Training Doctors to Support Patient Self-Care of Depression

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01618552
First received: May 8, 2012
Last updated: March 11, 2015
Last verified: March 2015
  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, 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.


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

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

Primary Outcome Measures:
  • Physician use of self-efficacy enhancing interviewing techniques [ Time Frame: During the 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 ]
  • General self-care self-efficacy (all health conditions) [ 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 chronic illness self-care behaviors (generic) [ 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 chronic illness medications (generic) [ 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 ]
  • Wallston Multidimensional Health Locus of Control Scale [ Time Frame: 5 minutes after an index visit with their primary care provider ] [ Designated as safety issue: No ]
    Perceived control over health

  • Healthcare Climate Questionnaire [ Time Frame: 5 minutes after an index visit with their primary care provider ] [ Designated as safety issue: No ]
    Patient perception of degree to which primary care provider is autonomy supportive


Enrollment: 182
Study Start Date: April 2013
Estimated Study Completion Date: May 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SEE IT training (interviewing skills)
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)
Brief video clip designed to increase primary care physician awareness of new medication treatments for patients with diabetes
Other: Knowledge enhancement
Brief video clip designed to increase primary care physician awareness of new medication treatments for 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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618552

Locations
United States, California
Sutter Health Sacramento
Sacramento, California, United States, 95816
University of California Davis Health System
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
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, R34MH095893
Study First Received: May 8, 2012
Last Updated: March 11, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of California, Davis:
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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on September 02, 2015