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

NCT03599050 | Completed

• 1 other identifier: 18-01003
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

High Blood Pressure; Hypertension

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Communication Simulation

EXPERIMENTAL

Nurses will use simulation over 12 weeks while fidelity is monitored using the NIH Behavior Change Consortium Treatment Fidelity Guidelines.

Behavioral: Audiotaped Counseling Session

Interventions

Audiotaped Counseling Session BEHAVIORAL

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

Communication Simulation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PCPs and nurses will be enrolled if they fulfill the following criteria:
• male or female healthcare provider (MD/DO, NP, and Registered Nurse) practicing at the clinic
• age 18 years or older.
• Patient eligibility criteria include:
• receiving care at the participating clinic
• having uncontrolled HTN (BP\>140/90 mmHg) at two visits in the past year
• being prescribed at least one antihypertensive medication and are non-adherent
• are ≥age 18 years
• fluent in English

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Antoinette Schoenthaler, MD

  NYU Langone Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: July 26, 2018
• Study Start: December 1, 2018
• Primary Completion: May 4, 2020
• Study Completion: May 31, 2020
• Last Updated: February 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)