Rural Area Pharmacist Intervention for Diabetes

NCT05761886 | Completed

• 1 other identifier: IRB00094019
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Telehealth; Rural populations; Clinical pharmacy services

Outcome Measures

Primary Outcomes (6)

• Patient enrollment rates

  Proportion of eligible patients enrolled

  Month 13

• Proportion of patients with complete data

  Proportion of patients with complete data

  Month 17

• Proportion of respondents selecting a response - Feasibility

  Proportion of respondents selecting a response of agree/strongly agree (disagree/strongly disagree for negatively worded items) on 70% of the survey items measuring perspectives regarding whether it was possible for the respondents to perform the program activities

  Month 17

• Proportion of respondents selecting a response - Acceptability

  Proportion of respondents selecting a response of agree/strongly agree (disagree/strongly disagree for negatively worded items) on 70% of the survey items measuring perspectives regarding whether they approve and like the program

  Month 17

• Proportion of respondents selecting a response - Appropriateness

  Proportion of respondents selecting a response of agree/strongly agree (disagree/strongly disagree for negatively worded items) on 70% of the survey items measuring perspectives regarding program fit with the needs of the respondents

  Month 17

• Proportion of items self-reported by pharmacist - Fidelity

  Proportion of items self-reported by pharmacist by checking (yes/no/not applicable) in a task-list of program activities

  Month 17

Secondary Outcomes (5)

• Change in HbA1c

  Month 17

• Change in Blood Pressure

  Month 17

• Number of Acute Care Days

  Month 17

• Change in patient-reported medication adherence scores

  Month 17

• Change in barriers to medication adherence

  Month 17

Study Arms (2)

telehealth-based clinical pharmacy intervention

EXPERIMENTAL

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

Other: telehealth-based clinical pharmacy intervention

usual care

NO INTERVENTION

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.

Interventions

telehealth-based clinical pharmacy intervention 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

telehealth-based clinical pharmacy intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Duke University: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Rohan Mahabaleshwarkar, PhD

  Atrium Health Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: the target sample size in our pilot study is 72 in the intervention group. The target for the control group is 168.

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 9, 2023
• Study Start: May 16, 2023
• Primary Completion: October 12, 2024
• Study Completion: March 26, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)