Impact of Shared Decision-Making With Decision Aids on Acoustic Neuroma Treatment Choice: A Randomized Controlled Trial

Taipei Medical University Shuang Ho Hospital78 enrolled

Overview

Patients with acoustic neuroma had several treatment options. One of standard treatment is to receive the Gamma knife stereotactic radiosurgery, other options included suboccipital craniotomy and conservative treatment. Thus, shared decision making (SDM) is necessary to aid patients to choose an appropriate treatment that suits their needs. The investigators have developed a decision aids (DAs) and plan to conduct a randomized controlled trial (RCT) to evaluate its impact on acoustic neuroma patients. The measurements include a battery of interview-based questionnaires and evaluations of decision regret and post-treatment depression. The investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after their treatment sessions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Neuroma, Acoustic

Interventions

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with acoustic neuroma. 2. Tumor diameter ≤ 3.5cm. 3. The tumor type is Schwannoma. Exclusion Criteria: 1. Patients with acoustic neuroma less than 20 years old 2. Pregnant woman 3. Patients can not cooperate with Gamma Knife treatment 4. Patients with acoustic neuroma who do not have their own abilities 5. Tumor diameter \> 3.5cm.

Outcomes

Primary Outcomes

Decisional conflict

Total score of decisional conflict scale

Time frame: 4 weeks after discussion of treatment choice

Knowledge

Total score on knowledge scale

Time frame: 4 weeks after discussion of treatment choice

Secondary Outcomes

Decision regret

Total score of decision regret, The dependent variable for this study was decision regret, assessed using the Decision Regret Scale (DRS). The DRS consists of five statements: (1) It was the right decision; (2) I regret the choice that was made; (3) I would go for the same choice if I had to do it over again; (4) the choice did me a lot of harm, and (5) the decision was a wise one. Agreement with each statement is measured on a five-point Likert scale (1 = strongly agree to 5 = strongly disagree). Score of each item is converted to a 0-100 scale by subtracting 1 from each item and multiplying by 25. Scores from items 2 and 4 are reversed. To obtain a global score, all items are summed and the total is divided by 5. Scores range from 0 (no regret) to 100 (high regret), increasing by increments of 5. Ref. Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D Med Decis Making. 2003 Jul-Aug; 23(4):281-92.

Time frame: 4 weeks after treatment

Post-treatment depression

Total score of Hospital anxiety and depression scale (HADS)