Trial Outcomes & Findings for Cholesterol Medication Packaging Study (NCT NCT01744977)

Last Updated: 2016-05-18

Results Overview

Pill refill obtained at 12 months to review change in cholesterol medication adherence over the 12 month period between groups

Recruitment status

COMPLETED

Study phase

Target enrollment

240 participants

Primary outcome timeframe

12 months

Results posted on

2016-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	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	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.
Overall Study STARTED	120	120
Overall Study 6 Month Completed	113	115
Overall Study COMPLETED	109	115
Overall Study NOT COMPLETED	11	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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.
Overall Study Withdrawal by Subject	1	2
Overall Study Death	2	3
Overall Study Lost to Follow-up	2	0
Overall Study No longer meets inclusion	6	0

Baseline Characteristics

Cholesterol Medication Packaging Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adherence Packaging Intervention Group n=120 Participants \[MeadWestvaco Packaging Intervention Arm\] 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	Education Only Group n=120 Participants 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.	Total n=240 Participants Total of all reporting groups
Age, Continuous	62.4 years STANDARD_DEVIATION 8.9 • n=5 Participants	62.9 years STANDARD_DEVIATION 8.6 • n=7 Participants	62.6 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	109 Participants n=5 Participants	110 Participants n=7 Participants	219 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	47 participants n=5 Participants	41 participants n=7 Participants	88 participants n=5 Participants
Race/Ethnicity, Customized African American or Other	73 participants n=5 Participants	79 participants n=7 Participants	152 participants n=5 Participants
Region of Enrollment United States	120 participants n=5 Participants	120 participants n=7 Participants	240 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Data on pill refill could not be obtained for 2 of the education only participants.

Pill refill obtained at 12 months to review change in cholesterol medication adherence over the 12 month period between groups

Outcome measures

Outcome measures
Measure	Adherence Packaging Intervention Group n=120 Participants \[MeadWestvaco Packaging Intervention Arm\] 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	Education Only Group n=118 Participants 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.
Cholesterol Medication Adherence	.99 adherence proportion Interval 0.74 to 0.99	.94 adherence proportion Interval 0.6 to 1.0

SECONDARY outcome

Timeframe: Baseline, 6months, 12months

Population: Cholesterol values could not be obtained for all patients at all time points.

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)

Outcome measures

Outcome measures
Measure	Adherence Packaging Intervention Group n=120 Participants \[MeadWestvaco Packaging Intervention Arm\] 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	Education Only Group n=120 Participants 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.
Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months Baseline (n=120/119)	110.1 mg/dL Standard Deviation 38.8	111.6 mg/dL Standard Deviation 31.7
Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months 6 months (n=112/115)	101.1 mg/dL Standard Deviation 29.4	105.8 mg/dL Standard Deviation 32.8
Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months 12 months (n=109/115)	101.3 mg/dL Standard Deviation 34.3	102.9 mg/dL Standard Deviation 33.1

Adverse Events

Adherence Packaging Intervention Group

Serious events: 33 serious events

Other events: 0 other events

Deaths: 0 deaths

Education Only Group

Serious events: 26 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Hayden Bosworth, PhD

Durham Veterans Affairs Medical Center

Phone: 919-286-6936

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Adherence Packaging Intervention Group n=120 participants at risk \[MeadWestvaco Packaging Intervention Arm\] 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	Education Only Group n=120 participants at risk 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.
General disorders Bee Sting- Emergency Room Visit	0.00% 0/120 • 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.	0.83% 1/120 • Number of events 1 • 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.
Reproductive system and breast disorders Bleeding- Emergency Room Visit	0.00% 0/120 • 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.	0.83% 1/120 • Number of events 1 • 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.
Cardiac disorders Cardiac Related Hospitalization or Visit	7.5% 9/120 • Number of events 13 • 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.	4.2% 5/120 • Number of events 6 • 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.
Gastrointestinal disorders Bowel Obstruction- Hospitalization	0.00% 0/120 • 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.	0.83% 1/120 • Number of events 1 • 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.
General disorders General Hospitalization	0.00% 0/120 • 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.	0.83% 1/120 • Number of events 1 • 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.
Infections and infestations Hospitalization-Infection	2.5% 3/120 • Number of events 3 • 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.	2.5% 3/120 • Number of events 4 • 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.
Renal and urinary disorders Hospitalization-Renal	0.00% 0/120 • 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.	0.83% 1/120 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Hospitalization- Respiratory	0.83% 1/120 • Number of events 1 • 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.	1.7% 2/120 • Number of events 2 • 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.
Vascular disorders Hospitalization-Stroke	0.83% 1/120 • Number of events 1 • 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.	0.00% 0/120 • 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.
Surgical and medical procedures Musculoskeletal Surgery	1.7% 2/120 • Number of events 2 • 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.	0.00% 0/120 • 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.
General disorders Death unrelated to study protocol	1.7% 2/120 • Number of events 2 • 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.	2.5% 3/120 • Number of events 3 • 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.
Gastrointestinal disorders Hospitalization-Gastrointestinal	0.83% 1/120 • Number of events 1 • 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.	0.83% 1/120 • Number of events 1 • 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.
General disorders Hospitalization-General	1.7% 2/120 • Number of events 2 • 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.	2.5% 3/120 • Number of events 5 • 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.
Musculoskeletal and connective tissue disorders Hospitalization-Musculoskeletal	1.7% 2/120 • Number of events 2 • 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.	0.83% 1/120 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hospitalization-Neoplasm	0.00% 0/120 • 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.	0.83% 1/120 • Number of events 1 • 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.
Nervous system disorders Hospitaliztion- Nervous	0.00% 0/120 • 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.	0.83% 1/120 • Number of events 1 • 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.
Psychiatric disorders Hospitalizations-Psychiatric	2.5% 3/120 • Number of events 4 • 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.	0.83% 1/120 • Number of events 1 • 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.
Renal and urinary disorders Hospitalization- Renal	2.5% 3/120 • Number of events 3 • 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.	0.83% 1/120 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Hospitaliztion- Respiratory	2.5% 3/120 • Number of events 5 • 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.	0.00% 0/120 • 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.
Surgical and medical procedures Surgery during Hospitaliztion	9.2% 11/120 • Number of events 12 • 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.	7.5% 9/120 • Number of events 11 • 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.
Vascular disorders Hospitalization- Vascular	1.7% 2/120 • Number of events 2 • 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.	0.83% 1/120 • Number of events 1 • 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.
Renal and urinary disorders Renal blockage- ER Visit	0.83% 1/120 • Number of events 1 • 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.	0.00% 0/120 • 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.
Respiratory, thoracic and mediastinal disorders Bronchitis/COPD- ER Visit	0.83% 1/120 • Number of events 1 • 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.	0.00% 0/120 • 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.
General disorders Scheduled Outpatient Surgery	1.7% 2/120 • Number of events 2 • 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.	0.83% 1/120 • Number of events 1 • 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.
Renal and urinary disorders Scheduled Outpatient Surgery- Renal	0.83% 1/120 • Number of events 2 • 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.	0.00% 0/120 • 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.
Musculoskeletal and connective tissue disorders Planned outpatient surgery- Shoulder	0.00% 0/120 • 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.	0.83% 1/120 • Number of events 1 • 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.