Electronic Frailty Index (eFI)Cacious-Diabetes Care

NCT05047237 | Completed

• 1 other identifier: IRB00076190
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Type2 Diabetes

Keywords

HbA1c; diabetes care; diabetes type 2; Guideline-Based Care; Pharmacist-Led Optimization

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (8)

• Rate of Emergency Department Visits and Hospitalizations

  Baseline through Month 18

• Number of Hypoglycemic Events Requiring Medical Assistance

  Time Frame: Baseline through Month 18

• Number of Injurious Falls

  Baseline through Month 18

• Mortality

  Baseline through Month 18

• Implementation Metric--Feasibility

  Baseline through Month 18

Study Arms (3)

Control

NO INTERVENTION

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

Active Decliners

NO INTERVENTION

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

Active Intervention

EXPERIMENTAL

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

Interventions

Pharmacist-Led Optimization Intervention BEHAVIORAL

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

Active Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kathryn E. Callahan, MD

  Atrium Health Wake Forest Baptist Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 17, 2021
• Study Start: October 29, 2021
• Primary Completion: November 1, 2024
• Study Completion: May 31, 2025
• Last Updated: July 2, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 mos and ending 5 years following article publication
• Access Criteria: The requests must include a proposal with clear aims as to why and how the data will be used. If proposal is approved, a data access agreement will need to be signed and will only be accessible for a 5-year period. All requests to gain access to the data will need to be sent to the study's PI, Kathryn Callahan, MD, MS, (kecallah@wakehealth.edu).

Locations

US (1)