Psoriasis
Conditions
Keywords
Pragmatic, Equivalency, Teledermatology
Brief summary
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.
Detailed description
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.
Interventions
OTHERCollaborative 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.
OTHERControl
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.
Sponsors
Patient-Centered Outcomes Research Institute
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Self-Administered Psoriasis Area and Severity Index (SA-PASI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Quality of Life as Measured by Dermatology-Specific, Quality of Life Instruments | 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. |
| Access to Care: Distance Traveled | 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). |
| Depression Severity | 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. |
| Other Psoriasis Disease Severity Measures | 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). |
| Access to Care: Wait Time | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| In-Person Model (Control) The control arm is the in-person model. Patients randomized to the in-person arm sought psoriasis care from Primary Care Physicians (PCPs) or dermatologists in person. | 148 |
| Online Model (Collaborative Connected-Health) The intervention arm is the online, collaborative connected-health model: an asynchronous, secure online platform where patients can upload images of psoriasis lesions and submit assessments. The collaborative connected-health model was designed such that any specialist services that usually occur in person could be delivered through asynchronous online healthcare in a flexible and prompt manner. In this pragmatic trial, the PCPs could access the dermatologists online asynchronously via consultation or requesting a dermatologist to assume care of a patient's psoriasis.
Patients randomized to the online group had the option of accessing dermatologists online asynchronously. During an online visit, the patient would upload clinical images and history and transmit the information to the dermatologist. Using the telehealth platform, the dermatologist would review the transmitted information, make treatment recommendations, prescribe medications, and provide educational materials | 148 |
| Total | 296 |
Baseline characteristics
| Characteristic | Total | Online Model (Collaborative Connected-Health) | In-Person Model (Control) |
|---|---|---|---|
| Age, Continuous | 49.0 Years STANDARD_DEVIATION 14 | 49.7 Years STANDARD_DEVIATION 13.6 | 48.2 Years STANDARD_DEVIATION 14 |
| Alcohol Use Current | 152 Participants | 69 Participants | 83 Participants |
| Alcohol Use Former | 67 Participants | 38 Participants | 29 Participants |
| Alcohol Use Never | 69 Participants | 36 Participants | 33 Participants |
| Alcohol Use Unknown or Not Reported | 8 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 100 Participants | 46 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 196 Participants | 102 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 19 Participants | 13 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 70 Participants | 34 Participants | 36 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 187 Participants | 90 Participants | 97 Participants |
| Region of Enrollment United States | 292 participants | 148 participants | 148 participants |
| Sex: Female, Male Female | 147 Participants | 73 Participants | 74 Participants |
| Sex: Female, Male Male | 149 Participants | 75 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 148 | 1 / 148 |
| other Total, other adverse events | 51 / 148 | 42 / 148 |
| serious Total, serious adverse events | 15 / 148 | 12 / 148 |
Outcome results
Primary
Improvement in Self-Administered Psoriasis Area and Severity Index (SA-PASI)
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Person Model (Control) | Improvement in Self-Administered Psoriasis Area and Severity Index (SA-PASI) | -0.82 Score on a Scale | Standard Deviation 3.43 |
| Online Model (Collaborative Connected-Health) | Improvement in Self-Administered Psoriasis Area and Severity Index (SA-PASI) | -1.37 Score on a Scale | Standard Deviation 3.33 |
Secondary
Access to Care: Distance Traveled
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).
Time frame: 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Person Model (Control) | Access to Care: Distance Traveled | 178.8 Kilometers | Standard Deviation 577.4 |
| Online Model (Collaborative Connected-Health) | Access to Care: Distance Traveled | 2.2 Kilometers | Standard Deviation 14.2 |
Secondary
Access to Care: Wait Time
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Person Model (Control) | Access to Care: Wait Time | 4.0 Hours | Standard Deviation 4.5 |
| Online Model (Collaborative Connected-Health) | Access to Care: Wait Time | 0.1 Hours | Standard Deviation 0.4 |
Secondary
Depression Severity
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Person Model (Control) | Depression Severity | -0.76 Score on a scale | Standard Deviation 4.66 |
| Online Model (Collaborative Connected-Health) | Depression Severity | -0.4 Score on a scale | Standard Deviation 3.94 |
Secondary
Improvement in Quality of Life as Measured by Dermatology-Specific, Quality of Life Instruments
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| In-Person Model (Control) | Improvement in Quality of Life as Measured by Dermatology-Specific, Quality of Life Instruments | Skindex-16 | -2.63 Score on a Scale | Standard Deviation 7.32 |
| In-Person Model (Control) | Improvement in Quality of Life as Measured by Dermatology-Specific, Quality of Life Instruments | DLQI | -1.18 Score on a Scale | Standard Deviation 4.77 |
| Online Model (Collaborative Connected-Health) | Improvement in Quality of Life as Measured by Dermatology-Specific, Quality of Life Instruments | Skindex-16 | -1.79 Score on a Scale | Standard Deviation 5.92 |
| Online Model (Collaborative Connected-Health) | Improvement in Quality of Life as Measured by Dermatology-Specific, Quality of Life Instruments | DLQI | -1.64 Score on a Scale | Standard Deviation 4.34 |
Secondary
Other Psoriasis Disease Severity Measures
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).
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| In-Person Model (Control) | Other Psoriasis Disease Severity Measures | BSA | -1.55 Score on a scale | Standard Deviation 8.87 |
| In-Person Model (Control) | Other Psoriasis Disease Severity Measures | PtGA | -.22 Score on a scale | Standard Deviation 1.26 |
| Online Model (Collaborative Connected-Health) | Other Psoriasis Disease Severity Measures | BSA | -3.38 Score on a scale | Standard Deviation 11.08 |
| Online Model (Collaborative Connected-Health) | Other Psoriasis Disease Severity Measures | PtGA | -.37 Score on a scale | Standard Deviation 1 |