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

Overview

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.

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.

Interventions

• 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 depic
• 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.

Primary outcome measures

• Adapted Measure of Patient-Centered Communication (MPCC) [Time frame: From enrollment to up to 6 weeks post-intervention/control]

Secondary outcome measures (1)

• Interpersonal Reactivity Index (IRI) [Time frame: From enrollment to up to 6 weeks post-intervention/control]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Connecticut Children's Medical Center — Hartford

Publications

• Maatouk-Burmann B, Ringel N, Spang J, Weiss C, Moltner A, Riemann U, Langewitz W, Schultz JH, Junger J. Improving patient-centered communication: Results of a randomized controlled trial. Patient Educ Couns. 2016 Jan;99(1):117-24. doi: 10.1016/j.pec.2015.08.012. Epub 2015 Aug 14. PMID 26490488
• Devine PG, Forscher PS, Austin AJ, Cox WT. Long-term reduction in implicit race bias: A prejudice habit-breaking intervention. J Exp Soc Psychol. 2012 Nov;48(6):1267-1278. doi: 10.1016/j.jesp.2012.06.003. PMID 23524616
• Carlson MM, Bear B, Alderfer MA, Schultz CL, Monroe DP, Crosby LE, Hildenbrand AK. Family-centered communication in pediatric sickle cell disease. Pediatr Blood Cancer. 2022 Dec;69(12):e30016. doi: 10.1002/pbc.30016. Epub 2022 Sep 24. PMID 36152000
• Badawy SM, Thompson AA, Holl JL, Penedo FJ, Liem RI. Healthcare utilization and hydroxyurea adherence in youth with sickle cell disease. Pediatr Hematol Oncol. 2018 Aug-Sep;35(5-6):297-308. doi: 10.1080/08880018.2018.1505988. Epub 2019 Jan 12. PMID 30636474
• Quarmyne MO, Dong W, Theodore R, Anand S, Barry V, Adisa O, Buchanan ID, Bost J, Brown RC, Joiner CH, Lane PA. Hydroxyurea effectiveness in children and adolescents with sickle cell anemia: A large retrospective, population-based cohort. Am J Hematol. 2017 Jan;92(1):77-81. doi: 10.1002/ajh.24587. Epub 2016 Nov 18. PMID 27761932
• Haywood C Jr, Diener-West M, Strouse J, Carroll CP, Bediako S, Lanzkron S, Haythornthwaite J, Onojobi G, Beach MC; IMPORT Investigators; IMPORT Investigators. Perceived discrimination in health care is associated with a greater burden of pain in sickle cell disease. J Pain Symptom Manage. 2014 Nov;48(5):934-43. doi: 10.1016/j.jpainsymman.2014.02.002. Epub 2014 Apr 15. PMID 24742787
• Labbe E, Herbert D, Haynes J. Physicians' attitude and practices in sickle cell disease pain management. J Palliat Care. 2005 Winter;21(4):246-51. PMID 16483093
• Haywood C Jr, Williams-Reade J, Rushton C, Beach MC, Geller G. Improving Clinician Attitudes of Respect and Trust for Persons With Sickle Cell Disease. Hosp Pediatr. 2015 Jul;5(7):377-84. doi: 10.1542/hpeds.2014-0171. PMID 26136312

Identifiers

NCT: NCT07540767 · 25-152 · 1K23HL175237-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗