Rural Area Pharmacist Intervention for Diabetes

NCT ID: NCT05761886

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-16
• Study Completion Date: 2025-03-26

Brief Summary

The goal of the project is to inform the system leaders regarding the feasibility and utility of having an embedded telehealth-based clinical pharmacist at rural primary care practices for supportive disease management of patients with Type 2 diabetes (T2D) and whether continuing and expanding the program within the system is worthwhile.

Detailed Description

Improvement of suboptimal type 2 diabetes (T2D) management and outcomes in rural areas in the United States (US) is an urgent national health policy priority. Novel approaches such as telehealth and supportive clinical management of T2D by non-physician providers have been recommended to fill gaps in care. With specialty in drug therapy, clinical pharmacists are in a position to uniquely contribute to filling gaps in T2D management related to medication therapy, which are common and often the cause of adverse outcomes in patients with T2D. The objective of this pilot study is to determine the feasibility, acceptability, appropriateness, fidelity, barriers and facilitators of implementation, and preliminary effectiveness of a telehealth-based clinical pharmacy intervention to inform the design of a subsequently planned fully powered effectiveness-implementation trial of the intervention. This pilot study will involve randomization based on the days the patients had encounters at participating practices (4 in North Carolina). The 2 study arms will be: 1) Usual care, receiving standard practice of care managed by physicians, nurse practitioners, and physician assistants with access to chronic disease management services and 2) Intervention arm, receiving the intervention consisting of clinical pharmacy services including identification and resolution of medication-related problems and patient needs, optimization of medication regimen and T2D education and self-management support, in addition to usual care. The intervention will last for 3 months and will consist of biweekly video/phone calls between patients and the pharmacist. Based on recommendations from literature on pilot studies, the total planned sample size is 240 patients. Implementation science framework by Proctor and colleagues and scales by Weiner and colleagues (for feasibility, acceptability, appropriateness, and fidelity) and Consolidated Framework for implementation Research (for barriers and facilitators of intervention implementation) will guide collection of data on outcomes. for using complementary medicine and healthcare avoidance. The results of our work will facilitate wide implementation of the intervention and thereby improved outcomes.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

telehealth-based clinical pharmacy intervention

will involve a pharmacist identifying and addressing medication-related problems (e.g., inappropriate dosage or indications, drug interactions, and therapeutic duplication); optimizing medication regimens (discontinuing if appropriate, providing subsidized and generic options, and reducing medication complexity); and providing T2D education and self-management support

Group Type: EXPERIMENTAL

telehealth-based clinical pharmacy intervention

Intervention Type: OTHER

The pharmacist will perform an initial comprehensive review of the medication regimen, make any adjustments, document those in the patient's electronic health record (EHR) and communicate with the patient's T2D care team as needed. They will also call (using an EHR-based software) the patient using phone/video to educate them about T2D self-management and identify any medication-related unmet needs. Periodic reviews of the medication regimen and roughly biweekly follow-up patient calls will occur with frequency based on need (as judged by the pharmacist). Patient intervention calls will be personalized depending on HbA1c levels, comorbidities, and medication complexity

usual care

will involve routine physician office visits every 3 (for those with HbA1c outside goal) - or every 6 months (for those with HbA1c within goal). Medication regimens are usually managed by physicians, nurse practitioners, and physician assistants, and Patients have access to centralized chronic disease management programs.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

telehealth-based clinical pharmacy intervention

The pharmacist will perform an initial comprehensive review of the medication regimen, make any adjustments, document those in the patient's electronic health record (EHR) and communicate with the patient's T2D care team as needed. They will also call (using an EHR-based software) the patient using phone/video to educate them about T2D self-management and identify any medication-related unmet needs. Periodic reviews of the medication regimen and roughly biweekly follow-up patient calls will occur with frequency based on need (as judged by the pharmacist). Patient intervention calls will be personalized depending on HbA1c levels, comorbidities, and medication complexity

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age >= 18 years and <=75 years (since children have different incidence, management, and outcomes of Type 2 diabetes (T2D) compared to adults and older adults aged more than 75 years may have had their hemoglobin A1C (HbA1c) goals adjusted to higher thresholds)
• HbA1c reading ≥ 8% recorded during 6 months prior to or up to 9 days after the encounter at the participating practices
• Uncontrolled type 2 diabetes (ICD-10-CM code E11.XX) recorded in the EHR in the year prior to up to 1 week after the uncontrolled HbA1c reading

Exclusion Criteria

• Patients with gestational or type 1 diabetes
• Those enrolled in any other chronic disease management programs delivered by non-physician healthcare professionals
• Those receiving T2D care from an endocrinologist
• Those receiving long term, hospice, or palliative care services
• Those with serious mental illnesses (schizophrenia and other psychotic disorders, major depressive disorders, bipolar disorders, and borderline personality disorder)
• Those with malignant cancer
• Those with cognitive impairment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rohan Mahabaleshwarkar, PhD

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00094019

Identifier Type: -

Identifier Source: org_study_id