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

NCT07540767 | Not Yet Recruiting

• 2 other identifiers: 25-1521K23HL175237-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sickle Cell Disease; Sickle Cell Anemia in Children; Sickle Cell Disease (SCD); Sickle Cell; Sickle Cell Anemia (HbSS)

Keywords

sickle cell; pediatrics

Outcome Measures

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.

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

Secondary Outcomes (1)

• Interpersonal Reactivity Index (IRI)

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

Study Arms (2)

Individuation Perspective-Taking (IPT) Intervention

EXPERIMENTAL

Health care provider participants will attend a virtual session presenting the IPT intervention.

Behavioral: Individuation and Perspective-Taking (IPT)

Educational Control Group

ACTIVE COMPARATOR

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

Interventions

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.

Individuation Perspective-Taking (IPT) Intervention

pediatric SCD pain management education session OTHER

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.

Educational Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Children's Hospital of Philadelphia: collaborator
• Yale-New Haven Children's Hospital: collaborator

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Related Publications (26)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Campbell AD, Ross PT, Kumagai AK, Christner JG, Lypson ML. Coming of age with sickle cell disease and the role of patient as teacher. J Natl Med Assoc. 2010 Nov;102(11):1073-8. doi: 10.1016/s0027-9684(15)30735-5.

  PMID: 21141297 BACKGROUND

• Darbari DS, Wang Z, Kwak M, Hildesheim M, Nichols J, Allen D, Seamon C, Peters-Lawrence M, Conrey A, Hall MK, Kato GJ, Taylor JG 6th. Severe painful vaso-occlusive crises and mortality in a contemporary adult sickle cell anemia cohort study. PLoS One. 2013 Nov 5;8(11):e79923. doi: 10.1371/journal.pone.0079923. eCollection 2013.

  PMID: 24224021 BACKGROUND

• Kidwell K, Albo C, Pope M, Bowman L, Xu H, Wells L, Barrett N, Patel N, Allison A, Kutlar A. Characteristics of sickle cell patients with frequent emergency department visits and hospitalizations. PLoS One. 2021 Feb 22;16(2):e0247324. doi: 10.1371/journal.pone.0247324. eCollection 2021.

  PMID: 33617594 BACKGROUND

• Kayle M, Docherty SL, Sloane R, Tanabe P, Maslow G, Pan W, Shah N. Transition to adult care in sickle cell disease: A longitudinal study of clinical characteristics and disease severity. Pediatr Blood Cancer. 2019 Jan;66(1):e27463. doi: 10.1002/pbc.27463. Epub 2018 Sep 24.

  PMID: 30251318 BACKGROUND

• Tanabe P, Spratling R, Smith D, Grissom P, Hulihan M. CE: Understanding the Complications of Sickle Cell Disease. Am J Nurs. 2019 Jun;119(6):26-35. doi: 10.1097/01.NAJ.0000559779.40570.2c.

  PMID: 31135428 BACKGROUND

• Burgess D, van Ryn M, Dovidio J, Saha S. Reducing racial bias among health care providers: lessons from social-cognitive psychology. J Gen Intern Med. 2007 Jun;22(6):882-7. doi: 10.1007/s11606-007-0160-1. Epub 2007 Mar 3.

  PMID: 17503111 BACKGROUND

• Haywood C Jr, Bediako S, Lanzkron S, Diener-West M, Strouse J, Haythornthwaite J, Onojobi G, Beach MC; IMPORT Investigators. An unequal burden: poor patient-provider communication and sickle cell disease. Patient Educ Couns. 2014 Aug;96(2):159-64. doi: 10.1016/j.pec.2014.05.013. Epub 2014 May 23.

  PMID: 24935607 BACKGROUND

• Farooq F, Mogayzel PJ, Lanzkron S, Haywood C, Strouse JJ. Comparison of US Federal and Foundation Funding of Research for Sickle Cell Disease and Cystic Fibrosis and Factors Associated With Research Productivity. JAMA Netw Open. 2020 Mar 2;3(3):e201737. doi: 10.1001/jamanetworkopen.2020.1737.

  PMID: 32219405 BACKGROUND

• Jabour SM, Beachy S, Coburn S, Lanzkron S, Eakin MN. The Role of Patient-Physician Communication on the Use of Hydroxyurea in Adult Patients with Sickle Cell Disease. J Racial Ethn Health Disparities. 2019 Dec;6(6):1233-1243. doi: 10.1007/s40615-019-00625-5. Epub 2019 Aug 13.

  PMID: 31410784 BACKGROUND

• Chapman EN, Kaatz A, Carnes M. Physicians and implicit bias: how doctors may unwittingly perpetuate health care disparities. J Gen Intern Med. 2013 Nov;28(11):1504-10. doi: 10.1007/s11606-013-2441-1. Epub 2013 Apr 11.

  PMID: 23576243 BACKGROUND

• Cronin RM, Yang M, Hankins JS, Byrd J, Pernell BM, Kassim A, Adams-Graves P, Thompson AA, Kalinyak K, DeBaun M, Treadwell M. Association between hospital admissions and healthcare provider communication for individuals with sickle cell disease. Hematology. 2020 Dec;25(1):229-240. doi: 10.1080/16078454.2020.1780737.

  PMID: 32552526 BACKGROUND

• Neumann M, Edelhauser F, Kreps GL, Scheffer C, Lutz G, Tauschel D, Visser A. Can patient-provider interaction increase the effectiveness of medical treatment or even substitute it?--an exploration on why and how to study the specific effect of the provider. Patient Educ Couns. 2010 Sep;80(3):307-14. doi: 10.1016/j.pec.2010.07.020. Epub 2010 Aug 5.

  PMID: 20691557 BACKGROUND

• Shih S, Cohen LL. A Systematic Review of Medication Adherence Interventions in Pediatric Sickle Cell Disease. J Pediatr Psychol. 2020 Jul 1;45(6):593-606. doi: 10.1093/jpepsy/jsaa031.

  PMID: 32417887 BACKGROUND

• Anderson LM, Leonard S, Jonassaint J, Lunyera J, Bonner M, Shah N. Mobile health intervention for youth with sickle cell disease: Impact on adherence, disease knowledge, and quality of life. Pediatr Blood Cancer. 2018 Aug;65(8):e27081. doi: 10.1002/pbc.27081. Epub 2018 Apr 25.

  PMID: 29693797 BACKGROUND

• Connolly ME, Bills SE, Hardy SJ. Neurocognitive and psychological effects of persistent pain in pediatric sickle cell disease. Pediatr Blood Cancer. 2019 Sep;66(9):e27823. doi: 10.1002/pbc.27823. Epub 2019 May 27.

  PMID: 31131984 BACKGROUND

• Kato GJ, Piel FB, Reid CD, Gaston MH, Ohene-Frempong K, Krishnamurti L, Smith WR, Panepinto JA, Weatherall DJ, Costa FF, Vichinsky EP. Sickle cell disease. Nat Rev Dis Primers. 2018 Mar 15;4:18010. doi: 10.1038/nrdp.2018.10.

  PMID: 29542687 BACKGROUND

• Brousseau DC, Panepinto JA, Nimmer M, Hoffmann RG. The number of people with sickle-cell disease in the United States: national and state estimates. Am J Hematol. 2010 Jan;85(1):77-8. doi: 10.1002/ajh.21570. No abstract available.

  PMID: 20029951 BACKGROUND

• Roter DL, Hall JA. Health education theory: an application to the process of patient-provider communication. Health Educ Res. 1991 Jun;6(2):185-93. doi: 10.1093/her/6.2.185.

  PMID: 10148690 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Siddika Mulchan, PsyD

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siddika Mulchan, PsyD

CONTACT

860-545-8122; smulchan@connecticutchildrens.org

Christopher Theriault, MA

CONTACT

860-837-5852; ctheriault@connecticutchildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)