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

NCT ID: NCT04633616

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2022-01-19

Brief Summary

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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

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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.

Conditions

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Psoriasis Atopic Dermatitis Acne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Tailored patient-provider communication versus non-tailored patient-provider communication on patient recruitment to clinical trials and patient engagement.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Investigators
Single-blinded

Study Groups

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Tailored Delivery of Education

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

Group Type EXPERIMENTAL

Tailored Patient-Provider Communication

Intervention Type OTHER

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.

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.

Group Type PLACEBO_COMPARATOR

Non-Tailored Patient-Provider Communication

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Psoriasis Foundation

OTHER

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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April Armstrong

Doctor/Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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April Armstrong, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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USC

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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APP-18-03588

Identifier Type: -

Identifier Source: org_study_id