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

24 oktober 2017 uppdaterad av: 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?

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

3

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Time Together
Time Together as described under "Interventions"
Övrig: Time Together
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.
Andra namn:
  • Protected Engagement Time

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Quality of interactions [patients]
Tidsram: 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]
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Global quality of interactions [patients, staff]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Umeå University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2017

Primärt slutförande (Faktisk)

1 juni 2017

Avslutad studie (Förväntat)

1 november 2017

Studieregistreringsdatum

Först inskickad

1 december 2016

Först inskickad som uppfyllde QC-kriterierna

1 december 2016

Första postat (Uppskatta)

5 december 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 oktober 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 oktober 2017

Senast verifierad

1 november 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 350000210

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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Kliniska prövningar på Time Together

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