Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Time Together: A Multi-site Nursing Intervention Project Using a Single System Experimental Design (TT)

24 oktober 2017 bijgewerkt door: Umeå University

The aim of this project is to test and evaluate a nursing intervention, Time Together (TT), created to enable quality interactions between patients and staff in psychiatric inpatient care. The research questions are:

Does TT influence the quality of interactions between staff and patients? Does TT influence patients' levels of anxiety and depressive symptoms? Does TT influence staffs' levels of perceived stress and levels of stress of conscience? Does TT influence the prevalence of coercive measures, mean length of hospital stay and the use of PRN medication?

In parallel, a process evaluation will be conducted, answering questions such as:

How do staff and patients describe their experiences of the intervention and how do contextual factors influence the effects of the intervention? What are the relationship between the outcome variables and the degree of compliance with the intended intervention? What problems are there with recruitment and dropouts?

Studie Overzicht

Toestand

Onbekend

Interventie / Behandeling

Gedetailleerde beschrijving

BACKGROUND:

Despite the long known significance of the nurse-patient relationship, research in psychiatric inpatient care still reports on unfulfilled expectations of, and difficulties in interactions and relationships between patients and staff. As one solution to the contemporary circumstances, interventions that creates structures that allow quality interactions between patients and staff are needed.

INTERVENTION TT is an intervention, developed from the intervention Protected Engagement Time. The structure of TT is that staff, for a fixed time during the day, dedicates their time to exclusively engage with the patients. Other duties of more administrative nature, visits and meetings are organized to be performed at other times during the day. This structure will be tested at three psychiatric inpatient care wards in the north of Sweden.

DESIGN AND METHODS An experimental single system design (A-B-Follow-up) will be used. As TT will be introduced as a routine ward activity during the B phase, all patients and staff on the participating wards will be participating in TT. However, participating in the evaluation will be voluntary. Data will be collected through questionnaires once every seventh weekday during 5 weeks for the A phase, and 12 weeks during B phase.

In parallel, a process evaluation will be conducted using semi structured interviews and participating observations.

Studietype

Ingrijpend

Inschrijving (Verwacht)

3

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion criteria for patients:

  • 18 years or older
  • Admitted to the wards during either A phase, B phase and/or follow-up
  • Experience of at least one TT session is required to participate in the B phase

Exclusion criteria for patients:

- Does not master the Swedish language well enough to complete questionnaires and participate in interviews.

Inclusion criteria for staff:

- Regularly employed at the ward during A and B phase and/or follow-up.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Time Together
Time Together as described under "Interventions"
For a fixed time during the day, staff dedicates their time to exclusively engage with the patients. Different activities will be offered to both patients and staff, such as playing board games, taking a walk, or having individual conversations. Other duties of more administrative nature, visits and meetings will be performed at other times during the day. Through this, opportunities for interaction are both created and protected.
Andere namen:
  • Protected Engagement Time

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Quality of interactions [patients]
Tijdsspanne: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
This is measured using The Caring Professional Scale (CPS) that consists of 14 items answered on a 5-point Likert scale.
Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
Perceived stress [staff]
Tijdsspanne: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
PSS consists of 10 items answered on a 5-point Likert scale
Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Global quality of interactions [patients, staff]
Tijdsspanne: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
A 100 mm Visual Analogue Scale expressing the most positive and the most negative rating will be anchored at each end
Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
Anxiety and depressive symptoms [patients]
Tijdsspanne: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
The Hospital Anxiety and Depression Scale (HAD) will be used to measure anxiety and depressive symptoms. All items are scored on a 4-point scale.
Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
Stress of Conscience [staff]
Tijdsspanne: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
The Stress of Conscience Questionnaire (SCQ) will be used to measure the frequencies of stressful situations and the degree to which these lead to stress of conscience among staff.
Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
Quality of care [staff]
Tijdsspanne: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
The Quality in Psychiatric Care- Inpatient Staff (QPC-IPS) questionnaire will be used to measure quality of care.
Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
Number of PRN medications given
Tijdsspanne: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
Data will be retrieved from ward registers.
Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
Length of hospital stay
Tijdsspanne: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
Data will be retrieved from ward registers.
Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
Use of coercion and violent situations
Tijdsspanne: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
Data will be retrieved from ward registers.
Changes during baseline and intervention period (measured weekly for a total of 16 weeks)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2017

Primaire voltooiing (Werkelijk)

1 juni 2017

Studie voltooiing (Verwacht)

1 november 2017

Studieregistratiedata

Eerst ingediend

1 december 2016

Eerst ingediend dat voldeed aan de QC-criteria

1 december 2016

Eerst geplaatst (Schatting)

5 december 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 oktober 2017

Laatste update ingediend die voldeed aan QC-criteria

24 oktober 2017

Laatst geverifieerd

1 november 2016

Meer informatie

Termen gerelateerd aan deze studie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren