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Training Doctors to Support Patient Self-Care of Depression

30. november 2015 opdateret af: University of California, Davis

Physician Training to Support Patient Self-Efficacy for Depression Care Behaviors

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

182

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Sacramento, California, Forenede Stater, 95817
        • University of California Davis Health System
      • Sacramento, California, Forenede Stater, 95816
        • Sutter Health Sacramento

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Adfærdsmæssigt: 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
Aktiv komparator: Control (knowledge enhancement)
Brief video clip designed to increase primary care physician awareness of new medication treatments for patients with diabetes
Andet: Knowledge enhancement
Brief video clip designed to increase primary care physician awareness of new medication treatments for diabetes

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Physician use of self-efficacy enhancing interviewing techniques
Tidsramme: During the 3 months after receiving intervention
During the 3 months after receiving intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient self-efficacy for depression self-care
Tidsramme: 5 minutes after an index visit with primary provider
5 minutes after an index visit with primary provider
Patient self-efficacy for diabetes self-care
Tidsramme: 5 minutes after an index visit with primary provider
5 minutes after an index visit with primary provider
General self-care self-efficacy (all health conditions)
Tidsramme: 5 minutes after an index visit with primary provider
5 minutes after an index visit with primary provider
Patient depressive symptoms
Tidsramme: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient depression self-care behaviors
Tidsramme: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient diabetes self-care behaviors
Tidsramme: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient chronic illness self-care behaviors (generic)
Tidsramme: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient adherence to depression and diabetes medications
Tidsramme: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient adherence to chronic illness medications (generic)
Tidsramme: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient adherence to depression counseling
Tidsramme: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient mental health status
Tidsramme: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient physical health status
Tidsramme: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient glycemic control
Tidsramme: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Wallston Multidimensional Health Locus of Control Scale
Tidsramme: 5 minutes after an index visit with their primary care provider
Perceived control over health
5 minutes after an index visit with their primary care provider
Healthcare Climate Questionnaire
Tidsramme: 5 minutes after an index visit with their primary care provider
Patient perception of degree to which primary care provider is autonomy supportive
5 minutes after an index visit with their primary care provider

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, Davis

Samarbejdspartnere

National Institute of Mental Health (NIMH)

Efterforskere

  • Ledende efterforsker: Anthony Jerant, MD, University of California, Davis

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2013

Primær færdiggørelse (Faktiske)

1. februar 2015

Studieafslutning (Faktiske)

1. maj 2015

Datoer for studieregistrering

Først indsendt

8. maj 2012

Først indsendt, der opfyldte QC-kriterier

11. juni 2012

Først opslået (Skøn)

13. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. november 2015

Sidst verificeret

1. november 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2012336397-1
  • R34MH095893 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Depression

Kliniske forsøg med SEE IT training

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Latvia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner