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Training Doctors to Support Patient Self-Care of Depression

This study is not yet open for participant recruitment.
Verified June 2012 by University of California, Davis
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01618552
First received: May 8, 2012
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  Purpose

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. This is important because most patients with these conditions struggle with self-care and are seen in primary care, yet PCPs are seldom trained to support self-care.


Condition Intervention
Depression
Diabetes
 Behavioral: SEE IT training
Other: Knowledge enhancement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physician Training to Support Patient Self-Efficacy for Depression Care Behaviors

Resource links provided by NLM:

MedlinePlus related topics: Depression Diabetes
U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Physician use of self-efficacy enhancing interviewing techniques [ Time Frame: 3 months after receiving intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient self-efficacy for depression self-care [ Time Frame: 5 minutes after an index visit with primary provider ] [ Designated as safety issue: No ]
  • Patient self-efficacy for diabetes self-care [ Time Frame: 5 minutes after an index visit with primary provider ] [ Designated as safety issue: No ]
  • Patient depressive symptoms [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient depression self-care behaviors [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient diabetes self-care behaviors [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient adherence to depression and diabetes medications [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient adherence to depression counseling [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient mental health status [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient physical health status [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient glycemic control [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Physician use of self-efficacy enhancing interviewing techniques [ Time Frame: Within 1 month of receiving intervention ] [ Designated as safety issue: No ]
  • Patient self-efficacy for depression self-care [ Time Frame: 3 months after the index visit with provider ] [ Designated as safety issue: No ]
  • Patient self-efficacy for diabetes self-care [ Time Frame: 3 months after the index visit with provider ] [ Designated as safety issue: No ]

Estimated Enrollment: 248
Study Start Date: April 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SEE IT (interviewing skills training)
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
 Behavioral: SEE IT training
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
Active Comparator: Control (knowledge enhancement)
Standardized patient instructors provide a scripted intervention to increase primary care physician awareness of the frequency and clinical impact of comorbid depression and diabetes
 Other: Knowledge enhancement
Standardized patient instructors provide a scripted intervention to increase primary care physician awareness of the frequency and clinical impact of comorbid depression and diabetes

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. 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Physicians

  • 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: Patients

  • 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

Exclusion Criteria: 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618552

Contacts
Contact: Dionne Evans Dean, MHA 916-734-5766 dionne.evans@ucdmc.ucdavis.edu
Contact: Anthony Jerant, MD 916-734-7081 anthony.jerant@ucdmc.ucdavis.edu

Locations
United States, California
University of California Davis Health System Not yet recruiting
Sacramento, California, United States, 95817
Contact: Dionne Evans Dean, MHA     916-734-5766     dionne.evans@ucdmc.ucdavis.edu    
Contact: Anthony Jerant, MD     916-734-7081     anthony.jerant@ucdmc.ucdavis.edu    
Principal Investigator: Anthony Jerant, MD            
Sutter Health Sacramento Not yet recruiting
Sacramento, California, United States, 95816
Contact: Andrew Hudnut, MD     916-453-5898     HudnutA@sutterhealth.org    
Principal Investigator: Andrew Hudnut, MD            
Sponsors and Collaborators
University of California, Davis
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Anthony Jerant, MD University of California, Davis
  More Information

Publications:

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01618552     History of Changes
Other Study ID Numbers: 2012336397-1
Study First Received: May 8, 2012
Last Updated: June 11, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of California, Davis:
Patient acceptance of health care
Patient compliance
Patient simulation
Physician patient relations
Chronic disease
Cluster randomization
Comorbidity
Depression
 Diabetes
Medical history taking
Office visits
Primary health care
Randomized controlled trials
Self care
Self efficacy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Diabetes Mellitus
Behavioral Symptoms
Mood Disorders
 Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013