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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; High Blood Pressure
• Intervention / Treatment: Behavioral: Audiotaped Counseling Session

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Communication Simulation; Nurses will use simulation over 12 weeks while fidelity is monitored using the NIH Behavior Change Consortium Treatment Fidelity Guidelines.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility measured by documenting total available and eligible nurses and patients approached to enroll 1 participant through final study visit	6 Months
Acceptability measured by % of nurses who complete the simulation	6 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Study Director: Antoinette Schoenthaler, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): May 4, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 18-01003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Will be used for secondary data analysis approved by the investigator
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No