Mindfulness and Shared Decision Making

NCT04255082 | Completed

• 1 other identifier: 030.HEP.2018.D
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the impact of mindfulness-based interventions on patient stress, patient-provider communication, and other measures of SDM at MDMC. There is a need to have a quantifiable measure of perceived stress and communication ability in patients. This is the first study of its kind to be conducted at MDMC. This pilot study will not only benefit the patients but also contribute to the medical community's understanding of treating the whole patient through mindfulness and shared decision making. 2.1. Study Objectives 2.1.1. Primary Objective To assess the impact of mindfulness-based interventions on inpatients and outpatients stress, patient-provider communication, and other measures of SDM at MDMC. 2.1.2. Secondary Objectives To evaluate the feasibility of such a study in the patient population.

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (1)

• Baseline and post-intervention perception of stress & anxiety by answering survey questions

  Effectiveness of the mindfulness-based intervention which will be assessed by survey questions: Baseline and post-intervention perception of stress and anxiety t of stress on communication Emotional/Brain state Level of SDM during a pivotal visit with provider e.g. treatment planning visit (for outpatients only) The Emotional Distress-Anxiety (PROMIS, 2016).

  6/1/2018 and 12/31/2020

Secondary Outcomes (1)

• Feasibility of a study in the patient population and setting by any difficulties faced during the study phase

  6/1/2018 and 12/31/2020

Interventions

assess the impact of mindfulness-based interventions on inpatients' and outpatients' stress, patient-provider communication, and other measures of SDM at MDMC. OTHER

Effectiveness of the mindfulness-based intervention which will be assessed by: Baseline and post-intervention perception of stress and anxiety Impact of stress on communication Emotional/Brain state Level of SDM during a pivotal visit with provider e.g. treatment planning visit (for outpatients only) The Emotional Distress-Anxiety (PROMIS, 2016), Communication Short Form (Cella, PROMIS, 2013), Emotional/Brain State Question (Mellin, 2017) and The Shared Decision Making dyadic OPTION scale (Melbourne, 2016) will be used to evaluate these outcomes. Feasibility of such a study in the patient population and setting. This will be measured by the barriers encountered and the ability to successfully carry out the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at MDMC, The Liver Institute, and Texas Oncology between 6/1/2018 and 12/31/2020.

You may qualify if:

• Age 18 years or older
• Inpatients and outpatients receiving treatment at MDMC, the Liver Institute, or Texas Oncology
• Provided written informed consent

You may not qualify if:

• Below 18 years of age

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

The Liver Institute at Methodist Dallas Medical Center

Irving, Texas, 75603, United States

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Parvez Mantry, M.D.

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: February 5, 2020
• Study Start: August 15, 2018
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: March 23, 2026

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)