- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02981563
Time Together: A Multi-site Nursing Intervention Project Using a Single System Experimental Design (TT)
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
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
Iscrizione (Anticipato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
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
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:
|
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
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
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 .
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