Feasibility and Pilot Studies in Palliative Care Research: A Systematic Review

Jones, Terry A.; Olds, Tim; Currow, David C.; Williams, Marie

doi:10.1016/j.jpainsymman.2017.02.015

Cited by 20 publications

(23 citation statements)

References 72 publications

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“…Feasibility studies in palliative care are rare. While many studies are described as feasibility studies, such studies do not always include criteria to judge success or failure [21,36]. In our study, we did formulate feasibility criteria on recruitment, data collection, patient burden and protocol adherence.…”

Section: Findings and Comparison To Literaturementioning

confidence: 99%

Feasibility of the PalliSupport care pathway: results from a mixed-method study in acutely hospitalized older patients at the end of life

Flierman

Rijn

Meij³

et al. 2020

Pilot Feasibility Stud

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Background A transitional care pathway (TCP) could improve care for older patients in the last months of life. However, barriers exist such as unidentified palliative care needs and suboptimal collaboration between care settings. The aim of this study was to determine the feasibility of a TCP, named PalliSupport, for older patients at the end of life, prior to a stepped-wedge randomized controlled trial. Methods A mixed-method feasibility study was conducted at one hospital with affiliated primary care. Patients were ≥ 60 years and acutely hospitalized. The intervention consisted of (1) training on early identification of the palliative phase and end of life conversations, (2) involvement of a transitional palliative care team during admission and post-discharge and (3) intensified collaboration between care settings. Outcomes were feasibility of recruitment, data collection, patient burden and protocol adherence. Experiences of 14 professionals were assessed through qualitative interviews. Results Only 16% of anticipated participants were included which resulted in difficulty assessing other feasibility criteria. The qualitative analysis identified misunderstandings about palliative care, uncertainty about professionals’ roles and difficulties in initiating end of life conversations as barriers. The training program was well received and professionals found the intensified collaboration beneficial for patient care. The patients that participated experienced low burden and data collection on primary outcomes and protocol adherence seems feasible. Discussion This study highlights the importance of performing a feasibility study prior to embarking on effectiveness studies. Moving forward, the PalliSupport care pathway will be adjusted to incorporate a more active recruitment approach, additional training on identification and palliative care, and further improvement on data collection.

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Section: Findings and Comparison To Literaturementioning

confidence: 99%

Feasibility of the PalliSupport care pathway: results from a mixed-method study in acutely hospitalized older patients at the end of life

Flierman

Rijn

Meij³

et al. 2020

Pilot Feasibility Stud

View full text Add to dashboard Cite

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“…In recent years the number of feasibility trials conducted in palliative care has increased and they have become an important requirement for funding bodies as well as being of high value to researchers in justifying study designs (to both funders and ethics committees). However, noticeably absent from many feasibility studies reported are those that conform to the recommendation that clear feasibility objectives are in place beforehand to inform whether the study protocol is ultimately feasible [22, 69]. This feasibility study conformed to this recommendation and concluded that whilst the study was indeed technically possible, based on the challenges reported and the number of design modifications required, it would be impractical to use the protocol tested to guide a full trial of the AMBER care bundle.…”

Section: Discussionmentioning

confidence: 99%

“…The UK Medical Research Council’s guidance on the development and evaluation of complex interventions [15] and the Methods of Researching End-of-life Care (MORECare) statement [16] both recommend a feasibility study before full evaluation. Feasibility studies, now more common in palliative and end of life care [22], enable researchers to identify problems that might undermine the acceptability and delivery of the intervention or the conduct of a fully powered trial [23, 24]. Researchers are then potentially able to remedy problems with the intervention, trial design, or conduct by returning to the development phase, rather than proceeding to a full trial.…”

Section: Introductionmentioning

confidence: 99%

Managing uncertain recovery for patients nearing the end of life in hospital: a mixed-methods feasibility cluster randomised controlled trial of the AMBER care bundle

Koffman

Yorganci

et al. 2019

Trials

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Background: The AMBER (Assessment, Management, Best Practice, Engagement, Recovery Uncertain) care bundle is a complex intervention used in UK hospitals to support patients with uncertain recovery. However, it has yet to be evaluated in a randomised controlled trial (RCT) to identify potential benefits or harms. The aim of this trial was to investigate the feasibility of a cluster RCT of the AMBER care bundle. Methods: This is a prospective mixed-methods feasibility cluster RCT. Quantitative data collected from patients (or proxies if patients lack capacity) were used (i) to examine recruitment, retention and follow-up rates; (ii) to test data collection tools for the trial and determine their optimum timing; (iii) to test methods to identify the use of financial resources; and (iv) to explore the acceptability of study procedures for health professionals and patients. Descriptive statistical analyses and thematic analysis used the framework approach. Results: In total, 894 patients were screened, of whom 220 were eligible and 19 of those eligible (8.6%) declined to participate. Recruitment to the control arm was challenging. Of the 728 patients screened for that arm, 647 (88.9%) were excluded. Overall, 65 patients were recruited (81.3% of the recruitment target of 80). Overall, many were elderly (≥80 years, 46.2%, n = 30, mean = 77.8 years, standard deviation [SD] = 12.3 years). Over half (53.8%) had a non-cancer diagnosis, with a mean of 2.3 co-morbidities; 24.6% patients (n = 16) died during their hospital stay and 35.4% (n = 23) within 100 days of discharge. In both trial arms, baseline IPOS subscale scores identified moderate patient anxiety (control: mean 13.3, SD 4.8; intervention: mean 13.3, SD 5.1), and howRwe identified a good care experience (control: mean 13.1, SD 2.5; intervention: mean 11.5, SD 2.1). Collecting quantitative service use and quality of life data was feasible. No patient participants regarded study involvement negatively. Focus groups with health professionals identified concerns regarding (i) the subjectivity of the intervention's eligibility criteria, (ii) the need to prognosticate to identify potential patients and (iii) consent procedures and the length of the questionnaire. Conclusions: A full trial of the AMBER care bundle is technically feasible but impractical due to fundamental issues in operationalising the intervention's eligibility criteria, which prevents optimal recruitment. Since this complex intervention continues to be used in clinical care and advocated in policy, alternative research approaches must be considered and tested. Trial registration: International Standard Randomised Controlled Trial Number (ISRCTN) Register, ISRCTN36040085.

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“…The UK Medical Research Council (MRC) guidance on the development and evaluation of complex interventions (15), and the Methods of Researching End-of-life Care (MORECare) statement (16) both recommend a feasibility study before full evaluation. Feasibility studies, now more common in palliative and end of life care (22), enable researchers to identify problems that might undermine the acceptability and delivery of the intervention or the conduct of a fully-powered trial (23) (24). Researchers are then potentially able to remedy problems with the intervention or trial design or conduct, by returning to the development phase, rather than proceeding to a full trial.…”

mentioning

confidence: 99%

Managing uncertain recovery for patients nearing the end of life in hospital; a mixed-method, feasibility cluster randomised controlled trial of the AMBER care bundle

Koffman

Yorganci

et al. 2019

Preprint

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Background: The AMBER (Assessment; Management; Best practice; Engagement; Recovery uncertain) care bundle is a complex intervention used in UK hospitals to support patients with uncertain recovery. However, it has yet to be evaluated in a randomised controlled trial (RCT) to identify potential benefits or harms. Aim: To investigate the feasibility of a cluster RCT of the AMBER care bundle. Methods: Mixed-method, feasibility cluster RCT. Prospective, quantitative data collected from patients (or proxies lacking capacity) to (i) examine recruitment, retention and follow-up rates; (ii) test trial data collection tools and determine their optimum timing; (iii) test methods to identify use of financial resources; (iv) explore the acceptability of study procedures for health professionals and patients. Descriptive statistical analyses and thematic analysis using the Framework approach.Results: 894 patients were screened, of whom, 220 were eligible and 19 (8.6%) declined to participate. Recruitment to the control arm was challenging; of the 728 patients screened, 647 (88.9%) were excluded. 65 (81.3% of the recruitment target) patients were recruited. Many were elderly (≥80 years 46.2%, n=30, mean-77.8 years SD=12.3 years). Over half (53.8%) had a noncancer diagnosis, with a mean of 2.3 co-morbidities. 24.6% patients (n=16) died during their hospital stay and 35.4%, (n=23) within 100 days of discharge. In both trial arms, baseline IPOS subscale scores identified 'moderate' patient anxiety (mean 13.3 (SD 4.8) control, 13.3 (SD 5.1) intervention), and howRwe identified a 'good' care experience (mean 13.1 (SD 2.5) control, 11.5 (SD 2.1) intervention). Collection of quantitative service use/quality of life data was feasible. No patient participants regarded study involvement negatively. Focus groups with health professionals identified concerns regarding (i) subjectivity of the intervention eligibility criteria; (ii) the need to prognosticate to identify potential patients; (iii) consent procedures and questionnaire length. Conclusions: A full trial of the AMBER care bundle is technically feasible but impractical due to fundamental issues in operationalising the intervention's eligibility criteria preventing optimal recruitment. Since this complex intervention continues to be used in clinical care and advocated in policy, alternative research approaches must be considered and tested. Trial registration: International Standard Randomised Controlled Trial Number (ISRCTN) Register, ISRCTN36040085 4 Background Clinical uncertainty in hospital settingsClinical uncertainty has been defined as the inability to determine the meaning and significance of illness-related events (1). It occurs in situations where health professionals are unable to accurately predict outcomes due to insufficient information. Evidence suggests that in the last 30 days of life, a combination of deteriorating health and clinical uncertainty are highly distressing for patients in hospital, and their families (2, 3). This is amplified when discussions about t...

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Feasibility and Pilot Studies in Palliative Care Research: A Systematic Review

Cited by 20 publications

References 72 publications

Feasibility of the PalliSupport care pathway: results from a mixed-method study in acutely hospitalized older patients at the end of life

Feasibility of the PalliSupport care pathway: results from a mixed-method study in acutely hospitalized older patients at the end of life

Managing uncertain recovery for patients nearing the end of life in hospital: a mixed-methods feasibility cluster randomised controlled trial of the AMBER care bundle

Managing uncertain recovery for patients nearing the end of life in hospital; a mixed-method, feasibility cluster randomised controlled trial of the AMBER care bundle

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