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Completed

NCT Number: NCT05047237

Electronic Frailty Index (eFI)Cacious-Diabetes Care

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacist-Led Optimization Intervention

Behavioral

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

Primary outcomes

  1. Proportion of subjects who Achieve Glycosylated Hemoglobin (HbA1c) values

    Time frame: Month 6

    Proportion of subjects who achieve target value of HbA1c >7.5%

  2. Change in HbA1c

    Time frame: From Baseline through Month 6

  3. Random Glucose Measurements

    Time frame: From Baseline through Month 12

    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.

  4. Estimated Change in Out-of-Pocket Costs

    Time frame: From Baseline through Month 6

    Change in diabetes medication cost

  5. Point estimates of Feasibility Measures: Participation/Reach

    Time frame: Month 6

    The proportion of those referred who chose to participate

  6. Point estimates of Feasibility Measures: Number Contacted/Reach

    Time frame: Month 6

    Total number of subjects contacted

  7. Point estimates of Feasibility Measures: Number at Risk/Reach

    Time frame: Month 6

    Total number of patients who meet inclusion/exclusion criteria at each site

  8. Feasibility Measures: Effort Required to Enroll-Number Calls

    Time frame: Month 6

    Number of calls to enroll

  9. Feasibility Measures: Effort Required to Enroll-Average Call Duration

    Time frame: Month 6

    Duration of calls to enroll in minutes.

  10. Point estimates of Feasibility Measure-Number of Visits

    Time frame: Month 12

    Mean and median number of visits with the pharmacist before glucose levels are met.

  11. Point estimates of Feasibility Measures: Time

    Time frame: Month 12

    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.

Secondary outcomes

  1. Rate of Emergency Department Visits and Hospitalizations

    Time frame: Baseline through Month 18

    Using EHR and Patient Ping, the number of contacts with the Emergency Department (ED) and hospitals (composite)

  2. Number of Hypoglycemic Events Requiring Medical Assistance

    Time frame: Time Frame: Baseline through Month 18

    Events defined as per action to control cardiovascular risk in diabetes (ACCORD) trial, as hypoglycemic episodes requiring hospitalization or care in an emergency department.

  3. Number of Injurious Falls

    Time frame: Baseline through Month 18

    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.

  4. Mortality

    Time frame: Baseline through Month 18

    Number of people who die as found in EHR and North Carolina (NC) death registry

  5. Implementation Metric--Feasibility

    Time frame: Baseline through Month 18

    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.

  6. Implementation Metric-- Acceptability

    Time frame: Baseline through Month 18

    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.

  7. Implementation Metric-- Appropriateness

    Time frame: Baseline through Month 18

    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.

  8. Implementation Metric- Value

    Time frame: Baseline through Month 18

    Three questions will be coded and analyzed through qualitative analysis. The study team will code comments by hand using content analysis and grounded theory.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Sep 17, 2021
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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