A Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes (PEI)
25. januar 2017 opdateret af: Norwegian University of Science and Technology
A Pilot Study to Evaluate Feasibility of Educational Programs With Regard to Good Fecal Incontinence Care in Nursing Homes
The investigators are planning to do a cluster randomized trial to test the effect of different educational programs for staff according to nursing home patients FI (fecal incontinence).
Since there are very few published trials of treatment of FI in older people, and no rigorously evaluated studies on interventions for FI in nursing homes, or rigorously evaluated continence education program for staff concerning continence care, a pilot study is necessary.
The aim for the pilot study is to evaluate feasibility, acceptability and adherence according to the educational intervention, methods used and outcome measures.
This is designed to be an external pilot study.
External pilot studies are small scale versions of the main study which are not intended to be part of the main study.
The pilot intervention period is 3 month.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Trondheim, Norge, 7004
- Sør-Trøndelag University College
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Nursing homes Wards with 24 hour long term care residency, similar nurse/patient ratio and General Practitioner consultancy, comparable patient groups according to frailty, comparable ward size according to number of patients and staff.
- Patients All patients on long term residency (1 month or more) are eligible for measurements.
- Registered nurses (RN) and authorized social educators (ASE) RN's and ASE's with position above 50% are eligible according to participation in the educational meeting and to be recruited as a local opinion leader in intervention 2. All staff is invited to the educational outreach meetings throughout the intervention period.
Exclusion Criteria:
- Nursing homes with diverse staff and patient composition
- Patients on short term residency
- Registered nurses (RN) and authorized social educators (ASE) RN's and ASE's with position less than 50%
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Educational and counselling program
In addition to educational meeting and printed educational material the investigators will include the use of local opinion leaders and educational outreach
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Educational and counselling program: In addition to educational meeting and printed educational material the investigators will include the use of local opinion leaders and educational outreach .
Local opinion leaders are defined as "use of providers nominated by their colleges as educationally influential".
Opinion leadership is the degree to which an individual is able to influence other individual's attitudes or overt behavior informally in a desired way with relative frequency.
Educational outreach is defined as "use of a trained person who meets with providers in their practice setting to give information with the intent of changing the providers practice."
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Aktiv komparator: Educational program
The investigators want to organize the educational meetings as an interactive workshop that target knowledge, attitudes, and skills at the individual healthcare professional/peer group level.
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Educational program: Educational meeting and printed educational material Educational meeting is defined as "participation of healthcare providers in conference, lectures, workshops or traineeships".
The investigators want to organize the educational meetings as an interactive workshop that target knowledge, attitudes, and skills at the individual healthcare professional/peer group level.
Printed educational material is defined as "distribution of published or printed recommendations for clinical care, including clinical practice guidelines".
In general, printed educational material target knowledge and potential skill gaps of individual healthcare professionals.
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Ingen indgriben: Control group
The control group will not receive any educational program.
It represents the present real life in nursing homes.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The proportion patients assessed by the clinical guidelines
Tidsramme: 3 months
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90% of the patients assessed by the clinical guideline
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3 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of completed patient health questionnaires
Tidsramme: 3 months
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Response rate more than 80%
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3 months
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Acceptable performance of multiple choice test measuring change in staff knowledge.
Tidsramme: 3 months
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80% claim that the test set understandable and relevant
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3 months
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The proportion of missing data in each completed questionnaire
Tidsramme: 3 months
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Less than 10%
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3 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Lene Blekken, DrPH, Norwegian University of Science and Technology
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2013
Primær færdiggørelse (Faktiske)
1. januar 2014
Studieafslutning (Faktiske)
1. april 2014
Datoer for studieregistrering
Først indsendt
4. juli 2013
Først indsendt, der opfyldte QC-kriterier
6. september 2013
Først opslået (Skøn)
11. september 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. januar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. januar 2017
Sidst verificeret
1. januar 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HIST
- ES507368 (Anden identifikator: Sør-Trøndelag University College, Norway)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .