Training Doctors to Support Patient Self-Care of Depression

NCT ID: NCT01618552

Last Updated: 2015-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-05-31

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.

Conditions

Depression; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

SEE IT training

Intervention Type: BEHAVIORAL

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

Control (knowledge enhancement)

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

Group Type: ACTIVE_COMPARATOR

Knowledge enhancement

Intervention Type: OTHER

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

Interventions

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

Intervention Type: BEHAVIORAL

Knowledge enhancement

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• 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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Jerant, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

Sutter Health Sacramento

Sacramento, California, United States

University of California Davis Health System

Sacramento, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19296179 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26956140 (View on PubMed)

Other Identifiers

R34MH095893

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2012336397-1

Identifier Type: -

Identifier Source: org_study_id