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

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT03599050

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
High Blood Pressure Hypertension	Behavioral: Audiotaped Counseling Session	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Dec 1, 2018

Actual Primary Completion Date :

May 4, 2020

Actual Study Completion Date :

May 31, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

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:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Study Director: Antoinette Schoenthaler, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03599050

Other Study ID Numbers:

18-01003

First Posted:

Jul 26, 2018

Last Update Posted:

Feb 14, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Feb 14, 2022