Study protocol: a clinical trial for improving mental health screening for Aboriginal and Torres Strait Islander pregnant women and mothers of young children using the Kimberley Mum's Mood Scale

All women who meet the inclusion criteria (sample frame A) and are receiving perinatal care from a partner health service will be invited to participate in the study when they receive routine perinatal screening by perinatal health professionals. Women will be provided with an information sheet and will be required to provide written informed consent prior to participating in the study.

Women are able to withdraw consent at any time and their data will be withdrawn from the study results if they request this.

All perinatal health professionals in partner health services will be offered approximately 2–3 h of KMMS training. Training will be divided into three sessions:

All training will be provided face-to-face or via online classroom workshops. For health professionals involved in the KMMS administrator or DMT training, support and mentoring in using the KMMS tools will be available for the duration of the study.

Perinatal health professionals from partner health services trained in the KMMS will consent participants and administer the KMMS instead of the EPDS in accordance with the KMMS guidelines for administration [19]. All women who are assessed as having an overall KMMS risk of moderate or high will be referred for further assessment; where possible this assessment will use the DMT. As part of this study, a proportion of women with an overall KMMS risk assessment of ‘low’ will also be referred for further assessment using the DMT to confirm that the current cut-point between low and moderate is valid.

The DMT is the standard reference assessment for all further KMMS clinical assessments. Diagnosis is based on the Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria for depressive and anxiety disorders [20] and severity (i.e. low, moderate, high) on the GP Mental State Examination [21]. Participants who are referred for an assessment using the DMT will be assessed as soon as practicable after the KMMS is administered. For those diagnosed with perinatal depression and/or anxiety, a follow-up management plan will be negotiated between the participant and the GP / mental health professional, ensuring appropriate support, referrals and treatment is discussed and agreed upon by both the woman and the health care professional.

It is recognised that health service implementation is a complex undertaking with many promising research findings failing to translate into improved patient outcomes [22, 23]. Using the Dynamic Sustainability Framework (DSF) [24] we seek to explore and report on the process of implementation. This includes an examination of how the intervention (components, practitioners, outcomes, delivery platform), practice setting (staffing, organisational culture, information systems, business model, training and supervision), and ecological settings (population characteristics, policy, regulation, funding) enable or inhibit implementation of the KMMS into routine clinical care. Specific to the DSF is the expectation that “change is a constant and thus the success of an intervention to be sustained over time lies in the measured, negotiated, and reciprocal fit of an intervention within a practice setting and the practice setting within the larger ecological system” [24]. The DSF posits that ‘fit’ involves the way an intervention is delivered, the characteristics of patients, providers and settings, and the broader system within which health care is situated [24]. The DSF’s recognition and embrace of the constancy of change is compelling and speaks to the realities of the Northern Australian health workforce which is characterised by high turnover, low stability and high use of temporary staffing [25]. Similarly, the emphasis the DSF places on ‘fit’ seems a pertinent starting point for evaluating the process of implementing the KMMS across the geographically large and culturally diverse region of the Kimberley. The learnings and reflections from the process of implementation will be shared with partner health services and the KAHPF, and submitted to relevant peer reviewed journals and national interest bodies contributing to the science of ‘what works’ in the validation and implementation of Aboriginal and Torres Strait Islander health improvement initiatives.

In addition to studying the implementation process, Kimberley Aboriginal and Torres Strait Islander women offered the KMMS as part of routine care will be invited to participate in the revalidation study. The revalidation will analyse the results of KMMS assessments, any further clinical assessments and support, and the routine care provided when screening for perinatal depression and/or anxiety (see below for detail). During this study, the only modification to the recommended standard of care in the Kimberley will be for a sample of women who score low risk on the KMMS to be offered a follow-up clinical assessment by a GP or mental health professional as part of revalidating the cut-point.

Women who do not consent to the study will continue with usual care and no identifying information will be collected on these women. De-identified information about the number, scores and basic demographics of all KMMS assessments will be requested from partner organisations as part of evaluating the implementation.

In the Pilbara and FNQ selected health services have agreed to trial the KMMS instead of the EPDS to screen for perinatal depression and anxiety. Partner health services will ask perinatal women for consent to participate in the study. This includes completing the KMMS and providing feedback on the screening tool. All women scoring moderate or high on the KMMS and a sample of women scoring low on the KMMS will be referred for a further clinical assessment using the DMT. As in the Kimberley, the KMMS will be offered in accordance with the national EPDS screening schedule [4] and rescreening will involve completing a new Part 1 and continuing the yarn in the original Part 2.

Women who do not consent to the study can use the KMMS, but no identifying information will be collected on these women.

Systematic and retrospective investigation of patient medical records has long been used in quality assessment and improvement studies, professional education and training, and as an assessment of patient care initiatives [26‐29]. This study will review the quality and appropriateness of KMMS and DMT assessments from all sites via two separate panel processes (Additional files 5 and 6).

The panels will convene every 3 months and will consist of a minimum of four members who have relevant clinical expertise and are sufficiently impartial to the study [29], i.e. health professionals not engaged in the administration of the KMMS or the DMT. The panels will be convened by a member of the research team. A minimum of nine and maximum of 12 files will be selected by the KMMS research team and reviewed by the panel at each meeting. A quota sampling strategy [26] will be used to select the files to ensure the panels are reviewing a spread of KMMS/DMT results, antenatal and postnatal women, health professionals, and health services.

Overall findings from each panel will be disseminated back to partner health services as a quality initiative. Where required, additional training and support will be offered to health services to ensure that Aboriginal and Torres Strait Islander women are receiving appropriate care and support via the KMMS and the medical files and records reflect the service provided.

User acceptability is a multi-faceted construct that investigates if and how recipients or administrators of a healthcare intervention consider it to be appropriate [30, 31]. The study will assess key domains of user acceptability (Table 1) using a range of methods including questionaries and qualitative interviewing.

Women consented to the KMMS study will be asked to complete a 5-item paper-based feedback questionnaire immediately after the administration of their first KMMS. This questionnaire will assess participants’ experience with the KMMS tool, specifically exploring perceptions of tool content (Table 1). Additionally, a subset of women (n = 6–12 per KMMS region) will be invited to participate in a face-to-face in-depth interview approximately 3–6 months after administration of their first KMMS. The interviews will be no longer than 1 h in duration and will use a methodological approach of phenomenology to explore experiences of completing the KMMS [30, 31]. Recruitment for in-depth interviewing will occur by following up with those women who expressed interest in an interview by leaving their details on the KMMS feedback questionnaire. Additional measures of purposive sampling such as the study team attending mums and bubs groups or playgroups may result in further recruitment. Participants will provide written consent prior to their involvement in the interviews.

Health professionals will also provide data on the acceptability of the KMMS training and KMMS tool. At the time of training, all health professionals will be asked to complete a paper-based feedback questionnaire. This feedback will relate to the health professional’s experience of the training, including their perceptions of the significance and prevalence of perinatal depression and anxiety in the region in which they work. All health professionals who have been trained and have subsequently administered the KMMS will be asked to complete an online questionnaire 6 months post KMMS administrator training. The questionnaire will assess KMMS use and the health professional’s experience of the KMMS as a feature of clinical care.

Additionally, a subset of KMMS-administrator health professionals (n = 6–12 per KMMS region) will be invited to complete an in-depth interview (in person or by phone) 6 or 12 months post administrator training. Recruitment will occur via phone calls to all trained administrators. Interviews will be no longer than 1 h in duration and will explore user acceptability measures identified in Table 1.

All user acceptability data will be anonymous (questionnaries) or de-identified (in-depth interviews) and participants confidentiality will be maintained at all times.

KMMS validation/revalidation internal consistency of Part 1 will be determined using Cronbach’s alpha [38]. Equivalence for identifying risk of depression and anxiety compared to the DMT will be determined from receiver operating characteristic curves. Sensitivity and specificity will be determined based on these cut-points.

Differences in characteristics between antenatal and postnatal participants, participants who are or are not diagnosed with depressive and/or anxiety disorders, and participants from different regions will be compared using χ² tests for categorical data and Mann–Whitney tests for continuous non-parametric data. Change in KMMS risk (from low to moderate/high, or vice versa) will be compared using McNemar’s test. Descriptive statistical analysis will be used when assessing trends and patterns in user acceptability.

User acceptability data will be descriptively and iteratively coded using NVivo11 (QSR International). The coding categories will be reviewed by the research team and Investigators before the data is thematically analysed [39]. Aboriginal and Torres Strait Islander investigators and project staff will be involved in all aspects of qualitative data coding and analysis to ensure that a cultural lens is applied in the coding and analysis of Aboriginal and Torres Strait Islander participants’ data [40‐42].

Quality assessments of the KMMS and DMT as per the Quality Assessment Panel will be descriptive using the structured process identified in Additional Information 3 and 4.

The process evaluation [43, 44] will collate, assess and report on KMMS user acceptability data, KMMS quality review data, rates of KMMS and DMT completed across the regions, consultations with health service administrators and management, field notes from the research team, TMG meeting minutes, and training calendars, via the DSF.