Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Effect of a multifaceted educational program for care staff concerning fecal incontinence in nursing home patients: study protocol of a cluster randomized controlled trial

Authors: Lene Elisabeth Blekken, Anne Guttormsen Vinsnes, Kari Hanne Gjeilo, Siv Mørkved, Øyvind Salvesen, Christine Norton, Sigrid Nakrem

Published in: Trials | Issue 1/2015

Login to get access

Abstract

Background

Fecal incontinence has a high prevalence in the older population, which cannot be explained by comorbidity or the anatomical or psychological changes of aging alone. Fecal incontinence leads to a high economic burden to the healthcare system and is an important cause of institutionalization. In addition, fecal incontinence is associated with shame, social isolation and reduced quality of life. The importance of identifying treatable causes in the frail elderly is strongly emphasized. It is recommended that an assessment of fecal incontinence should be implemented as part of an evaluation of older patients. Although there is a substantial evidence base to guide choice of implementation activities targeting healthcare professionals, little implementation research has focused on the care of older people nor involved care processes or care personnel. This study is based on the assumption that fecal incontinence among nursing home patients can be prevented, cured or ameliorated by offering care staff knowledge of best practice through a multifaceted educational program. The primary objective is to test the hypothesis that a multifaceted educational program for nursing home care staff on assessment and treatment of fecal incontinence reduces patients’ frequency of fecal incontinence.

Methods/design

The study is a two-armed, parallel cluster-randomized controlled trial. Primary outcome is the frequency of fecal incontinence among patients. Sample size calculations resulted in a need for a total sample of 240 patients. Twenty nursing home units in one city in Norway will be recruited and allocated to intervention or control by an independent statistician using computer-generated tables. The intervention is a multifaceted educational program. Units in the control arm will provide care as usual. The intervention period is 3 months. Data will be collected at baseline, 3, and 6 months. Data will be analyzed using mixed effect models with the cluster treated as a random effect.

Discussion

This study is the first randomized controlled trial specifically focusing on this neglected area. The result of the study will give evidence for best practice for continence care in nursing homes, and organizational advice concerning implementation strategies.

Trial registration

ClinicalTrials.gov: NCT02183740, registered June 2014.
Literature
1.
2.
Shah BJ, Chokhavatia S, Rose S. Fecal incontinence in the elderly: FAQ. Am J Gastroenterol. 2012;107:1635–46.CrossRefPubMed
3.
Aslan E, Beji NK, Erkan HA, Yalcin O, Gungor F. The prevalence of and the related factors for urinary and fecal incontinence among older residing in nursing homes. J Clin Nurs. 2009;18:3290–8.CrossRefPubMed
4.
Schnelle JF, Kapur K, Alessi C, Osterweil D, Beck JG, Al-Samarrai NR, et al. Does an exercise and incontinence intervention save healthcare costs in a nursing home population? J Am Geriatr Soc. 2003;51:161–8.CrossRefPubMed
5.
6.
Saga S, Vinsnes AG, Mørkved S, Norton C, Seim A. Prevalence and correlates of fecal incontinence among nursing home residents: a population-based cross-sectional study. BMC Geriatr. 2013;13:87.CrossRefPubMedPubMedCentral
7.
O’Connell B, Ostaszkiewicz J, Day K. The challenge of managing continence care in residential aged care settings: recommendations for research and practice. Geriaction. 2005;23:5–18.
8.
Kenefick N. The epidemiology of Faecal Incontinence. In: Norton C, Chelvanayagam S, editors. Bowel continence nursing. Beaconfield: Beaconfield Publisher Ltd; 2004. p. 14–22.
9.
Taylor DW, Cahill JJ, Rizk DEE. Denial, shame and acceptance: generating base-line knowledge and understanding of fecal incontinence amongst long-term care residents and care providers. Publ Health Res. 2014;4:13–8.
10.
Harari D. Bowel care in old age. In: Norton C, Chelvanayagam S, editors. Bowel continence nursing. Beaconfield: Beaconfield Publisher Ltd; 2004. p. 132–49.
11.
Mangnall J, Taylor P, Thomas S, Watterson L. Continence problems in care homes: auditing assessment and treatment. Nurs Older People. 2006;18:20–2.CrossRefPubMed
12.
Thekkinkattil DK, Lim M, Finan PJ, Sagar PM, Burke D. Awareness of investigations and treatment of faecal incontinence among the general practitioners: a postal questionnaire survey. Colorectal Dis J Assoc Coloproctol. 2008;10:263–7.CrossRef
13.
14.
Grimshaw JM, Eccles MP, Lavis JN, Hill SJ, Squires JE. Knowledge translation of research findings. Implement Sci. 2012;7:3–17.CrossRef
15.
Mezirow & Associates. Learning as transformation. San Fransisco: Jossey Bass; 2000.
16.
Argyris C. Organisatorisk læring - singel - og double loop. In: Illeris K, editor. Tekster om læring. Fredriksberg: Roskilde Universitets Forlag; 2000.
17.
Grol R, Grimshaw J. From best evidence to best practice: effective implementation of change in patients’ care. Lancet. 2003;362:1225–30.CrossRefPubMed
18.
Boström A-M, Slaughter SE, Dagmara C, Estabrooks C. What do we know about knowledge translation in the care of older adults? A scoping review. J Am Med Dir Assoc. 2012;13:210–9.CrossRefPubMed
19.
Titler M. The evidence for evidence-based practice implementation. In: Hughes RG, editor. Patient safety and Quality: An evidence-Baced Handbook for Nurses. Rockville: AHRQ Publications; 2008.
20.
Craig P, Petticrew M. Developing and evaluating complex interventions: reflections on the 2008 MRC guidance. Int J Nurs Stud. 2013;50:585–7.CrossRefPubMed
21.
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;50:587–92.
22.
Lancaster GA, Campbell MJ, Eldridge S, Farrin A, Marchant M, Muller S. Trials in primary care: statistical issues in the design, conduct and evaluation of complex interventions. Stat Methods Med Res. 2010;19:349–77.CrossRefPubMed
23.
Eldridge S, Kerry SM. A practical guide to cluster randomised trials in health services research. Chichester, West Sussex: John Wiley & Sons; 2012.CrossRef
24.
Ringard Å, Sagan A, Saunes IS, Lindahl AK. Norway: Health system review. Health Sys Transitio. 2013;15:1–162.
25.
26.
Rogers EM. Diffusion of innovations. New York: Free Press; 2003.
27.
Eccles M, Grimshaw J, Walker A, Johnston M, Pitts N. Changing the behavior of healthcare professionals: the use of theory in promoting the uptake of research findings. J Clin Epidemiol. 2005;58:107–12.CrossRefPubMed
28.
Grimshaw JM, Thomas RE, MacLennan G, Fraser C, Ramsay CR, Vale L. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess. 2004;8:1–72.CrossRef
29.
Mezirow J. Transformative learning as discourse. J Transform Educ 2003; doi:10. 1177/1541344603252172.
30.
Kvalsund R. Organisering av kompetanseutvikling i arbeidslivet. In: Aarsand LHE, Tønseth C, Tøsse S, editors. Voksne, læring og kompetanse. Oslo: Gyldendal Akademiske; 2011.
31.
Tøsse S. Historie, praksis, teori og politikk: om kunnskapsgrunnlaget for voksnes læring. Trondheim: Tapir Akademisk Forlag; 2011.
32.
Bulechec G. Nursing Interventions classification (NIC). St Louis: Mosby Elsevier; 2013.
33.
Herdman T. Nursing Diagnoses. Definition and Classification (2012–2014) North America Nursing Diagnosis Associations (NANDA). Chichester: Wiley-Blackwell/NANDA International; 2012.
34.
Flodgren G, Parmelli E, Doumit G, Gattellari M, O’Brien MA, Grimshaw J, et al. Local opinion leaders: effects on professional practice and health care outcomes. Cochrane Database Syst Rev, 2011; doi:10. 1002/14651858. CD000125.pub4.
35.
Norton PG, Murray M, Doupe MB, Cummings GG, Poss JW, Squires JE, et al. Facility versus unit level reporting of quality indicators in nursing homes when performance monitoring is the goal. BMJ Open 2014; doi:10. 1136/bmjopen-2013-004488.
36.
Morris JN, Belleville-Taylor P, Fries BE, Hawes C, Murphy K, Mor V, et al. InterRAI Long-Term Care Facilities (LTCF) Assessment Form and User’s Manual. Version 9.1 norwegian version. Washington, DC: interRAI; 2012.
37.
38.
Sirnes SM. Flervalgsoppgaver - konstruksjon og analyse. Bergen: Fagbokforlaget; 2005.
39.
Nøst TH, Tettum BI, Frigstad SA, Woldstad K, Haugan B, Oppheim AE, et al. N-Catch II – et granskningsinstrument for vurdering av sykepleiedokumentasjon. Sykepleien (In press).
40.
Paans W, Sermeus W, Nieweg RMB. D-Catch instrument: development and psychometric testing of a measurement instrument for nursing documentation in hospitals. J Adv Nurs. 2010;66:1388–400.CrossRefPubMed
41.
Björvell C, Wredling R, Thorell-Ekstrand I. Long-term increase in quality of nursing documentation: effects of a comprehensive intervention. Scand J Caring Sci. 2002;16:34–42.CrossRefPubMed
42.
Eldridge SM, Ashby D, Feder GS, Rudnicka AR, Ukoumunne OC. Lessons for cluster randomized trials in the twenty-first century: a systematic review of trials in primary care. Clin Trials. 2004;1:80–90.CrossRefPubMed
43.
44.
Smeeth L, Ng ES. Intraclass correlation coefficients for cluster randomized trials in primary care: data from the MRC Trial of the Assessment and Management of Older People in the Community. Control Clin Trials. 2002;23:409–21.CrossRefPubMed
45.
Fayers PM, Machin D. Randomized clinical trials: design, practice and reporting. Chichester: Wiley-Blackwell; 2010.
46.
Nylenna M. Helsetjenesten i Norge: et overblikk. Oslo: Gyldendal Akademisk; 2014.
Metadata
Title
Effect of a multifaceted educational program for care staff concerning fecal incontinence in nursing home patients: study protocol of a cluster randomized controlled trial
Authors
Lene Elisabeth Blekken
Anne Guttormsen Vinsnes
Kari Hanne Gjeilo
Siv Mørkved
Øyvind Salvesen
Christine Norton
Sigrid Nakrem
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0595-3

Other articles of this Issue 1/2015

Trials 1/2015 Go to the issue

Study protocol

Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial

Study protocol

A comparison of Percutaneous femoral access in Endovascular Repair versus Open femoral access (PiERO): study protocol for a randomized controlled trial

Study protocol

Treatment of depression and anxiety with internet-based cognitive behavior therapy in patients with a recent myocardial infarction (U-CARE Heart): study protocol for a randomized controlled trial

Erratum

Erratum to: KCTU randomisation and IMP management system

Update

Statistical analysis plan for the Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial (LiGHT): a multi-centre randomised controlled trial

Study protocol

Effects of acupuncture and computer-assisted cognitive training for post-stroke attention deficits: study protocol for a randomized controlled trial