospitalization |
|
| General Hospitalization | General disorders | Systematic Assessment | chemotherapy complication |
|
| Hospitalization-Infection | Infections and infestations | Systematic Assessment | Sepsis related to kidney failure |
|
| Hospitalization-Renal | Renal and urinary disorders | Systematic Assessment | Increased Cr, acute renal failure |
|
| Hospitalization- Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Includes: pneumonia, lung disease |
|
| Hospitalization-Stroke | Vascular disorders | Systematic Assessment |
|
| Musculoskeletal Surgery | Surgical and medical procedures | Systematic Assessment | Knee Arthroplasty Surgery |
|
| Death unrelated to study protocol | General disorders | Systematic Assessment | Unrelated pt deaths (cancer, CHF complications, not specified) |
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| Hospitalization-Gastrointestinal | Gastrointestinal disorders | Systematic Assessment | Events include: small bowel obstruction and diverticulitis |
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| Hospitalization-General | General disorders | Systematic Assessment | Events include: Re-occurring treatment for prior dx (spinal injury), Multi-factorial hospitalization causes, MVA events, & Unspecified causes |
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| Hospitalization-Infection | Infections and infestations | Systematic Assessment | Events include: Fever during radiation treatment, Febrile Neutropenia, Cellulitis, Fainting, Food poisoning, UTI |
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| Hospitalization-Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment | Events include: Assault, Spinal surgery rehab, Fractures, |
|
| Hospitalization-Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Events include: Lymphadenopathy sarcoma |
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| Hospitaliztion- Nervous | Nervous system disorders | Systematic Assessment | Events include: spinal cord injury biopsy |
|
| Hospitalizations-Psychiatric | Psychiatric disorders | Systematic Assessment | Events include: Psychiatric events (due to HIPAA can not collect/provide details) |
|
| Hospitalization- Renal | Renal and urinary disorders | Systematic Assessment | Events include: Renal failure, hematuria, Acute kidney disease |
|
| Hospitaliztion- Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Events include: Pneumonia, Lung Mass, Impaired gas exchange, pulmonary embolism |
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| Surgery during Hospitaliztion | Surgical and medical procedures | Systematic Assessment | Event include:renal biopsy, amputation (and revision), coronary angiograph, lesion, lung removal, spinal cord bx, spinal surgery, carotid endarterectomy, tendon repair, tumor, nephrectomy, back surgery, hip arthroplasty, cath, appendix, etc |
|
| Hospitalization- Vascular | Vascular disorders | Systematic Assessment | Events include: Stroke, Blood clot |
|
| Renal blockage- ER Visit | Renal and urinary disorders | Systematic Assessment | Events include: Blocked catheter, |
|
| Bronchitis/COPD- ER Visit | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Pt came to ER for SOB via EMS. |
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| Scheduled Outpatient Surgery | General disorders | Systematic Assessment | Events include: laryngoscopy with lesion removal, thyroid nodule |
|
| Scheduled Outpatient Surgery- Renal | Renal and urinary disorders | Systematic Assessment | Events include: PCN placement for ureteral obstruction, bladder tumor resection, |
|
| Planned outpatient surgery- Shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Rotator cuff repair |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| 12 months (n=109/115) |
|