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Hearing Norton Sound: mixed methods protocol of a community randomised trial to address childhood hearing loss in rural Alaska.

ABSTRACT: INTRODUCTION:Childhood hearing loss has implications for school achievement, economic outcomes and quality of life. This study will engage rural Alaska communities in research to improve the school hearing screening and referral process, partnering with stakeholders to develop a locally derived, evidence-based solution to improve timely identification and treatment of childhood hearing loss. METHODS AND ANALYSIS:Mixed methods community randomised trial in 15 communities in the Norton Sound region of northwest Alaska. Data collection will span from April 2017 until February 2020. Qualitative and mixed methods components are described in this protocol and the community randomised trial in the companion protocol. Focus groups and community events will be held leading up to the randomised trial to obtain community perspectives on childhood hearing loss in Alaska and elicit community input during trial protocol refinement (exploratory sequential stage). Stakeholder groups, including parents, children, teachers, school administrators and community health aides, will participate, along with community leaders, tribal leaders and community members. The randomised trial will be combined with qualitative, semi-structured interviews to elicit stakeholder perspectives on the intervention (explanatory sequential stage). The five stakeholder groups described above will participate in interviews. The study will conclude with additional focus groups and community events to discuss results and provide community insight for future implementation. Concluding focus groups will include policymakers, healthcare administrators, and tribal and community leaders in addition to the stakeholder groups. Informed consent and child assent will be required. Recordings will be transcribed and deidentified, with only stakeholder group recorded. Analyses will include categorical coding as well as narrative and thematic analysis. ETHICS AND DISSEMINATION:The Hearing Norton Sound study has been approved by the Institutional Review Boards of Alaska Area, Norton Sound, and Duke University, with trial registration on clinicaltrials.gov. Study results will be distributed with equal emphasis on scientific and community dissemination. TRIAL REGISTRATION NUMBER:NCT03309553; Results.

SUBMITTER: Emmett SD

PROVIDER: S-EPMC6347925 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Hearing Norton Sound: mixed methods protocol of a community randomised trial to address childhood hearing loss in rural Alaska.

Emmett Susan D SD Robler Samantha Kleindienst SK Gallo Joseph J JJ Wang Nae-Yuh NY Labrique Alain A Hofstetter Philip P

BMJ open 20190122 1

<h4>Introduction</h4>Childhood hearing loss has implications for school achievement, economic outcomes and quality of life. This study will engage rural Alaska communities in research to improve the school hearing screening and referral process, partnering with stakeholders to develop a locally derived, evidence-based solution to improve timely identification and treatment of childhood hearing loss.<h4>Methods and analysis</h4>Mixed methods community randomised trial in 15 communities in the Nor ...[more]

PMID: 30674486

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Project description:IntroductionThe population in rural Alaska experiences a disproprionately high burden of infection-mediated hearing loss. While the state mandates school hearing screening, many children with hearing loss are not identified or are lost to follow-up before ever receiving treatment. A robust, tribally owned healthcare system exists in Alaska, but children with hearing loss must first be identified and referred for existing infrastructure to be used. This trial will evaluate a new school hearing screening and referral process in rural Alaska, with the goal of improving timely identification and treatment of childhood hearing loss.Methods and analysisComparative effectiveness community randomised trial testing digital innovations to improve school hearing screening and referral in 15 communities in the Norton Sound region of northwest Alaska, with data collection from October 2017 to February 2020. All children (K-12) attending school in Bering Strait School District with parental informed consent and child assent will be eligible (target recruitment n=1500). Participating children will undergo both the current school hearing screen and new mobile health (mHealth) screen, with screening test validity evaluated against an audiometric assessment. Communities will be cluster randomised to continue the current primary care referral process or receive telemedicine referral for follow-up diagnosis and treatment. The primary outcome will be time to International Statistical Classification of Diseases, 10th Revision, ear/hearing diagnosis from screening date, measured in days. Secondary outcomes will include: sensitivity and specificity of current school and mHealth screening protocols measured against a benchmark audiometric assessment (air and bone conduction audiometry, tympanometry and digital otoscopy); hearing loss prevalence; hearing-related quality of life; and school performance (AIMSweb). Intention-to-treat analysis will be used.Ethics and disseminationThis study has been approved by the Institutional Review Boards of Alaska Area, Norton Sound and Duke University and is registered on clinicaltrials.gov. Results will be distributed with equal emphasis on scientific and community dissemination.Trial registration numberNCT03309553; Pre-results.

Project description:Community involvement is important in good research practice. We led a community-based study to improve early detection and treatment of childhood hearing loss in rural Alaska. This study evaluated a cell phone-based hearing screening process and compared a new telemedicine specialty referral pathway to the standard primary care referral pathway. The study included community involvement, engagement, and participation from the very beginning to inform how to best design the trial. We obtained insight and feedback from community members through involvement of a core stakeholder team and through community engagement and participation in focus groups and community events. Feedback received through community involvement and participation influenced the design of the trial at key decision points. Community member guidance shaped the research question, the outcomes to be measured, and the procedures for completing the project, such as participant recruitment. This study offers an example of community involvement, engagement and participation that could be mirrored in future research to maintain the interests of participating communities. Background Effective systems for early identification and treatment of childhood hearing loss are essential in rural Alaska, where data indicate a high prevalence of childhood ear infections and hearing loss. However, loss to follow-up from school hearing screening programs is pervasive. The Hearing Norton Sound study was a mixed methods community randomized controlled trial that was developed to address this gap. The study engaged community members and participants in the design of the trial, including involvement of stakeholders as collaborators. Methods Community engagement and participation in research design occurred through focus groups and through the integration of stakeholders into the study team. Representation was cross-sectoral, involving individuals from multiple levels of the school and health system, as well as community members from each of the 15 communities. Feedback obtained between April 2017 and August 2017 informed the final design of the randomized trial, which began enrollment of children in October 2017 and concluded in March 2019. Results Stakeholder involvement and community participation shaped the design of specific trial elements (research question; comparators; outcomes and measures; telemedicine protocols; and recruitment and retention). Community involvement was strengthened by the use of multiple modalities of involvement and by the positionality of lead stakeholders on the study team. Conclusions This study highlights the effectiveness of multifaceted stakeholder involvement and participation in the design of health research conducted within Alaska Native communities. It offers an example of involvement and reporting that could be mirrored in future research in order to protect and further the interests of the participating community. Trial registration ClinicalTrials.gov, NCT03309553 , First registered 10/9/2017.

Project description:ObjectivesChildhood hearing loss has well-known lifelong consequences. Certain rural populations are at higher risk for infection-related hearing loss. For Alaska Native children, historical data on hearing loss prevalence suggest a higher burden of infection-related hearing loss, but updated prevalence data are urgently needed in this high-risk population.DesignHearing data were collected as part of two school-based cluster-randomized trials in 15 communities in rural northwest Alaska over two academic years (2017-2019). All enrolled children from preschool to 12th grade were eligible. Pure-tone thresholds were obtained using standard audiometry and conditioned play when indicated. The analysis included the first available audiometric assessment for each child (n = 1634 participants, 3 to 21 years), except for the high-frequency analysis, which was limited to year 2 when higher frequencies were collected. Multiple imputation was used to quantify the prevalence of hearing loss in younger children, where missing data were more frequent due to the need for behavioral responses. Hearing loss in either ear was evaluated using both the former World Health Organization (WHO) definition (pure-tone average [PTA] > 25 dB) and the new WHO definition (PTA ≥ 20 dB), which was published after the study. Analyses with the new definition were limited to children 7 years and older due to incomplete data obtained on younger children at lower thresholds.ResultsThe overall prevalence of hearing loss (PTA > 25 dB; 0.5, 1, 2, 4 kHz) was 10.5% (95% confidence interval [CI], 8.9 to 12.1). Hearing loss was predominately mild (PTA >25 to 40 dB; 8.9%, 95% CI, 7.4 to 10.5). The prevalence of unilateral hearing loss was 7.7% (95% CI, 6.3 to 9.0). Conductive hearing loss (air-bone gap of ≥ 10 dB) was the most common hearing loss type (9.1%, 95% CI, 7.6 to 10.7). Stratified by age, hearing loss (PTA >25 dB) was more common in children 3 to 6 years (14.9%, 95% CI, 11.4 to 18.5) compared to children 7 years and older (8.7%, 95% CI, 7.1 to 10.4). In children 7 years and older, the new WHO definition increased the prevalence of hearing loss to 23.4% (95% CI, 21.0 to 25.8) compared to the former definition (8.7%, 95% CI, 7.1 to 10.4). Middle ear disease prevalence was 17.6% (95% CI, 15.7 to 19.4) and was higher in younger children (23.6%, 95% CI, 19.7 to 27.6) compared to older children (15.2%, 95% CI, 13.2 to 17.3). High-frequency hearing loss (4, 6, 8kHz) was present in 20.5% (95% CI, 18.4 to 22.7 [PTA >25 dB]) of all children and 22.8% (95% CI, 20.3 to 25.3 [PTA >25 dB]) and 29.7% (95% CI, 27.0 to 32.4 [PTA ≥ 20 dB]) of children 7 years and older (limited to year 2).ConclusionsThis analysis represents the first prevalence study on childhood hearing loss in Alaska in over 60 years and is the largest cohort with hearing data ever collected in rural Alaska. Our results highlight that hearing loss continues to be common in rural Alaska Native children, with middle ear disease more prevalent in younger children and high-frequency hearing loss more prevalent with increasing age. Prevention efforts may benefit from managing hearing loss type by age. Lastly, continued research is needed on the impact of the new WHO definition of hearing loss on field studies.

Project description:IntroductionIn January 2017, mifepristone-induced medical abortion was made available in Canada. In this study, we will seek to (1) understand facilitators and barriers to the implementation of mifepristone across Canada, (2) assess the impact of a 'community of practice' clinical and health service support platform and (3) engage in and assess the impact of integrated knowledge translation (iKT) activities aimed to improve health policy, systems and service delivery issues to enhance patient access to mifepristone.Methods and analysisThis prospective mixed-methods implementation study will involve a national sample of physicians and pharmacists recruited via an online training programme, professional networks and a purpose-built community of practice website. Surveys that explore constructs related to diffusion of innovation and Godin's behaviour change frameworks will be conducted at baseline and at 6 months, and qualitative data will be collected from electronic interactions on the website. Survey participants and a purposeful sample of decision-makers will be invited to participate in in-depth interviews. Descriptive analyses will be conducted for quantitative data. Thematic analysis guided by the theoretical frameworks will guide interpretation of qualitative data. We will conduct and assess iKT activities involving Canada's leading health system and health professional leaders, including evidence briefs, Geographical Information System (GIS)maps, face-to-face meetings and regular electronic exchanges. Findings will contribute to understanding the mechanisms of iKT relationships and activities that have a meaningful effect on uptake of evidence into policy and practice.Ethics and disseminationEthical approval was received from the University of British Columbia Children's and Women's Hospital Ethics Review Board (H16-01006). Full publication of the work will be sought in an international peer-reviewed journal. Findings will be disseminated to research participants through newsletters and media interviews, and to policy-makers through invited evidence briefs and face-to-face presentations.

Project description:ObjectiveParents may rely on information provided by extended family members when making decisions concerning the health of their children. We evaluate whether extended family members affected the success of an information intervention promoting infant health.MethodsThis is a secondary, sequential mixed-methods study based on a cluster randomised controlled trial of a peer-led home-education intervention conducted in Mchinji District, Malawi. We used linear multivariate regression to test whether the intervention impact on child height-for-age z-scores (HAZ) was influenced by extended family members. 12 of 24 clusters were assigned to the intervention, in which all pregnant women and new mothers were eligible to receive 5 home visits from a trained peer counsellor to discuss infant care and nutrition. We conducted focus group discussions with mothers, grandmothers and peer counsellors, and key-informant interviews with husbands, chiefs and community health workers to better understand the roles of extended family members in infant feeding.ResultsExposure to the intervention increased child HAZ scores by 0.296 SD (95%?CI 0.116 to 0.484). However, this effect is smaller in the presence of paternal grandmothers. Compared with an effect size of 0.441 to 0.467 SD (95%?CI -0.344 to 1.050) if neither grandmother is alive, the effect size was 0.235 (95% CI -0.493 to 0.039) to 0.253 (95% CI -0.529 to 0.029) SD lower if the paternal grandmother was alive. There was no evidence of an effect of parents' siblings. Maternal grandmothers did not affect intervention impact, but were associated with a lower HAZ score in the control group. Qualitative analysis suggested that grandmothers, who act as secondary caregivers and provide resources for infants, were slower to dismiss traditionally held practices and adopt intervention messages.ConclusionThe results indicate that the intervention impacts are diminished by paternal grandmothers. Intervention success could be increased by integrating senior women.

Project description:BackgroundPoor participant understanding of research information can be a problem in community interventional studies with rural African women, whose levels of illiteracy are high. This study aimed to improve the informed consent process for women living in rural eastern Uganda. We assessed the impact of alternative consent models on participants' understanding of clinical trial information and their contribution to the informed consent process in rural Uganda.MethodsThe study applied a parallel mixed-methods design for a prospective comparative cohort, nested within a pilot study on the community distribution of an alcohol-based hand rub to prevent neonatal sepsis (BabyGel pilot trial). Women of at least 34 weeks' pregnancy, suitable for inclusion in the BabyGel pilot trial, were recruited into this study from their homes in 13 villages in Mbale District. As part of the informed consent process, information about the trial was presented using one of three consent methods: standard researcher-read information, a slide show using illustrated text on a flip chart or a video showing the patient information being read as if by a newsreader in either English or the local language. In addition, all women received the patient information sheet in their preferred language. Each information-giving method was used in recruitment for 1 week. Two days after recruitment, women's understanding of the clinical trial was evaluated using the modified Quality of Informed Consent (QuIC) tool. They were also shown the other two methods and their preference assessed using a 5-point Likert scale. Semi-structured interviews were administered to each participant. The interviews were audio-recorded, transcribed and translated verbatim, and thematically analysed.ResultsA total of 30 pregnant women in their homes participated in this study. Their recall of the trial information within the planned 48 h was assessed for the majority (90%, 27/30). For all three consent models, women demonstrated a high understanding of the study. There was no statistically significant difference between the slide-show message (mean 4.7; standard deviation, SD 0.47; range 4-5), video message (mean 4.9; SD 0.33; range 4-5) and standard method (mean 4.5; SD 0.53; range 4-5; all one-way ANOVA, p =?0.190). The slide-show message resulted in the most objective understanding of question items with the highest average QuIC score of 100 points. For women who had been recruited using any of the three models, the slide show was the most popular method, with a mean score for all items of not less than 4.2 (mean 4.8; SD 0.6; range 4-5). Most women (63%, 19/30) preferred the slide-show message, compared with 17% (5/30) and 20% (6/30) for the standard and video messages, respectively. The reasons given included the benefits of having pictures to aid understanding and the logical progression of the information.ConclusionOur results from this small study suggest that slide-show messages may be an effective and popular alternative way of presenting trial information to women in rural Uganda, many of whom have little or no literacy.Trial registrationISRCTN, ISRCTN67852437 . Registered on 18 March 2018.

Dataset Information

Hearing Norton Sound: mixed methods protocol of a community randomised trial to address childhood hearing loss in rural Alaska.

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Hearing Norton Sound: mixed methods protocol of a community randomised trial to address childhood hearing loss in rural Alaska.

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