Implementation of a multicomponent intervention to prevent physical restraints in nursing home residents (IMPRINT): study protocol for a cluster-randomised controlled trial

BMC Geriatrics

Sascha Köpke²  Gabriele Meyer⁶  Burkhard Haastert⁴  Charalabos-Markos Dintsios³  Andrea Icks³  Ramona Kupfer¹  Adrienne Henkel²  Ralph Möhler⁵  Jens Abraham⁶ 

[1] University of Hamburg, MIN Faculty, Health Sciences, Martin-Luther-King-Platz 6, Hamburg, 20146, Germany;University of Lübeck, Institute of Social Medicine, Nursing Research Unit, Ratzeburger Allee 160, Lübeck, 23538, Germany;Heinrich-Heine-University Düsseldorf, Medical Faculty, Department of Public Health, Moorenstraße 5, Düsseldorf, 40225, Germany;mediStatistica, Lambertusweg 1b, Neuenrade, 58809, Germany;Witten/Herdecke University, Faculty of Health, School of Nursing Science, Stockumer Str. 12, Witten, 58453, Germany;Martin Luther University Halle-Wittenberg, Medical Faculty, Institute of Health and Nursing Science, Magdeburger Str. 8, Halle (Saale), 06112, Germany

关键词: Dementia;    Guidelines;    Physical restraints;    Nursing homes;   

Others  :  1220849
DOI  :  10.1186/s12877-015-0086-0

 received in 2015-05-12, accepted in 2015-07-13,  发布年份 2015

【 摘 要 】

Background

Physical restraints such as bedrails and belts are regularly applied in German nursing homes despite clear evidence showing their lack of effectiveness and safety. In a cluster-randomised controlled trial, the efficacy and safety of a guideline-based multicomponent intervention programme has been proven. The present study aims to evaluate the effectiveness of two different versions of the original intervention in nursing home residents in four different regions throughout Germany.

Methods/Design

The study is a pragmatic cluster-randomised controlled trial comparing two intervention groups, i.e. (1) the updated original multicomponent intervention programme and (2) the concise version of the updated programme, with a control group receiving optimised usual care. The first intervention group receives an educational programme for all nurses, additional training and structured support for nominated key nurses, printed study material and other supportive material. In the second intervention group, nurses do not receive education as part of the intervention, but may be trained by nominated key nurses who have received a short train-the-trainer module. All other components are similar to the first intervention group. The control group receives the printed study material only. Overall, 120 nursing homes including approximately 10,800 residents will be recruited and randomly assigned to one of the three groups. The primary outcome is defined as the proportion of residents with at least one physical restraint after 12 months follow-up. The use of physical restraints will be assessed by direct observation. Secondary outcomes are the residents’ quality of life and safety parameters, e.g. falls and fall-related fractures. In addition, comprehensive process and economic evaluations will be performed.

Conclusions

We expect a clinically relevant reduction in the proportion of residents with physical restraints. It is also expected that the process outcomes of this trial will enrich the knowledge about facilitators and barriers for the implementation of the multicomponent intervention programme.

Trial registration

ClinicalTrials.gov: NCT02341898

【 授权许可】

   
2015 Abraham et al.

【 图 表 】

Fig. 1.

【 参考文献 】

• [1]Köpke S, Mühlhauser I, Gerlach A, Haut A, Haastert B, Möhler R, Meyer G: Effect of a guideline-based multicomponent intervention on use of physical restraints in nursing homes: a randomized controlled trial. JAMA. 2012, 307:2177-84.
• [2]Möhler R, Richter T, Köpke S, Meyer G: Interventions for preventing and reducing the use of physical restraints in long-term geriatric care - a Cochrane review. J Clin Nurs. 2012, 21:3070-81.
• [3]Tang WS, Chow YL, Koh SSL: The effectiveness of physical restraints in reducing falls among adults in acute care hospitals and nursing homes: a systematic review. JBI Libr Syst Rev 2012, 10:307-51.
• [4]Bleijlevens MH, Wagner LM, Capezuti E, Hamers JP: A Delphi consensus study to determine an internationally acceoted definition on physical restraints. Symposium, 65. GSA Annual seintific meeting November 14th-18th, 2012, San Diego. Geront 2012, 52(s1):136.
• [5]Meyer G, Köpke S, Haastert B, Mühlhauser I: Restraint use among nursing home residents: cross-sectional study and prospective cohort study. J Clin Nurs. 2009, 18:981-90.
• [6]Hamers J, Huizing A: Why do we use physical restraints in the elderly? Z Gerontol Geriatr. 2005, 38:19-25.
• [7]Evans D, Wood J, Lambert L: A review of physical restraint minimization in the acute and residential care settings. J Adv Nurs. 2002, 40:616-25.
• [8]Goethals S, Dierckx de Casterlé B, Gastmans C: Nurses' decision-making in cases of physical restraint: a synthesis of qualitative evidence. J Adv Nurs 2012, 68:1198-210.
• [9]Möhler R, Meyer G: Attitudes of nurses towards the use of physical restraints in geriatric care: a systematic review of qualitative and quantitative studies. Int J Nurs Stud. 2014, 51:274-88.
• [10]Oliver D, Connelly JB, Victor CR, Shaw FE, Whitehead A, Genc Y, et al.: Strategies to prevent falls and fractures in hospitals and care homes and effect of cognitive impairment: systematic review and meta-analyses. BMJ. 2007, 334:82.
• [11]Berzlanovich A, Schöpfer J, Keil W: Deaths due to physical restraint. Dtsch Arztebl Int. 2012, 109:27-32.
• [12]Castle N, Engberg J: The health consequences of using physical restraints in nursing homes. Med Care. 2009, 47:1164-73.
• [13]Engberg J, Castle N, McCaffrey D: Physical restraint initiation in nursing homes and subsequent resident health. Gerontologist. 2008, 48:442-52.
• [14]Parker K, Miles SH: Deaths caused by bedrails. J Am Geriatr Soc. 1997, 45:797-802.
• [15]Pedal I: Plötzliche Todesfälle mechanisch fixierter Patienten. [Sudden fatalities in mechanically restrained patients]. Z Gerontol Geriatr 1996, 29:180-4.
• [16]Huizing A, Hamers J, de Jonge J, Candel M, Berger MP: Organisational determinants of the use of physical restraints: a multilevel approach. Soc Sci Med. 2007, 65:924-33.
• [17]Sullivan-Marx E, Strumpf N, Evans L, Baumgarten M, Maislin G: Predictors of continued physical restraint use in nursing home residents following restraint reduction efforts. J Am Geriatr Soc. 1999, 47:342-8.
• [18]Morley JE: Clinical practice in nursing homes as a key for progress. J Nutr Health Aging. 2010, 14:586-93.
• [19]Möhler R, Richter T, Köpke S, Meyer G. Interventions for preventing and reducing the use of physical restraints in long-term geriatric care. Cochrane Database Syst Rev. 2011;CD007546.
• [20]Gerlach A, Köpke S, Haut A, Meyer G. Prozessevaluation der Implementierung einer Leitlinien-gestützten komplexen Intervention in Alten- und Pflegeheimen. [Process evaluation of the implementation of a guideline-based complex intervention in nursing homes]. 13th Annual meeting of the German Network for Evidence-based Medicine March 15th-17th, 2012, Hamburg. Düsseldorf: German Medical Science GMS Publishing House; 2012. Doc12ebm013.
• [21]Köpke S, Gerlach A, Möhler R, Haut A, Meyer G. Leitlinie FEM – Evidenzbasierte Praxisleitlinie. Vermeidung von freiheitseinschränkenden Maßnahmen in der beruflichen Altenpflege. [Evidence-based practice guideline. Avoidance of physical restraints in long-term geriatric care]. University of Hamburg & Witten/Herdecke University; 2009. URL:. http://www.leitlinie-fem.de/download/LeitlinieFEM.pdf webcite
• [22]Köpke S, Meyer G, Haut A, Gerlach A: Methodenpapier zur Entwicklung einer Praxisleitlinie zur Vermeidung von freiheitseinschränkenden Maßnahmen in der beruflichen Altenpflege. [Methods paper on the development of a practice guideline for the avoidance of physical restraints in nursing homes]. Z Evid Fortbild Qual Gesundh wesen 2008, 102:45-53.
• [23]Logsdon RG: QoL-AD - Germany/German - Version of 8 Jul 08. Mapi Research Institute, Lyon; 1996.
• [24]Logsdon RG, Gibbons LE, McCurry SM, Teri L: Quality of life in Alzheimer's disease: patient and caregiver reports. J Ment Health. 1999, 5:21-32.
• [25]Logsdon RG, Gibbons LE, McCurry SM, Teri L: Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002, 64:510-9.
• [26]Verbeek H, Meyer G, Leino-Kilpi H, Zabalequi A, Hallberg I, Saks K, et al.: A European study investigating patterns of transition from home care towards institutional dementia care: the protocol of a RightTimePlaceCare study. BMC Public Health. 2012, 23:68. BioMed Central Full Text
• [27]Köhler L, Weyerer S, Schäufele M: Proxy screening tools improve the recognition of dementia in old-age homes: results of a validation study. Age Ageing. 2007, 36:549-54.
• [28]Cohen-Mansfield J, Marx MS, Rosenthal AS: A description of agitation in a nursing home. J Gerontol. 1989, 44:M77-84.
• [29]Cohen-Mansfield J: Instruction Manual for the Cohen-Mansfield Agitation Inventory (CMAI). The Research Institute of the Hebrew Home of Greater Washington, Rockville, Maryland; 1991.
• [30]Cohen-Mansfield J: Assessment of agitation. Int Psychogeriatr. 1996, 8:233-45.
• [31]Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M: Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008, 337:a1655.
• [32]Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J: Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015, 350:h1258.
• [33]Strack M: Organisationskultur im Competing Values Model: Messeigenschaften der deutschen Adaption des OCAI. [Organizational culture in the Competing Values Model: Measurement characteristics of the German adaptation of the OCAI]. Journal-BMP 2012, 3:30-41.
• [34]Hamers JP, Meyer G, Köpke S, Lindenmann R, Groven R, Huizing AR: Attitudes of Dutch, German and Swiss nursing staff towards physical restraint use in nursing home residents: A cross-sectional study. Int J Nurs Stud. 2009, 46:248-55.
• [35]Lindenmann R. Freiheitsbeschränkende Maßnahmen: Einstellung von Pflegepersonen und Prävalenz in den öffentlichen geriatrischen Institutionen der Stadt Luzern. [Physical restraints: Attitudes of nursing staff and prevalence in state-run geriatric institutions in the city of Luzern]. Master's thesis. Maastricht University, Maastricht, the Netherlands; 2006
• [36]Meyer G, Wegscheider K, Kersten JF, Icks A, Mühlhauser I: Increased use of hip protectors in nursing homes: economic analysis of a cluster randomized, controlled trial. J Am Geriatr Soc. 2005, 53:2153-8.
• [37]Donner A, Klar N: Design and Analysis of Cluster Randomization Trials in Health Research. Arnold, London; 2000.
• [38]Brown H, Prescott R. Applied Mixed Models in Medicine. Statistics in Practice. 2nd ed. John Wiley & Sons; 2006.
• [39]Mayring P: Qualitative Inhaltsanalyse. Grundlagen und Techniken. [Qualitative content analysis. Basics and techniques]. 11th ed. Beltz, Weinheim; 2010.
• [40]Briggs AH, Wonderling DE, Mooney CZ: Pulling cost-effectiveness analysis up by its bootstraps: a non-parametric approach to confidence interval estimation. Health Econ. 1997, 6:327-40.
• [41]Hunink MG, Bult JR, de Vries J, Weinstein MC: Uncertainty in decision models analyzing cost-effectiveness: the joint distribution of incremental costs and effectiveness evaluated with a nonparametric bootstrap method. Med Decis Making. 1998, 18:337-46.
• [42]Fenwick E, Claxton K, Sculpher M: Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Econ. 2001, 10:779-87.
• [43]Fenwick E, O'Brien BJ, Briggs A: Cost-effectiveness acceptability curves--facts, fallacies and frequently asked questions. Health Econ. 2004, 13:405-15.
• [44]Meyer G, Warnke A, Bender R, Mühlhauser I: Effect on hip fractures of increased use of hip protectors in nursing homes: cluster randomised controlled trial. BMJ. 2003, 326:76.
• [45]Meyer G, Köpke S, Haastert B, Mühlhauser I: Comparison of a fall risk assessment tool with nurses' judgement alone: a cluster-randomised controlled trial. Age Ageing. 2009, 38:417-23.
• [46]Campbell MK, Piaggio G, Elbourne DR, Altman DG: Consort 2010 statement: extension to cluster randomised trials. BMJ 2012, 345:Article ID e5661.