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The implementation of the Dutch Serial Trial Intervention (STA OP!).


- candidate number6353
- NTR NumberNTR1967
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-aug-2009
- Secondary IDs2009/119 METc, VU Medical Center
- Public TitleThe implementation of the Dutch Serial Trial Intervention (STA OP!).
- Scientific TitleThe implementation of the serial trial intervention for pain and challenging behavior in advanced dementia patients in Dutch nursing homes, "STA OP!".
- ACRONYMSTA OP
- hypothesisPain (physical discomfort) and challenging behavior are highly prevalent in nursing home residents with dementia. It has been shown that pain is undertreated in this group, and that psychosocial interventions for behavioral problems are, allthough effective, not adequately implemented. Too often psychoactive medication is used to control these behaviors. A stepwise protocol (the Serial Trail Intervention, STI) has been shown to be effective in US nursing homes in controlling pain and challenging behavior. This protocol has been translated and adapted for the Dutch nursing homes.

To study the effects of implementation of the Dutch STI on pain and challenging behavior. The Research-questions are:
1. Is the use of the STI-protocol more effective than usual care in reducing symptoms of pain and challenging behavior in nursing home residents?
2. Does the use of the STI-protocol lead to less depressive symptoms and a better quality of life in advanced dementia patients?
3. Does the STI-protocol lead to change of use in analgesics and psychotropic drugs?
4. Does the use of the STI-protocol lead to a more frequent use of comfort interventions?
- Healt Condition(s) or Problem(s) studiedDementia, Pain, Challenging behaviour
- Inclusion criteria1. Global Detoriation Scale (Reisberg 1983), (GDS) > 5;
2. No chronic psychiatric diagnosis other than dementia;
3. CMAI > 44, NPI > 4, MDS-pain = pain.
In all included residents:
1. PACSLAC-D (pain observations);
2. Depression (Cornell and MDS-depression);
3. Quality of Life (Qualidem);
4. ADL (Katz);
5. Co-morbidity (ICD-10);
6. Demographics;
7. Apo-E4 (Buccal mucosa swab).
- Exclusion criteria1. GDS-score < 5;
2. Chronic psychiatric diagnosis other than dementia.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2009
- planned closingdate1-sep-2011
- Target number of participants168
- InterventionsIn 5 meetings of 4 hrs each, nurses and nursing home physicians of all experimental wards are trained in the use of the steps in the protocol. The training is given by two collaborating, experienced trainers: one is an advanced practice nurse and the other has a medical background, while both have specific expertise regarding dementia, pain and discomfort. In the sessions it will be discussed how nurses and nursing home physicians can recognize symptoms related to pain and affective discomfort, and how nurses and physicians can communicate with each other about these symptoms. It is also discussed in general, when a subsequent protocol step is needed when targeted assessments are negative or when the symptoms related to pain or affective discomfort have not been reduced sufficiently by targeted interventions. These targeted interventions will include non-pharmaclogical (e.g. snoezelen, psychosocial interventions, movement) and pharmacological interventions in a stepwise manner.

The STI-protocol consists of five steps:
1. The FIRST step is to perform a physical needs assessment that focuses on probable causes of behavioural symptoms related to pain or affective discomfort;
2. The SECOND step is to perform a needs assessment that focuses on affective needs of people with dementia;
3. The THIRD step concerns a trial of non-pharmacological comfort interventions;
4. The FOURTH step is a trial of analgesics;
5. STEP FIVE refers to consultation of other health care professionals or practitioners, or a trial of psychotropic drugs.
- Primary outcomePain: measured with painscale of the Dutch version of the MDS-RAI and PACSLAC-D Behavior: CMAI, NPI-NH.
- Secondary outcome1. Depression: Cornell-depression and MDS-DRS;
2. Quality of Life: Qualidem;
3. Use of anti-psychotic medication.
- TimepointsMeasurements take place at baseline and after 3 and 6 months after baseline.
- Trial web sitehttp://www.vumc.nl/afdelingen/UNO/StemmingEnGedrag/StaOpOnderzoek/
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. M.J.C. Pieper
- CONTACT for SCIENTIFIC QUERIESDrs. M.J.C. Pieper
- Sponsor/Initiator VU University Medical Center, EMGO Institute
- Funding
(Source(s) of Monetary or Material Support)
Innovatiefonds zorgverzekeraars
- PublicationsN/A
- Brief summaryPain (physical discomfort) and challenging behavior are highly prevalent in nursing home residents with dementia. It has been shown that pain is undertreated in this group, and that psychosocial interventions for behavioral problems are, allthoug effective, not adequately implemented. Too often psychoactive medication is used to control these behaviors. A stepwise protocol (the Serial Trail Intervention, STI) has been shown to be effective in US nursing homes in controlling pain and challenging behavior. This protocol has been translated and adapted for the Dutch nursing homes.

In 5 meetings of 4 hrs each, nurses and nursing home physicians of all experimental wards are trained in the use of the steps in the protocol. The training is given by two collaborating, experienced trainers: one is an advanced practice nurse and the other has a medical background, while both have specific expertise regarding dementia, pain and discomfort. In the sessions it will be discussed how nurses and nursing home physicians can recognize symptoms related to pain and affective discomfort, and how nurses and physicians can communicate with each other about these symptoms. It is also discussed in general, when a subsequent protocol step is needed when targeted assessments are negative or when the symptoms related to pain or affective discomfort have not been reduced sufficiently by targeted interventions. These targeted interventions will include non-pharmaclogical (e.g. snoezelen, psychosocial interventions, movement) and pharmacological interventions in a stepwise manner.

The STI-protocol consists of five steps:
1. The FIRST step is to perform a physical needs assessment that focuses on probable causes of behavioural symptoms related to pain or affective discomfort;
2. The SECOND step is to perform a needs assessment that focuses on affective needs of people with dementia;
3. The THIRD step concerns a trial of non-pharmacological comfort interventions;
4. The FOURTH step is a trial of analgesics;
5. STEP FIVE refers to consultation of other health care professionals or practitioners, or a trial of psychotropic drugs.
- Main changes (audit trail)
- RECORD26-aug-2009 - 25-sep-2012


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