Clinical trial NCT01618552: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-06-13
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Physician use of self-efficacy enhancing interviewing techniques
timeFrame: During the 3 months after receiving intervention
Secondary outcomes:
measure: Patient self-efficacy for depression self-care
timeFrame: 5 minutes after an index visit with primary provider
measure: Patient self-efficacy for diabetes self-care
timeFrame: 5 minutes after an index visit with primary provider
measure: General self-care self-efficacy (all health conditions)
timeFrame: 5 minutes after an index visit with primary provider
measure: Patient depressive symptoms
timeFrame: 3 months after an index visit with their primary care provider
measure: Patient depression self-care behaviors
timeFrame: 3 months after an index visit with their primary care provider
measure: Patient diabetes self-care behaviors
timeFrame: 3 months after an index visit with their primary care provider
measure: Patient chronic illness self-care behaviors (generic)
timeFrame: 3 months after an index visit with their primary care provider
measure: Patient adherence to depression and diabetes medications
timeFrame: 3 months after an index visit with their primary care provider
measure: Patient adherence to chronic illness medications (generic)
timeFrame: 3 months after an index visit with their primary care provider
measure: Patient adherence to depression counseling
timeFrame: 3 months after an index visit with their primary care provider
measure: Patient mental health status
timeFrame: 3 months after an index visit with their primary care provider
measure: Patient physical health status
timeFrame: 3 months after an index visit with their primary care provider
measure: Patient glycemic control
timeFrame: 3 months after an index visit with their primary care provider
measure: Wallston Multidimensional Health Locus of Control Scale
timeFrame: 5 minutes after an index visit with their primary care provider
measure: Healthcare Climate Questionnaire
timeFrame: 5 minutes after an index visit with their primary care provider
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sutter Health Sacramento
state: California
city: Sacramento
country: United States
facility: University of California Davis Health System
state: California
Study officials:
affiliation: University of California, Davis
name: Anthony Jerant, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.