Trial Outcomes & Findings for Tele-Pharmacy Intervention to Improve Treatment Adherence (NCT NCT02512276)

Last Updated: 2019-06-06

Results Overview

Average proportion of days covered (PDC) for medications to treat eligible conditions. An eligible condition is a diagnosis of either hyperlipidemia, hypertension, or diabetes and evidence of poor control for that condition at the time of enrollment. Adherence will be measured as an average of averages PDC only for medications that qualified a patient for inclusion in the study. Medication adherence is often reported as percentage of days covered.

Recruitment status

COMPLETED

Study phase

Target enrollment

4078 participants

Primary outcome timeframe

12 months

Results posted on

2019-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Telepharmacist Intervention Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications \[defined as combined (average of averages) proportion of days covered (PDC) \< 80%\] who also have poor or worsening disease control. Telepharmacist intervention: The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes.	Usual Care Patients randomized to this arm will receive usual care.
Overall Study STARTED	2038	2040
Overall Study COMPLETED	2030	2029
Overall Study NOT COMPLETED	8	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tele-Pharmacy Intervention to Improve Treatment Adherence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telepharmacist Intervention n=2038 Participants Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications \[defined as combined (average of averages) proportion of days covered (PDC) \< 80%\] who also have poor or worsening disease control. Telepharmacist intervention: The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes.	Usual Care n=2040 Participants Patients randomized to this arm will receive usual care.	Total n=4078 Participants Total of all reporting groups
Age, Continuous	60.4 years STANDARD_DEVIATION 11.7 • n=5 Participants	59.2 years STANDARD_DEVIATION 11.5 • n=7 Participants	59.8 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	924 Participants n=5 Participants	917 Participants n=7 Participants	1841 Participants n=5 Participants
Sex: Female, Male Male	1114 Participants n=5 Participants	1123 Participants n=7 Participants	2237 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian	94 Participants n=5 Participants	95 Participants n=7 Participants	189 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	579 Participants n=5 Participants	448 Participants n=7 Participants	1027 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	113 Participants n=5 Participants	91 Participants n=7 Participants	204 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Other	68 Participants n=5 Participants	95 Participants n=7 Participants	163 Participants n=5 Participants
Race/Ethnicity, Customized Patient Declined/ Missing	84 Participants n=5 Participants	72 Participants n=7 Participants	156 Participants n=5 Participants
Race/Ethnicity, Customized White	1093 Participants n=5 Participants	1236 Participants n=7 Participants	2329 Participants n=5 Participants
Region of Enrollment United States	2038 Participants n=5 Participants	2040 Participants n=7 Participants	4078 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Intention to treat

Outcome measures

Outcome measures
Measure	Telepharmacist Intervention n=2038 Participants Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications \[defined as combined (average of averages) proportion of days covered (PDC) \< 80%\] who also have poor or worsening disease control. Telepharmacist intervention: The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes.	Usual Care n=2040 Participants Patients randomized to this arm will receive usual care.
Medication Adherence	46.2 percentage of days covered Standard Deviation 33.9	42.1 percentage of days covered Standard Deviation 33.8

SECONDARY outcome

Timeframe: 12 months

Population: Intention to treat

Percentage of patients achieving good disease control for all eligible conditions. Disease control was evaluated using laboratory or blood pressure values in the electronic health record and was based on clinical guideline targets (HbA1c values for patients with diabetes, systolic and diastolic blood pressure for patients with hypertension, and LDL values for patients with hyperlipidemia). This outcome measure disease control was measured as the proportion of patients achieving "good" disease control based on guideline-specified targets for all of their eligible conditions, as opposed to at least 1 for Outcome Measure 3. An eligible condition is a diagnosis of either hyperlipidemia, hypertension, or diabetes and evidence of poor control for that condition at the time of enrollment.

Outcome measures

Outcome measures
Measure	Telepharmacist Intervention n=2038 Participants Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications \[defined as combined (average of averages) proportion of days covered (PDC) \< 80%\] who also have poor or worsening disease control. Telepharmacist intervention: The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes.	Usual Care n=2040 Participants Patients randomized to this arm will receive usual care.
Disease Control - All Eligible Conditions	67.4 percentage of participants	66.2 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intention to treat

Percentage of patients achieving good disease control for at least one eligible condition. Disease control was evaluated using laboratory or blood pressure values in the electronic health record and was based on clinical guideline targets (HbA1c values for patients with diabetes, systolic and diastolic blood pressure for patients with hypertension, and LDL values for patients with hyperlipidemia). This outcome measure disease control was measured as the proportion of patients achieving "good" disease control based on guideline-specified targets for all at least 1 eligible condition, as opposed to all of their eligible conditions for Outcome Measure 2. An eligible condition is a diagnosis of either hyperlipidemia, hypertension, or diabetes and evidence of poor control for that condition at the time of enrollment.

Outcome measures

Outcome measures
Measure	Telepharmacist Intervention n=2038 Participants Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications \[defined as combined (average of averages) proportion of days covered (PDC) \< 80%\] who also have poor or worsening disease control. Telepharmacist intervention: The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes.	Usual Care n=2040 Participants Patients randomized to this arm will receive usual care.
Disease Control	72.9 percentage of participants	71.2 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intention to treat

Number of patients with at least 1 ER visit.

Outcome measures

Outcome measures
Measure	Telepharmacist Intervention n=2038 Participants Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications \[defined as combined (average of averages) proportion of days covered (PDC) \< 80%\] who also have poor or worsening disease control. Telepharmacist intervention: The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes.	Usual Care n=2040 Participants Patients randomized to this arm will receive usual care.
Healthcare Utilization - ER Visits	90 Participants	113 Participants

SECONDARY outcome

Timeframe: 12 months

Number of patients with at least 1 office visit.

Outcome measures

Outcome measures
Measure	Telepharmacist Intervention n=2038 Participants Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications \[defined as combined (average of averages) proportion of days covered (PDC) \< 80%\] who also have poor or worsening disease control. Telepharmacist intervention: The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes.	Usual Care n=2040 Participants Patients randomized to this arm will receive usual care.
Healthcare Utilization - Office Visits	641 Participants	594 Participants

SECONDARY outcome

Timeframe: 12 months

Number of patients with at least 1 hospitalization.

Outcome measures

Outcome measures
Measure	Telepharmacist Intervention n=2038 Participants Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications \[defined as combined (average of averages) proportion of days covered (PDC) \< 80%\] who also have poor or worsening disease control. Telepharmacist intervention: The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes.	Usual Care n=2040 Participants Patients randomized to this arm will receive usual care.
Healthcare Utilization - Hospitalizations	170 Participants	156 Participants

Adverse Events

Telepharmacist Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Niteesh K. Choudhry, MD, PhD

Brigham and Women's Hospital

Phone: 617-278-0930

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place