Clinical trial NCT04633616: Tailored Patient-Provider Communication (TPPC): Evaluating the Impact of TPPC in Dermatology Patients
Official title: Tailored Patient-Provider Communication (TPPC): A Pragmatic Single-Blinded Trial Evaluating the Impact of TPPC in Dermatology Patients Compared to Standard Patient-Provider Communication.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Atopic Dermatitis
Acne
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Psoriasis Foundation
First posted: 2020-11-18
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Tailored patient-provider communication versus non-tailored patient-provider communication on patient recruitment to clinical trials and patient engagement.
Primary purpose: OTHER

Brief summary: The impact of tailored patient-provider communication to improve clinical trial recruitment, patient knowledge, and patient engagement will be studied. Tailored patient-provider communication refers to the individualization of patient-provider communication using patients' preferred methods of communication. This involves the utilization of social messaging such as e-mail or text and/or social media platforms. These communication methods purport to and meet individual patient needs whilst ensuring that information is received and in a format that is familiar to each patient. The primary outcomes of the proposed research is to evaluate the impact of tailored patient-provider communication on patient response rates (speed and number), clinical trial recruitment rates, patient knowledge, and patient engagement.

Detailed description: This is a 3-month, pragmatic, single-blinded randomized controlled trial evaluating the impact of tailored patient-provider communication on patient engagement and clinical outcomes of adult dermatology patients compared to non-tailored patient-provider communication. The pragmatic trial will compare patient engagement and clinical outcomes between the two models. The rationale for proposing a pragmatic trial is to test whether tailored patient-provider communication works in real life. This design allows for a large spectrum of everyday clinical settings in order to maximize applicability and generalizability. The pragmatic approaches are especially pronounced along the inclusive eligibility criteria, experimental intervention flexibility, and primary outcome being highly relevant to patients and providers alike.

The investigators will recruit from approximately 32,310 adult patients from target populations, southern California to enroll 134 participants in the study. In addition to recruiting from the general population, the investigators will place a specific emphasis on recruiting patients living in rural and underserved communities; the investigators will also recruit from a full range of dermatological diseases.

Patient recruitment and enrollment will begin the first month of year one and continue through the fourth month of year one. The expected duration of this pragmatic, single-blinded randomized controlled equivalency trial for each participant will be a maximum of 3 months, including an initial baseline visit. No additional follow-up visits beyond this are expected for this research study.

Patients will be randomized to receive patient education via tailored or non-tailored patient-provider communication. The study team will know which form of communication each patient will receive while study participants will not know the different types of communication being studied. Patients randomized to either study population groups can be assessed remotely or in-person at the screening/baseline visit. At month 3, all patients will take high-quality photographs of their skin and submit these pictures to our dermatologist online. Any additional in-person or remote visits will be determined by providers and patients just as they would occur in the real-world. Primary and secondary outcomes will be monitored at months 0, 1.5, and 3.

Eligibility criteria: Inclusion Criteria:

* Provide signed and dated informed consent form
* Speak English or Spanish
* Male or female, at least 18 years of age
* Have an active, physician-diagnosed dermatological condition
* Have access to an electronic device that is capable of capturing images with a minimum resolution of 1024x768 pixels
* Have access to at least one form of social messaging (e-mail, SMS, WhatsApp, or Facebook) which can connect online

Exclusion Criteria:

* Does not have an active dermatological condition at the beginning of the study
* Does not live in southern California
* Unable to fulfill the required tasks of the study

Primary outcomes:
measure: Patient Response Rates
timeFrame: 3 months
Secondary outcomes:
measure: Patient Activation
timeFrame: 3 months
measure: Patient Experience
timeFrame: 3 months
measure: Patient Drop-out Rate
timeFrame: 3 months
Other outcomes:
measure: Potential clinical trial recruitment rate
timeFrame: 3 months
measure: Patient Knowledge
timeFrame: 3 months
Locations:
city: Los Angeles
country: United States
facility: USC
state: California
Study officials:
affiliation: University of Southern California
name: April Armstrong, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: