NCT01618552

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

May 8, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

May 8, 2012

Last Update Submit

November 30, 2015

Conditions

Keywords

Chronic diseaseCluster randomizationComorbidityDepressionDiabetesMedical history takingOffice visitsPatient acceptance of health carePatient compliancePatient simulationPhysician patient relationsPrimary health careRandomized controlled trialsSelf careSelf efficacy

Outcome Measures

Primary Outcomes (1)

  • Physician use of self-efficacy enhancing interviewing techniques

    During the 3 months after receiving intervention

Secondary Outcomes (15)

  • Patient self-efficacy for depression self-care

    5 minutes after an index visit with primary provider

  • Patient self-efficacy for diabetes self-care

    5 minutes after an index visit with primary provider

  • General self-care self-efficacy (all health conditions)

    5 minutes after an index visit with primary provider

  • Patient depressive symptoms

    3 months after an index visit with their primary care provider

  • Patient depression self-care behaviors

    3 months after an index visit with their primary care provider

  • +10 more secondary outcomes

Study Arms (2)

SEE IT training (interviewing skills)

EXPERIMENTAL

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

Control (knowledge enhancement)

ACTIVE COMPARATOR

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

Other: Knowledge enhancement

Interventions

SEE IT trainingBEHAVIORAL

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

SEE IT training (interviewing skills)

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

Control (knowledge enhancement)

Eligibility Criteria

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

You may qualify if:

  • 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
  • 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
  • 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
  • +2 more criteria

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sutter Health Sacramento

Sacramento, California, 95816, United States

Location

University of California Davis Health System

Sacramento, California, 95817, United States

Location

Related Publications (2)

  • 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.

    PMID: 19296179BACKGROUND
  • 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.

MeSH Terms

Conditions

DepressionDiabetes MellitusChronic DiseasePatient Acceptance of Health CarePatient Compliance

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Anthony Jerant, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2012

First Posted

June 13, 2012

Study Start

April 1, 2013

Primary Completion

February 1, 2015

Study Completion

May 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations