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Training Doctors to Support Patient Self-Care of Depression

Primary Purpose

Depression, Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SEE IT training
Knowledge enhancement
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Chronic disease, Cluster randomization, Comorbidity, Depression, Diabetes, Medical history taking, Office visits, Patient acceptance of health care, Patient compliance, Patient simulation, Physician patient relations, Primary health care, Randomized controlled trials, Self care, Self efficacy

Eligibility Criteria

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

Inclusion Criteria: Physicians (targeted enrollment=56; actual enrollment=50)

  • Currently in practice at a participating office within one of the 2 participating health systems (University of California Davis Primary Care Network, Sutter Sacramento Health System)
  • Trained as a family physician, general practitioner, and/or general internist
  • Able to read and speak English

Inclusion Criteria: Group of patients with diabetes and depressive symptoms (targeted enrollment=168; actual enrollment=15)

  • Receive primary health care in one of the participating offices, from one of the participating primary care physicians
  • Aged 18 years or older
  • Able to read and speak English
  • Self-report of adequate vision, hearing, and hand function to complete self-administered questionnaires on a touch screen notebook computer
  • Have concurrent diagnoses of depression and diabetes, determined via medical record review
  • Have at least mild depressive symptoms, manifested by a score of 10 or greater on a telephone-administered Patient Health Questionnaire (PHQ-9).
  • Have an office visit scheduled with their assigned primary care provider within 1 month of study eligibility screening
  • Made 2 or more of their primary care office visits during the preceding year with their assigned primary care provider

Inclusion Criteria: Group of patients with various health conditions, ie, not limited to diabetes and depression (targeted enrollment=336; actual enrollment=117)

  • Receive primary health care in one of the participating offices, from one of the participating primary care physicians
  • Aged 18 years or older
  • Able to read and speak English
  • Self-report of adequate vision, hearing, and hand function to complete self-administered questionnaires on a touch screen notebook computer
  • Have an office visit scheduled with their assigned primary care provider within 1 month of study eligibility screening
  • Made 2 or more of their primary care office visits during the preceding year with their assigned primary care provider

Exclusion Criteria: Patients (applies to all study patients)

  • Self-report or medical record evidence of unstable overall medical status
  • Self-report or medical record evidence of terminal illness
  • Self-report or medical record evidence of bipolar disorder, chronic psychosis (schizophrenia or other), or personality disorder
  • Self-report or medical record evidence of a history of attempted suicide
  • Planned transfer of care to a health system other than the 2 participating systems within 6 months
  • Inability to understand any of the screening questions, after appropriate explanation (e.g. due to cognitive impairment, developmental delay, or other reasons)

Sites / Locations

  • Sutter Health Sacramento
  • University of California Davis Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SEE IT training (interviewing skills)

Control (knowledge enhancement)

Arm Description

Intervention to train primary care physicians in the use of self-efficacy enhancing interviewing techniques (SEE IT) with patients who have coexisting depression and diabetes

Brief video clip designed to increase primary care physician awareness of new medication treatments for patients with diabetes

Outcomes

Primary Outcome Measures

Physician use of self-efficacy enhancing interviewing techniques

Secondary Outcome Measures

Patient self-efficacy for depression self-care
Patient self-efficacy for diabetes self-care
General self-care self-efficacy (all health conditions)
Patient depressive symptoms
Patient depression self-care behaviors
Patient diabetes self-care behaviors
Patient chronic illness self-care behaviors (generic)
Patient adherence to depression and diabetes medications
Patient adherence to chronic illness medications (generic)
Patient adherence to depression counseling
Patient mental health status
Patient physical health status
Patient glycemic control
Wallston Multidimensional Health Locus of Control Scale
Perceived control over health
Healthcare Climate Questionnaire
Patient perception of degree to which primary care provider is autonomy supportive

Full Information

First Posted
May 8, 2012
Last Updated
November 30, 2015
Sponsor
University of California, Davis
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01618552
Brief Title
Training Doctors to Support Patient Self-Care of Depression
Official Title
Physician Training to Support Patient Self-Efficacy for Depression Care Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will determine whether practicing primary care providers (PCPs) can be trained to support patient self-care of depression and co-existing diabetes during office visits, and begin to explore whether this might improve depression and diabetes outcomes, and whether the effects of the training generalize to patients with health conditions other than depression and diabetes. This is important because most patients with chronic conditions struggle with self-care and are seen in primary care, yet PCPs are seldom trained to support self-care.
Detailed Description
Many primary care patients struggle with health behaviors that can reduce depressive symptoms, such as adhering to prescribed treatments. Bolstering patient self-efficacy can improve health behaviors and outcomes, including those related to depression. However, current self-efficacy interventions are provided outside of primary care, and so cannot harness the power of therapeutic primary care provider (PCP)-patient relationships. Teaching PCPs to employ self-efficacy enhancing interviewing techniques (SEE IT) with patients would build upon existing therapeutic relationships, greatly increasing the reach of self-efficacy enhancement. The randomized controlled trial (RCT) in this proposal will examine whether, as compared with an attention control condition, a brief (< 1 hour) office-based intervention for practicing PCPs will lead to significantly greater use of SEE IT during unannounced follow-up SP encounters (postintervention and 3 months). The interventions will be delivered to PCPs during their regular office hours by standardized patient (SP) instructors. All study SPs will portray patients with both depression and diabetes, since these conditions commonly co-occur and entail a heavy burden of health-enhancing behaviors. Exploratory (due to limited statistical power) analyses will explore intervention effects on the following outcomes among real patients with co-occurring depression and diabetes: self-efficacy for depression and diabetes self-care, actual self-care behaviors (e.g. medication adherence), symptom severity, and health status. Further exploratory (due to limited statistical power) analyses will explore intervention effects on the following outcomes among real patients with various chronic conditions (ie, not limited to depression and diabetes): self-care self-efficacy, actual self-care behaviors, symptom severity, and health status. Pre- and post-RCT focus groups with stakeholders (PCPs, office staff, patients, and SP instructors) will guide refinement of the SEE IT intervention. The proposed research activities will inform the design (e.g. sample size) and conduct of a future R01-funded, multi-center, cluster RCT of the finalized intervention, adequately powered to examine effects on a range of patient outcomes; sustainability of effects on PCP interviewing over time; and generalizability to other practice settings and common co-morbid mental health and physical illness clusters. The SEE IT intervention begins to address the broader health needs of individuals with depression in primary care, and has unique potential to reduce the tremendous burden of mental illness related morbidity and mortality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Diabetes
Keywords
Chronic disease, Cluster randomization, Comorbidity, Depression, Diabetes, Medical history taking, Office visits, Patient acceptance of health care, Patient compliance, Patient simulation, Physician patient relations, Primary health care, Randomized controlled trials, Self care, Self efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SEE IT training (interviewing skills)
Arm Type
Experimental
Arm Description
Intervention to train primary care physicians in the use of self-efficacy enhancing interviewing techniques (SEE IT) with patients who have coexisting depression and diabetes
Arm Title
Control (knowledge enhancement)
Arm Type
Active Comparator
Arm Description
Brief video clip designed to increase primary care physician awareness of new medication treatments for patients with diabetes
Intervention Type
Behavioral
Intervention Name(s)
SEE IT training
Intervention Description
Standardized patient instructors provide a scripted intervention to train primary care physicians in the use of self-efficacy enhancing interviewing techniques (SEE IT) during office visits with patients who have coexisting depression and diabetes
Intervention Type
Other
Intervention Name(s)
Knowledge enhancement
Intervention Description
Brief video clip designed to increase primary care physician awareness of new medication treatments for diabetes
Primary Outcome Measure Information:
Title
Physician use of self-efficacy enhancing interviewing techniques
Time Frame
During the 3 months after receiving intervention
Secondary Outcome Measure Information:
Title
Patient self-efficacy for depression self-care
Time Frame
5 minutes after an index visit with primary provider
Title
Patient self-efficacy for diabetes self-care
Time Frame
5 minutes after an index visit with primary provider
Title
General self-care self-efficacy (all health conditions)
Time Frame
5 minutes after an index visit with primary provider
Title
Patient depressive symptoms
Time Frame
3 months after an index visit with their primary care provider
Title
Patient depression self-care behaviors
Time Frame
3 months after an index visit with their primary care provider
Title
Patient diabetes self-care behaviors
Time Frame
3 months after an index visit with their primary care provider
Title
Patient chronic illness self-care behaviors (generic)
Time Frame
3 months after an index visit with their primary care provider
Title
Patient adherence to depression and diabetes medications
Time Frame
3 months after an index visit with their primary care provider
Title
Patient adherence to chronic illness medications (generic)
Time Frame
3 months after an index visit with their primary care provider
Title
Patient adherence to depression counseling
Time Frame
3 months after an index visit with their primary care provider
Title
Patient mental health status
Time Frame
3 months after an index visit with their primary care provider
Title
Patient physical health status
Time Frame
3 months after an index visit with their primary care provider
Title
Patient glycemic control
Time Frame
3 months after an index visit with their primary care provider
Title
Wallston Multidimensional Health Locus of Control Scale
Description
Perceived control over health
Time Frame
5 minutes after an index visit with their primary care provider
Title
Healthcare Climate Questionnaire
Description
Patient perception of degree to which primary care provider is autonomy supportive
Time Frame
5 minutes after an index visit with their primary care provider

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Physicians (targeted enrollment=56; actual enrollment=50) Currently in practice at a participating office within one of the 2 participating health systems (University of California Davis Primary Care Network, Sutter Sacramento Health System) Trained as a family physician, general practitioner, and/or general internist Able to read and speak English Inclusion Criteria: Group of patients with diabetes and depressive symptoms (targeted enrollment=168; actual enrollment=15) Receive primary health care in one of the participating offices, from one of the participating primary care physicians Aged 18 years or older Able to read and speak English Self-report of adequate vision, hearing, and hand function to complete self-administered questionnaires on a touch screen notebook computer Have concurrent diagnoses of depression and diabetes, determined via medical record review Have at least mild depressive symptoms, manifested by a score of 10 or greater on a telephone-administered Patient Health Questionnaire (PHQ-9). Have an office visit scheduled with their assigned primary care provider within 1 month of study eligibility screening Made 2 or more of their primary care office visits during the preceding year with their assigned primary care provider Inclusion Criteria: Group of patients with various health conditions, ie, not limited to diabetes and depression (targeted enrollment=336; actual enrollment=117) Receive primary health care in one of the participating offices, from one of the participating primary care physicians Aged 18 years or older Able to read and speak English Self-report of adequate vision, hearing, and hand function to complete self-administered questionnaires on a touch screen notebook computer Have an office visit scheduled with their assigned primary care provider within 1 month of study eligibility screening Made 2 or more of their primary care office visits during the preceding year with their assigned primary care provider Exclusion Criteria: Patients (applies to all study patients) Self-report or medical record evidence of unstable overall medical status Self-report or medical record evidence of terminal illness Self-report or medical record evidence of bipolar disorder, chronic psychosis (schizophrenia or other), or personality disorder Self-report or medical record evidence of a history of attempted suicide Planned transfer of care to a health system other than the 2 participating systems within 6 months Inability to understand any of the screening questions, after appropriate explanation (e.g. due to cognitive impairment, developmental delay, or other reasons)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Jerant, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sutter Health Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
University of California Davis Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19296179
Citation
Jerant A, Kravitz RL, Azari R, White L, Garcia JA, Vierra H, Virata MC, Franks P. Training residents to employ self-efficacy-enhancing interviewing techniques: randomized controlled trial of a standardized patient intervention. J Gen Intern Med. 2009 May;24(5):606-13. doi: 10.1007/s11606-009-0946-4. Epub 2009 Mar 19.
Results Reference
background
PubMed Identifier
26956140
Citation
Jerant A, Kravitz RL, Tancredi D, Paterniti DA, White L, Baker-Nauman L, Evans-Dean D, Villarreal C, Ried L, Hudnut A, Franks P. Training Primary Care Physicians to Employ Self-Efficacy-Enhancing Interviewing Techniques: Randomized Controlled Trial of a Standardized Patient Intervention. J Gen Intern Med. 2016 Jul;31(7):716-22. doi: 10.1007/s11606-016-3644-z. Epub 2016 Mar 8.
Results Reference
derived

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