Dataset Information

Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial.

ABSTRACT: INTRODUCTION:Approximately one out of six patients in primary care suffers from depression, which often remains undetected. Evidence regarding the efficacy of depression screening in primary care, however, is inconsistent. A previous single-centre randomised controlled trial (RCT) in cardiac patients, the DEPSCREEN-INFO trial, provided the first evidence that written feedback to patients following a positive depression screening reduces depression severity and leads to more comprehensive patient engagement in mental healthcare. To amplify these effects, the feedback should be tailored according to patients' needs and preferences. The GET.FEEDBACK.GP RCT will test the efficacy of this patient-targeted feedback intervention in primary care. METHODS AND ANALYSIS:The multicentre three-arm GET.FEEDBACK.GP RCT aims to recruit a total of 1074 primary care patients from North, East and South Germany. Patients will be screened for depression using the Patient Health Questionnaire-9 (PHQ-9). In the case of a positive depression screening result (PHQ-9 score ?10), the participant will be randomised into one of three groups to either receive (a) patient-targeted and general practitioner (GP)-targeted feedback regarding the depression screening results, (b) only GP-targeted feedback or (c) no feedback. Patients will be followed over a period of 12 months. The primary outcome is depression severity (PHQ-9) 6 months after screening. Secondary outcomes include patient engagement in mental healthcare, professional depression care and cost-effectiveness. According to a statistical analysis plan, the primary endpoint of all randomised patients will be analysed regarding the intention-to-treat principle. ETHICS AND DISSEMINATION:The Ethics Committee of the Hamburg Medical Association approved the study. A clinical trial company will ensure data safety, monitoring and supervision. The multicentre GET.FEEDBACK.GP RCT is the first trial in primary care that tests the efficacy of a patient-targeted feedback intervention as an adjunct to depression screening. Its results have the potential to influence future depression guidelines and will be disseminated in scientific as well as patient-friendly language. TRIAL REGISTRATION NUMBER:NCT03988985.

SUBMITTER: Kohlmann S

PROVIDER: S-EPMC7507856 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial.

Kohlmann Sebastian S Lehmann Marco M Eisele Marion M Braunschneider Lea-Elena LE Marx Gabriella G Zapf Antonia A Wegscheider Karl K Härter Martin M König Hans-Helmut HH Gallinat Jürgen J Joos Stefanie S Resmark Gaby G Schneider Antonius A Allwang Christine C Szecsenyi Joachim J Nikendei Christoph C Schulz Sven S Brenk-Franz Katja K Scherer Martin M Löwe Bernd B

BMJ open 20200921 9

<h4>Introduction</h4>Approximately one out of six patients in primary care suffers from depression, which often remains undetected. Evidence regarding the efficacy of depression screening in primary care, however, is inconsistent. A previous single-centre randomised controlled trial (RCT) in cardiac patients, the DEPSCREEN-INFO trial, provided the first evidence that written feedback to patients following a positive depression screening reduces depression severity and leads to more comprehensive ...[more]

PMID: 32958483

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Project description:BackgroundDepression is one of the most disabling disorders worldwide, yet it often remains undetected. One promising approach to address both early detection and disease burden is depression screening followed by direct feedback to patients. Evidence suggests that individuals often seek information regarding mental health on the internet. Thus, internet-based screening with automated feedback has great potential to address individuals with undetected depression.ObjectivesTo determine whether automated feedback after internet-based depression screening reduces depression severity as compared to no feedback.MethodsThe internet-based, observer-blinded DISCOVER RCT aims to recruit a total of 1074 individuals. Participants will be screened for depression using the Patient Health Questionnaire (PHQ-9). In case of a positive screening result (PHQ-9 ≥ 10), participants with undetected depression will be randomised into one of three balanced study arms to receive either (a) no feedback (control arm), (b) standard feedback, or (c) tailored feedback on their screening result. The tailored feedback version will be adapted to participants' characteristics, i.e. symptom profile, preferences, and demographic characteristics. The primary hypothesis is that feedback reduces depression severity six months after screening compared to no feedback. The secondary hypothesis is that tailored feedback is more efficacious compared to standard feedback. Further outcomes are depression care, help-seeking behaviour, health-related quality of life, anxiety, somatic symptom severity, intervention acceptance, illness beliefs, adverse events, and a health economic evaluation. Follow-ups will be conducted one month and six months after screening by self-report questionnaires and clinical interviews. According to a statistical analysis plan, the primary outcome will be analysed on an intention-to-treat basis applying multilevel modelling.DiscussionThe results of the DISCOVER RCT will inform about how automated feedback after internet-based screening could improve early detection and resolution of depression. Ways of dissemination and how the trial can contribute to an understanding of help-seeking behaviour processes will be discussed. If the results show that automated feedback after internet-based depression screening can reduce depression severity, the intervention could be easily implemented and might substantially reduce the disease burden of individuals with undetected depression.Ethical approvalThe study is approved by the Ethics Committee of the Hamburg Medical Association.Trial registrationThe trial was registered at ClinicalTrials.gov in November 2020 (identifier: NCT04633096).

Project description:BACKGROUND: Randomised controlled clinical (drug) trials supply high quality evidence for therapeutic strategies in primary care. Until now, experience with drug trials in German general practice has been sparse. In 2007/2008, the authors conducted an investigator-initiated, non-commercial, double-blind, randomised controlled pilot trial (HWI-01) to assess the clinical equivalence of ibuprofen and ciprofloxacin in the treatment of uncomplicated urinary tract infection (UTI). Here, we report the feasibility of this trial in German general practices and the implementation of Good Clinical Practice (GCP) standards as defined by the International Conference on Harmonisation (ICH) in mainly inexperienced general practices. METHODS: This report is based on the experience of the HWI-01 study conducted in 29 German general practices. Feasibility was defined by 1) successful practice recruitment, 2) sufficient patient recruitment, 3) complete and accurate data collection and 4) appropriate protection of patient safety. RESULTS: The final practice recruitment rate was 18%. In these practices, 79 of 195 screened UTI patients were enrolled. Recruitment differed strongly between practices (range 0-12, mean 2.8 patients per practice) and was below the recruitment goal of approximately 100 patients. As anticipated, practice nurses became the key figures in the screening und recruitment of patients. Clinical trial demands, in particular for completing symptom questionnaires, documentation of source data and reporting of adverse events, did not agree well with GPs' documentation habits and required support from study nurses. In many cases, GPs and practice staff seemed to be overwhelmed by the amount of information and regulations. No sudden unexpected serious adverse reactions (SUSARs) were observed during the trial. CONCLUSIONS: To enable drug trials in general practice, it is necessary to adapt the setup of clinical research infrastructure to the needs of GPs and their practice staff. Risk adaption of clinical trial regulations is necessary to facilitate non-commercial comparative effectiveness trials in primary health care. TRIAL REGISTRATION: TRIAL REGISTRATION NUMBER: ISRCTN00470468.

Project description:PurposeThe first aim of this qualitative study was to identify general practitioners' (GPs') views on depression screening combined with GP-targeted feedback in primary care. The second aim was to determine the needs and preferences of GPs with respect to GP-targeted feedback to enhance the efficacy of depression screening.MethodsA semistructured qualitative interview was conducted with officially registered GPs in Hamburg (Germany). Interviews were audio recorded and transcribed verbatim. An inductive approach was used to code the transcripts.ResultsNine GPs (27 to 70 years; 5 male) from Hamburg, Germany, participated. Regarding depression screening combined with GP-targeted feedback, five thematic groups were identified: application of screening; screening and patient-physician relationships; GPs' attitudes towards screening; benefits and concerns related to screening; and GPs' needs and preferences regarding feedback. While the negative aspects of screening can be described in rather general terms (e.g., screening determines the mental health competence, screening threatens the doctor-patient relationship, revealing questions harm the patients), its advantages were very specific (e.g., promoting the identification of undetected cases, relief of the daily workload, wider communication channel to reach more patients). Standardized GP-targeted feedback of the screening results was perceived as helpful and purposeful. GPs preferred feedback materials that eased their clinical workload (e.g., short text with visuals, pictures, or images).ConclusionAddressing GPs' needs is essential when implementing depression screening tools in clinical practice. To overcome prejudices and enhance the efficacy of screening, further education for GPs on the purpose and application on depression screening may be needed. Standardized GP-targeted feedback in combination with depression screening could be the missing link to improve the detection of depression in primary care.

Project description:BackgroundAlthough absolute risk of death associated with raised blood pressure increases with age, the benefits of treatment are greater in older patients. However, fewer patients in this group are identified, treated, and controlled.AimTo evaluate the impact of the provision of different levels of feedback on identification, treatment, and control of older patients with hypertension.Design of studyRandomised controlled trial.SettingFifty-two Scottish general practices.MethodPractices were randomly allocated to either control (n = 19), audit only feedback (n = 16), or audit plus risk feedback, prioritising patients by absolute risk (n = 17). Electronic data were extracted from practice computer systems annually from 1999 to 2001 and used to develop feedback. Data were collected for 30 345 patients aged 65-79 years.ResultsThe majority of known patients with hypertension in each group had an initial blood pressure recorded (control = 89.6%; audit = 80.4%; risk = 96.1%) and this increased over the study period (control = 92.3%; audit = 86.0%; risk = 96.6%). Initially, more than 80% of patients in each group were treated but many were uncontrolled (blood pressure >/=160/ >/=90 mmHg) (control = 41.5%; audit = 41.3%; risk = 36.1%). The numbers of untreated and uncontrolled patients in each group reduced (control = 32.3%; audit = 38.3%; risk = 32.6%). There was some evidence of a significant difference in mean systolic pressure between the audit plus risk and audit only groups: (149.6 versus 152.7 mmHg; P = 0.019) and of significantly greater control in the audit plus risk group compared with the other groups 49.4% (versus audit only = 35.4%; versus control = 46.5%; odds ratio = 1.72 [95% confidence interval = 1.09 to 2.70]; P = 0.019).ConclusionsLevels of identification, treatment, and control improved in each group. Although there were still significant numbers of patients with uncontrolled hypertension, there is some evidence to suggest that providing patient-specific feedback may have a positive impact on identification and management of hypertension in older people and produce an increase in control.

Project description:BackgroundDespite the growing use of opioids to treat cancer pain and the probability of opioid aberrancy in the cancer setting, clinical practice guidelines (CPGs) or recommendations for active screening and monitoring of opioid compliance are lacking.ObjectivesTo evaluate the current practices and attitudes clinicians have toward monitoring and prescribing opioids in patients with cancer; to describe the current practice of screening and monitoring opioid compliance in the cancer setting; to provide insight into the role that CPGs may have in addressing opioid aberrancy in the oncologic population.HypothesisClinicians adopt diverse clinical practices and attitudes toward opioid screening and monitoring based on cancer status.DesignA 24-question survey that evaluated the practices and attitudes that clinicians have when screening, monitoring, and prescribing opioids in patients with active cancer and history of cancer was completed by 105 pain management physicians. A comprehensive literature review was completed, evaluating the current state of available literature regarding opioid aberrancy and opioid risk in the cancer setting and CPGs for opioid monitor compliance in the cancer setting.SettingMulticenter, survey-based study to clinicians regarding pain management strategies in patients with active cancer, patients with a history of cancer, and patients with no history of cancer.ResultsCancer status plays a role in the clinician's decision to screen and monitor opioid compliance in the oncologic population. For patients with active cancer, clinicians are more likely to prescribe opioids despite patient refusal for toxicology screen as well as history of substance abuse. For patients with no history of cancer, clinicians are more likely to refuse a prescription refill and eliminate opioids from treatment regimen.ConclusionsBased upon the results of our study and evidence from current literature provided, the authors advocate for further investigation and development of CPGs to ensure the safe and prudent screening, monitoring, and prescribing of opioids in the oncologic population.

Project description:BackgroundMultimorbidity is common among general practice patients and increases a general practitioner's (GP's) workload. But the extent of multimorbidity may depend on its definition and whether a time delimiter is included in the definition or not.AimsThe aims of the study were (1) to compare practice prevalence rates yielded by different models of multimorbidity, (2) to determine how a time delimiter influences the prevalence rates and (3) to assess the effects of multimorbidity on the number of direct and indirect patient contacts as an indicator of doctors' workload.MethodsThis retrospective observational study used electronic medical records from 142 German general practices, covering 13 years from 1994 to 2007. The four models of multimorbidity ranged from a simple definition, requiring only two diseases, to an advanced definition requiring at least three chronic conditions. We also included a time delimiter for the definition of multimorbidity. Descriptive statistics, such as means and correlation coefficients, were applied.FindingsThe annual percentage of multimorbid primary care patients ranged between 84% (simple model) and 16% (advanced model) and between 74% and 13% if a time delimiter was included. Multimorbid patients had about twice as many contacts annually than the remainder. The number of contacts were different for each model, but the ratio remained similar. The number of contacts correlated moderately with patient age (r = 0.35). The correlation between age and multimorbidity increased from model to model up to 0.28 while the correlations between contacts and multimorbidity varied around 0.2 in all four models.ConclusionMultimorbidity seems to be less prevalent in primary care practices than usually estimated if advanced definitions of multimorbidity and a temporal delimiter are applied. Although multimorbidity increases in any model a doctor's workload, it is especially the older person with multiple chronic diseases who is a challenge for the GP.

Dataset Information

Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial.

Publications

Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial.

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