DiabetesNCT05047237
Electronic Frailty Index (eFI)Cacious-Diabetes Care
A study testing Pharmacist-Led Optimization Intervention in people with Diabetes and Type2 Diabetes, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes, Type2 Diabetes
- What is being tested?
- Pharmacist-Led Optimization Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2021to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: eFIcacious-Diabetes Care: a Pilot Study of a Pharmacist-Led Optimization Intervention to Achieve Guideline-based Care for Frail Older Adults
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.
Read the 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
- Being tested
- Pharmacist-Led Optimization Intervention
- Keywords
- HbA1c, diabetes care, diabetes type 2, Guideline-Based Care, Pharmacist-Led Optimization
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-Led Optimization InterventionBehavioural
Educational information mailed to participants and up to three pharmacist visits.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Pharmacist-Led Optimization Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who Achieve Glycosylated Hemoglobin (HbA1c) values
Proportion of subjects who achieve target value of HbA1c >7.5%
Measured: Month 6
Change in HbA1c
Measured: 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.
Measured: From Baseline through Month 12
Estimated Change in Out-of-Pocket Costs
Change in diabetes medication cost
Measured: From Baseline through Month 6
Point estimates of Feasibility Measures: Participation/Reach
The proportion of those referred who chose to participate
Measured: Month 6
Point estimates of Feasibility Measures: Number Contacted/Reach
Total number of subjects contacted
Measured: Month 6
Point estimates of Feasibility Measures: Number at Risk/Reach
Total number of patients who meet inclusion/exclusion criteria at each site
Measured: Month 6
Feasibility Measures: Effort Required to Enroll-Number Calls
Number of calls to enroll
Measured: Month 6
Feasibility Measures: Effort Required to Enroll-Average Call Duration
Duration of calls to enroll in minutes.
Measured: Month 6
Point estimates of Feasibility Measure-Number of Visits
Mean and median number of visits with the pharmacist before glucose levels are met.
Measured: 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.
Measured: Month 12
Secondary outcomes (8)
Rate of Emergency Department Visits and Hospitalizations
Using EHR and Patient Ping, the number of contacts with the Emergency Department (ED) and hospitals (composite)
Measured: 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.
Measured: 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.
Measured: Baseline through Month 18
Mortality
Number of people who die as found in EHR and North Carolina (NC) death registry
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline through Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start29 Oct 2021
- Primary completion1 Nov 2024
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn E. Callahan, MD, Principal investigator, Atrium Health Wake Forest Baptist Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047237
- Sponsor's protocol ID
- IRB00076190
- Status last verified
- Sep 2024
- First submitted
- 7 Sep 2021
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our study, "eFIcacious-Diabetes Care: a Pilot Study of a Pharmacist-Led Optimization Intervention to Achieve Guideline-based Care for Frail Older Adults" agrees to share study data that fulfill the International Committee of Medical Journal Editors (ICMJE) requirements starting after the first 3 months after our study has started and five years after our first article publication. We agree to provide data to researchers who can provide our lab with a methodologically sound proposal, and who need our data to help achieve aims outlined in their proposal. The study's data will be comprised of individual participant data that underlie the results reported in our publication. Participant data will be deidentified and can be used in text, tables, figures, and appendices, after approval from the study's primary investigator.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eFIcacious-Diabetes Care: a Pilot Study of a Pharmacist-Led Optimization Intervention to Achieve Guideline-based Care for Frail Older Adults
- ClinicalTrials.gov ID
- NCT05047237
- Acronym / sponsor ID
- IRB00076190
- Conditions
- Diabetes, Type2 Diabetes
- Keywords
- HbA1c, diabetes care, diabetes type 2, Guideline-Based Care, Pharmacist-Led Optimization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Pharmacist-Led Optimization InterventionSubjects 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-Led Optimization InterventionEducational information mailed to participants and up to three pharmacist visits. | Behavioural | Active Intervention |
Primary outcome
Proportion of subjects who Achieve Glycosylated Hemoglobin (HbA1c) values
Time frame: Month 6
Proportion of subjects who achieve target value of HbA1c >7.5%
Change in HbA1c
Time frame: From Baseline through Month 6
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.
Estimated Change in Out-of-Pocket Costs
Time frame: From Baseline through Month 6
Change in diabetes medication cost
Point estimates of Feasibility Measures: Participation/Reach
Time frame: Month 6
The proportion of those referred who chose to participate
Point estimates of Feasibility Measures: Number Contacted/Reach
Time frame: Month 6
Total number of subjects contacted
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
Feasibility Measures: Effort Required to Enroll-Number Calls
Time frame: Month 6
Number of calls to enroll
Feasibility Measures: Effort Required to Enroll-Average Call Duration
Time frame: Month 6
Duration of calls to enroll in minutes.
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.
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.
8 secondary outcomes
Rate of Emergency Department Visits and Hospitalizations
Time frame: Baseline through Month 18
Number of Hypoglycemic Events Requiring Medical Assistance
Time frame: Time Frame: Baseline through Month 18
Number of Injurious Falls
Time frame: Baseline through Month 18
Mortality
Time frame: Baseline through Month 18
Implementation Metric--Feasibility
Time frame: Baseline through Month 18
Implementation Metric-- Acceptability
Time frame: Baseline through Month 18
Implementation Metric-- Appropriateness
Time frame: Baseline through Month 18
Implementation Metric- Value
Time frame: Baseline through Month 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: Yes. Our study, "eFIcacious-Diabetes Care: a Pilot Study of a Pharmacist-Led Optimization Intervention to Achieve Guideline-based Care for Frail Older Adults" agrees to share study data that fulfill the International Committee of Medical Journal Editors (ICMJE) requirements starting after the first 3 months after our study has started and five years after our first article publication. We agree to provide data to researchers who can provide our lab with a methodologically sound proposal, and who need our data to help achieve aims outlined in their proposal. The study's data will be comprised of individual participant data that underlie the results reported in our publication. Participant data will be deidentified and can be used in text, tables, figures, and appendices, after approval from the study's primary investigator.
Related trials for Diabetes
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn E. Callahan, MD principal investigator
Atrium Health Wake Forest Baptist Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-Led Optimization Intervention in people with Diabetes and Type2 Diabetes, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who Achieve Glycosylated Hemoglobin (HbA1c) values (time frame: Month 6). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.