NCT03677609

Brief Summary

Mindsets play an important role in motivating and shaping health behavior and outcomes. For example, when patients have the mindset that a treatment will work, they are more likely to adhere to treatment medications and the treatment itself becomes more effective as a result of this mindset. Providers have an opportunity to shape important patient mindsets as part of clinical care, and these mindsets may influence patients' adherence to medication, screening and vaccination recommendations, and diet, exercise, and treatment recommendations that can help patients manage chronic illness. To help care teams capitalize on the potential of leveraging mindsets in medicine and improve patient health behavior and outcomes, we developed and implemented the Medicine Plus Mindset Training as part of Primary Care 2.0. Built on more than two decades of research, this training program (a) Informs Primary Care teams about the power of patient mindsets in shaping treatment outcomes (b) Provides care teams with a language and framework to identify which patient mindsets may be at play (i.e. patient mindsets about illness, treatment, their body, and the provider/care team) and (c) Equips care teams with skills and techniques to effectively shape patient mindsets to improve health outcomes. By motivating care teams to recognize patient mindsets that may be hindering health behavior change (such as "this illness is a catastrophe") or medication adherence (such as "this medication is going to cause side effects"), care teams become better equipped to help their patients adopt more useful mindsets (such as "this treatment will work," "this illness is manageable," "my body is capable," and "I am in good hands").

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78,128

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

2.7 years

First QC Date

September 14, 2018

Last Update Submit

June 1, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • Physician Wellbeing Questionnaire

    Assessing physician wellbeing, including burnout and job satisfaction using self-report Questionnaire developed and validated at Stanford Healthcare

    3 months after the training

  • Patient health: Diabetes control: Hemoglobin A1C

    Disease status for patients with diabetes measured via patient Hemoglobin A1C

    3-6 months post intervention

  • Patient health: Hypertension control: blood pressure

    Disease status for patients with hypertension measured via patient systolic blood pressure

    3-6 months post intervention

  • Patient health: Pre-Diabetes status: Fasting Blood Sugar

    Disease status for patients with pre-diabetes measured via fasting blood sugar

    3-6 months post intervention

  • Patient adherence: Vaccine and screening recommendations

    Patient adherence to recommended vaccines and screenings

    1-6 months post visit.

Secondary Outcomes (6)

  • Physician satisfaction survey

    Immediately post-training

  • Physician use of mindset skills survey

    1, 3, 6, and 12 months post-training

  • Physician Wellbeing Questionnaire

    Immediately after the training

  • Physician Wellbeing Questionnaire

    6 months after the training

  • Physician Wellbeing Questionnaire

    12 months after the training

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Physicians will receive a training or trainings to improve their communication and interaction with patients. The primary trainings will involve teaching physicians how to understand and leverage patient psychology as part of clinical care. Impact on patient health will then be assessed.

Behavioral: Mindset & Communication Training

Control

NO INTERVENTION

Interventions

The mindset training is a two-hour, live training, with a one-hour follow-up one month later, that teaches care providers to recognize, shape, and leverage patient mindsets in healthcare.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients will be screened and included if they have diabetes, hypertension, or pre-diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94025, United States

Location

MeSH Terms

Conditions

Diabetes MellitusHypertensionGlucose IntoleranceOverweightObesity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesHyperglycemiaOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kari Leibowitz, MA

    Stanford University

    STUDY DIRECTOR
  • Alia Crum, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

September 14, 2018

First Posted

September 19, 2018

Study Start

January 4, 2018

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

June 4, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations