- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01618552
Training Doctors to Support Patient Self-Care of Depression
maanantai 30. marraskuuta 2015 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
182
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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California
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Sacramento, California, Yhdysvallat, 95817
- University of California Davis Health System
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Sacramento, California, Yhdysvallat, 95816
- Sutter Health Sacramento
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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)
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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
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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
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Active Comparator: Control (knowledge enhancement)
Brief video clip designed to increase primary care physician awareness of new medication treatments for patients with diabetes
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Brief video clip designed to increase primary care physician awareness of new medication treatments for diabetes
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
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Physician use of self-efficacy enhancing interviewing techniques
Aikaikkuna: During the 3 months after receiving intervention
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During the 3 months after receiving intervention
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Patient self-efficacy for depression self-care
Aikaikkuna: 5 minutes after an index visit with primary provider
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5 minutes after an index visit with primary provider
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Patient self-efficacy for diabetes self-care
Aikaikkuna: 5 minutes after an index visit with primary provider
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5 minutes after an index visit with primary provider
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General self-care self-efficacy (all health conditions)
Aikaikkuna: 5 minutes after an index visit with primary provider
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5 minutes after an index visit with primary provider
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Patient depressive symptoms
Aikaikkuna: 3 months after an index visit with their primary care provider
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3 months after an index visit with their primary care provider
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Patient depression self-care behaviors
Aikaikkuna: 3 months after an index visit with their primary care provider
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3 months after an index visit with their primary care provider
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Patient diabetes self-care behaviors
Aikaikkuna: 3 months after an index visit with their primary care provider
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3 months after an index visit with their primary care provider
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Patient chronic illness self-care behaviors (generic)
Aikaikkuna: 3 months after an index visit with their primary care provider
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3 months after an index visit with their primary care provider
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Patient adherence to depression and diabetes medications
Aikaikkuna: 3 months after an index visit with their primary care provider
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3 months after an index visit with their primary care provider
|
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Patient adherence to chronic illness medications (generic)
Aikaikkuna: 3 months after an index visit with their primary care provider
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3 months after an index visit with their primary care provider
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Patient adherence to depression counseling
Aikaikkuna: 3 months after an index visit with their primary care provider
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3 months after an index visit with their primary care provider
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Patient mental health status
Aikaikkuna: 3 months after an index visit with their primary care provider
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3 months after an index visit with their primary care provider
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Patient physical health status
Aikaikkuna: 3 months after an index visit with their primary care provider
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3 months after an index visit with their primary care provider
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Patient glycemic control
Aikaikkuna: 3 months after an index visit with their primary care provider
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3 months after an index visit with their primary care provider
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Wallston Multidimensional Health Locus of Control Scale
Aikaikkuna: 5 minutes after an index visit with their primary care provider
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Perceived control over health
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5 minutes after an index visit with their primary care provider
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Healthcare Climate Questionnaire
Aikaikkuna: 5 minutes after an index visit with their primary care provider
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Patient perception of degree to which primary care provider is autonomy supportive
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5 minutes after an index visit with their primary care provider
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Anthony Jerant, MD, University of California, Davis
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Maanantai 1. huhtikuuta 2013
Ensisijainen valmistuminen (Todellinen)
Sunnuntai 1. helmikuuta 2015
Opintojen valmistuminen (Todellinen)
Perjantai 1. toukokuuta 2015
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 8. toukokuuta 2012
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 11. kesäkuuta 2012
Ensimmäinen Lähetetty (Arvio)
Keskiviikko 13. kesäkuuta 2012
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Keskiviikko 2. joulukuuta 2015
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 30. marraskuuta 2015
Viimeksi vahvistettu
Sunnuntai 1. marraskuuta 2015
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2012336397-1
- R34MH095893 (Yhdysvaltain NIH-apuraha/sopimus)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset SEE IT training
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Federal University of UberlandiaUniversidade Federal de Sao CarlosPeruutettuÄskettäinen sydäninfarkti | Uloshengitysvirtauksen rajoitusBrasilia
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Maastricht University Medical CenterValmisPaikallisesti edennyt peräsuolen syöpäAlankomaat
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University of Texas at AustinBaylor College of Medicine; University of Kansas Medical CenterValmis
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Philips Clinical & Medical Affairs GlobalValmisÄäreisvaltimotauti | Kriittinen raajan iskemiaItävalta
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Oslo University HospitalCentre for Appearance Research, University of the West of England, UKIlmoittautuminen kutsustaPalovammoja | Huuli- ja kitalakihalkio | Kraniofacial poikkeavuudet | Ihon kunto | Muut olosuhteet, jotka johtavat näkyvään eroonNorja
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ShireValmis
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Integro TheranosticsRekrytointiRintasyöpä | DCIS | Invasiivinen rintasyöpäsyöpäYhdysvallat
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Liverpool School of Tropical MedicineKenya Medical Research Institute; LVCT HealthEi vielä rekrytointiaRaskaus | Terveysjärjestelmät | Sähköiset yhteisön terveystietojärjestelmät | Synnytyksen klinikan käyttöönotto
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ShireValmisHunterin oireyhtymäEspanja, Yhdysvallat, Kanada, Yhdistynyt kuningaskunta, Ranska, Australia, Meksiko
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Peking University Third HospitalRekrytointi