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Collaborative Connected Health (CCH) for PCORI (PCORI)

19. juli 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

300

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

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

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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:

-

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.
Andet: 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.
Eksperimentel: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Improvement in Self-Administered Psoriasis Area and Severity Index (SA-PASI)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Improvement in Quality of Life as Measured by Dermatology-Specific, Quality of Life Instruments
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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

Sponsor

University of Southern California

Samarbejdspartnere

Patient-Centered Outcomes Research Institute

Efterforskere

  • Ledende efterforsker: April Armstrong, MD MPH, University of Southern California

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 (Faktiske)

2. februar 2015

Primær færdiggørelse (Faktiske)

20. august 2017

Studieafslutning (Faktiske)

20. august 2017

Datoer for studieregistrering

Først indsendt

6. januar 2015

Først indsendt, der opfyldte QC-kriterier

5. februar 2015

Først opslået (Skøn)

6. februar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HS-15-00417

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Psoriasis

Kliniske forsøg med Control

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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