Clinical trial NCT01280227: Supporting Patient Provider Communication in Paediatric Care
Official title: Supporting Patient Provider Communication for Children With Cancer and Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Congenital Heart Disease
Keywords: Symptom management
Symptom assessment
Patient satisfaction
Patient-provider communication
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2011-01-20
Enrollment: 144
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Patient-provider communication
timeFrame: Single measure, video recording of medical consultation lasting approximately one hour
Secondary outcomes:
measure: Patient-provider communication
timeFrame: Single measure, video recording of medical consultation lasting approximately one hour
measure: Time requirements, ease of use
timeFrame: Single measure, after collection of all patient data
measure: Congruence between children's reported symptoms and problems and those addressed by their clinicians as evidenced in documented patient care.
timeFrame: Single measure, ten minutes post intervention
measure: State anxiety
timeFrame: 10 minutes pre and 10 minutes post intervention
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet-Radiumhospitalet
Study officials:
affiliation: Oslo University Hospital
name: Cornelia M Ruland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.