TY - JOUR
T1 - Clinical efficacy of a Decision Support Tool (Link-me) to guide intensity of mental health care in primary practice
T2 - a pragmatic stratified randomised controlled trial
AU - Fletcher, Susan
AU - Spittal, Matthew J.
AU - Chondros, Patty
AU - Palmer, Victoria J.
AU - Chatterton, Mary Lou
AU - Densley, Konstancja
AU - Potiriadis, Maria
AU - Harris, Meredith
AU - Bassilios, Bridget
AU - Burgess, Philip
AU - Mihalopoulos, Cathrine
AU - Pirkis, Jane
AU - Gunn, Jane
N1 - Funding Information:
MS is a recipient of an Australian Research Council Future Fellowship ( FT180100075 ) funded by the Australian Government. JP is funded by a National Health and Medical Research Council Investigator Grant (GNT1173126). We are grateful to the many dedicated general practitioners, practice staff, and general practice patients who took part in Link-me. We also thank the regional trial coordinators at participating Primary Health Networks, care navigators, and research assistants who assisted with trial establishment, intervention delivery, and data collection. Finally, we thank the Evaluation Advisory Group for their advice throughout the trial; the Expert Working Group for their input into the Decision Support Tool; and the Department of Health and North Western Melbourne, Brisbane North, and North Coast Primary Health Networks for their input into the development and implementation of the trial protocol.
Funding Information:
MS is a recipient of an Australian Research Council Future Fellowship (FT180100075) funded by the Australian Government. JP is funded by a National Health and Medical Research Council Investigator Grant (GNT1173126). We are grateful to the many dedicated general practitioners, practice staff, and general practice patients who took part in Link-me. We also thank the regional trial coordinators at participating Primary Health Networks, care navigators, and research assistants who assisted with trial establishment, intervention delivery, and data collection. Finally, we thank the Evaluation Advisory Group for their advice throughout the trial; the Expert Working Group for their input into the Decision Support Tool; and the Department of Health and North Western Melbourne, Brisbane North, and North Coast Primary Health Networks for their input into the development and implementation of the trial protocol.
Funding Information:
Link-me was funded by the Australian Government Department of Health as part of a national evaluation of the implementation of broader mental health reforms. The Department of Health assisted in refining the study design and provided approval to submit this report for publication, but had no role in data collection, data analysis, data interpretation, or writing of the report. SF, MJS and JG had full access to all the data in the study and had final responsibility for the decision to submit for publication. All authors had full access to all the data in the study.
Publisher Copyright:
© 2021 Elsevier Ltd
PY - 2021/3
Y1 - 2021/3
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/85100881685
U2 - 10.1016/S2215-0366(20)30517-4
DO - 10.1016/S2215-0366(20)30517-4
M3 - Article
C2 - 33571453
AN - SCOPUS:85100881685
SN - 2215-0366
VL - 8
SP - 202
EP - 214
JO - The Lancet Psychiatry
JF - The Lancet Psychiatry
IS - 3
ER -