Electronic Frailty Index (eFI)Cacious-Diabetes Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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eFIcacious-Diabetes Care: a Pilot Study of a Pharmacist-Led Optimization Intervention to Achieve Guideline-based Care for Frail Older Adults

Conditions
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Diabetes, Type2 Diabetes

Intervention / Treatment
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* Behavioral: Pharmacist-Led Optimization Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Subjects in this arm will receive standard of care treatment with no intervention. They will receive month 6 follow up. | |
| No Intervention: Active Decliners<br>Subjects who decline intervention. Standard of care treatment with month 6 follow up. | |
| Experimental: Active Intervention<br>Subjects are mailed Information about Type 2 Diabetes Mellitus (T2DM) Guidelines and Appointment Information (Face to face [F2F] or Telehealth). They attend up to 3 pharmacist visits, depending on if they reach target glucose levels. And they attend interviews. They also have month 6 follow up. | Behavioral: Pharmacist-Led Optimization Intervention<br>* Educational information mailed to participants and up to three pharmacist visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who Achieve Glycosylated Hemoglobin (HbA1c) values | Proportion of subjects who achieve target value of HbA1c >7.5% | Month 6 | 
| Change in HbA1c |  | 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. | From Baseline through Month 12 | 
| Estimated Change in Out-of-Pocket Costs | Change in diabetes medication cost | From Baseline through Month 6 | 
| Point estimates of Feasibility Measures: Participation/Reach | The proportion of those referred who chose to participate | Month 6 | 
| Point estimates of Feasibility Measures: Number Contacted/Reach | Total number of subjects contacted | Month 6 | 
| Point estimates of Feasibility Measures: Number at Risk/Reach | Total number of patients who meet inclusion/exclusion criteria at each site | Month 6 | 
| Feasibility Measures: Effort Required to Enroll-Number Calls | Number of calls to enroll | Month 6 | 
| Feasibility Measures: Effort Required to Enroll-Average Call Duration | Duration of calls to enroll in minutes. | Month 6 | 
| Point estimates of Feasibility Measure-Number of Visits | Mean and median number of visits with the pharmacist before glucose levels are met. | 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. | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Emergency Department Visits and Hospitalizations | Using EHR and Patient Ping, the number of contacts with the Emergency Department (ED) and hospitals (composite) | 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: 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. | Baseline through Month 18 | 
| Mortality | Number of people who die as found in EHR and North Carolina (NC) death registry | 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. | 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. | 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. | 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. | Baseline through Month 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HbA1c, diabetes care, diabetes type 2, Guideline-Based Care, Pharmacist-Led Optimization