Training in the 21st Century: Using Virtual Role-Plays to Improve Nurse Communication for Medication Adherence

Hypertension Clinical Trial

Official title:

Training in the 21st Century: Using Virtual Role-Plays to Improve Nurse Communication for Medication Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599050
• Other study ID #: 18-01003
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: January 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will utilize a three-phase approach that is informed by a theory-driven implementation framework to: 1) conduct a needs analysis in order to identify individual-, health care team-, and practice-level barriers and facilitators to conducting adherence counseling in safety-net primary care practices; 2) develop a virtual communication simulation designed to improve the quality of adherence counseling by allowing nurses repeated opportunities to practice discussing medication adherence with virtual patients; and 3) conduct a pilot study to evaluate the feasibility, acceptability and preliminary efficacy of the simulation on changes in: a) nurses' collaborative communication skills, b) medication adherence, and c) reduction in BP in a sample of 20 patients with uncontrolled hypertension (HTN) who are non-adherent to their medications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 31, 2020
• Est. primary completion date: May 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• PCPs and nurses will be enrolled if they fulfill the following criteria:

1. male or female healthcare provider (MD/DO, NP, and Registered Nurse) practicing at the clinic

2. age 18 years or older. No exclusions will be made based on provider race/ethnic origin. We will oversample males to examine differential communication skills based on gender.

• Patient eligibility criteria include:

1. receiving care at the participating clinic

2. having uncontrolled HTN (BP>140/90 mmHg) at two visits in the past year

3. being prescribed at least one antihypertensive medication and are non-adherent

4. are =age 18 years

5. fluent in English

Exclusion Criteria:

• Unable to give consent
• Have a diagnosis of cognitive dysfunction or significant psychiatric comorbidity,
• Participating in another HTN-related study.

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

Behavioral:
• Audiotaped Counseling Session
Patients and nurses will complete audio taped counseling session at least 3 months following the baseline visit. Patients will rate quality of nurse communication skills

Locations

Country	Name	City	State
United States	NYU School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility measured by documenting total available and eligible nurses and patients approached to enroll 1 participant through final study visit		6 Months
Primary	Acceptability measured by % of nurses who complete the simulation		6 Months