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OpenTrials
Completed

NCT Number: NCT03599050

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.

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Key information

Conditions

High Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Feasibility measured by documenting total available and eligible nurses and patients approached to enroll 1 participant through final study visit

    Time frame: 6 Months

  2. Acceptability measured by % of nurses who complete the simulation

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 26, 2018
Registry last updated
Feb 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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