Cost-effectiveness of Multidisciplinary Management of Tinnitus

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Tinnitus

Treatments: Behavioral: Specialized Care; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT00733044

06-0012

ZonMw 80-007022-98-07715

Details and patient eligibility

About

Background: Tinnitus is a common chronic health condition that affects 10% to 20% of the general population. Among severe sufferers it causes disability in various areas. As a result of the tinnitus quality of life is often impaired. At present there is no cure or uniformly effective treatment, leading to fragmentized and costly tinnitus care. Evidence suggests an integral multidisciplinary approach in treating tinnitus is effective. The main objective of this study is to examine the effectiveness, costs, and cost-effectiveness of an integral treatment provided by a specialized tinnitus center versus usual care. This paper describes the study protocol.

Methods/Design: In a randomized controlled clinical trial 198 tinnitus patients will be randomly assigned to a specialized tinnitus care group or a usual care group. Adult tinnitus sufferers referred to the audiological centre are eligible. Included patients will be followed for 12 months.

Primary outcome measure is generic quality of life (measured with the Health Utilities Index Mark III). Secondary outcomes are severity of tinnitus, general distress, tinnitus cognitions, tinnitus specific fear, and costs. Based on health state utility outcome data the number of patients to include is 198. Economic evaluation will be from a societal perspective.

Discussion/ Conclusion: This is, to our knowledge, the first randomized controlled trial that evaluates an integral treatment of tinnitus that includes a full economic evaluation from a societal perspective. If this intervention proves to be effective and cost-effective, implementation of this intervention is considered and anticipated.

Enrollment: 492 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjective tinnitus complaints
• Referred to Tinnitus centre Limburg

Exclusion criteria

• Not being able to write and read in Dutch

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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492 participants in 2 patient groups

Specialized Care

Experimental group

Description:

Stepped-care cognitive behavioural approach with elements from tinnitus retraining therapy

Treatment:

Behavioral: Specialized Care

Usual Care

Active Comparator group

Description:

Audiological diagnostics and intervention and, if necessary, one or more consultations with a social worker with a maximum of ten one hour session

Treatment:

Other: Usual Care