Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study.

BACKGROUND: Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in "real-world" clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers' increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study. METHODS: The COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7-14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies. RESULTS: We successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board administrators. CONCLUSIONS: Although we incorporated strategies based on the best available evidence at the outset of the study, hospital recruitment required three times as much time and considerably more staff than anticipated. To reach our goal, we tailored strategies to individuals, hospitals, and health systems. Successful recruitment of a sufficient number and representative mix of hospitals requires considerable preparation, planning, and flexibility. Strategies presented here may assist future trial organizers in implementing cluster-randomized pragmatic trials. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02588664 . Registered on 23 October 2015.

Integrated care improves risk-factor modification after stroke: initial results of the Integrated Care for the Reduction of Secondary Stroke model.

OBJECTIVE: Despite evidence demonstrating that risk-factor management is effective in reducing recurrent cerebrovascular disease, there are very few structured care programmes for stroke survivors. The aim was to implement and evaluate an integrated care programme in stroke. METHODS: 186 patients with stroke were randomised to either the treatment (integrated care) or control (usual care) group and were followed up over 12 months. The Integrated Care for the Reduction of Secondary Stroke (ICARUSS) model of integrated care involved collaboration between a specialist stroke service, a hospital coordinator and a patient's general practitioner. The primary aim was to promote the management of vascular risk factors through ongoing patient contact and education. RESULTS: In the 12 months poststroke, systolic blood pressure (sBP) decreased in the treatment group but increased in controls. The group difference was significant, and remained so when age, sex, disability and sBP at discharge were accounted for (p = 0.04). Treatment patients also exhibited better modification of body mass index (p = 0.007) and number of walks taken (p<0.001) than controls. Rankin scores indicated significantly reduced disability in treatment patients relative to controls in the year poststroke (p = 0.003). CONCLUSIONS: Through an integrated system of education, advice and support to both patient and GP, the ICARUSS model was effective in modifying a variety of vascular risk factors and therefore should decrease the likelihood or recurrent stroke or vascular event.

[The characteristics of the effect of point and classical massage on the hemodynamics of patients with a history of transient ischemic attacks in the vertebrobasilar system]. / Osobennosti vliianiia tochechnogo i klassicheskogo massazha na gemodinamiku bol'nykh, perenesshikh tranzitornye ishemicheskie ataki v vertebrobaziliarnom basseine.

Clinical and instrumental studies have revealed differences in effects of nerve ending and classic massage on hemodynamics in 41 patients early after transitory ischemic attacks in the vertebrobasilar area. Point massage produced more potent vasotropic effect, contraindications to it are minimal. It can be considered as a pathogenetic therapy aimed at correction of cerebral circulation in patients with vertebrobasilar area applicable early after acute cerebrovascular episodes.

[The use of point massage in patients with circulatory encephalopathy]. / Primenenie tochechnogo massazha u bol'nykh s distsirkuliatornoi éntsefalopatiei.

The comprehensive studies involving rheoencephalography and tetrapolar thoracic rheography made in 120 patients with dyscirculatory encephalopathy (DE) indicated that pointed massage caused a noticeable rearrangement of hemodynamic processes, which depended on the clinical cause of the disease and the baseline status of the circulatory system. This makes it possible to consider pointed massage as a therapeutical factor aimed at correcting cerebral circulation, which is indicated particularly in DE patients having a history of transitory ischemic attacks in the vertebrobasilar bed.

[Forms and method of rehabilitation therapy and social-occupational rehabilitation of patients with the sequelae of cerebrovascular diseases]. / Formy metody vosstanovitel'noi terapii i sotsial'no-trudovoi reabilitatsii bol'nkh s posledstviiami sosudistykh zabolevanii mozga.

The authors give some data on restitutional therapy of 516 patients (400 with sequelae following strokes and 116 with transient disorders of cerebral circulation). Treatment of the first group was made in a neurological ward, the second--in a cardiological sanatorium. The programme of restitutional therapy provided the use of psychosocial and biological methods, an appeal to the personality and stage-by-stage accomplishment of rehabilitative measures. Comprehensive restitutional therapy included psychotherapy, medical-activizing regimes, medical gymnastics, massage, occupational therapy, medicinal therapy, etc. The authors elaborated differentiated complexes of rehabilitative treatment for patients with spastic hemiparesis, normal or decreased tone, as well as for patients with transient disorders of cerebral circulation in conditions of a cardiological sanatorium. The indices of effectiveness were the following: an improvement of the condition in patients after brain strokes--97.8%, in patients with transient disorders of cerebral circulation--94%.