The purpose of this research is to explore whether a pharmacist-led diabetes management program can help optimize diabetes care for older adults. Participation in this study will involve meeting with a pharmacist who works with subjects' doctors, getting some routine bloodwork typical for people with diabetes, and potentially adjusting the subject's diabetes medications to reach American Diabetes Association guidelines. This study aims to bring older adults with diabetes whose measurements and medications are different from the guidelines of the American Diabetes Association into guidelines-based ranges.
This study is a pragmatic pilot study assessing the feasibility and acceptability, and preliminary impact of a pharmacist-led care pathway to align patient care with guidelines for type 2 diabetes mellitus (T2DM) management in frail older adults, leveraging existing resources and pathways of care led by Clinical Prescribing Pharmacists. Eligible participants will be identified from the Electronic Health Record (EHR). Research staff will then approach the primary care physicians for identified patients to confirm that patients are appropriate for the intervention, as determined by the primary care physician (PCP). Patients will then be contacted both by letter and phone call, and invited to participate in the pharmacist-led pathway. Telephonic informed consent will be obtained. Outcomes for all participants will be accessed passively via the EHR. The study team hypothesizes that patients who go through the pharmacist-led primary care intervention will be more likely to have guideline-concordant medical therapy as compared with an EHR-based control group. Also, the study team believes that the intervention will reach at least 50% of those referred by their physicians to participate, the median number of outpatient visits will be three or less, and that the intervention will require a total of \<3 hours for pharmacists and patients across the 3-month intervention period. In addition, the study team expects patients, physicians, and pharmacists will report the intervention is feasible, acceptable, appropriate, and high-value. Lastly, the study team believes that the intervention group will have a lower mortality than the comparison group.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
42
Educational information mailed to participants and up to three pharmacist visits.
Atrium Health Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Proportion of subjects who Achieve Glycosylated Hemoglobin (HbA1c) values
Proportion of subjects who achieve target value of HbA1c \>7.5%
Time frame: Month 6
Change in HbA1c
Time frame: From Baseline through Month 6
Random Glucose Measurements
The study team will track any glucose measurements obtained between initial enrollment and 6-12 months follow up after completion of the intervention, up until a total of 12 months after initial enrollment. This will be reported as a glucose trajectory.
Time frame: From Baseline through Month 12
Estimated Change in Out-of-Pocket Costs
Change in diabetes medication cost
Time frame: From Baseline through Month 6
Point estimates of Feasibility Measures: Participation/Reach
The proportion of those referred who chose to participate
Time frame: Month 6
Point estimates of Feasibility Measures: Number Contacted/Reach
Total number of subjects contacted
Time frame: Month 6
Point estimates of Feasibility Measures: Number at Risk/Reach
Total number of patients who meet inclusion/exclusion criteria at each site
Time frame: Month 6
Feasibility Measures: Effort Required to Enroll-Number Calls
Number of calls to enroll
Time frame: Month 6
Feasibility Measures: Effort Required to Enroll-Average Call Duration
Duration of calls to enroll in minutes.
Time frame: Month 6
Point estimates of Feasibility Measure-Number of Visits
Mean and median number of visits with the pharmacist before glucose levels are met.
Time frame: Month 12
Point estimates of Feasibility Measures: Time
Time until achieved medication goal per patient will be reported. An achieved medication goal is the following: HbA1c \<8 while taking no sulfonylurea or insulin, or HbA1c between 7.5-8 on sulfonylurea or insulin (these would both meet guidelines-based care.
Time frame: Month 12
Rate of Emergency Department Visits and Hospitalizations
Using EHR and Patient Ping, the number of contacts with the Emergency Department (ED) and hospitals (composite)
Time frame: Baseline through Month 18
Number of Hypoglycemic Events Requiring Medical Assistance
Events defined as per action to control cardiovascular risk in diabetes (ACCORD) trial, as hypoglycemic episodes requiring hospitalization or care in an emergency department.
Time frame: Time Frame: Baseline through Month 18
Number of Injurious Falls
Identified by International Classification of Diseases-10th Revision (ICD-10) diagnostic codes; defined as per systolic blood pressure intervention trial (SPRINT) as falls requiring hospitalization or care in an emergency department.
Time frame: Baseline through Month 18
Mortality
Number of people who die as found in EHR and North Carolina (NC) death registry
Time frame: Baseline through Month 18
Implementation Metric--Feasibility
Feasibility (FIM): This is a questionnaire that helps determine feasibility of the intervention. Score ranges from 4-20, with a higher score meaning the participant feels the intervention is more feasible.
Time frame: Baseline through Month 18
Implementation Metric-- Acceptability
This is a questionnaire that helps determine acceptability of the intervention. Score ranges from 4-20, with a higher score meaning the participant feels the intervention is more acceptable.
Time frame: Baseline through Month 18
Implementation Metric-- Appropriateness
This is a questionnaire that helps determine appropriateness of the intervention. Score ranges from 4-20, with a higher score meaning the participant feels the intervention is more appropriate.
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Time frame: Baseline through Month 18
Implementation Metric- Value
Three questions will be coded and analyzed through qualitative analysis. The study team will code comments by hand using content analysis and grounded theory.
Time frame: Baseline through Month 18