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Process evaluation of a cluster randomised intervention in Swedish primary care: using care managers in collaborative care to improve care quality for patients with depression.

ABSTRACT: BACKGROUND:The collaborative care model with a care manager has previously generated beneficial results for patients with depression in terms of decreased burden of depression symptoms. A care manager function has been tested in Sweden in the PRIM-CARE RCT with successful results. The aim of the present study was to evaluate the process of implementing care managers in collaborative care for patients with depression in Swedish primary health care in the PRIM-CARE RCT. METHODS:The study followed UK Medical Research Council guidance for process evaluation. Field notes from the implementation of the PRIM - CARE RCT were used, as well as data collected from five focus group discussions with General Practitioners (n?=?29) and three focus group discussions with care managers (n?=?11). Data were analysed with content analysis. RESULTS:Training sessions, careful preparation and extensive initial support to the care manager and staff at the Primary Care Centres were important ingredients in the implementation. The close access to facilitators, the recurrent peer support meetings, and the weekly newsletter strengthened the care manager function. CONCLUSIONS:A complex intervention adapted to the Swedish primary care context focusing on a care manager function for patients with depression could be performed through a stepwise implementation process. Financial support from the health care regions included in the study helped to reduce the impact of identified barriers. This process evaluation has revealed new and important knowledge for primary care development concerning infrastructure and organization building, knowledge sharing, and facilitating factors and barriers. TRIAL REGISTRATION:NCT02378272 Care Manager - Coordinating Care for Person Centered Management of Depression in Primary Care (PRIM - CARE). Registered March 4 2015. Retrospectively registered.

SUBMITTER: Svenningsson I

PROVIDER: S-EPMC6660943 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Process evaluation of a cluster randomised intervention in Swedish primary care: using care managers in collaborative care to improve care quality for patients with depression.

Svenningsson I I Petersson E-L EL Udo C C Westman J J Björkelund C C Wallin L L

BMC family practice 20190727 1

<h4>Background</h4>The collaborative care model with a care manager has previously generated beneficial results for patients with depression in terms of decreased burden of depression symptoms. A care manager function has been tested in Sweden in the PRIM-CARE RCT with successful results. The aim of the present study was to evaluate the process of implementing care managers in collaborative care for patients with depression in Swedish primary health care in the PRIM-CARE RCT.<h4>Methods</h4>The ...[more]

PMID: 31351444

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Project description:BACKGROUND:Depression is one of the leading causes of disability and affects 10-15% of the population. The majority of people with depressive symptoms seek care and are treated in primary care. Evidence internationally for high quality care supports collaborative care with a care manager. Our aim was to study clinical effectiveness of a care manager intervention in management of primary care patients with depression in Sweden. METHODS:In a pragmatic cluster randomized controlled trial 23 primary care centers (PCCs), urban and rural, included patients aged ??18 years with a new (<?1 month) depression diagnosis. Intervention consisted of Care management including continuous contact between care manager and patient, a structured management plan, and behavioral activation, altogether around 6-7 contacts over 12 weeks. Control condition was care as usual (CAU). OUTCOME MEASURES:Depression symptoms (measured by Mongomery-Asberg depression score-self (MADRS-S) and BDI-II), quality of life (QoL) (EQ-5D), return to work and sick leave, service satisfaction, and antidepressant medication. Data were analyzed with the intention-to-treat principle. RESULTS:One hundred ninety two patients with depression at PCCs with care managers were allocated to the intervention group, and 184 patients at control PCCs were allocated to the control group. Mean depression score measured by MADRS-S was 2.17 lower in the intervention vs. the control group (95% CI [0.56; 3.79], p?=?0.009) at 3 months and 2.27 lower (95% CI [0.59; 3.95], p?=?0.008) at 6 months; corresponding BDI-II scores were 1.96 lower (95% CI [-?0.19; 4.11], p?=?0.07) in the intervention vs. control group at 6 months. Remission was significantly higher in the intervention group at 6 months (61% vs. 47%, p?=?0.006). QoL showed a steeper increase in the intervention group at 3 months (p?=?0.01). During the first 3 months, return to work was significantly higher in the intervention vs. the control group. Patients in the intervention group were more consistently on antidepressant medication than patients in the control group. CONCLUSIONS:Care managers for depression treatment have positive effects on depression course, return to work, remission frequency, antidepressant frequency, and quality of life compared to usual care and is valued by the patients. TRIAL REGISTRATION:Identifier: NCT02378272 . February 2, 2015. Retrospectively registered.

Project description:BackgroundSmall trials with short term follow up suggest pharmacists' interventions targeted at healthcare professionals can improve prescribing. In comparison with clinical guidance, contemporary statin prescribing is sub-optimal and achievement of cholesterol targets falls short of accepted standards, for patients with atherosclerotic vascular disease who are at highest absolute risk and who stand to obtain greatest benefit. We hypothesised that a pharmacist-led complex intervention delivered to doctors and nurses in primary care, would improve statin prescribing and achievement of cholesterol targets for incident and prevalent patients with vascular disease, beyond one year.MethodsWe allocated general practices to a 12-month Statin Outreach Support (SOS) intervention or usual care. SOS was delivered by one of 11 pharmacists who had received additional training. SOS comprised academic detailing and practical support to identify patients with vascular disease who were not prescribed a statin at optimal dose or did not have cholesterol at target, followed by individualised recommendations for changes to management. The primary outcome was the proportion of patients achieving cholesterol targets. Secondary outcomes were: the proportion of patients prescribed simvastatin 40 mg with target cholesterol achieved; cholesterol levels; prescribing of simvastatin 40 mg; prescribing of any statin and the proportion of patients with cholesterol tested. Outcomes were assessed after an average of 1.7 years (range 1.4-2.2 years), and practice level simvastatin 40 mg prescribing was assessed after 10 years.FindingsWe randomised 31 practices (72 General Practitioners (GPs), 40 nurses). Prior to randomisation a subset of eligible patients were identified to characterise practices; 40% had cholesterol levels below the target threshold. Improvements in data collection procedures allowed identification of all eligible patients (n = 7586) at follow up. Patients in practices allocated to SOS were significantly more likely to have cholesterol at target (69.5% vs 63.5%; OR 1.11, CI 1.00-1.23; p = 0.043) as a result of improved simvastatin prescribing. Subgroup analysis showed the primary outcome was achieved by prevalent but not incident patients. Statistically significant improvements occurred in all secondary outcomes for prevalent patients and all but one secondary outcome (the proportion of patients with cholesterol tested) for incident patients. SOS practices prescribed more simvastatin 40 mg than usual care practices, up to 10 years later.InterpretationThrough a combination of educational and organisational support, a general practice based pharmacist led collaborative intervention can improve statin prescribing and achievement of cholesterol targets in a high-risk primary care based population.Trial registrationInternational Standard Randomised Controlled Trials Register ISRCTN61233866.

Project description:To determine the effectiveness of collaborative care in reducing depression in primary care patients with diabetes or heart disease using practice nurses as case managers. A two-arm open randomised cluster trial with wait-list control for 6 months. The intervention was followed over 12 months. Eleven Australian general practices, five randomly allocated to the intervention and six to the control. 400 primary care patients (206 intervention, 194 control) with depression and type 2 diabetes, coronary heart disease or both. The practice nurse acted as a case manager identifying depression, reviewing pathology results, lifestyle risk factors and patient goals and priorities. Usual care continued in the controls. A five-point reduction in depression scores for patients with moderate-to-severe depression. Secondary outcome was improvements in physiological measures. Mean depression scores after 6 months of intervention for patients with moderate-to-severe depression decreased by 5.7±1.3 compared with 4.3±1.2 in control, a significant (p=0.012) difference. (The plus-minus is the 95% confidence range.) Intervention practices demonstrated adherence to treatment guidelines and intensification of treatment for depression, where exercise increased by 19%, referrals to exercise programmes by 16%, referrals to mental health workers (MHWs) by 7% and visits to MHWs by 17%. Control-practice exercise did not change, whereas referrals to exercise programmes dropped by 5% and visits to MHWs by 3%. Only referrals to MHW increased by 12%. Intervention improvements were sustained over 12 months, with a significant (p=0.015) decrease in 10-year cardiovascular disease risk from 27.4±3.4% to 24.8±3.8%. A review of patients indicated that the study's safety protocols were followed. TrueBlue participants showed significantly improved depression and treatment intensification, sustained over 12 months of intervention and reduced 10-year cardiovascular disease risk. Collaborative care using practice nurses appears to be an effective primary care intervention. ACTRN12609000333213 (Australia and New Zealand Clinical Trials Registry).

Project description:ObjectivesTo study the implementation of a cluster randomised controlled effectiveness-implementation hybrid trial testing the effectiveness of a medication review at hospital discharge combined with a communication stimulus between hospital physicians (HPs) and general practitioners (GPs) on rehospitalisation of multimorbid older patients.DesignExtension of Grant's mixed method process evaluation framework to trials with multilevel clustering.SettingGeneral internal medicine wards in Swiss hospitals.ParticipantsConvenience samples of 15 chief physicians (of 21 hospitals participating in the effectiveness trial), 60 (74) senior HPs, 65 (164) junior HPs and 187 (411) GPs.Implementation strategyTwo-hour teaching sessions for senior HPs on a patient-centred, checklist-guided discharge routine.Process evaluation componentsData collection on recruitment, delivery and response from chief physicians (semistructured interviews), senior HPs, junior HPs, GPs (surveys) and patients (via HPs). Quantitative data were summarised using descriptive statistics, and interviews analysed using thematic analysis.Outcome measuresIntervention dose (quantitative), implementation fidelity (qualitative), feasibility and acceptability, facilitators and barriers, implementation support strategies.ResultsRecruitment of hospitals was laborious but successful, with 21 hospitals recruited. Minimal workload and a perceived benefit for the clinic were crucial factors for participation. Intervention dose was high (95% of checklist activities carried out), but intervention fidelity was limited (discharge letters) or unknown (medication review). Recruitment and retention of patients was challenging, partly due to patient characteristics (old, frail) and the COVID-19 pandemic: Only 612 of the anticipated 2100 patients were recruited, and 31% were lost to follow-up within the first month after discharge. The intervention was deemed feasible and helpful by HPs, and the relevance of the topic appreciated by both HPs and GPs.ConclusionsThe results from this evaluation will support interpretation of the findings of the effectiveness study and may inform researchers and policy makers who aim at improving hospital discharge.Trial registration numberISRCTN18427377.

Project description:INTRODUCTION:India has high prevalence of hypertension but low awareness, treatment and control rate. A cluster randomised trial entitled 'm-Power Heart Project' is being implemented to test the effectiveness of a nurse care coordinator (NCC) led complex intervention to address uncontrolled hypertension in the community health centres (CHCs). The trial's process evaluation will assess the fidelity and quality of implementation, clarify the causal mechanisms and identify the contextual factors associated with variation in the outcomes. The trial will use a theory-based mixed-methods process evaluation, guided by the Consolidated Framework for Implementation Research. METHODS AND ANALYSIS:The process evaluation will be conducted in the CHCs of Visakhapatnam (southern India). The key stakeholders involved in the intervention development and implementation will be included as participants. In-depth interviews will be conducted with intervention developers, doctors, NCCs and health department officials and focus groups with patients and their caregivers. NCC training will be evaluated using Kirkpatrick's model for training evaluation. Key process evaluation indicators (number of patients recruited and retained; concordance between the treatment plans generated by the electronic decision support system and treatment prescribed by the doctor and so on) will be assessed. Fidelity will be assessed using Borrelli et al's framework. Qualitative data will be analysed using the template analysis technique. Quantitative data will be summarised as medians (IQR), means (SD) and proportions as appropriate. Mixed-methods analysis will be conducted to assess if the variation in the mean reduction of systolic blood pressure between the intervention CHCs is influenced by patient satisfaction, training outcome, attitude of doctors, patients and NCCs about the intervention, process indicators etc. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the ethics committees at Public Health Foundation of India and Deakin University. Findings will be disseminated via peer-reviewed publications, national and international conference presentations. TRIAL REGISTRATION NUMBER:NCT03164317; Pre-results.

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Process evaluation of a cluster randomised intervention in Swedish primary care: using care managers in collaborative care to improve care quality for patients with depression.

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Process evaluation of a cluster randomised intervention in Swedish primary care: using care managers in collaborative care to improve care quality for patients with depression.

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