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A randomised controlled trial of hospital-based case management to improve colorectal cancer patients' health-related quality of life and evaluations of care.

ABSTRACT: To analyse the effectiveness of hospital-based case management (CM) in terms of patient-reported outcomes.Randomised controlled trial allocating participants 1?:?1 to either a CM intervention or a control group. Allocation status was evident to participants and case managers, but blinded to researchers.Patients were recruited at a Danish surgical department where the case managers were situated.Colorectal cancer patients who were to undergo further investigation or treatment. Exclusion criteria were participation in another study, poor Danish language skills or apparent cognitive impairment. 140 participants were randomised to each group. Recruitment period was 11 March 2009 to 29 December 2010.Control group patients had usual care. Intervention group patients had usual care supplemented by hospital-based CM started at first visit to the out-patient clinic (before treatment start) and ended 4 weeks after completed cancer treatment. CM was conducted by nurse case managers who undertook care pathway supervision, information dissemination to health professionals and outreaching patient support.Patient-reported global quality of life measured with the EORTC QLQ-C30 and eight ad hoc, piloted patient evaluation items assessed at eight, 30 and 52 weeks after randomisation.The two groups were comparable as to questionnaire response rates and completed scales/items. There were no statistically significant group differences on any of the health-related quality of life subscales at eight, 30 or 52 weeks. In patient evaluations, all point estimates favoured CM at week 8 and 30; at week 52, 6 of 7 estimates favoured CM.We found no evidence that CM influenced colorectal cancer patients' health-related quality of life. Patients allocated to CM evaluated their care more positively than patients receiving usual care.Clinicaltrials.gov identifier: NCT00845247.

SUBMITTER: Wulff CN

PROVIDER: S-EPMC3532978 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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A randomised controlled trial of hospital-based case management to improve colorectal cancer patients' health-related quality of life and evaluations of care.

Wulff Christian Nielsen CN Vedsted Peter P Søndergaard Jens J

BMJ open 20121121 6

<h4>Objective</h4>To analyse the effectiveness of hospital-based case management (CM) in terms of patient-reported outcomes.<h4>Design</h4>Randomised controlled trial allocating participants 1 : 1 to either a CM intervention or a control group. Allocation status was evident to participants and case managers, but blinded to researchers.<h4>Setting</h4>Patients were recruited at a Danish surgical department where the case managers were situated.<h4>Participants</h4>Colorectal cancer patients who w ...[more]

PMID: 23175735

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Project description:Over 20% of hospital bed use is inappropriate, implying a waste of resources and the increase of patient iatrogenic risk.This is a cluster, pragmatic, randomised controlled trial, carried out in a large University Hospital of Northern Italy, aiming to evaluate the effect of a strategy to reduce unnecessary hospital days. The primary outcome was the percentage of patient-days compatible with discharge. Among secondary objectives, to describe the strategy's effect in the long-term, as well as on hospital readmissions, considered to be a marker of the quality of hospital care. The 12 medical wards with the longest length of stay participated. Effectiveness was measured at the individual level on 3498 eligible patients during monthly index days. Patients admitted or discharged on index days, or with stay >90 days, were excluded. All ward staff was blinded to the index days, while staff in the control arm and data analysts were blinded to the trial's objectives and interventions. The strategy comprised the distribution to physicians of the list of their patients whose hospital stay was compatible with discharge according to a validated Delay Tool, and of physician length of stay profiles, followed by audits managed autonomously by the physicians of the ward.During the 12 months of data collection, over 50% of patient-days were judged to be compatible with discharge. Delays were mainly due to problems with activities under medical staff control. Multivariate analysis considering clustering showed that the strategy reduced patient-days compatible with discharge by 16% in the intervention vs control group, (OR=0.841; 95% CI, 0.735 to 0.963; P=0.012). Follow-up at 1 year did not yield a statistically significant difference between the percentages of patient-days judged to be compatible with discharge between the two arms (OR=0.818; 95% CI, 0.476 to 1.405; P=0.47). There was no significant difference in 30-day readmission and mortality rates for all eligible patients (N=3498) between the two arms.Results indicate that a strategy, involving physician direct accountability, can reduce unnecessary hospital days. Relatively simple interventions, like the one assessed in this study, should be implemented in all hospitals with excessive lengths of stay, since unnecessary prolongation may be harmful to patients.ClinicalTrials.gov, identifier NCT01422811.

Project description:OBJECTIVE:To test effects on care quality of Chronic Care Model-based Parkinson disease (PD) management. METHODS:This 2-group stratified randomized trial involved 328 veterans with PD in southwestern United States. Guided care management, led by PD nurses, was compared to usual care. Primary outcomes were adherence to 18 PD care quality indicators. Secondary outcomes were patient-centered outcome measures. Data sources were telephone survey and electronic medical record (EMR). Outcomes were analyzed as intent-to-treat comparing initial and final survey and repeated-measures mixed-effects models. RESULTS:Average age was 71 years; 97% of participants were male. Mean proportion of participants receiving recommended PD care indicators was significantly higher for the intervention than for usual care (0.77 vs 0.58) (mean difference 0.19, 95% confidence interval [CI] 0.16, 0.22). Of 8 secondary outcomes, the only significant difference of the changes over time was in the positive Patient Health Questionnaire-2 depression screen for intervention minus usual care (-11.52 [95% CI -20.42, -2.62]). CONCLUSION:A nurse-led chronic care management intervention, Care Coordination for Health Promotion and Activities in Parkinson's Disease (CHAPS), substantially increased adherence to PD quality of care indicators among veterans with PD, as documented in the EMR. Of 8 secondary outcomes assessed, a screening measure for depressive symptomatology was the only measure that was better in the intervention compared to usual care. More telephone calls in CHAPS were the only utilization difference over usual care. While CHAPS appears promising for improving PD care, additional iterative research is needed to refine the CHAPS model in routine clinical care so that it measurably improves patient-centered outcomes (NCT01532986). CLASSIFICATION OF EVIDENCE:This study provides Class I evidence that for patients with PD, CHAPS increased adherence to PD quality of care indicators.

Project description:BackgroundPatients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of recurrent stroke and other cardiovascular diseases and commonly suffer from reduced quality of life. We aimed to determine whether the disease management programme STROKE-CARD can prevent cardiovascular diseases and improve quality of life in these patients.MethodsIn this pragmatic open-label two-centre randomised controlled trial with blinded outcome assessment, we randomly assigned patients with acute ischaemic stroke or TIA (ABCD2 score ≥3) in a 2:1 ratio to receive STROKE-CARD care or standard care. STROKE-CARD care is a disease management programme by a multidisciplinary stroke team that comprises a standardised 3-month visit and access to a web-based patient portal targeting risk factor management, post-stroke complications, comorbidities and cardiovascular warning signs, rehabilitation demands, and patient education, counselling, and self-empowerment. Co-primary outcomes were analysed on an intention-to-treat basis and were: (i) major cardiovascular disease events defined as nonfatal ischaemic or haemorrhagic stroke, nonfatal myocardial infarction, or vascular death occurring between hospital discharge and 12 months; and (ii) health-related quality of life at 12 months quantified with the EuroQol-5-Dimensions-3-Levels (EQ-5D-3L) overall utility score. This trial is registered with ClinicalTrials.gov, number NCT02156778.FindingsOf 2149 patients enrolled between January 2014 and December 2017 (mean age 69 years, 41% female, 83% with ischaemic stroke, 17% with TIA), 1438 were assigned to STROKE-CARD care and 711 to standard care. Major cardiovascular disease events occurred in 78 patients in the STROKE-CARD care group (5.4%) and in 59 patients in the standard care group (8.3%) (hazard ratio, 0.63; 95% confidence interval: 0.45-0.88; P=0.007). STROKE-CARD care also led to a better EQ-5D-3L overall utility score at 12 months (P<0.001). Among pre-specified secondary outcomes, STROKE-CARD care improved all individual EQ-5D-3L dimensions and functional outcome on the modified Rankin Scale at 12 months. Post hoc explanatory analyses identified considerable demands for additional rehabilitation and refinement of preventive therapy regimes at the 3-month visit and high proportions of post-stroke complications and warning signs of imminent cardiovascular diseases within the first three months.InterpretationThe pragmatic and easily implementable STROKE-CARD care programme reduced cardiovascular risk and improved health-related quality of life and functional outcome in patients with acute ischaemic stroke or TIA.FundingTirol Kliniken, Tyrolean Health Insurance Company, Tyrol Health Care Funds, Boehringer Ingelheim, Nstim Services, Sanofi, Bayer Healthcare.

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A randomised controlled trial of hospital-based case management to improve colorectal cancer patients' health-related quality of life and evaluations of care.

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A randomised controlled trial of hospital-based case management to improve colorectal cancer patients' health-related quality of life and evaluations of care.

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