Supporting Patient Provider Communication in Paediatric Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer Congenital Heart Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

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.

Group Type EXPERIMENTAL

SiSom

Intervention Type 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.

2

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SiSom

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Symptom assessment tool

Eligibility Criteria

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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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No