scholarly journals Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e025692 ◽  
Author(s):  
Corita R Grudzen ◽  
Deborah J Shim ◽  
Abigail M Schmucker ◽  
Jeanne Cho ◽  
Keith S Goldfeld
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Case Management ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Randomised Controlled ◽  
End Stage

IntroductionEmergency department (ED)-initiated palliative care has been shown to improve patient-centred outcomes in older adults with serious, life-limiting illnesses. However, the optimal modality for providing such interventions is unknown. This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement.Methods and analysisThis is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. We will enrol 1350 patients aged 50+ years and 675 of their caregivers across nine EDs. Eligible patients: (1) have advanced cancer (metastatic solid tumour) or end-stage organ failure (New York Heart Association class III or IV heart failure, end-stage renal disease with glomerular filtration rate <15 mL/min/m2, or global initiative for chronic obstructive lung disease stage III, IV or oxygen-dependent chronic obstructive pulmonary disease); (2) speak English; (3) are scheduled for ED discharge or observation status; (4) reside locally; (5) have a working telephone and (6) are insured. Patients will be excluded if they: (1) have dementia; (2) have received hospice care or two or more palliative care visits in the last 6 months or (3) reside in a long-term care facility. We will use patient-level block randomisation, stratified by ED site and disease. Effectiveness will be compared by measuring the impact of each intervention on the specified outcomes. The primary outcome will measure change in patient quality of life.Ethics and disseminationInstitutional Review Board approval was obtained at all study sites. Trial results will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03325985; Pre-results.

scholarly journals Evaluating the provision of Further Enabling Care at Home (FECH+) for informal caregivers of older adults discharged home from hospital: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046600
Author(s):  
Anne-Marie Hill ◽  
Rachael Moorin ◽  
Susan Slatyer ◽  
Christina Bryant ◽  
Keith Hill ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Informal Caregivers ◽  
Care Recipient ◽  
Care At Home ◽  
Randomised Controlled

IntroductionThere are personal and societal benefits from caregiving; however, caregiving can jeopardise caregivers’ health. The Further Enabling Care at Home (FECH+) programme provides structured nurse support, through telephone outreach, to informal caregivers of older adults following discharge from acute hospital care to home. The trial aims to evaluate the efficacy of the FECH+ programme on caregivers’ health-related quality of life (HRQOL) after care recipients’ hospital discharge.Methods and analysisA multisite, parallel-group, randomised controlled trial with blinded baseline and outcome assessment and intention-to-treat analysis, adhering to Consolidated Standards of Reporting Trials guidelines will be conducted. Participants (N=925 dyads) comprising informal home caregiver (18 years or older) and care recipient (70 years or older) will be recruited when the care recipient is discharged from hospital. Caregivers of patients discharged from wards in three hospitals in Australia (one in Western Australia and two in Queensland) are eligible for inclusion. Participants will be randomly assigned to one of the two groups. The intervention group receive the FECH+ programme, which provides structured support and problem-solving for the caregiver after the care recipient’s discharge, in addition to usual care. The control group receives usual care. The programme is delivered by a registered nurse and comprises six 30–45 min telephone support sessions over 6 months. The primary outcome is caregivers’ HRQOL measured using the Assessment of Quality of Life—eight dimensions. Secondary outcomes include caregiver preparedness, strain and distress and use of healthcare services. Changes in HRQOL between groups will be compared using a mixed regression model that accounts for the correlation between repeated measurements.Ethics and disseminationParticipants will provide written informed consent. Ethics approvals have been obtained from Sir Charles Gairdner and Osborne Park Health Care Group, Curtin University, Griffith University, Gold Coast Health Service and government health data linkage services. Findings will be disseminated through presentations, peer-reviewed journals and conferences.Trial registration numberACTRN12620000060943.

scholarly journals Nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer: study protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e037759
Author(s):  
Daisuke Fujisawa ◽  
Shigeki Umemura ◽  
Ayumi Okizaki ◽  
Eriko Satomi ◽  
Takuhiro Yamaguchi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Advanced Lung Cancer ◽  
Intervention Programme ◽  
Care Intervention ◽  
Randomised Controlled

IntroductionIt has been suggested that palliative care integrated into standard cancer treatment from the early phase of the disease can improve the quality of life of patients with cancer. In this paper, we present the protocol for a multicentre randomised controlled trial to examine the effectiveness of a nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer.Methods and analysisA total of 206 patients will be randomised (1:1) to the intervention group or the control group (usual care). The intervention, triggered with a brief self-administered screening tool, comprises comprehensive need assessments, counselling and service coordination by advanced-level nurses. The primary outcome is the Trial Outcome Index of the Functional Assessment of Cancer Therapy (FACT) at 12 weeks. The secondary outcomes include participants’ quality of life (FACT-Lung), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), illness perception (Prognosis and Treatment Perceptions Questionnaire), medical service use and survival. A mixed-method approach is expected to provide an insight about how this intervention works.Ethics and disseminationThis study has been approved by the Institutional Review Board of the National Cancer Center Japan (approval number: 2016-235). The findings will be disseminated through peer-reviewed publications and conference presentations and will be reflected on to the national healthcare policy.Trial registration numberUMIN000025491.

scholarly journals Maintaining quality of life in patients with chronic obstructive pulmonary disease (COPD) by extending the maintenance phase of community-based pulmonary rehabilitation: protocol for a randomised controlled trial (ComEx3 Study)

2020 ◽  
Vol 7 (1) ◽  
pp. e000548
Author(s):  
Derrick Lopez ◽  
Nola Cecins ◽  
Joanne Cockram ◽  
Anna Collins ◽  
Holly Landers ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Obstructive Pulmonary Disease ◽  
Randomised Controlled Trial ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Randomised Controlled ◽  
Maintenance Programme

IntroductionPulmonary rehabilitation is a core component of the treatment of people with chronic obstructive pulmonary disease (COPD); however, the benefits gained diminish in the ensuing months. The optimal strategy for maintaining the benefits is unclear with weekly supervised maintenance exercise programmes proposed as one strategy. However, the long-term future of maintenance programs is dependent on quality evidence.Methods and analysisThe ComEx3 randomised controlled trial will investigate the efficacy of extending a weekly supervised maintenance programme for an additional 6 months following an initial 10-week maintenance programme (intervention) by comparing with a control group who receive the same 10-week maintenance programme followed by 6 months of usual care. 120 participants with COPD will be recruited. Primary objective is to determine health-related quality of life over 12 months. Secondary objectives are to determine functional exercise capacity trajectory and to perform an economic evaluation of the intervention to the health system. Outcomes will be analysed for superiority according to intention-to-treat and per-protocol approaches.Ethics and disseminationApproval has been received from the relevant ethics committees. Findings will be disseminated in peer-reviewed journals and conferences, targeting those involved in managing people with COPD as well as those who develop policies and guidelines.Clinical trial registrationANZCTR 12618000933257

scholarly journals Oral nutritional supplement use is weakly associated with increased subjective health-related quality of life in malnourished older adults: a multicentre randomised controlled trial

2021 ◽  
pp. 1-9
Author(s):  
Lisa Söderström ◽  
Leif Bergkvist ◽  
Andreas Rosenblad
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Randomised Controlled Trial ◽  
Linear Regression ◽  
Multiple Linear Regression ◽  
Controlled Trial ◽  
Health Related ◽  
Randomised Controlled ◽  
Eq Vas

Abstract Malnutrition is common among older adults in health-care settings and is associated with decreased quality of life (QoL). The present study aimed to investigate the effect on health-related QoL (HRQoL) among older adults after 6 months of treatment with individual dietary advice (DA) and/or oral nutritional supplements (ONS), utilising 409 patients included in a multicentre randomised controlled trial of patients ≥ 65 years old, stratified according to nutrition status (malnourished/at risk of malnutrition), admitted to hospital in Sweden 2010–2014. Patients were randomised into four arms: DA, ONS, DA + ONS or routine care (control). The intervention started at discharge from hospital, with HRQoL measured using European QoL five-dimension, three-level (EQ-5D-3L) and European QoL-visual analogue scale (EQ-VAS) at baseline and at 6-month, 1-year and 3-year follow-ups. Data were analysed using the Kruskal–Wallis test and multiple linear regression. Overall, HRQoL increased from baseline to follow-ups, although the magnitude of change in EQ-5D-3L did not differ significantly between the four arms in any of the nutrition groups. However, a significant difference was observed for change in EQ-VAS from baseline to 6-month follow-up in the malnourished group, with mean changes of 22·4 and –3·4 points for the ONS and control groups, respectively (P = 0·009). In the multiple linear regression analyses, participants in the ONS arm had 27·5, 34·4 and 38·8 points larger increases in EQ-VAS from baseline to the 6-month (P = 0·011), 1-year (P = 0·007) and 3-year (P = 0·032), respectively, follow-ups than the control group. The use of ONS improved subjectively assessed HRQoL in these malnourished older adults.

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