The DOMUS study protocol: a randomized clinical trial of accelerated transition from oncological treatment to specialized palliative care at home

Background

The focus of Specialized Palliative Care (SPC) is to improve care for patients with incurable diseases and their families, which includes the opportunity to make their own choice of place of care and ultimately place of death.The Danish Palliative Care Trial (DOMUS) aims to investigate whether an accelerated transition process from oncological treatment to continuing SPC at home for patients with incurable cancer results in more patients reaching their preferred place of care and death. The SPC in this trial is enriched with a manualized psychological intervention.

Methods/Design

DOMUS is a controlled randomized clinical trial with a balanced parallel-group randomization (1:1). The planned sample size is 340 in- and outpatients treated at the Department of Oncology at Copenhagen University Hospital. Patients are randomly assigned either to: a) standard care plus SPC enriched with a standardized psychological intervention for patients and caregivers at home or b) standard care alone. Inclusion criteria are incurable cancer with no or limited antineoplastic treatment options.

Discussion

Programs that facilitate transition from hospital treatment to SPC at home for patients with incurable cancer can be a powerful tool to improve patients’ quality of life and support family/caregivers during the disease trajectory. The present study offers a model for achieving optimal delivery of palliative care in the patient’s preferred place of care and attempt to clarify challenges.

Trial registration

Clinicaltrials.gov Identifier: NCT01885637

     

Music therapy to promote psychological and physiological relaxation in palliative care patients: protocol of a randomized controlled trial

Background

Music therapy is one of the most frequently used complementary therapies in different palliative care settings. Despite its long tradition and high acceptance by other health-care professionals, evidence on the effectiveness of music therapy interventions for terminally ill patients is rare. Recent reviews and health-care reports consistently point out the need of music therapists to provide an evidence-based rationale for their clinical treatments in this field. Therefore, the present study evaluates the psychological and physiological response of palliative care patients to a standardized music therapy relaxation intervention in a randomized controlled trial.

Methods/design

A sample of 84 participants from a palliative care unit in Heidelberg is randomized to either two sessions of music therapy or two sessions of a verbal relaxation exercise, each lasting 30 minutes. The music therapy sessions consist of live played monochord music and a vocal improvisation, the control group uses a prerecorded excerpt from the mindfulness-based stress reduction program containing no musical elements. Outcome measures include self-report data on subjective relaxation, well-being, pain intensity, and quality of life, as well as continuous recording of heart rate variability and blood volume pulse as indicators of autonomous nervous system functioning.

Discussion

To our knowledge, this study is the first clinical trial in Europe and one of very few randomized controlled trials worldwide to systematically examine the effects of music therapy in palliative care.

Trial registration

German Clinical Trials Register – DRKS00006137

     

Improving patient knowledge of palliative care: A randomized controlled intervention study

ObjectivesTo determine if laypersons’ knowledge about palliative care can improve with a brief education intervention.Methods152 adults were recruited to participate in a web-based randomized intervention trial that followed a 2 (content) × 2 (format) between-subjects design. Groups received either a video intervention, an information page intervention, a video control, or an information page control. An ANCOVA with contrast coding of two factors was utilized to assess if knowledge, as measured by the Palliative Care Knowledge Scale (PaCKS), increased post intervention.ResultsThere was a significant difference between intervention group means and control group means on PaCKS scores from T1 to T2 F(1, 139) = 11.10, p = 0.00, η_p² = 0.074. There was no significant difference in PaCKS change scores between the video intervention and information page intervention.ConclusionsThis study demonstrates that an information page and a brief video can improve knowledge of palliative care in laypersons.Practice implicationsSelf-administered educational interventions could be made available in diverse settings in order to reach patients and their families who may benefit from but are unaware of palliative care. Interventions more intensive than the one tested in this study might result in even more significant improvements in knowledge.     

A randomized controlled trial and economic evaluation of counselling in primary care.

BACKGROUND: Counselling in primary care settings remains largely unevaluated. Such evaluation has been strongly recommended. AIM: To determine the relative effectiveness and cost-effectiveness of generic counselling and usual general practitioner (GP) care for patients with minor mental health problems. METHOD: A randomized controlled trial and health economic evaluation were carried out in nine general practices. Access to generic counselling (brief counselling, generally involving up to six 50-minute sessions) was compared with usual GP care. A total of 162 patients aged 16 years and over with diverse mental health problems (excluding phobic conditions and psychoses) were randomized. The Hospital Anxiety and Depression (HAD) scale, COOP/WONCA (World Organization of Family Doctors) functional health assessment charts, and the delighted-terrible faces scale were used to assess outcome four months after randomization. RESULTS: The two groups were similar at baseline. There were significant improvements in both groups between randomization and follow-up for most outcome measures, but no significant differences between the study arms. The 95% confidence limits were narrow and excluded clinically significant effects. Under various assumptions concerning the cost of secondary care referrals and of counselling time, no clear cost advantage was associated with either intervention. CONCLUSIONS: This pragmatic trial demonstrates no difference in functional or mental health outcome at four months between subjects offered access to counselling and those given usual care by their GP. There is no clear difference in the cost-effectiveness of the two interventions. Purchasers should take account of these findings in allocating resources within primary care.     

Screening elderly people in primary care: a randomized controlled trial.

A randomized controlled trial was carried out to test the effectiveness of a screening programme carried out by nurses for elderly people aged 75 years and over in a general practice. A total of 151 people were randomly allocated to the test group and 145 to the control group. The test group received a home visit from a nurse at which an assessment lasting 45 minutes was made of: activities of daily living, social functioning, sensory functions, mental and emotional problems, current medical problems, blood pressure, urinalysis, haemoglobin level and compliance with medication. Both groups completed a selection of items from four health indices before and 20 months after the intervention. At follow up, the test group scored significantly better than the control group on a morale scale. However, this trial provided no evidence for better resolution of physical problems or finding activities of daily living easier in the test group compared with the control group. It is suggested that the main benefit of such a screening process is that the special attention and education provided improves adaptation to old age and awareness of the support systems available. The government has proposed an annual review of elderly people in their own home and this study suggests that the objectives of this scheme should be clarified.     

A randomised,multicentre clinical trial of specialised palliative care plus standard treatment versus standard treatment alone for cancer patients with palliative care needs: the Danish palliative care trial (DanPaCT) protocol

Background

Advanced cancer patients experience considerable symptoms, problems, and needs. Early referral of these patients to specialised palliative care (SPC) could improve their symptoms and problems.The Danish Palliative Care Trial (DanPaCT) investigates whether patients with metastatic cancer, who report palliative needs in a screening, will benefit from being referred to ‘early SPC’.

Methods/Design

DanPaCT is a clinical, multicentre, parallel-group superiority trial with balanced randomisation (1:1). The planned sample size is 300 patients. Patients are randomised to specialised palliative care (SPC) plus standard treatment versus standard treatment. Consecutive patients from oncology departments are screened for palliative needs with a questionnaire if they: a) have metastatic cancer; b) are 18 years or above; and c) have no prior contact with SPC. Patients with palliative needs (i.e. symptoms/problems exceeding a certain threshold) according to the questionnaire are eligible. The primary outcome is the change in the patients’ primary need (the most severe symptom/problem measured with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)). Secondary outcomes are other symptoms/problems (EORTC QLQ-C30), satisfaction with health care (FAMCARE P-16), anxiety and depression (the Hospital Anxiety and Depression scale), survival, and health care costs.

Discussion

Only few trials have investigated the effects of SPC. To our knowledge DanPaCT is the first trial to investigate screening based ‘early SPC’ for patients with a broad spectrum of cancer diagnosis.

Trial registration

Current controlled Trials NCT01348048

     

Barrier-belief lifestyle counseling in primary care: A randomized controlled trial of efficacy

Objective

Intervening on barrier beliefs (BBs) may inhibit the role of barriers as mediating factors in lifestyle behavior. The aim of this study was to analyze the effects of a barrier-belief counseling intervention (BBCI) on physical activity (PA) and healthy food intake.

Web-based telemedicine for management of type 2 diabetes through glucose uploads: a randomized controlled trial

Aims: To evaluate the feasibility and effectiveness of a telemedicine system based on internet in the follow-up of patients with type 2 diabetes mellitus (T2DM). Methods: A prospective randomized telemedicine study with two parallel groups was designed. 114 patients diagnosed T2DM were randomly divided into telemedicine group and traditional face-to-face visit group as control. 57 cases were included for each group. 108 patients completed the trial, in which 53 cases in telemedicine group and 55 cases in control group. Patients in telemedicine group were taught to use telemedicine software to upload their blood glucose and other metabolic information at home at least every 2 weeks, and the researchers gave proper advices according to patients’ key behaviors. The telemedicine interval is 3 months. Results: Compared to control group, telemedicine group exhibited better HbA1c and fasting blood glucose controlling (P < 0.05). Moreover, telemedicine intervention decreased hypoglycemia risk (P = 0.044), and contributed to levels of HbA1c less than 7% which is the target of our study (P = 0.049). Conclusions: Telemedicine system can provide a tighter glycemic control for the treatment of T2DM patients, especially in cases with difficulties to access to the medical centre.     

Collaborative care for depression in UK primary care: a randomized controlled trial

BACKGROUND: Collaborative care is an effective intervention for depression which includes both organizational and patient-level intervention components. The effect in the UK is unknown, as is whether cluster- or patient-randomization would be the most appropriate design for a Phase III clinical trial. METHOD: We undertook a Phase II patient-level randomized controlled trial in primary care, nested within a cluster-randomized trial. Depressed participants were randomized to 'collaborative care' - case manager-coordinated medication support and brief psychological treatment, enhanced specialist and GP communication - or a usual care control. The primary outcome was symptoms of depression (PHQ-9). RESULTS: We recruited 114 participants, 41 to the intervention group, 38 to the patient randomized control group and 35 to the cluster-randomized control group. For the intervention compared to the cluster control the PHQ-9 effect size was 0.63 (95% CI 0.18-1.07). There was evidence of substantial contamination between intervention and patient-randomized control participants with less difference between the intervention group and patient-randomized control group (-2.99, 95% CI -7.56 to 1.58, p=0.186) than between the intervention and cluster-randomized control group (-4.64, 95% CI -7.93 to -1.35, p=0.008). The intra-class correlation coefficient for our primary outcome was 0.06 (95% CI 0.00-0.32). CONCLUSIONS: Collaborative care is a potentially powerful organizational intervention for improving depression treatment in UK primary care, the effect of which is probably partly mediated through the organizational aspects of the intervention. A large Phase III cluster-randomized trial is required to provide the most methodologically accurate test of these initial encouraging findings.     

A simplified blood culture sampling protocol for reducing contamination and costs: a randomized controlled trial

ObjectivesBlood culture contamination carries risks for patients, such as unnecessary antimicrobial therapy and other additional hazards and costs. One method shown to be effective in reducing contamination is initial blood specimen diversion during collection. We hypothesized that initial blood specimen diversion without a designated device or procedure would suffice for reduction in blood culture contamination rate.MethodsFrom 1 September 2017 through to 6 September 2018, we conducted a randomized controlled trial to assess the effect of an initial-specimen diversion technique (ISDT) on the rate of blood-culture contamination by changing the order of sampling using regular vacuum specimen tubes instead of commercially available sterile diversion devices. We included adults from whom the treating physician planned to take blood cultures and additional blood chemistry tests. Additionally, we evaluated the potential economic benefits of an ISDT. This was a researcher-initiated trial, Clinicaltrials.gov NCT03088865.ResultsIn all, 756 patients were enrolled. This method, compared with the standard procedure in use at our medical centre, reduced contamination by 66% (95% CI 17%–86%), from 20/400 (5%) with the standard method to 6/356 (1.6%) with the ISDT, without compromising detection of true bloodstream infection and at no additional cost. Hospital-wide implementation of ISDT was associated with a 1.1% saving in hospitalization days.ConclusionsWe offer this novel approach as a simple, cost-effective measure to reduce risks to patient safety from contaminated blood cultures, without the need for using costly devices.     

A randomized controlled trial of exercise therapy for dizziness and vertigo in primary care.

BACKGROUND: 'Vestibular rehabilitation' (VR) is an increasingly popular treatment option for patients with persistent dizziness. Previous clinical trials have only evaluated the effects of specialist therapy programmes in small, selective, or uncontrolled patient samples. AIM: To determine the benefits of VR compared with standard medical care, using a brief intervention for dizzy patients in primary care. METHOD: Adults consulting their general practitioner (GP) with dizziness or vertigo were randomly assigned to treatment or control groups. Patients in both groups received the same evaluation at baseline, six-week follow-up, and six-month follow-up, comprising examination of nystagmus, postural control, and movement-provoked dizziness, and a questionnaire assessment of subjective status, symptoms, handicap, anxiety, and depression. At baseline and six weeks later, the treatment group also received an individualized 30-minute therapy session, in which they were taught head, eye, and body exercises designed to promote vestibular compensation and enhance skill and confidence in balance. RESULTS: The treatment group (n = 67) improved on all measures, whereas the control group (n = 76) showed no improvement, resulting in a significant difference between the two groups on physical indices of balance and subjective indices of symptoms and distress. Odds ratios for improvement in treated patients relative to untreated patients were 3.1:1 at six weeks (95% CI = 1.4-6.8) and 3.8:1 at six months (95% CI = 1.6-8.7). CONCLUSION: VR is a simple, inexpensive, and beneficial treatment, and may be an appropriate first stage of management for many dizzy patients in primary care.     

Providing palliative care for a dying teen at home: perspectives and challenges

Adolescents and young adults with cancer are a heterogeneous group. Management of this special group requires a broad-based interdisciplinary clinical team, which should include palliative care (PC), psychology, social work, oncology, and nursing representatives. The function of PC is to provide impeccable pain and other symptom control and to coordinate care as the disease progresses. The cure rate of cancer in adolescents is high but between 10% and 40% of them will develop incurable disease depending on tumor type and prognostic factors. PC in adolescents should also take care of the specific physical and psychosocial developmental changes in this age group. A 16-year old boy suffered with incurable disease and team has provided the PC at the door step taken as a case study.     

Exploratory cluster randomised controlled trial of shared care development for long-term mental illness.

BACKGROUND: Primary care clinicians have a considerable amount of contact with patients suffering from long-term mental illness. The United Kingdom's National Health Service now requires general practices to contribute more systematically to care for this group of patients. AIMS: To determine the effects of Mental Health Link, a facilitation-based quality improvement programme designed to improve communication between the teams and systems of care within general practice. Design of study: Exploratory cluster randomised controlled trial. SETTING: Twenty-three urban general practices and associated community mental health teams. METHOD: Practices were randomised to service development as usual or to the Mental Health Link programme. Questionnaires and an audit of notes assessed 335 patients' satisfaction, unmet need, mental health status, processes of mental and physical care, and general practitioners' satisfaction with services and beliefs about service development. Service use and intervention costs were also measured. RESULTS: There were no significant differences in patients' perception of their unmet need, satisfaction or general health. Intervention patients had fewer psychiatric relapses than control patients (mean = 0.39 versus 0.71, respectively, P = 0.02) but there were no differences in documented processes of care. Intervention practitioners were more satisfied and services improved significantly for intervention practices. There was an additional mean direct cost of pound 63 per patient with long-term mental illness for the intervention compared with the control. CONCLUSION: Significant differences were seen in relapse rates and practitioner satisfaction. Improvements in service development did not translate into documented improvements in care. This could be explained by the intervention working via the improvements in informal shared care developed through better link working. This type of facilitated intervention tailored to context has the potential to improve care and interface working.     

A cluster randomised controlled trial of patient-held medical records for people with schizophrenia receiving shared care.

BACKGROUND: Patient-held records can improve communication across the primary-secondary interface. There has been no previous rigorous assessment of the utility of patient-held records for people with schizophrenia from a primary care perspective and their value for this population is unclear. AIM: To evaluate the effectiveness of a patient-held record for patients with schizophrenia receiving shared care. DESIGN OF STUDY: Cluster randomised controlled trial. SETTING: Seventy-four general practices and six community mental health localities in Birmingham, England between June 1998 and June 1999. METHOD: A sample of 201 patients with schizophrenia (ICD-10 classification F20) was recruited; of these, 100 were intervention and 101 were control. Patient-held records were given to the intervention patients. At 12-month follow-up, all patients were accounted for and 191 (95%) were revisited. Primary outcomes were the Verona Service Satisfaction Scale-54 (VSSS-54) and the Krawiecka and Goldberg (K & G) rating scale of psychopathology at 12-month follow-up. Secondary outcomes were use of primary and secondary care services. RESULTS: A total of 63/92 (68.5%) patients still had the patient-held record, 64/92 (69.6%) had used it, and 39 (60.9%) of the 64 who had used it said the patient-held record was regularly used by their keyworker. However the patient-held record had no significant effect on primary outcomes (VSSS-54: F1,116 = 0.06, P = 0.801, K & G: F1,116 = 0.6, P = 0.439) or on use of services. A higher symptom score was associated with not using the patient-held record. CONCLUSIONS: The trial provides no good evidence to suggest that patient-held records should be introduced as part of routine shared care for all patients with schizophrenia. However, the patient-held record was acceptable to patients with schizophrenia and acted as a communication tool, particularly between patients and keyworkers.     

Study protocol: delayed intervention randomised controlled trial within the Medical Research Council (MRC) Framework to assess the effectiveness of a new palliative care service

Background  

Palliative care has been proposed to help meet the needs of patients who suffer progressive non-cancer conditions but there have been few evaluations of service development initiatives. We report here a novel protocol for the evaluation of a new palliative care service in this context.     

A randomized controlled trial of disclosing genetic risk information for Alzheimer disease via telephone

PurposeTelephone disclosure of genetic test results can improve access to services. To date, studies of its impact have focused on return of Mendelian risk information, principally hereditary cancer syndromes.MethodsIn a multisite trial of Alzheimer disease genetic risk disclosure, asymptomatic adults were randomized to receive test results in person or via telephone. Primary analyses examined patient outcomes 12 months after disclosure.ResultsData from 257 participants showed that telephone disclosure occurred 7.4 days sooner and was 30% shorter, on average, than in-person disclosure (both P < 0.001). Anxiety and depression scores were well below cutoffs for clinical concern across protocols. Comparing telephone and in-person disclosure protocols, 99% confidence intervals of mean differences were within noninferiority margins on scales assessing anxiety, depression, and test-related distress, but inconclusive about positive impact. No differences were observed on measures of recall and subjective impact. Subanalyses supported noninferiority on all outcomes among apolipoprotein E (APOE) ɛ4–negative participants. Subanalyses were inconclusive for APOE ɛ4–positive participants, although mean anxiety and depression scores were still well below cutoffs for clinical concern.ConclusionTelephone disclosure of APOE results and risk for Alzheimer disease is generally safe and helps providers meet demands for services, even when results identify an increased risk for disease.     

Promoting advance planning for health care and research among older adults: A randomized controlled trial

Background  

Family members are often required to act as substitute decision-makers when health care or research participation decisions must be made for an incapacitated relative. Yet most families are unable to accurately predict older adult preferences regarding future health care and willingness to engage in research studies. Discussion and documentation of preferences could improve proxies' abilities to decide for their loved ones. This trial assesses the efficacy of an advance planning intervention in improving the accuracy of substitute decision-making and increasing the frequency of documented preferences for health care and research. It also investigates the financial impact on the healthcare system of improving substitute decision-making.