Atrium Health Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
NCT Number: NCT05047237
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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Notify Me65 year and older
All sexes
Interventional
Not applicable
Winston-Salem, North Carolina, 27157, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Educational information mailed to participants and up to three pharmacist visits.
Time frame: Month 6
Proportion of subjects who achieve target value of HbA1c >7.5%
Time frame: From Baseline through Month 6
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.
Time frame: From Baseline through Month 6
Change in diabetes medication cost
Time frame: Month 6
The proportion of those referred who chose to participate
Time frame: Month 6
Total number of subjects contacted
Time frame: Month 6
Total number of patients who meet inclusion/exclusion criteria at each site
Time frame: Month 6
Number of calls to enroll
Time frame: Month 6
Duration of calls to enroll in minutes.
Time frame: Month 12
Mean and median number of visits with the pharmacist before glucose levels are met.
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.
Time frame: Baseline through Month 18
Using EHR and Patient Ping, the number of contacts with the Emergency Department (ED) and hospitals (composite)
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.
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.
Time frame: Baseline through Month 18
Number of people who die as found in EHR and North Carolina (NC) death registry
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.
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.
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.
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.
Wake Forest University Health Sciences
Other
eFIcacious-Diabetes Care: a Pilot Study of a Pharmacist-Led Optimization Intervention to Achieve Guideline-based Care for Frail Older Adults
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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