Clinical trial NCT05047237: Electronic Frailty Index (eFI)Cacious-Diabetes Care
Official title: eFIcacious-Diabetes Care: a Pilot Study of a Pharmacist-Led Optimization Intervention to Achieve Guideline-based Care for Frail Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Type2 Diabetes
Keywords: HbA1c
diabetes care
diabetes type 2
Guideline-Based Care
Pharmacist-Led Optimization
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 42
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Attributed to a Atrium Health Wake Forest Baptist-affiliated Accountable Care Organization
* At least 2 consecutive International Classification of Diseases 10th Revision (ICD-10) codes for type two diabetes mellitus in the prior 2 years
* Has a calculable Electronic Frailty Index (eFI) score \>0.21
* A glycosylated hemoglobin (HbA1c) value \<7.5% in the prior 2 years
* Currently taking a sulfonylurea or insulin for Type 2 Diabetes Mellitus (T2DM)

Exclusion Criteria:

* Moderate to severe hearing loss (due to phone interventions)
* Diagnosed Alzheimer's disease or related dementia (unable to participate)
* Non-English speaking (not all pharmacists speak a second language; subtleties may not be conveyed effectively)
* No phone number available for patient (follow up contacts will be by telehealth or phone

Primary outcomes:
measure: Proportion of subjects who Achieve Glycosylated Hemoglobin (HbA1c) values
timeFrame: Month 6
measure: Change in HbA1c
timeFrame: From Baseline through Month 6
measure: Random Glucose Measurements
timeFrame: From Baseline through Month 12
measure: Estimated Change in Out-of-Pocket Costs
timeFrame: From Baseline through Month 6
measure: Point estimates of Feasibility Measures: Participation/Reach
timeFrame: Month 6
measure: Point estimates of Feasibility Measures: Number Contacted/Reach
timeFrame: Month 6
measure: Point estimates of Feasibility Measures: Number at Risk/Reach
timeFrame: Month 6
measure: Feasibility Measures: Effort Required to Enroll-Number Calls
timeFrame: Month 6
measure: Feasibility Measures: Effort Required to Enroll-Average Call Duration
timeFrame: Month 6
measure: Point estimates of Feasibility Measure-Number of Visits
timeFrame: Month 12
measure: Point estimates of Feasibility Measures: Time
timeFrame: Month 12
Secondary outcomes:
measure: Rate of Emergency Department Visits and Hospitalizations
timeFrame: Baseline through Month 18
measure: Number of Hypoglycemic Events Requiring Medical Assistance
timeFrame: Time Frame: Baseline through Month 18
measure: Number of Injurious Falls
timeFrame: Baseline through Month 18
measure: Mortality
timeFrame: Baseline through Month 18
measure: Implementation Metric--Feasibility
timeFrame: Baseline through Month 18
measure: Implementation Metric-- Acceptability
timeFrame: Baseline through Month 18
measure: Implementation Metric-- Appropriateness
timeFrame: Baseline through Month 18
measure: Implementation Metric- Value
timeFrame: Baseline through Month 18
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Atrium Health Wake Forest Baptist Health
name: Kathryn E. Callahan, MD
role: PRINCIPAL_INVESTIGATOR
References: