Training Doctors to Support Patient Self-Care of Depression
30. november 2015 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
182
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
Sacramento, California, Forente stater, 95817
- University Of California Davis Health System
-
Sacramento, California, Forente stater, 95816
- Sutter Health Sacramento
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
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
|
Brief video clip designed to increase primary care physician awareness of new medication treatments for diabetes
|
Hva måler studien?
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Anthony Jerant, MD, University of California, Davis
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2013
Primær fullføring (Faktiske)
1. februar 2015
Studiet fullført (Faktiske)
1. mai 2015
Datoer for studieregistrering
Først innsendt
8. mai 2012
Først innsendt som oppfylte QC-kriteriene
11. juni 2012
Først lagt ut (Anslag)
13. juni 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
2. desember 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. november 2015
Sist bekreftet
1. november 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2012336397-1
- R34MH095893 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .