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

ABSTRACT: 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.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.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.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 studyMethodological 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.

SUBMITTER: Ersek M

PROVIDER: S-EPMC4426859 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature

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

Ersek Mary M Polissar Nayak N Pen Anna Du AD Jablonski Anita A Herr Keela K Neradilek Moni B MB

Clinical trials (London, England) 20120809 5

<h4>Background</h4>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 necessa ...[more]

PMID: 22879574

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Project description:Chronic pain is common among older adults and is associated with adverse physical and psychological outcomes. Given the burden of pain and limited healthcare resources, devising innovative and cost-effective ways of managing chronic pain is of high priority. The aim of this paper is to explore the experiences and perceptions of peer volunteers (PVs) in a peer-led pain management program among nursing home residents in Hong Kong. Forty-six PVs were recruited and trained to lead a pain management program (PAP). The PAP consisted of one 1 hour session per week for 12 weeks. It included 20 min of physical exercises performed under the supervision of PVs, followed by 30 min of pain management education, including information on pain situations, the impacts of pain, the use of drugs and non-drug strategies for pain management, demonstrations, and return demonstrations of various non-drug pain management techniques. Quantitative data were collected from questionnaires (demographics, pain situation, and pain knowledge) for all PVs. Qualitative data (PVs' experiences in leading the PAP, their perceived benefits, barriers encountered, and recommendations for improving the PAP) were collected at week 12 (upon completion of the PAP). Data were analyzed using the Statistical Package for Social Sciences and content analysis for qualitative data. A total of 46 PVs were recruited (34 females, 74%), with a mean ± SD age of 61.0 ± 5.1 years. Thirty-one of them reported having chronic pain. Before the training, their self-rated pain knowledge was 40.0 ± 20.5 (maximum 100 points) while their actual pain knowledge score was 86.1 ± 10.6 (maximum 100 points). The PVs reported an improvement in their knowledge and skills after leading PAPs. No PVs reported having received any negative comments about their role in leading the PAP but mentioned that they had received feedback on how to improve the program. This study provides further evidence that peer-led pain management programs are feasible and can lead to positive experiences for the PVs. Peer support models are coming into wide use because they show promise in helping patients to manage chronic conditions. Peer volunteers will become important resources in elderly care. The barriers that were identified may lead to improvements in the design and planning of future PAPs.

Project description:BackgroundPharmacy interventions are a subset of public health interventions and its research is usually performed within the scope of a trial. The economic evaluation of pharmacy interventions requires certain considerations which have some similarities to those of public health interventions and to economic evaluations alongside trials. The objective of this research is to perform an overview of systematic reviews of economic evaluations of pharmacy services and triangulate results with recommendations for economic evaluations of both public health interventions and alongside trials.Methods(1) Exploratory review of recommendations on the economic evaluation of public health interventions, (2) exploratory review of recommendations for conducting economic evaluations alongside trials, (3) overview of systematic reviews of economic evaluations of pharmacy interventions (protocol registered with PROSPERO 2016 outlining information sources, inclusion criteria, appraisal of reviews and synthesis methods).ResultsFourteen systematic reviews containing 75 index publications were included. Reviews reported favorable economic findings for 71% of studies with full economic evaluations. The types of economic analysis are diverse. Two critical quality domains are absent from most reviews. Key findings include the following: certain types of risk of bias, wider scope of study designs, and most economic quality criteria met but some issues unresolved or unclear. Triangulation revealed additional gaps. Limitations include choice of critical quality domains and potential biases in the overview process.ConclusionsEconomic evaluations of pharmacy-based public health interventions seem to follow most economic quality criteria, but there are still some issues in certain key areas to improve. These findings may assist in improving the design of pilot trials of economic evaluations in pharmacy, leading to robust evidence for payers. Based on the findings, we propose a methodological approach for the economic evaluation of pharmacy-based public health interventions.Systematic review registrationPROSPERO CRD42016032768.

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

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

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