General Practice and Primary Care - Research Publications
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ItemThe CORE study-An adapted mental health experience codesign intervention to improve psychosocial recovery for people with severe mental illness: A stepped wedge cluster randomized-controlled trial(WILEY, 2021-12)BACKGROUND: Mental health policies outline the need for codesign of services and quality improvement in partnership with service users and staff (and sometimes carers), and yet, evidence of systematic implementation and the impacts on healthcare outcomes is limited. OBJECTIVE: The aim of this study was to test whether an adapted mental health experience codesign intervention to improve recovery-orientation of services led to greater psychosocial recovery outcomes for service users. DESIGN: A stepped wedge cluster randomized-controlled trial was conducted. SETTING AND PARTICIPANTS: Four Mental Health Community Support Services providers, 287 people living with severe mental illnesses, 61 carers and 120 staff were recruited across Victoria, Australia. MAIN OUTCOME MEASURES: The 24-item Revised Recovery Assessment Scale (RAS-R) measured individual psychosocial recovery. RESULTS: A total of 841 observations were completed with 287 service users. The intention-to-treat analysis found RAS-R scores to be similar between the intervention (mean = 84.7, SD= 15.6) and control (mean = 86.5, SD= 15.3) phases; the adjusted estimated difference in the mean RAS-R score was -1.70 (95% confidence interval: -3.81 to 0.40; p = .11). DISCUSSION: This first trial of an adapted mental health experience codesign intervention for psychosocial recovery outcomes found no difference between the intervention and control arms. CONCLUSIONS: More attention to the conditions that are required for eight essential mechanisms of change to support codesign processes and implementation is needed. PATIENT AND PUBLIC INVOLVEMENT: The State consumer (Victorian Mental Illness Awareness Council) and carer peak bodies (Tandem representing mental health carers) codeveloped the intervention. The adapted intervention was facilitated by coinvestigators with lived-experiences who were coauthors for the trial and process evaluation protocols, the engagement model and explanatory model of change for the trial.
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ItemMatching depression management to severity prognosis in primary care: results of the Target-D randomised controlled trial(ROYAL COLL GENERAL PRACTITIONERS, 2021-02)BACKGROUND: Mental health treatment rates are increasing, but the burden of disease has not reduced. Tools to support efficient resource distribution are required. AIM: To investigate whether a person-centred e-health (Target-D) platform matching depression care to symptom severity prognosis can improve depressive symptoms relative to usual care. DESIGN AND SETTING: Stratified individually randomised controlled trial in 14 general practices in Melbourne, Australia, from April 2016 to February 2019. In total, 1868 participants aged 18-65 years who had current depressive symptoms; internet access; no recent change to antidepressant; no current antipsychotic medication; and no current psychological therapy were randomised (1:1) via computer-generated allocation to intervention or usual care. METHOD: The intervention was an e-health platform accessed in the GP waiting room, comprising symptom feedback, priority-setting, and prognosis-matched management options (online self-help, online guided psychological therapy, or nurse-led collaborative care). Management options were flexible, neither participants nor staff were blinded, and there were no substantive protocol deviations. The primary outcome was depressive symptom severity (9-item Patient Health Questionnaire [PHQ-9]) at 3 months. RESULTS: In intention to treat analysis, estimated between- arm difference in mean PHQ-9 scores at 3 months was -0.88 (95% confidence interval [CI] = -1.45 to -0.31) favouring the intervention, and -0.59 at 12 months (95% CI = -1.18 to 0.01); standardised effect sizes of -0.16 (95% CI = -0.26 to -0.05) and -0.10 (95% CI = -0.21 to 0.002), respectively. No serious adverse events were reported. CONCLUSION: Matching management to prognosis using a person-centred e-health platform improves depressive symptoms at 3 months compared to usual care and could feasibly be implemented at scale. Scope exists to enhance the uptake of management options.
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ItemNo Preview AvailableClinical efficacy of a Decision Support Tool (Link-me) to guide intensity of mental health care in primary practice: a pragmatic stratified randomised controlled trial(ELSEVIER SCI LTD, 2021-03)BACKGROUND: The volume and heterogeneity of mental health problems that primary care patients present with is a substantial challenge for health systems, and both undertreatment and overtreatment are common. We developed Link-me, a patient-completed Decision Support Tool, to predict severity of depression or anxiety, identify priorities, and recommend interventions. In this study, we aimed to examine if Link-me reduces psychological distress among individuals predicted to have minimal/mild or severe symptoms of anxiety or depression. METHODS: In this pragmatic stratified randomised controlled trial, adults aged 18-75 years reporting depressive or anxiety symptoms or use of mental health medication were recruited from 23 general practices in Australia. Participants completed the Decision Support Tool and were classified into three prognostic groups (minimal/mild, moderate, severe), and those in the minimal/mild and severe groups were eligible for inclusion. Participants were individually and randomly assigned (1:1) by a computer-generated allocation sequence to receive either prognosis-matched care (intervention group) or usual care plus attention control (control group). Participants were not blinded but intervention providers were only notified of those allocated to the intervention group. Outcome assessment was blinded. The primary outcome was the difference in the change in scores between the intervention and control group, and within prognostic groups, on the 10-item Kessler Psychological Distress Scale at 6 months post randomisation. The trial was registered on the Australian and New Zealand Clinical Trials Registry, ACTRN12617001333303. OUTCOMES: Between Nov 21, 2017, and Oct 31, 2018, 24 616 patients were invited to complete the eligibility screening survey. 1671 of these patients were included and randomly assigned to either the intervention group (n=834) or the control group (n=837). Prognosis-matched care was associated with greater reductions in psychological distress than usual care plus attention control at 6 months (p=0·03), with a standardised mean difference (SMD) of -0·09 (95% CI -0·17 to -0·01). This reduction was also seen in the severe prognostic group (p=0·003), with a SMD of -0·26 (-0·43 to -0·09), but not in the minimal/mild group (p=0·73), with a SMD of 0·04 (-0·17 to 0·24). In the complier average causal effect analysis in the severe prognostic group, differences were larger among those who received some or all aspects of the intervention (SMD range -0·58 to -1·15). No serious adverse effects were recorded. INTERPRETATION: Prognosis-based matching of interventions reduces psychological distress in patients with anxiety or depressive symptoms, particularly in those with severe symptoms, and is associated with better outcomes when patients access the recommended treatment. Optimisation of the Link-me approach and implementation into routine practice could help reduce the burden of disease associated with common mental health conditions such as anxiety and depression. FUNDING: Australian Government Department of Health.
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ItemNo Preview AvailableRapid Design and Delivery of an Experience-Based Co-designed Mobile App to Support the Mental Health Needs of Health Care Workers Affected by the COVID-19 Pandemic: Impact Evaluation Protocol (Preprint)(JMIR Publications, 2020-12-02)BACKGROUND
The COVID-19 pandemic has highlighted the importance of health care workers’ mental health and well-being for the successful function of the health care system. Few targeted digital tools exist to support the mental health of hospital-based health care workers, and none of them appear to have been led and co-designed by health care workers.
OBJECTIVERMHive is being led and developed by health care workers using experience-based co-design (EBCD) processes as a mobile app to support the mental health challenges posed by the COVID-19 pandemic to health care workers. We present a protocol for the impact evaluation for the rapid design and delivery of the RMHive mobile app.
METHODSThe impact evaluation will adopt a mixed methods design. Qualitative data from photo interviews undertaken with up to 30 health care workers and semistructured interviews conducted with up to 30 governance stakeholders will be integrated with qualitative and quantitative user analytics data and user-generated demographic and mental health data entered into the app. Analyses will address three evaluation questions related to engagement with the mobile app, implementation and integration of the app, and the impact of the app on individual mental health outcomes. The design and development will be described using the Mobile Health Evidence Reporting and Assessment guidelines. Implementation of the app will be evaluated using normalization process theory to analyze qualitative data from interviews combined with text and video analysis from the semistructured interviews. Mental health impacts will be assessed using the total score of the 4-item Patient Health Questionnaire (PHQ4) and subscale scores for the 2-item Patient Health Questionnaire for depression and the 2-item Generalized Anxiety Scale for anxiety. The PHQ4 will be completed at baseline and at 14 and 28 days.
RESULTSThe anticipated average use period of the app is 30 days. The rapid design will occur over four months using EBCD to collect qualitative data and develop app content. The impact evaluation will monitor outcome data for up to 12 weeks following hospital-wide release of the minimal viable product release. The study received funding and ethics approvals in June 2020. Outcome data is expected to be available in March 2021, and the impact evaluation is expected to be published mid-2021.
CONCLUSIONSThe impact evaluation will examine the rapid design, development, and implementation of the RMHive app and its impact on mental health outcomes for health care workers. Findings from the impact evaluation will provide guidance for the integration of EBCD in rapid design and implementation processes. The evaluation will also inform future development and rollout of the app to support the mental health needs of hospital-based health care workers more widely.
INTERNATIONAL REGISTERED REPORTDERR1-10.2196/26168
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ItemRapid Design and Delivery of an Experience-Based Co-designed Mobile App to Support the Mental Health Needs of Health Care Workers Affected by the COVID-19 Pandemic: Impact Evaluation Protocol(JMIR PUBLICATIONS, INC, 2021-03)BACKGROUND: The COVID-19 pandemic has highlighted the importance of health care workers' mental health and well-being for the successful function of the health care system. Few targeted digital tools exist to support the mental health of hospital-based health care workers, and none of them appear to have been led and co-designed by health care workers. OBJECTIVE: RMHive is being led and developed by health care workers using experience-based co-design (EBCD) processes as a mobile app to support the mental health challenges posed by the COVID-19 pandemic to health care workers. We present a protocol for the impact evaluation for the rapid design and delivery of the RMHive mobile app. METHODS: The impact evaluation will adopt a mixed methods design. Qualitative data from photo interviews undertaken with up to 30 health care workers and semistructured interviews conducted with up to 30 governance stakeholders will be integrated with qualitative and quantitative user analytics data and user-generated demographic and mental health data entered into the app. Analyses will address three evaluation questions related to engagement with the mobile app, implementation and integration of the app, and the impact of the app on individual mental health outcomes. The design and development will be described using the Mobile Health Evidence Reporting and Assessment guidelines. Implementation of the app will be evaluated using normalization process theory to analyze qualitative data from interviews combined with text and video analysis from the semistructured interviews. Mental health impacts will be assessed using the total score of the 4-item Patient Health Questionnaire (PHQ4) and subscale scores for the 2-item Patient Health Questionnaire for depression and the 2-item Generalized Anxiety Scale for anxiety. The PHQ4 will be completed at baseline and at 14 and 28 days. RESULTS: The anticipated average use period of the app is 30 days. The rapid design will occur over four months using EBCD to collect qualitative data and develop app content. The impact evaluation will monitor outcome data for up to 12 weeks following hospital-wide release of the minimal viable product release. The study received funding and ethics approvals in June 2020. Outcome data is expected to be available in March 2021, and the impact evaluation is expected to be published mid-2021. CONCLUSIONS: The impact evaluation will examine the rapid design, development, and implementation of the RMHive app and its impact on mental health outcomes for health care workers. Findings from the impact evaluation will provide guidance for the integration of EBCD in rapid design and implementation processes. The evaluation will also inform future development and rollout of the app to support the mental health needs of hospital-based health care workers more widely. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26168.
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ItemThe assertive cardiac care trial: A randomised controlled trial of a coproduced assertive cardiac care intervention to reduce absolute cardiovascular disease risk in people with severe mental illness in the primary care setting(ELSEVIER SCIENCE INC, 2020-10)BACKGROUND: Cardiovascular disease (CVD) accounts for 40% of the excess mortality identified in people with severe mental illness (SMI). Modifiable CVD risk factors are higher and can be exacerbated by the cardiometabolic impact of psychotropic medications. People with SMI frequently attend primary care presenting a valuable opportunity for early identification, prevention and management of cardiovascular health. The ACCT Healthy Hearts Study will test a coproduced, nurse-led intervention delivered with general practitioners to reduce absolute CVD risk (ACVDR) at 12 months compared with an active control group. METHODS/DESIGN: ACCT is a two group (intervention/active control) individually randomised (1:1) controlled trial (RCT). Assessments will be completed baseline (pre-randomisation), 6 months, and 12 months. The primary outcome is 5-year ACVDR measured at 12 months. Secondary outcomes include 6-month ACVDR; and blood pressure, lipids, HbA1c, BMI, quality of life, physical activity, motivation to change health behaviour, medication adherence, alcohol use and hospitalisation at 6 and 12 months. Linear mixed-effects regression will estimate mean difference between groups for primary and secondary continuous outcomes. Economic cost-consequences analysis will be conducted using quality of life and health resource use information and routinely collected government health service use and medication data. A parallel process evaluation will investigate implementation of the intervention, uptake and outcomes. DISCUSSION: ACCT will deliver a coproduced and person-centred, guideline level cardiovascular primary care intervention to a high need population with SMI. If successful, the intervention could lead to the reduction of the mortality gap and increase opportunities for meaningful social and economic participation. Trial registration ANZCTR Trial number: ACTRN12619001112156.