Nursing Home Care Intervention Post Stroke (SHARE) 1 year effect on the burden of family caregivers for older adults in Brazil: A randomized controlled trial

Abstract Background Heart failure (HF) afflicts 6.5 million Americans with devastating consequences to patients and their family caregivers. Families are rarely prepared for worsening HF and are not informed about end-of-life and palliative care (EOLPC) conservative comfort options especially during the end stage. West Virginia (WV) has the highest rate of HF deaths in the U.S. where 14% of the population over 65 years have HF. Thus, there is a need to investigate a new family EOLPC intervention (FamPALcare), where nurses coach family-managed advanced HF care at home. Methods This study uses a randomized controlled trial (RCT) design stratified by gender to determine any differences in the FamPALcare HF patients and their family caregiver outcomes versus standard care group outcomes (N = 72). Aim 1 is to test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for advanced HF. Aim 2 is to assess implementation of the FamPALcare intervention and research procedures for subsequent clinical trials. Intervention group will receive routine standard care, plus 5-weekly FamPALcare intervention delivered by community-based nurses. The intervention sessions involve coaching patients and family caregivers in advanced HF home care and supporting EOLPC discussions based on patients’ preferences. Data are collected at baseline, 3, and 6 months. Recruitment is from sites affiliated with a large regional hospital in WV and community centers across the state. Discussion The outcomes of this clinical trial will result in new knowledge on coaching techniques for EOLPC and approaches to palliative and end-of-life rural home care. The HF population in WV will benefit from a reduction in suffering from the most common advanced HF symptoms, selecting their preferred EOLPC care options, determining their advance directives, and increasing skills and resources for advanced HF home care. The study will provide a long-term collaboration with rural community leaders, and collection of data on the implementation and research procedures for a subsequent large multi-site clinical trial of the FamPALcare intervention. Multidisciplinary students have opportunity to engage in the research process. Trial registration ClinicalTrials.gov NCT04153890, Registered on 4 November 2019

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Immunogenicity and Safety of Intradermal Trivalent Influenza Vaccination in Nursing Home Older Adults: A Randomized Controlled Trial

Journal of the American Medical Directors Association ◽

10.1016/j.jamda.2014.05.002 ◽

2014 ◽

Vol 15 (8) ◽

pp. 607.e5-607.e12 ◽

Cited By ~ 2

Author(s):

Tuen-Ching Chan ◽

Ivan Fan-Ngai Hung ◽

Kwok-Hung Chan ◽

Clara Pui-Yan Li ◽

Patrick Tsz-Wai Li ◽

...

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Nursing Home ◽

Influenza Vaccination ◽

Controlled Trial ◽

Randomized Controlled

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The ACHRU-CPP versus usual care for older adults with type-2 diabetes and multiple chronic conditions and their family caregivers: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-017-1795-9 ◽

2017 ◽

Vol 18 (1) ◽

Cited By ~ 3

Author(s):

Maureen Markle-Reid ◽

Jenny Ploeg ◽

Kimberly D. Fraser ◽

Kathryn Ann Fisher ◽

Noori Akhtar-Danesh ◽

...

Keyword(s):

Type 2 Diabetes ◽

Older Adults ◽

Randomized Controlled Trial ◽

Usual Care ◽

Family Caregivers ◽

Chronic Conditions ◽

Controlled Trial ◽

Multiple Chronic Conditions ◽

Randomized Controlled

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Addressing methodological challenges in implementing the nursing home pain management algorithm randomized controlled trial

Clinical Trials ◽

10.1177/1740774512454243 ◽

2012 ◽

Vol 9 (5) ◽

pp. 634-644 ◽

Cited By ~ 14

Author(s):

Mary Ersek ◽

Nayak Polissar ◽

Anna Du Pen ◽

Anita Jablonski ◽

Keela Herr ◽

...

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Nursing Home ◽

Pain Management ◽

Outcome Measures ◽

Controlled Trial ◽

Self Report ◽

Evidence Based ◽

Randomized Controlled ◽

Methodological Challenges

Background Unrelieved pain among nursing home (NH) residents is a well-documented problem. Attempts have been made to enhance pain management for older adults, including those in NHs. Several evidence-based clinical guidelines have been published to assist providers in assessing and managing acute and chronic pain in older adults. Despite the proliferation and dissemination of these practice guidelines, research has shown that intensive systems-level implementation strategies are necessary to change clinical practice and patient outcomes within a health-care setting. One promising approach is the embedding of guidelines into explicit protocols and algorithms to enhance decision making. Purpose The goal of the article is to describe several issues that arose in the design and conduct of a study that compared the effectiveness of pain management algorithms coupled with a comprehensive adoption program versus the effectiveness of education alone in improving evidence-based pain assessment and management practices, decreasing pain and depressive symptoms, and enhancing mobility among NH residents. Methods The study used a cluster-randomized controlled trial (RCT) design in which the individual NH was the unit of randomization. The Roger’s Diffusion of Innovations theory provided the framework for the intervention. Outcome measures were surrogate-reported usual pain, self-reported usual and worst pain, and self-reported pain-related interference with activities, depression, and mobility. Results The final sample consisted of 485 NH residents from 27 NHs. The investigators were able to use a staggered enrollment strategy to recruit and retain facilities. The adaptive randomization procedures were successful in balancing intervention and control sites on key NH characteristics. Several strategies were successfully implemented to enhance the adoption of the algorithm. Limitations/Lessons The investigators encountered several methodological challenges that were inherent to both the design and implementation of the study. The most problematic issue concerned the measurement of outcomes in persons with moderate to severe cognitive impairment. It was difficult to identify valid, reliable, and sensitive outcome measures that could be applied to all NH residents regardless of the ability to self-report. Another challenge was the inability to incorporate advances in implementation science into the ongoing study Conclusions Methodological challenges are inevitable in the conduct of an RCT. The need to optimize internal validity by adhering to the study protocol is compromised by the emergent logistical issues that arise during the course of the study.

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