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Collaborative Connected Health (CCH) for PCORI (PCORI)

19 lipca 2019 zaktualizowane przez: April Armstrong, University of Southern California

Collaborative Connected Health (CCH): A Pragmatic Trial Evaluating Effectiveness of CCH in Psoriasis Management Compared to In-person Visits.

The investigators propose to evaluate whether an innovative collaborative connected health (CCH) model increases access to specialists and improves patient outcomes. CCH offers multiple modalities for patients and primary care providers (PCPs) to access dermatologists online directly and asynchronously to maximize effectiveness in a real-world setting. CCH also fosters team care and patient engagement through active sharing of management plans and multidirectional, informed communication among patients, PCPs, and dermatologists. The specific aims of the proposal are to (1) determine whether the CCH model results in equivalent improvements in psoriasis disease severity compared to in-person care, (2) determine whether the CCH model results in equivalent improvements in quality of life and mental health compared to in-person care, and (3) assess whether the CCH model provides better access to care than in-person care.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

The investigators propose to conduct a 12-month, pragmatic, randomized controlled trial to evaluate the impact of a collaborative connected health model for psoriasis management compared to inperson care. The pragmatic trial will compare psoriasis severity, quality-of-life, mental health, and access-to-care between the two models. We will enroll 300 psoriasis patients from Colorado and California. In addition to recruiting patients from the general population, we will place a specific emphasis on recruiting psoriasis patients living in rural and underserved communities. We will also recruit from the full disease spectrum of mild, moderate, and severe psoriasis patients. We will use an intention-to-treat approach to analyze outcomes and perform longitudinal data analysis using repeated measures approach to identify potential differences in the trend over time between the two arms. To evaluate the utility of CCH for increasing access from patients' and clinicians' perspective, the study team will conduct key informant interviews and use qualitative analytical techniques with investigator triangulation and member checking to enhance the validity of the conclusions.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

300

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • California
      • Los Angeles, California, Stany Zjednoczone, 90089
        • University of Southern California
      • Sacramento, California, Stany Zjednoczone, 95817
        • University of California Davis School of Medicine
    • Colorado
      • Aurora, Colorado, Stany Zjednoczone, 80045
        • University of Colorado Denver

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Be age 18 years and older
  • Have physician-diagnosed plaque psoriasis
  • Have access to internet and a digital camera or a mobile phone with camera features
  • Have a primary care provider or the ability to establish primary care

Exclusion Criteria:

-

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Inny: Control
In-person care is the control group because it is currently considered the standard of care in delivering dermatologic services. The intervention includes regular visits to a physician, and may include such treatments as ointments, steroids or ultraviolet therapy at the discretion of a physician. In-person care is the major healthcare-delivery model for managing chronic skin diseases and a realistic, primary option that patients face. The patients in the in-person arm can seek psoriasis care from primary care practitioners or dermatologists, just as they would in the real world.
Inny: Control
In-person care is the control group because it is currently considered the standard of care in delivering dermatologic services. The intervention includes regular visits to a physician, and may include such treatments as ointments, steroids or UV therapy at the discretion of a physician. In-person care is the major healthcare-delivery model for managing chronic skin diseases and a realistic, primary option that patients face. The patients in the in-person arm can seek psoriasis care from PCPs or dermatologists, just as they would in the real world.
Eksperymentalny: CCH Model
The intervention arm will be the collaborative connected health (CCH) model, which purports to increase access to specialists and improve outcomes. Specifically, CCH offers multiple modalities for patients and primary care providers (PCPs) to access dermatologists online directly and asynchronously. CCH also fosters team care and patient engagement through active sharing of management plans and multidirectional, informed communication among patients, PCPs, and dermatologists.
Inny: Collaborative Connected health, (CCH)
CCH is an asynchronous, secure online platform where patients can upload images of psoriasis lesions and submit assessments. Likewise, practitioners can request and/or initiate dermatology consultations, assume longitudinal care or communicate with patients directly.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Improvement in Self-Administered Psoriasis Area and Severity Index (SA-PASI)
Ramy czasowe: 12 months
Participants are asked to complete self-administered Psoriasis Area and Severity Index (SA-PASI). SA-PASI combines the assessment of lesion severity (erythema, induration, and scale) and the affected areas into a single score between 0 (no disease) to 72 (maximal disease). The primary outcome of the study was the mean percent improvement in SA-PASI averaged over three, six, nine, and 12 months. The percent improvement in SA-PASI was defined as the difference in SA-PASI scores between the baseline and each of the follow-up visits divided by the SA-PASI score from the baseline visit.
12 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Improvement in Quality of Life as Measured by Dermatology-Specific, Quality of Life Instruments
Ramy czasowe: 12 months

Quality of life will be assessed using dermatology-specific, quality of life instruments, Skindex-16 and Dermatology Life Quality Index (DLQI). Scores for these assessments will be compared between patients randomized to the CCH model and in-person care.

Skindex-16 is a validated and reliable instrument that comprehensively captures the effects of skin disease on health-related quality of life. It discriminates among patients with different effects and is responsive to clinical changes over time. Skindex-16 scores range from 0 (no effect) to 100 (effect experienced all the time), and the responses are aggregated in symptoms, emotions, and functioning subscales.

The Dermatology Life Quality Index (DLQI) is another validated dermatology-specific quality-of-life instrument that has been used in many psoriasis trials. DLQI scores range from 0 to 30, with higher scores indicating more severe impact on quality of life.
12 months
Access to Care: Distance Traveled
Ramy czasowe: 12 months.
Access to care is an overall term to capture the transportation to care factors including total distance traveled to see a provider (round-trip driving distance from patient's home to provider's office multiplied by the number of in-person visits during the study period).
12 months.
Depression Severity
Ramy czasowe: 12 months

Participants will be assessed for depression severity using the Patient Health Questionnaire (PHQ), a validated, self-administered diagnostic instrument for common mental disorders. The PHQ-9 score can range from 0 to 27 with 0 = "No" depression and 27 = "Severe" depression.

The PHQ is a validated, self-administered version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) depression criteria as "0" (not at all) to "3" (nearly every day). A PHQ-9 score of 10 or greater has 89% sensitivity and 88% specificity for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. PHQ-9 is a validated tool for diagnosis of depression and monitoring response to interventions.
12 months
Other Psoriasis Disease Severity Measures
Ramy czasowe: 12 months

Body surface area (BSA) involvement and patient global assessment (PtGA) will be compared between the patients randomized to the CCH model and the in-person care.

The BSA assessment is a well-established, validated measure used by psoriasis patients to report percent body surface affected by psoriasis in numerous prior studies. BSA ranges from 0% (no involvement) to 100% (complete body surface affected). The PtGA is a validated instrument that measures the overall psoriasis severity from the patients' perspective.40 PtGA is an ordinal six-point scale ranging from 0 (clear) to 5 (severe).
12 months
Access to Care: Wait Time
Ramy czasowe: 12 months
Access to care is an overall term to capture transportation factors including time taken to be seen by a provider. me. Wait time is measured by calculating roundtrip transportation time plus in-office waiting time multiplied by the number of in-person visits during the study period.
12 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Southern California

Współpracownicy

Patient-Centered Outcomes Research Institute

Śledczy

  • Główny śledczy: April Armstrong, MD MPH, University of Southern California

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

2 lutego 2015

Zakończenie podstawowe (Rzeczywisty)

20 sierpnia 2017

Ukończenie studiów (Rzeczywisty)

20 sierpnia 2017

Daty rejestracji na studia

Pierwszy przesłany

6 stycznia 2015

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 lutego 2015

Pierwszy wysłany (Oszacować)

6 lutego 2015

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 sierpnia 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 lipca 2019

Ostatnia weryfikacja

1 lipca 2019

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • HS-15-00417

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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