Development of a Provider-Focused Intervention to Improve Health Outcomes in Pediatric Sickle Cell Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorConnecticut Children's Medical Center

About this trial

The goal of this interventional study is to learn about the impact of an intervention for health care providers that teaches individuation and perspective-taking (IPT) skills to enhance patient-centered communication in pediatric sickle cell disease (SCD). The main question it aims to answer is:

Does an intervention that teaches individuation and perspective-taking (IPT) skills to pediatric sickle cell disease (SCD) health care providers (HCPs) enhance patient-centered communication?

Researchers will compare the IPT intervention to a control group who will receive education about SCD pain management to see if the IPT intervention improves patient-centered communication.

Participants will complete baseline surveys and then be randomly assigned into the intervention or control group. After completing their assigned session (IPT training or education), they will be asked to complete the same surveys as completed at baseline.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Licensed health care provider (HCP) who provides care to youth with SCD

HCP employed by Connecticut Children's, Yale New Haven Children's Hospital, or Children's Hospital of Philadelphia and primary work area is Hematology/Oncology

Disqualifiers

HCP who does not provide care to youth with SCD

HCP is a medical trainee, not including fellows

HCP not employed by CT Children's, Yale New Haven Children's Hospital, or Children's Hospital of Philadelphia

Not fluent in English

Trial design

Design model

Parallel

Treatments tested in this trial

  • Individuation and Perspective-Taking (IPT)

    Behavioral

    IPT currently consists of one 90-minute virtual training session that incorporates didactic education and practice using the IPT skills in the context of SCD patient stories. After reviewing didactic information about the impact of patient-centered communication on patient health behaviors (e.g., adherence), HCPs are introduced to the two IPT skills and taught how to practice them by changing their communication with patients. HCPs then watch short videos that are publicly available online depicting 3-5 patients with SCD that differ in demographics and symptom presentation. The intervention facilitator uses verbal prompts (e.g., How do participants think that patient must be feeling?) to assist HCPs in applying the IPT skills to each of these patients. Finally, the facilitator leads a discussion about HCP responses that are and are not consistent with the IPT skills and explores ways HCPs can apply the skills in their clinical practice.

  • pediatric SCD pain management education session

    Other intervention

    The SCD pain management education session currently consists of one 90-minute virtual presentation that focuses on best practices in pediatric SCD pain management, including published guidelines from the American Society of Hematology.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Individuation Perspective-Taking (IPT) InterventionExperimental treatment 1 intervention
Group B: Educational Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adapted Measure of Patient-Centered Communication (MPCC)

The adapted Measured of Patient-Centered Communication (MPCC) is an observer-scored set of indices that assesses patient-centered communication during clinic visits. In this adapted version, Individuation and Perspective-Taking are two additional components that will be scored, along with the six components of the Patient-Centered Clinical Method. Each of these components has been operationalized to be reliably scored by independent raters. For each patient video, the participant's communication will be scored for the presence/absence of each of these 8 components. Thus, a given patient video will be summarized using a total score ranging from 0 to 8, with higher scores reflecting greater patient-centered communication. For this study, two independent reviewers (the PI and RA) will score participants' responses to each patient video for the 8 components.

Time frame
From enrollment to up to 6 weeks post-intervention/control

Secondary outcomes

1

Interpersonal Reactivity Index (IRI)

The Interpersonal Reactivity Index (IRI) is a 28-item self-report measure used to assess four facets of empathy with four subscales (7 items each): Perspective-Taking (adopting the point of view of others), Empathic Concern (feeling sympathy and concern), Fantasy (ability to imagine the feelings of fictitious characters), and Personal Distress (feeling anxiety/unease during tense interpersonal situations). Responses are given on a 5-point Likert scale and summed for a total score ranging from 0-112, with higher scores indicating greater perceived empathy (better outcome). The IRI has been used to assess empathy in medical students and HCPs.

Time frame
From enrollment to up to 6 weeks post-intervention/control

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Connecticut Children's Medical Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Children's Hospital of Philadelphia

Collaborator

Yale-New Haven Children's Hospital

Collaborator

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