Trial Outcomes & Findings for Pharmacist-led Group Medical Visits to Help With Diabetes Management (NCT NCT00554671)

NCT ID: NCT00554671

Last Updated: 2018-07-11

Results Overview

Hemoglobin A1c levels at 6 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 250 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2018-07-11

Participant Flow

Participant milestones

Measure	Pharmacist-led Group Medical Visits Pharmacist-led group medical visits which consists of medication titration and behavioral modification Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals Group support: Peer support are provided in the group setting Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision	Usual Care Patients continued on usual care without pharmacist-led group medical visits
Overall Study STARTED	117	133
Overall Study COMPLETED	97	117
Overall Study NOT COMPLETED	20	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacist-led Group Medical Visits to Help With Diabetes Management

Baseline characteristics by cohort

Measure	Pharmacist-led Group Medical Visits n=117 Participants Pharmacist-led group medical visits which consists of medication titration and behavioral modification Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals Group support: Peer support are provided in the group setting Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision	Usual Care n=133 Participants Patients continued on usual care without pharmacist-led group medical visits	Total n=250 Participants Total of all reporting groups
Age, Continuous	65.8 years STANDARD_DEVIATION 8.7 • n=5 Participants	65.0 years STANDARD_DEVIATION 9.8 • n=7 Participants	65.4 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	112 Participants n=5 Participants	128 Participants n=7 Participants	240 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	88 participants n=5 Participants	104 participants n=7 Participants	192 participants n=5 Participants
Race/Ethnicity, Customized African American	12 participants n=5 Participants	15 participants n=7 Participants	27 participants n=5 Participants
Race/Ethnicity, Customized Asian Pacific Islander	15 participants n=5 Participants	8 participants n=7 Participants	23 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Unknown	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Hemoglobin A1c	8.2 percent Hemoglobin A1c STANDARD_DEVIATION 1.5 • n=5 Participants	8.2 percent Hemoglobin A1c STANDARD_DEVIATION 1.3 • n=7 Participants	8.2 percent Hemoglobin A1c STANDARD_DEVIATION 1.4 • n=5 Participants
Systolic Blood Pressure	136.5 mmHg STANDARD_DEVIATION 19.0 • n=5 Participants	136.2 mmHg STANDARD_DEVIATION 17.4 • n=7 Participants	136.3 mmHg STANDARD_DEVIATION 18.1 • n=5 Participants
LDL cholesterol	87.6 mg/dL STANDARD_DEVIATION 29.8 • n=5 Participants	93.7 mg/dL STANDARD_DEVIATION 33.7 • n=7 Participants	91.0 mg/dL STANDARD_DEVIATION 32.1 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: At the 6 month visit, some patients dropped out of the study or died.

Hemoglobin A1c levels at 6 months

Outcome measures

Measure	Pharmacist-led Group Medical Visits n=102 Participants Pharmacist-led group medical visits which consists of medication titration and behavioral modification Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals Group support: Peer support are provided in the group setting Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision	Usual Care n=122 Participants Patients continued on usual care without pharmacist-led group medical visits
Hemoglobin A1c	7.8 percent Hemoglobin A1c Standard Deviation 1.2	8.1 percent Hemoglobin A1c Standard Deviation 1.4

PRIMARY outcome

Timeframe: 13 months

hemoglobin A1c levels at 13 months

Outcome measures

Measure	Pharmacist-led Group Medical Visits n=97 Participants Pharmacist-led group medical visits which consists of medication titration and behavioral modification Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals Group support: Peer support are provided in the group setting Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision	Usual Care n=117 Participants Patients continued on usual care without pharmacist-led group medical visits
Hemoglobin A1c	7.9 percent Hemoglobin A1c Standard Deviation 1.3	8.0 percent Hemoglobin A1c Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline and 13 months

Population: 117 patients randomized to Pharmacist-led Group Medical Visits, 2 patients died before study end date and 18 patients dropped out.133 patients randomized to Usual care, 4 patients died before study end date and 12 patients dropped out.

Medical Outcomes Study 36-Item Short Form Survey (SF-36) is a popular, multi-purpose health status survey that addresses quality of life from physical and mental health perspectives. SF-36v is the survey adapted for veterans. Items are summed and averaged in two subscores, the Physical Composite Summary Score and the Mental Composite Summary Score, and scaled to a range of 0 to 100, with lower scores denoting poorer health.

Outcome measures

Measure	Pharmacist-led Group Medical Visits n=117 Participants Pharmacist-led group medical visits which consists of medication titration and behavioral modification Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals Group support: Peer support are provided in the group setting Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision	Usual Care n=133 Participants Patients continued on usual care without pharmacist-led group medical visits
Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment Baseline Physical Composite Summary Score	39.2 Scores of SF-36v Standard Deviation 9.7	39.3 Scores of SF-36v Standard Deviation 9.8
Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment 13 Months Physical Composite Scores	39.6 Scores of SF-36v Standard Deviation 10.5	39.1 Scores of SF-36v Standard Deviation 9.7
Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment Baseline Mental Composite Summary Score	48.8 Scores of SF-36v Standard Deviation 11.0	50.4 Scores of SF-36v Standard Deviation 11.7
Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment 13 Months Mental Composite Summary Score	50.1 Scores of SF-36v Standard Deviation 10.5	51.0 Scores of SF-36v Standard Deviation 11.0

SECONDARY outcome

Timeframe: 13 months (during study) and 13 months (after the study) = 26 months

Population: 117 patients randomized to Pharmacist-led Group Medical Visits. 133 patients were randomized to Usual care.

The reported values represent the "Total VHA expenditure per person". Institutional costs from health service utilization on the study patients during and 13 months after the intervention. Baseline is considered time 0.

Outcome measures

Measure	Pharmacist-led Group Medical Visits n=117 Participants Pharmacist-led group medical visits which consists of medication titration and behavioral modification Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals Group support: Peer support are provided in the group setting Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision	Usual Care n=133 Participants Patients continued on usual care without pharmacist-led group medical visits
Health-care Costs to the VHA 13 months after study - study period	-1575 United States Dollar Standard Deviation 30774	2360 United States Dollar Standard Deviation 23708
Health-care Costs to the VHA 13 months after study - 13 months before baseline	4220 United States Dollar Standard Deviation 31091	5752 United States Dollar Standard Deviation 29690
Health-care Costs to the VHA baseline or time "0"	22062 United States Dollar Standard Deviation 67524	15200 United States Dollar Standard Deviation 23812
Health-care Costs to the VHA Study period - 13 months prior to baseline	4656 United States Dollar Standard Deviation 31881	2645 United States Dollar Standard Deviation 25580

Adverse Events

Pharmacist-led Group Medical Visits

Serious events: 38 serious events

Other events: 5 other events

Deaths: 0 deaths

Usual Care

Serious events: 44 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pharmacist-led Group Medical Visits n=117 participants at risk Pharmacist-led group medical visits which consists of medication titration and behavioral modification Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals Group support: Peer support are provided in the group setting Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision	Usual Care n=133 participants at risk Patients continued on usual care without pharmacist-led group medical visits
General disorders ER visits	20.5% 24/117 • Number of events 33 • 13 months of the study period Collection via monthly phone calls and face-to-face study visits	18.0% 24/133 • Number of events 30 • 13 months of the study period Collection via monthly phone calls and face-to-face study visits
General disorders hospitalization	22.2% 26/117 • Number of events 40 • 13 months of the study period Collection via monthly phone calls and face-to-face study visits	15.8% 21/133 • Number of events 25 • 13 months of the study period Collection via monthly phone calls and face-to-face study visits
General disorders Death	1.7% 2/117 • Number of events 2 • 13 months of the study period Collection via monthly phone calls and face-to-face study visits	3.0% 4/133 • Number of events 4 • 13 months of the study period Collection via monthly phone calls and face-to-face study visits

Other adverse events

Measure	Pharmacist-led Group Medical Visits n=117 participants at risk Pharmacist-led group medical visits which consists of medication titration and behavioral modification Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals Group support: Peer support are provided in the group setting Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision	Usual Care n=133 participants at risk Patients continued on usual care without pharmacist-led group medical visits
Endocrine disorders Hypoglycemia,	1.7% 2/117 • Number of events 117 • 13 months of the study period Collection via monthly phone calls and face-to-face study visits	0.75% 1/133 • Number of events 133 • 13 months of the study period Collection via monthly phone calls and face-to-face study visits
Endocrine disorders Hyperglycemia	2.6% 3/117 • Number of events 3 • 13 months of the study period Collection via monthly phone calls and face-to-face study visits	4.5% 6/133 • Number of events 6 • 13 months of the study period Collection via monthly phone calls and face-to-face study visits

Additional Information

Wen-Chih Wu, MD

Providence VA Medical Center

Phone: 4012737100

Email: wen-chih.wu@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place