Randomised controlled feasibility trial of the Active Communication Education programme plus hearing aid provision versus hearing aid provision alone (ACE to HEAR): a study protocol

Abstract

IntroductionUp to 30% of hearing aids fitted to new adult clients are reported to be of low benefit and used intermittently or not at all. Evidence suggests that additional interventions paired with service-delivery redesign may help improve hearing aid use and benefit. The range of interventions available is limited. In particular, the efficacy of interventions like the Active Communication Education (ACE) programme that focus on improving communication success with hearing-impaired people and significant others, has not previously been assessed. We propose that improved communication outcomes associated with the ACE intervention, lead to an increased perception of hearing aid value and more realistic expectations associated with hearing aid use and ownership, which are reported to be key barriers and facilitators for successful hearing aid use. This study will assess the feasibility of delivering ACE and undertaking a definitive randomised controlled trial to evaluate whether ACE would be a cost-effective and acceptable way of increasing quality of life through improving communication and hearing aid use in a public health service such as the National Health Service.Methods and analysisThis will be a randomised controlled, open feasibility trial with embedded economic and process evaluations delivered in audiology departments in two UK cities. We aim to recruit 84 patients (and up to 84 significant others) aged 18 years and over, who report moderate or less than moderate benefit from their new hearing aid. The feasibility of a large-scale study and the acceptability of the ACE intervention will be measured by recruitment rates, treatment retention, follow-up rates and qualitative interviews.Ethics and disseminationEthical approval granted by South East Coast-Surrey Research Ethics Committee (16/LO/2012). Dissemination of results will be via peer-reviewed research publications both online and in print, conference presentations, posters, patient forums and Trust bulletins.Trial registration numberISRCTN28090877.

Effectiveness and cost effectiveness of digital hearing aids in patients with tinnitus and hearing loss: a randomised feasibility trial (THE HUSH Trial)

“…The feasibility assessment was adapted from that proposed by Thyer et al [ 46 ]. The trial would be deemed successful if (1) 80% of recruitment target achieved; (2) number of sites retained, number of site achieving recruitment target, study consent and retention rates and proposed sample sizes, indicate delivery of the full RCT is plausible within a 5-year study period and (3) participants and clinicians report acceptability of the trial.…”

Randomised controlled feasibility trial of an active communication education programme plus hearing aid provision versus hearing aid provision alone (ACE To HEAR)

“…The methods are summarised below and published in more detail elsewhere. 31 This was an open feasibility RCT with embedded economic and process evaluations. The required regulatory approvals were in place prior to study commencement.…”

“…The full eligibility criteria can be found in the published protocol. 31 The study sites estimated that there would be approximately 400 new HA fitted across the study centres each month. Assuming 10% eligibility, 35% did not attend (DNA) and 30% consent rate, around 350 cases per month across the two centres would have needed to be screened to recruit the required 88 HA users in 12 months.…”

Protocol for a multi-centre randomised controlled stand-alone feasibility trial to assess potential effectiveness and cost-effectiveness of digital hearing aids in patients with tinnitus and hearing loss (the HUSH trial)

“…There are few examples of multi-centre RCTs in UK audiology clinics on which to inform the setting of predefined thresholds for specific feasibility outcomes. Upon the recommendation of the TSC, an adaptation of the feasibility assessment proposed by Thyer et al [35] will be used to determine whether a fully powered randomised trial will be feasible. This will be assessed using both the quantitative and qualitative data gathered within the context of the present trial.…”