F07 F84 G40 G80 I60 Q75 Q87.2 Q90 Q93.5 G10 G20.9 G35 R47
Conditions
Interventions
Group 1: New service delivery (nSD): Patients in the intervention group, who are insured at AOK Rheinland/Hamburg, receive the new care model. The model goes beyond the current service delivery under
Sponsors
Humanwissenschaftliche Fakultät, Universität zu Köln
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for the patients in the three study groups are - apart from the respective care model and the health insurance membership - the presence of a congenital or acquired severe disability which is associated with the absence or loss of speech and / or speaking ability (usually F84 or R 47 in combination with other neurophysiological injuries according to ICD-10). Reliable data on the prevalence are missing. Extrapolations on the basis of larger studies in schools and statistics on frequencies of individual diagnoses show a prevalence of 1.04 % in Germany in relation to the nationwide population – resulting in about 840,000 patients. The patients’ age group covers the entire spectrum from the toddler to the very old. Instead of the patients their informal and formal caregivers and health care professionals will be required to complete the questionnaires. Only in the case of qualitative interviews it could be possible to interview patients with sufficient communication skills.
Exclusion criteria
Exclusion criteria: Lack of spoken language due to hearing impairment/deafness (exception/inclusion: patients with hearing impairment and multiple disabilities)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome within the summative evaluation is pragmatic communication skills as the ability to communicate in everyday situations (such as greeting, agreeing, rejecting). These parameters are collected using a survey instrument which is adapted to the target group and based on the Pragmatics Profile subscale of the diagnostic assessment “The Clinical Evaluation Language Fundamentals” (CELF-5) and the COCP program. There will be one baseline measurement and two follow-ups (T0-T2): T0: Standardized survey of informal and formal caregivers a few days after the initial consultation (only in the prospective comparison groups with the new service delivery (nSD) and the service delivery under existing contract (SDeC)) T1: Standardized survey of informal and formal caregivers about 4 weeks after service delivery of speech generating devices (only in the prospective comparison groups with the new service delivery (nSD) and the service delivery under existing contract (SDeC)) T2: Standardized survey of informal and formal caregivers about 4 months after service delivery of speech generating devices (only in the prospective comparison groups with the new service delivery (nSD) and the service delivery under existing contract (SDeC)) and retrospective survey of informal and formal caregivers (effective date) in the standard care (SC) | — |
Secondary
| Measure | Time frame |
|---|---|
| The DISABKIDS questionnaire is used to measure the secondary outcome "quality of life". It is an instrument for measuring the health-related quality of life of chronically diseased children aged 8 to 18 years. The instrument was adapted to the target group. The validated short version of the questionnaire WHODAS 2.0 is used to measure the secondary outcome "participation". The tool QUEST 2.0-G is used to assess the secondary outcome of user satisfaction with technical aids. There will be one baseline measurement and two follow-ups (T0-T2): T0: Standardized survey of informal and formal caregivers a few days after the initial consultation (only in the prospective comparison groups with the new service delivery (nSD) and the service delivery under existing contract (SDeC)) T1: Standardized survey of informal and formal caregivers about 4 weeks after service delivery of speech generating devices (only in the prospective comparison groups with the new service delivery (nSD) and the service delivery under existing contract (SDeC)) T2: Standardized survey of informal and formal caregivers about 4 months after service delivery of speech generating devices (only in the prospective comparison groups with the new service delivery (nSD) and the service delivery under existing contract (SDeC)) and retrospective survey of informal and formal caregivers (effective date) in the standard care (SC) | — |
Countries
Germany
Contacts
Public ContactSarah Uthoff
Department für Versorgungsforschung, Universität Oldenburg
Outcome results
None listed