Challenges in efficacy research: the case of feeding alternatives in patients with dementia

Abstract

Aims To explore factors at the family caregiver and nursing home administrative levels that may affect participation in a clinical trial to determine the efficacy of hand feeding versus percutaneous gastrostomy tube feeding in persons with late-stage dementia. Background Decision-making regarding use of tube feeding vs. hand feeding for persons with late-stage dementia is fraught with practical, emotional and ethical issuesand is not informed by high levels of evidence. Design Qualitative case study. Methods Transcripts of focus groups with family caregivers were reviewed for themes guided by behavioral theory. Analyses of notes from contacts with nursing home administrators and staff were reviewed for themes guided by an organizational readiness model. Data were collected between the years 2009–2012. Results Factors related to caregiver willingness to participate included understanding of the prognosis of dementia, perceptions of feeding needs and clarity about research protocols. Nursing home willingness to participate was influenced by corporate approval, concerns about legal and regulatory issues and prior relationships with investigators. Conclusion Participation in rigorous trials requires lengthy navigation of complex corporate requirements and training competent study staff. Objective deliberation by caregivers will depend on appropriate recruitment timing, design of recruitment materials and understanding of study requirements. The clinical standards and policy environment and the secular trends therein have relevance to the responses of people at all levels.

Challenges of conducting research in long-term care facilities: a systematic review

“…Of the 39 papers included in this review, 20 were based on studies conducted in the United States [ 24 – 43 ], 15 were based on those from the United Kingdom [ 44 – 58 ], and 1 study from each of Australia [ 59 ], New Zealand [ 60 ], France [ 61 ] and Norway [ 62 ]. Most of the 39 papers reported on challenges experienced in research with LTC residents as research subjects.…”

“…A total of 18 studies reported challenges that could be categorized under this theme [ 24 – 30 , 32 , 37 , 43 , 45 – 49 , 52 , 55 , 59 ]. Some of the major issues included within this theme were: recruitment and retention of LTC facilities, owners or administrators unfamiliar with research, not interested or feel threatened.…”

“…Hickman et al reported that just over half (53%) of the facilities they surveyed had previously participated in research, with experiences ranging from a single resident enrolled in an off-site study to larger scale studies involving modifications to the physical environment [ 30 ]. Some LTC owners and/or administrators refused to allow research to be conducted in their facilities, while others were prohibited from participating due to corporate policies [ 24 , 49 ]. Additionally, some were reluctant to take part because their facilities would be subjected to more government inspection as a result [ 24 ].…”

“…Some LTC owners and/or administrators refused to allow research to be conducted in their facilities, while others were prohibited from participating due to corporate policies [ 24 , 49 ]. Additionally, some were reluctant to take part because their facilities would be subjected to more government inspection as a result [ 24 ]. In general, large, privately-owned LTC chains have less flexibility when there is a corporate-wide policy that prohibits research, whereas small independent non-profit facilities may be restricted from participating in research due to their limited resources [ 29 ].…”

“…Investigators also face logistical challenges. In the experiences of several investigators, experimental treatments or placebos were not always administered according to plan during the investigators’ absence [ 24 , 49 , 59 ]. Medical and hospitalization records might not be easily accessible, due to little uniformity in the collection of health records [ 28 , 55 ].…”