Supporting Patient Provider Communication in Paediatric Care

NCT01280227 | Completed

• 2 other identifiers: S-05288175389/V50
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Children with Cancer or congenital heart disease (CHD) experience complex, physical, psychosocial and behavioural symptoms and problems due to the illness, treatment, and medical procedures. To help children cope with their problems and prevent psychological distress, the investigators developed SiSom, a support system to help children with cancer or CHD report their symptoms and problems in an age-adjusted manner on a touch-pad, portable computer. This quasi-experimental study with 202 children age 7-12 with CHD or cancer will test the following hypotheses: When children use SiSom to report their symptoms and problems, and this information is provided to their clinicians in their outpatient consultations:

• Children and parents will experience less anxiety.
• Children and parents will be more satisfied with the outpatient visit.
• There will be greater congruence between children's reported symptoms and problems and those addressed by their clinicians as evidenced in documented patient care. To better understand the mechanisms by which these effects may occur, the investigators will also explore:
• Differences between control and experimental groups in patient-provider communication in terms of instrumental and affective behaviour, participation, initiative and person addressed;
• The relationships among outcomes of patient-provider communication, congruence between patients' reported symptoms and those addressed by their clinicians and children's and parents' anxiety and satisfaction; and how these relationships differ between treatment and control conditions. Finally, the investigators will investigate time requirements, ease of use and usefulness of SiSom by children and clinicians. For analyses the investigators will use inferential statistics and qualitative analyses of the video-taped consultation sessions. This study will contribute to improving patient-centred care for a particularly vulnerable population, and to a better understanding of the triadic communication and interactions among child-parent and clinician.

Conditions

Cancer; Congenital Heart Disease

Keywords

Symptom management; Symptom assessment; Patient satisfaction; Patient-provider communication

Outcome Measures

Primary Outcomes (1)

• Patient-provider communication

  Single measure, video recording of medical consultation lasting approximately one hour

Secondary Outcomes (4)

• Patient-provider communication

  Single measure, video recording of medical consultation lasting approximately one hour

• Time requirements, ease of use

  Single measure, after collection of all patient data

• Congruence between children's reported symptoms and problems and those addressed by their clinicians as evidenced in documented patient care.

  Single measure, ten minutes post intervention

• State anxiety

  10 minutes pre and 10 minutes post intervention

Study Arms (2)

1

EXPERIMENTAL

Patients uses the symptom assessment tool SiSom. A summary of their reported symptoms are printed out and given to the pediatrician and nurse before the consultation. The consultation is videotaped.

Behavioral: SiSom

2

NO INTERVENTION

The control group do not use the symptom assessment tool "SiSom" before the consultation. The control group receives usual care and the consultation is videoptaped.

Interventions

SiSom BEHAVIORAL

SiSom is a symptom assessment tool designed to help the child report disease specific problems.The child also report the severity of their problems. After using the tool a report is printed and given to the clinician.

Also known as: Symptom assessment tool

1

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Between 7 and 12 years.
• Ethnic norwegian.
• Undergoing treatment for cancer or diagnosed with a congenital heart disease.

You may not qualify if:

• Receiving or have received radiation the brain as this may affect their abilities to use SiSom and communicate during consultations.
• Syndromes, mental retardation, developmental disorders, language disorders, or cognitive disorders that affect their ability to report symptoms or communicate during consultations.
• Other ethnic origin.

Sponsors & Collaborators

• Oslo University Hospital: lead
• The Research Council of Norway: collaborator

Study Sites (1)

Rikshospitalet-Radiumhospitalet

Oslo, 0027, Norway

Location

Related Publications (7)

• Vatne TM, Finset A, Ornes K, Ruland CM. Application of the verona coding definitions of emotional sequences (VR-CoDES) on a pediatric data set. Patient Educ Couns. 2010 Sep;80(3):399-404. doi: 10.1016/j.pec.2010.06.026.

  PMID: 20663629 BACKGROUND

• Ruland CM, Starren J, Vatne TM. Participatory design with children in the development of a support system for patient-centered care in pediatric oncology. J Biomed Inform. 2008 Aug;41(4):624-35. doi: 10.1016/j.jbi.2007.10.004. Epub 2007 Nov 13.

  PMID: 18082468 BACKGROUND

• Ruland CM, Slaughter L, Starren J, Vatne TM, Moe EY. Children's contributions to designing a communication tool for children with cancer. Stud Health Technol Inform. 2007;129(Pt 2):977-82.

  PMID: 17911861 BACKGROUND

• Slaughter LA, Ruland CM, Vatne TM. Constructing an effective information architecture for a pediatric cancer symptom assessment tool. AMIA Annu Symp Proc. 2006;2006:1102.

  PMID: 17238721 BACKGROUND

• Ruland CM, Slaughter L, Starren J, Vatne TM. Children as design partners in the development of a support system for children with cancer. Stud Health Technol Inform. 2006;122:80-5.

  PMID: 17102222 BACKGROUND

• Vatne TM, Ruland CM, Ornes K, Finset A. Children's expressions of negative emotions and adults' responses during routine cardiac consultations. J Pediatr Psychol. 2012 Mar;37(2):232-40. doi: 10.1093/jpepsy/jsr074. Epub 2011 Sep 9.

  PMID: 21908544 RESULT

• Vatne TM, Slaugther L, Ruland CM. How children with cancer communicate and think about symptoms. J Pediatr Oncol Nurs. 2010 Jan-Feb;27(1):24-32. doi: 10.1177/1043454209349358. Epub 2009 Oct 15.

  PMID: 19833978 RESULT

MeSH Terms

Conditions

Neoplasms; Heart Defects, Congenital; Patient Satisfaction

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Cornelia M Ruland, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: January 20, 2011
• Study Start: January 1, 2005
• Primary Completion: October 1, 2010
• Study Completion: July 1, 2016
• Last Updated: April 6, 2017

Record last verified: 2017-04

Locations

NO (1)