Electronic Frailty Index (eFI)Cacious-Diabetes Care

NCT ID: NCT05047237

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-29
• Study Completion Date: 2025-05-31

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.

Conditions

Diabetes; Type2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

Subjects in this arm will receive standard of care treatment with no intervention. They will receive month 6 follow up.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Active Decliners

Subjects who decline intervention. Standard of care treatment with month 6 follow up.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Active Intervention

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.

Group Type: EXPERIMENTAL

Pharmacist-Led Optimization Intervention

Intervention Type: BEHAVIORAL

Educational information mailed to participants and up to three pharmacist visits.

Interventions

Pharmacist-Led Optimization Intervention

Educational information mailed to participants and up to three pharmacist visits.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathryn E. Callahan, MD

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Wake Forest Baptist Health

Locations

Atrium Health Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00076190

Identifier Type: -

Identifier Source: org_study_id