A Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes (PEI)
25. januar 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Trondheim, Norge, 7004
- Sør-Trøndelag University College
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
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."
|
|
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.
|
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.
|
|
Ingen inngripen: Control group
The control group will not receive any educational program.
It represents the present real life in nursing homes.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The proportion patients assessed by the clinical guidelines
Tidsramme: 3 months
|
90% of the patients assessed by the clinical guideline
|
3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of completed patient health questionnaires
Tidsramme: 3 months
|
Response rate more than 80%
|
3 months
|
|
Acceptable performance of multiple choice test measuring change in staff knowledge.
Tidsramme: 3 months
|
80% claim that the test set understandable and relevant
|
3 months
|
|
The proportion of missing data in each completed questionnaire
Tidsramme: 3 months
|
Less than 10%
|
3 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Lene Blekken, DrPH, Norwegian University of Science and Technology
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2013
Primær fullføring (Faktiske)
1. januar 2014
Studiet fullført (Faktiske)
1. april 2014
Datoer for studieregistrering
Først innsendt
4. juli 2013
Først innsendt som oppfylte QC-kriteriene
6. september 2013
Først lagt ut (Anslag)
11. september 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
26. januar 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. januar 2017
Sist bekreftet
1. januar 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HIST
- ES507368 (Annen identifikator: Sør-Trøndelag University College, Norway)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .