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Stanford Clinics Physician Mindset Training

Primary Purpose

Diabetes, Diabetes Mellitus, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindset & Communication Training
Sponsored by
Kari Alyse Leibowitz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

Outcomes

Primary Outcome Measures

Physician Wellbeing Questionnaire
Assessing physician wellbeing, including burnout and job satisfaction using self-report Questionnaire developed and validated at Stanford Healthcare
Patient health: Diabetes control: Hemoglobin A1C
Disease status for patients with diabetes measured via patient Hemoglobin A1C
Patient health: Hypertension control: blood pressure
Disease status for patients with hypertension measured via patient systolic blood pressure
Patient health: Pre-Diabetes status: Fasting Blood Sugar
Disease status for patients with pre-diabetes measured via fasting blood sugar
Patient adherence: Vaccine and screening recommendations
Patient adherence to recommended vaccines and screenings

Secondary Outcome Measures

Physician satisfaction survey
Physician satisfaction with training, measured via self-report satisfaction survey developed as part of training
Physician use of mindset skills survey
Use of mindset techniques in clinical care providers measured via self-report survey assessing reported use of mindset skills in practice; survey developed as part of training
Physician Wellbeing Questionnaire
Assessing physician wellbeing, including burnout and job satisfaction using self-report Questionnaire developed and validated at Stanford Healthcare
Physician Wellbeing Questionnaire
Assessing physician wellbeing, including burnout and job satisfaction using self-report Questionnaire developed and validated at Stanford Healthcare
Physician Wellbeing Questionnaire
Assessing physician wellbeing, including burnout and job satisfaction using self-report Questionnaire developed and validated at Stanford Healthcare
Physician mindset: Mindset Beliefs Survey
Physician beliefs regarding the power and importance of mindset in clinical care, measured via self-report survey developed as part of the training

Full Information

First Posted
September 14, 2018
Last Updated
June 1, 2021
Sponsor
Kari Alyse Leibowitz
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1. Study Identification

Unique Protocol Identification Number
NCT03677609
Brief Title
Stanford Clinics Physician Mindset Training
Official Title
Stanford Clinics Physician Mindset Training
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kari Alyse Leibowitz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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").
Detailed Description
Healthcare providers at four Stanford clinic sites will be the investigators' main participants and the study will follow a wait-list control design. The investigators will track patient health outcomes. The intervention described in this study will only be for the healthcare team. The investigators will track both provider outcomes (using self-report survey measures) and patient outcomes (using health information already being collected by the clinic). Although the investigators will be tracking the outcomes of all physicians at the clinics, only select patient outcomes will be included as part of the study. The study will begin with the care team filling out baseline self-report surveys online and/or in person. Prior to delivering the intervention, the clinics will be split, and half of the clinic sites will be assigned to be wait-list control clinics, while the other half of sites will receive the mindset training. The intervention for the care team will be delivered in person by members of the research team. The care team will be told that the investigators are assessing the impact of a novel training program for providers.The care team will truthfully be informed that the training they are receiving is designed to enhance their interactions with patients. Questionnaires: The care team: Physicians will be asked to fill out an initial brief survey about their mindsets about connecting with patients, burnout, job satisfaction, and their efficacy using harnessing mindsets in clinical practice. Care team members will then be asked to fill out the same survey after receiving their training. Charts will be reviewed to assess patient health outcomes. Data from the electronic medical record will be used to assess patient health outcomes at all clinics. Overview of Expected Outcomes: This training was designed to improve care teams' ability to shape patient mindsets in clinical care, and therefore influence patient outcomes in the following ways: Increase adherence to medication, screening, and vaccination recommendations. When care teams are better able to instill the mindset that treatment is likely to be beneficial and not harmful, patients will be more motivated to adhere to treatment recommendations. When care teams are better able to instill the mindset that patients are in good hands (e.g. the provider/care team is both warm/"gets them" and competent/"gets it"), patients will trust recommendations more and be more likely to follow through with them. Reduce unnecessary antibiotic use. When care teams are better able to instill the mindsets that an illness is manageable and the patient's body is capable, patients will be more likely to believe care teams when they say antibiotics are unnecessary (e.g. in the case of colds or certain respiratory illnesses), thereby reducing overall antibiotic usage. Improve health outcomes for patients with chronic illness. When care teams are better able to instill the mindsets that chronic illness is manageable, that patients' bodies are capable, that treatment is likely to be effective, and that they are in good hands, patients will be more likely to manage their chronic illness through both medication and lifestyle change, which will lead to improved health outcomes for these patients. Outcome Computation Plans for Requested Data: To assess the impact of the training, we will review patient-level primary care data from January 1, 2016-June 1, 2020. Using the data requested, we will compute outcomes for each of the three broad categories as follows. We will compare outcomes within each clinic before and after the training was implemented, and will also compare outcomes at the two initial intervention clinics to outcomes at the two initial-wait list clinics during the time period in which two of the clinics had received the training and two had not. Increase Adherence Prescription fills, refills, & discontinuations Refill requests will serve as a proxy measure for whether patients are taking their medications as prescribed. • Medications of interest: Prescriptions fills, refills, & discontinuations for medications for chronic disease management medications such as: o Antidepressants • SSRIs & SNIs Statins Hypertension medication • Beta blockers Ace inhibitors Calcium Channel Blockers Thiazide diuretics All common blood pressure medications Diabetic medications • Variable(s) we will compute: We will compute the percentage of patients who re-fill new prescriptions. Denominator: Patients who have received a new prescription for one of the medications listed above. New prescriptions will be defined as any prescription not previously given in the past year (we will exclude patients for whom this is their first visit to this provider). Patients who are receiving a different prescription for the same condition will count as new prescriptions. Numerator: Patients from the above group who requested a refill request for their eligible prescription within one year after the clinic visit. If possible, we will also use pharmacy data to assess the number of patients who fill the new prescription initially. If possible, we will also assess the number of patients whose medication is discontinued because the patient stopped taking the medication. Follow-up lab visit for patients with diabetes Patients with uncontrolled diabetes are recommended to have lab work every 3 months, and patients with controlled diabetes are recommended to have lab work every 6 months. Completion of such lab visits is an indication of adherence. • Variables we will compute: We will compute the percentage of patients with uncontrolled diabetes (defined as A1c > 8 or A1c > 9) coming in for lab work follow ups within 5 months after clinic visit. Denominator: Patients with uncontrolled diabetes Numerator: Patients from the above group who come in for lab work within 5 months after clinic visit We will compute the percentage of patients with controlled diabetes (defined as 6.5 < A1c < 8 or 6.5 < A1c < 9) coming in for lab work follow ups within 12 months after clinic visit. Denominator: Patients with controlled diabetes Numerator: Patients from the above group who come in for lab work within 12 months after clinic visit Referral adherence When providers refer patients for diagnostic screenings such as Colonoscopy, Fit or Mammograms, completion of these referrals is a sign of adherence. Variables we will compute: o We will compute the percentage of patients following through with recommended screening referrals. Denominator: Patients who are referred for Colonoscopy, Fit, or Mammogram. Numerator: Patients from the above group who completed their screening within 6 months of order date Vaccine adherence Pneummococcol vaccinations are recommended to patients ages 65 and older. Completed pneummococcol vaccinations are an indication of patient adherence to provider recommendations. Variables we will compute: o We will compute the percentage of patients 65 and older who received the pneumococcol vaccination. Denominator: Patients in the clinic who are 65 and older Numerator: Patients from the above group who completed the pneumococcol vaccination within 6 months of visit o We will compute the percentage of patients aged 65-67, who are newly eligible to receive the pneumococcol vaccination, who received the pneumococcol vaccination. Denominator: Patients in the clinic who are between 65 and 67 years of age Numerator: Patients from the above group who completed the pneumococcol vaccination within 6 months of visit Reduce antibiotic use Reduction in antibiotic prescriptions While in most cases we hope to increase adherence to medication prescriptions, there are many cases in which antibiotics are unnecessary. For example, antibiotics are often unnecessarily prescribed for common colds, bronchitis, chest colds, flu, and sore throats. A 2016 CDC report found that an estimated 30% of antibiotics prescribed in outpatient settings are unnecessary. In order to combat antibiotic resistant bacteria, the CDC set a 2015 goal to reduce inappropriate antibiotic use in outpatient settings by 50% by 2020. Thus, reduction in overall antibiotic use is a desirable outcome. ● Variable(s) we will compute: We will compute overall antibiotic prescriptions by looking at the number of patients prescribed antibiotics at clinic visits. Denominator: Number of clinic encounters Numerator: Number of antibiotics prescribed We will compute antibiotic prescriptions for respiratory illness by looking at the number of patients with respiratory illnesses prescribed antibiotics at clinic visits. Denominator: Number of encounters with respiratory illness diagnoses (including bronchitis and cough/congestion) Numerator: Number of antibiotics prescribed at the above encounters Improve health outcomes Reduction in patient BMI Reduction in BMI for patients who are overweight is an indication of improved health outcomes. ● Variable(s) we will compute: Overall reduction in BMI for patients who are overweight ▪ First we will select patients with a BMI > 25 ▪ Then we will compute change in BMI between visits for these patients. Reduction in BMI for patients with diabetes First we will select patients who have a diagnosis of diabetes and have a BMI > 25 Then we will compute change in BMI between visits for these patients. Reduction in patient blood pressure Reduction in blood pressure for patients with hypertension is an indication of improved health outcomes. Variable(s) we will compute: Overall reduction in systolic blood pressure for patients with hypertension ▪ First we will select patients with a diagnosis of hypertension ▪ Then we will compute change in blood pressure between visits for the above patients Overall reduction in systolic blood pressure for patients with uncontrolled hypertension ▪ First we will select patients with blood pressure > 140/90 ▪ Then we will compute change in blood pressure between visits for the above patients Reduction in patient A1c levels Improved A1c control for patients with diabetes is an indication of improved health outcomes. ● Variables we will compute: Overall reduction in A1c for patients with diabetes ▪ First we will select patients with a diagnosis of diabetes ▪ Then we will compute change in A1c between visits for the above Reduction in A1c for patients with uncontrolled diabetes ▪ First we will select patients with uncontrolled diabetes (A1c > 8 or A1c > 9) ▪ Then we will compute change in A1c between visits for the above patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Hypertension, Pre Diabetes, Overweight and Obesity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
78128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Mindset & Communication Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physician Wellbeing Questionnaire
Description
Assessing physician wellbeing, including burnout and job satisfaction using self-report Questionnaire developed and validated at Stanford Healthcare
Time Frame
3 months after the training
Title
Patient health: Diabetes control: Hemoglobin A1C
Description
Disease status for patients with diabetes measured via patient Hemoglobin A1C
Time Frame
3-6 months post intervention
Title
Patient health: Hypertension control: blood pressure
Description
Disease status for patients with hypertension measured via patient systolic blood pressure
Time Frame
3-6 months post intervention
Title
Patient health: Pre-Diabetes status: Fasting Blood Sugar
Description
Disease status for patients with pre-diabetes measured via fasting blood sugar
Time Frame
3-6 months post intervention
Title
Patient adherence: Vaccine and screening recommendations
Description
Patient adherence to recommended vaccines and screenings
Time Frame
1-6 months post visit.
Secondary Outcome Measure Information:
Title
Physician satisfaction survey
Description
Physician satisfaction with training, measured via self-report satisfaction survey developed as part of training
Time Frame
Immediately post-training
Title
Physician use of mindset skills survey
Description
Use of mindset techniques in clinical care providers measured via self-report survey assessing reported use of mindset skills in practice; survey developed as part of training
Time Frame
1, 3, 6, and 12 months post-training
Title
Physician Wellbeing Questionnaire
Description
Assessing physician wellbeing, including burnout and job satisfaction using self-report Questionnaire developed and validated at Stanford Healthcare
Time Frame
Immediately after the training
Title
Physician Wellbeing Questionnaire
Description
Assessing physician wellbeing, including burnout and job satisfaction using self-report Questionnaire developed and validated at Stanford Healthcare
Time Frame
6 months after the training
Title
Physician Wellbeing Questionnaire
Description
Assessing physician wellbeing, including burnout and job satisfaction using self-report Questionnaire developed and validated at Stanford Healthcare
Time Frame
12 months after the training
Title
Physician mindset: Mindset Beliefs Survey
Description
Physician beliefs regarding the power and importance of mindset in clinical care, measured via self-report survey developed as part of the training
Time Frame
1, 3, 6, and 12 months post-training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will be screened and included if they have diabetes, hypertension, or pre-diabetes Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kari Leibowitz, MA
Organizational Affiliation
Stanford University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alia Crum, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94025
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Stanford Clinics Physician Mindset Training

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