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

24 ottobre 2017 aggiornato da: 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?

Panoramica dello studio

Stato

Sconosciuto

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

3

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altri nomi:
  • Protected Engagement Time

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of interactions [patients]
Lasso di tempo: 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]
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Global quality of interactions [patients, staff]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

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Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2017

Completamento primario (Effettivo)

1 giugno 2017

Completamento dello studio (Anticipato)

1 novembre 2017

Date di iscrizione allo studio

Primo inviato

1 dicembre 2016

Primo inviato che soddisfa i criteri di controllo qualità

1 dicembre 2016

Primo Inserito (Stima)

5 dicembre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 ottobre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 ottobre 2017

Ultimo verificato

1 novembre 2016

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 350000210

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Time Together

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