Tailored Patient-Provider Communication (TPPC): Evaluating the Impact of TPPC in Dermatology Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04633616
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Southern California
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

April Armstrong, MD, MPH
Principal Investigator Affiliation University of Southern California
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis, Atopic Dermatitis, Acne
Additional Details

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.

Arms & Interventions

Arms

Experimental: Tailored Delivery of Education

Communication will be tailored as the mode of weblink delivery will be customized to patient preference.

Placebo Comparator: Non-tailored Delivery of Education

Communication will be non-tailored such that patients will not be able to choose their preferred mode of communication and will receive hardcopy.

Interventions

Other: - Tailored Patient-Provider Communication

Every 1.5 months, patients randomized to the tailored patient-provider communication model will receive weblinks directing patients to disease-specific educational videos and associated questionnaires. Communication will be tailored as the mode of weblink delivery will be customized to patient preference. Patients can choose messages to be delivered via e-mail, SMS, WhatsApp, or Facebook. For example, if one patient determines SMS messaging as their preferred communication mode, then this patient will receive a weblink via SMS directing the patient to customized educational videos and questionnaires. Weblinks delivered via tailored patient-provider communication will be enabled by Wecudos.

Other: - Non-Tailored Patient-Provider Communication

Every 1.5 months, patients randomized to the non-tailored patient-provider communication model will receive weblinks directing patients to disease-specific educational videos and associated questionnaires. Communication will be non-tailored such that patients will not be able to choose their preferred mode of communication and will receive hardcopy. Patients will receive hardcopy on how to access psoriasis education. Weblinks delivered via non-tailored patient-provider communication will be enabled by Wecudos.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

USC, Los Angeles, California

Status

Recruiting

Address

USC

Los Angeles, California, 90033

Site Contact

Charlotte Read

charlotte.read@med.usc.edu

3238653641

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