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

April 24, 2026 updated by: Siddika Mulchan, Connecticut Children's Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Research documents poor health outcomes for youth with sickle cell disease (SCD), and interventions for patients and families demonstrate only variable effectiveness. More recent studies have called for interventions targeting health care providers (HCPs) to improve patient health outcomes. The investigators developed and piloted an individuation and perspective-taking (IPT) intervention for pediatric SCD HCPs.

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 the 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. This single-session virtual format was well-received and deemed feasible by HCPs in the investigators' formative work, who expressed concerns about attending multiple sessions.

The primary objective is to test the preliminary efficacy of the IPT intervention on improving patient-centered communication in a multi-center sample of pediatric SCD HCPs using a randomized design. HCPs from three medical centers will be randomized to the IPT intervention or to a didactic information control group, completing pre- and post-test measures to assess changed in patient-centered communication.

The investigators hypothesize that the IPT intervention will have positive effects on HCP communication and has the potential to impact patient-reported (e.g., trust, satisfaction with care, and self-efficacy) and clinical health (e.g., pain management, frequency of admission, hydroxyurea adherence) outcomes for adolescents with SCD. Improving HCPs patient-centered communication may increase patients' disease management self-efficacy, thereby improving adherence to preventative measures and reducing the frequency of emergent encounters and hospital admissions.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individuation Perspective-Taking (IPT) Intervention
Health care provider participants will attend a virtual session presenting the IPT intervention.
Behavioral: Individuation and Perspective-Taking (IPT)
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.
Active Comparator: Educational Control Group
Health care provider participants will attend a virtual presentation on didactic information about best practices in pediatric SCD pain management.
Other: pediatric SCD pain management education session
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adapted Measure of Patient-Centered Communication (MPCC)
Time Frame: From enrollment to up to 6 weeks post-intervention/control
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.
From enrollment to up to 6 weeks post-intervention/control

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interpersonal Reactivity Index (IRI)
Time Frame: From enrollment to up to 6 weeks post-intervention/control
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.
From enrollment to up to 6 weeks post-intervention/control

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Connecticut Children's Medical Center

Collaborators

Children's Hospital of Philadelphia
National Heart, Lung, and Blood Institute (NHLBI)
Yale-New Haven Children's Hospital

Investigators

  • Principal Investigator: Siddika Mulchan, PsyD, Connecticut Children's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2027

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-152
  • 1K23HL175237-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be aggregated for all study analyses.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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