Dataset Information

Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial).

ABSTRACT:

Background

Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Nevertheless, specialised mental health care may be required for specific patients. Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for an appointment with specialists, (b) long travel distances to specialists, particularly in rural and remote areas, and (c) patients' reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to examine the effectiveness and cost-effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care.

Methods

In an individually randomised, prospective, two-arm superiority trial with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in general practices in Germany. The intervention includes a newly developed treatment model based on video consultations with focus on diagnostics, treatment planning, and short-term intervention by mental health specialists. We will systematically compare the effectiveness, cost-effectiveness, and adverse effects of this new model with usual care by the GP: the primary outcome is the absolute change in the mean depressive and anxiety symptom severity measured on the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from baseline to 6 months after baseline assessment. Follow-up in both groups will be conducted by blinded outcome assessors at 6 months and 12 months after baseline. The main analysis will be based on the intention-to-treat principle. We will optimise the likelihood of treatment effectiveness by strict inclusion criteria for patients, enhanced intervention integrity, and conducting a process evaluation.

Discussion

To the best of our knowledge, this is the first confirmatory study on a video-based, integrated care model for the treatment of anxiety and depressive disorders in GP patients in Germany.

Trial registration

ClinicalTrials.gov, United States National Institutes of Health NCT04316572 . Prospectively registered on 20 March 2020.

SUBMITTER: Haun MW

PROVIDER: S-EPMC8097128 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundMost people affected by depression or anxiety disorders are treated solely by their primary care physician. Access to specialized mental health care is impeded by patients' comorbidity and immobility in aging societies and long waiting times at the providers' end. Video-based integrated care models may leverage limited resources more efficiently and provide timely specialized care in primary care settings.ObjectiveThe study aims to evaluate the feasibility of mental health specialist video consultations with primary care patients with depression or anxiety disorders.MethodsParticipants were recruited by their primary care physicians during regular practice visits. Patients who had experienced at least moderate symptoms of depression and/or anxiety disorders were considered eligible for the study. Patients were randomized into 2 groups receiving either treatment-as-usual as provided by their general practitioner or up to 5 video consultations conducted by a mental health specialist. Video consultations focused on systematic diagnosis and proactive monitoring using validated clinical rating scales, the establishment of an effective working alliance, and a stepped-care algorithm within integrated care adjusting treatments based on clinical outcomes. Feasibility outcomes were recruitment, rate of loss to follow-up, acceptability of treatment, and attendance at sessions. Effectiveness outcomes included depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), burden of specific somatic complaints (Somatic Symptom Disorder-B Criteria Scale-12), recovery (Recovery Assessment Scale-German [RAS-G]), and perception of chronic illness care (Patient Assessment of Chronic Illness Care), which were measured at baseline and 16 weeks postallocation by assessors blinded to the group allocation.ResultsA total of 50 patients with depression and/or anxiety disorders were randomized, 23 in the intervention group and 27 in the treatment-as-usual group. The recruitment yield (number randomized per number screened) and the consent rate (number randomized per number eligible) were 69% (50/73) and 86% (50/58), respectively. Regarding acceptability, 87% (20/23) of the participants in the intervention group completed the intervention. Of the 108 planned video consultations, 102 (94.4%) were delivered. Follow-up rates were 96% (22/23) and 85% (23/27) for the intervention and control groups, respectively. The change from baseline scores at postmeasurement for the No Domination by Symptoms domain of recovery (RAS-G) was somewhat higher in the intervention group than in the control group (Mann-Whitney U test: rank-biserial r=0.19; 95% CI -0.09 to 0.46; P=.18). We did not detect any notable differences between the intervention and control groups in terms of other effectiveness outcomes. We did not observe any serious adverse events related to the trial.ConclusionsThe intervention and study procedures were found to be feasible for patients, primary care practice staff, and mental health specialists. A sufficiently powered pragmatic trial on mental health specialist video consultations should be conducted to investigate their effectiveness in routine care.Trial registrationGerman Clinical Trials Register DRKS00015812; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015812.

Project description:IntroductionMost people suffering from depression and anxiety disorders are entirely treated in primary care. Due to growing challenges in ageing societies, for example, patients' immobility and multimorbidity, the transition to specialised care becomes increasingly difficult. Although the co-location of general practitioners and mental health specialists improves the access to psychosocial care, integrated in-person approaches are not practical for rural and single-doctor practices with limited personnel and financial resources. Treating primary care patients via internet-based video consultations by remotely located mental health specialists bears the potential to overcome structural barriers and provide low-threshold care. The aim of this randomised controlled feasibility trial is to investigate the feasibility of implementing of mental health specialist video consultations in primary care practices.Methods and analysisFifty primary care patients with significant depression and/or anxiety symptomatology will be randomised in two groups receiving either the treatment as usual as provided by their general practitioner or up to five video consultations conducted by a mental health specialist. The video consultations focus on (1) systematic diagnosis plus proactive monitoring using validated clinical rating scales, (2) the establishment of an effective working alliance and (3) a stepped-care algorithm within integrated care adjusting treatments based on clinical outcomes. We will investigate the following outcomes: effectiveness of the recruitment strategies, patient acceptance of randomisation, practicability of the technical and logistical processes related to implementing video consultations in the practices' workflows, feasibility of the data collection and clinical parameters.Ethics and disseminationThis trial has undergone ethical scrutiny and has been approved by the Medical Faculty of the University of Heidelberg Ethics Committee (S-634/2018). The findings will be disseminated to the research community through presentations at conferences and publications in scientific journals. This feasibility trial will prepare the ground for a large-scale, fully powered randomised controlled trial.Trial registration numberDRKS00015812.

Project description:IntroductionGeneral practitioners (GP) report increasing difficulties in referring patients with somatic symptom disorder (SSD) in specialised psychosocial care. Barriers are structural conditions of the respective healthcare system and patients' reservations against receiving specialised psychosocial care. As patients with SSD often predominantly assume somatic influencing factors for the development and maintenance of their somatic complaints, close collaboration between the GP and mental health specialist (MHS) seems particularly important. Integrating internet-based video consultations by remotely located MHS and primary care can improve effective treatment of patients with SSD by overcoming structural barriers and provide low-threshold and timely care. The aim of this randomised controlled feasibility trial is to investigate the feasibility of implementing MHS video consultations in primary care practices.Methods and analysisFifty primary care patients with SSD will be individually randomised in two groups receiving either enhanced treatment as usual as provided by their GP (control group) or two versus five video consultations conducted by an MHS additionally to enhanced treatment as usual. The video consultations focus on (a) diagnostic clarification, (b) the development of a biopsychosocial disorder model, and (c) development of a treatment plan against the background of a stepped-care algorithm based on clinical outcomes. We will investigate the following outcomes: effectiveness of the recruitment strategies, patient acceptance of randomisation, practicability of the technical and logistical processes related to implementing video consultations in the practices' workflows, feasibility of the data collection and clinical parameters.Ethics and disseminationThis trial has undergone ethical scrutiny and has been approved by the Medical Faculty of the University of Heidelberg Ethics Committee (S-620/2021). The findings will be disseminated to the research community through presentations at conferences and publications in scientific journals. This feasibility trial will prepare the ground for a large-scale, fully powered randomised controlled trial.Trial registration numberDRKS00026075.

Project description:ObjectiveDespite available effective treatments for mental health disorders, few patients in need receive even the most basic care. Integrated telepsychiatry services may be a viable option to increase access to mental healthcare. The aim of this qualitative process evaluation embedded in a randomised controlled feasibility trial was to explore health providers' experiences with a mental healthcare model integrating mental health specialist video consultations (MHSVC) and primary care.MethodsA qualitative process evaluation focusing on MHSVC in primary care was conducted. In 13 semistructured interviews, we assessed the experience of all mental health specialists, primary care physicians and medical assistants who participated in the trial. A thematic analysis, focusing on the implementation, mechanisms of impact and context, was applied to investigate the data.ResultsConsidering (1) the implementation, participants evaluated the consultations as feasible, easy to use and time saving. Concerning (2) the mechanisms of impact, the consultations were regarded as effective for patients. Providers attributed the patients' improvements to two key aspects: the familiarity of the primary care practice and the fast access to specialist mental healthcare. Mental health specialists observed trustful therapeutic alliances emerging and described their experience as comparable to same-room care. However, compared with same-room care, specialists perceived the video consultations as more challenging and sometimes more exhausting due to the additional effort required for establishing therapeutic alliances. Regarding (3) the intervention's context, shorter travel distances for patients positively affected the implementation, while technical failures, that is, poor Internet connectivity, emerged as the main barrier.ConclusionsMHSVCs in primary care are feasible and successful in improving access to mental healthcare for patients. To optimise engagement and comfort of both patients and health providers, future work should focus on empirical determinants for establishing robust therapeutic alliances with patients receiving MHSVC (eg, leveraging non-verbal cues for therapeutic purposes).Trial registration numberDRKS00015812; Results.

Project description:BACKGROUND:Due to limited access to specialist services, most patients with common mental disorders (depression or anxiety, or both) usually receive treatment in primary care. More recently, innovative technology-based care models (eg, video consultations) have been proposed to facilitate access to specialist services. Against this background, the PROVIDE (Improving Cross-Sectoral Collaboration Between Primary and Psychosocial Care: An Implementation Study on Video Consultations) project aims to improve the provision of psychosocial care through implementing video consultations integrated into routine primary care. OBJECTIVE:From the patients' perspective, this qualitative preimplementation study explored (1) anticipated benefits from and (2) barriers to implementing mental health specialist video consultations embedded in primary care services and (3) prerequisites for interacting with therapists via video consultations. METHODS:Using a purposive (ie, stratified) sampling strategy, we recruited 13 patients from primary care practices and a tertiary care hospital (psychosomatic outpatient clinic) for one-off semistructured interviews. In a computer-assisted thematic analysis, we inductively (bottom-up) derived key themes concerning the practicability of mental health specialist video consultations. To validate our results, we discussed our findings with the interviewees as part of a systematic member checking. RESULTS:Overall, we derived 3 key themes and 10 subthemes. Participants identified specific benefits in 2 areas: the accessibility of mental health specialist care (shorter waiting times: 11/13, 85%; lower threshold for seeking specialist mental health care: 6/13, 46%; shorter travel distances: 3/13, 23%); and the environment in primary care (familiar travel modalities, premises, and employees: 5/13, 38%). The main barriers to the implementation of mental health video consultations from the patients' perspective were the lack of face-to-face contact (13/13, 100%) and technical challenges (12/13, 92%). Notably, participants' prerequisites for interacting with therapists (12/13, 92%) did not seem to differ much from those concerning face-to-face contacts. CONCLUSIONS:Mental health service users mostly welcomed mental health specialist video consultations in primary care. Taking a pragmatic stance, service users, who are often frustrated about uncoordinated care, particularly valued the embedment of the consultations in the familiar environment of the primary care practice. With respect to interventional studies and implementation, our findings underscore the need to minimize technical disruptions during video consultations and to ensure optimal resemblance to face-to-face settings (eg, by training therapists in consistently reacting to nonverbal cues). TRIAL REGISTRATION:German Clinical Trials Register DRKS00012487; https://tinyurl.com/uhg2one.

Project description:BackgroundMany patients with mental disorders are treated by their general practitioner (GP). Innovative technology-based integrated care models (e.g., mental health specialist video consultations) have been proposed to facilitate access to specialist services in primary care settings. While perspectives of patients and providers have been examined, there is little insight into the perspectives of health policy experts on such models. The purpose of this study was to examine the perspectives of health policy experts on (1) current challenges for continuity of care, (2) anticipated benefits and barriers for implementation of mental health specialist video consultations along with (3) practical and regulative preconditions for sustained implementation in primary care.MethodsIn a cross-sectional qualitative study, we conducted 15 semi-structured interviews with health policy experts representing various stakeholders in the German health care system: health insurances, governmental bodies, clinicians' professional associations, and patient representatives. Following a critical realism approach, we applied a qualitative inductive content analysis to derive key themes from the material.ResultsHealth policy experts saw long waiting times for patients and a lack of collaboration between in- and outpatient mental health services as well as mental health specialists and GPs as main barriers for current continuity of care. Health policy experts also felt that video consultations bear great potential to foster coordinated care between GPs and specialists and ensure timely referral for severely burdened patients. Increased workload for the general practice staff to facilitate video consultations and difficulties in establishing reliable therapeutic alliances between patients and specialists via remote treatment were considered as major barriers. Health policy experts varied significantly in their level of knowledge concerning legal frameworks and regulations pertaining to video consultations. However, the implementation of appropriate reimbursement schemes and sufficient data protection were regarded as the major regulative challenges.ConclusionsHealth policy experts mostly consider mental health specialist video consultations as a promising way to overcome current challenges for the management of patients with mental disorders at the interface between primary and specialist care. To ensure sustained implementation, a multi-stakeholder approach accounting for the perspective of health policy experts, patients, and providers should be followed.Trial registrationGerman Clinical Trials Register DRKS00012487.

Project description:BackgroundAlthough real-time mental health specialist video consultations have been proposed as an effective care model for treating patients with mental health conditions in primary care, little is known about their integration into routine practice from the perspective of family physicians.ObjectiveThis study aimed to determine the degree to which family physicians advocate that mental health specialist video consultations can be integrated into routine primary care, where most patients with mental health conditions receive treatment.MethodsIn a cross-sectional qualitative study, we conducted 4 semistructured focus groups and 3 telephonic interviews in a sample of 19 family physicians from urban and rural districts. We conducted a qualitative content analysis applying the Tailored Implementation in Chronic Diseases framework in a combined bottom-up (data-driven) and top-down strategy for deriving key domains.ResultsFamily physicians indicated that mental health specialist video consultations are a promising and practical way to address the most pressing challenges in current practice, that is, to increase the accessibility and co-ordination of specialized care. Individual health professional factors were the most frequently discussed topics. Specifically, family physicians valued the anticipated clinical outcomes for patients and the anticipated resources set for the primary care practice as major facilitators (16/19, 84%). However, family physicians raised a concern regarding a lack of facial expressions and physical interaction (19/19, 100%), especially in emergency situations. Therefore, most family physicians considered a viable emergency plan for mental health specialist video consultations that clearly delineates the responsibilities and tasks of both family physicians and mental health specialists to be essential (11/19, 58%). Social, political, and legal factors, as well as guideline factors, were hardly discussed as prerequisites for individual family physicians to integrate mental health specialist video consultations into routine care. To facilitate the implementation of future mental health specialist video consultation models, we compiled a checklist of recommendations that covers (1) buy-in from practices (eg, emphasizing logistical and psychological relief for the practice), (2) the engagement of patients (eg, establishing a trusted patient-provider relationship), (3) the setup and conduct of consultations (eg, reliable emergency plans), and (4) the fostering of collaboration between family physicians and mental health specialists (eg, kick-off meetings to build trust).ConclusionsBy leveraging the primary care practice as a familiar environment for patients, mental health specialist video consultations provide timely specialist support and potentially lead to benefits for patients and more efficient processes of care. Integration should account for the determinants of practice as described by the family physicians.Trial registrationGerman Clinical Trials Register DRKS00012487; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00012487.

Project description:BackgroundMany patients with mental disorders remain untreated. Video-based mental health care demonstrates comparable effectiveness to face-to-face treatments and is a promising mode for delivering specialized care within primary care. Nevertheless, professionals struggle with implementing video consultations in their daily practice. Specifically, little is known about mental health specialists' acceptance of mental health video consultations in routine practice. The PROVIDE (ImPROving cross-sectoral collaboration between primary and psychosocial care: An implementation study on VIDEo consultations) project aims to improve cross-sectoral collaboration between primary and psychosocial care through implementing video consultations in primary care. To increase the uptake of video consultations, it is crucial to account for necessary prerequisites and to tailor interventions to the needs of the target group prior to implementation.ObjectiveThe aim of this study was to explore the acceptance of video consultations embedded in primary care from the perspectives of mental health specialists in Germany.MethodsWe conducted a qualitative, exploratory, preimplementation study in urban and rural counties. We conducted three semistructured focus groups with 11 mental health specialists. We used qualitative content analysis combining an inductive-deductive approach, applying the Tailored Implementation in Chronic Diseases (TICD) framework to the text material, which comprises individual health professional factors; patient factors; professional interactions; incentives and resources; capacity for organizational change; social, political, and legal factors; and guideline factors.ResultsAgainst the background of long waiting times and a shortage of mental health specialists, especially in rural areas, participants valued video consultations as a potential means to improve access to mental health care. With respect to the TICD framework domains, the participants most often discussed individual health professional factors, followed by patient factors. All participants highlighted the importance of a trusting relationship between the patient and the therapist and doubted whether such a relationship could be established through video consultations (11/11, 100%). However, participants considered mental health specialist video consultations to be particularly suited for patients in rural areas, those with impaired mobility, and those who may otherwise remain untreated (6/11, 55%). Most participants expected video consultations to help the aforementioned patient groups avoid tedious searching for an available therapist and save on travel time and, therefore, improve access to specialized care for patients (7/11, 64%). Moreover, the participants expected video consultations to improve collaboration with the family physician (6/11, 55%). Finally, participants identified organizational aspects, such as reliable scheduling, the duration of the individual consultation (9/11, 82%), and reimbursement conditions (7/11, 67%), as key drivers for the acceptance and adoption of the model.ConclusionsWhile mental health specialists expect video consultations to improve access to specialized care for some patients, they consistently wonder whether such consultations can establish a trusting patient-therapist relationship. When implementing video consultations, these concerns should be addressed by training providers in managing technology-based treatment settings, with extra consideration for fostering the patients' and therapists' engagement.Trial registrationGerman Clinical Trials Register DRKS00012487; https://tinyurl.com/uhg2one.