StaN: Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia

Sponsor

Centre for Addiction and Mental Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT03672201

Collaborator

University of Calgary (Other), Lawson Health Research Institute (Other), Douglas Mental Health University Institute (Other)

220

Enrollment

Locations

Arms

40.9

Anticipated Duration (Months)

36.7

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The object of this study to evaluation an Integrated Care Pathway (ICP) to treat Aggression and Agitation in Alzheimer's disease (AD-AA). The ICP is an algorithmic approach to use psychotropic medications and non-pharmacological interventions based on standardized assessments which fosters measurement-based decision making. This study will assess the efficacy of the ICP to treat AD-AA and its impact on inappropriate use of medications in inpatient settings and Long-Term Care Facilities (LTCF).

The investigators will enroll and randomize 220 participants with AD-AA (110 inpatient and 110 LTCFs) to ICP vs. Treatment As Usual. Further, this study will also examine the impact of the ICP on caregiver burden and undertake a cost-effectiveness analysis of the ICP for patients with AD-AA.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease Alzheimer Dementia (AD) Aggression	Behavioral: Non-Pharmacological Intervention Other: Pharmacological Intervention	N/A

Detailed Description

This project will take place in 7 sites across two settings: Inpatient (CAMH in Toronto, Douglas Hospital Research Centre in Montreal, Parkwood Institute in London, and the University of Calgary in Calgary); and LTCFs affiliated with CAMH in Toronto and Parkwood Institute in London.

After a project initiation phase of 6 months, the investigators will enroll and randomize 220 participants with AD-AA (110 inpatient and 110 in LTCFs) to ICP vs.TAU. In this randomized control trial (RCT) phase of the project, participants will be treated for 12 weeks. There will be two primary outcome measures: (i) the Cohen-Mansfield Agitation Inventory (CMAI) Total Frequency Score (CMAI-frequency) and (ii) the proportion of participants on polypharmacy. These measures will be conducted at baseline, end of non-pharmacological intervention phase, the mid-point of pharmacological interventions and end of RCT. Neuropsychiatric Inventory-Questionnaire (NPI-C) will be used to assess global burden of neuropsychiatric symptoms at baseline, end of non-pharmacological intervention phase and exit. The modified Clinical Global Impression of Change (CGIC) will also be measured at predetermined time points throughout the 12 weeks to determine response as defined by CGIC < 3. CGIC is a 7-point Likert scale to rate each patient along a continuum from marked improvement to marked worsening, based on global clinical impression. Rating of < 3 indicates moderate or marked improvement in agitation as compared to baseline. At the end of the RCT, each participant will be naturalistically followed up for an additional 6 months during which the investigators will collect both clinical and health economics data from the Institute for Clinical Evaluative Sciences (ICES) database. The RCT phase will be completed after 18 months, and during the last part of this project, the investigators will analyze the data from the RCT and complete all naturalistic follow-ups.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Participants and assessors will be blind to the group assignment.

Primary Purpose:

Treatment

Official Title:

Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia

Actual Study Start Date :

Nov 1, 2018

Anticipated Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: The Integrated Care Pathway (ICP) Arm The ICP consists of 1) a cleanup phase during which a thorough assessment of pharmacotherapy to discontinue unnecessary medications, is performed; 2) Structured non-pharmacological interventions, which would have started as soon as randomization occurred and would continue before any pharmacological intervention for 2 weeks as stand-alone interventions; and 3) a pharmacological intervention phase: in this phase the medications algorithm for AD-AA is initiated.	Behavioral: Non-Pharmacological Intervention The behavioural intervention will be a structured implementation of individualized activities to be followed and customized as per the needs of the participant. Other Names: Behavioural Intervention Other: Pharmacological Intervention The medication algorithm provides recommendations to the treatment team about algorithmic treatment and assessments as per the ICP but ultimately the decision to prescribe any particular intervention will be the treatment team's decision and the recommendations of the research team for ICP arm will not be binding for the treatment team.
No Intervention: Treatment-As-Usual (TAU) Arm Following eligibility and baseline assessments, half of the participants will be randomized to TAU. TAU will consist of the typical care that the interdisciplinary team provides at each site for AD-AA. No predetermined cleanup phase, non-pharmacological interventions, algorithmic pharmacological interventions will be systematically part of TAU.

Arm

Intervention/Treatment

Active Comparator: The Integrated Care Pathway (ICP) Arm

The ICP consists of 1) a cleanup phase during which a thorough assessment of pharmacotherapy to discontinue unnecessary medications, is performed; 2) Structured non-pharmacological interventions, which would have started as soon as randomization occurred and would continue before any pharmacological intervention for 2 weeks as stand-alone interventions; and 3) a pharmacological intervention phase: in this phase the medications algorithm for AD-AA is initiated.

Behavioral: Non-Pharmacological Intervention

The behavioural intervention will be a structured implementation of individualized activities to be followed and customized as per the needs of the participant.

Other Names:

Behavioural Intervention

Other: Pharmacological Intervention

The medication algorithm provides recommendations to the treatment team about algorithmic treatment and assessments as per the ICP but ultimately the decision to prescribe any particular intervention will be the treatment team's decision and the recommendations of the research team for ICP arm will not be binding for the treatment team.

No Intervention: Treatment-As-Usual (TAU) Arm

Following eligibility and baseline assessments, half of the participants will be randomized to TAU. TAU will consist of the typical care that the interdisciplinary team provides at each site for AD-AA. No predetermined cleanup phase, non-pharmacological interventions, algorithmic pharmacological interventions will be systematically part of TAU.

Outcome Measures

Primary Outcome Measures

Change in Cohen-Mansfield Agitation Inventory - Total Frequency Score (CMAI - Frequency) [Conducted at baseline, 3 weeks, 8 weeks, and 12 weeks]
The Cohen-Mansfield Agitation Inventory (CMAI) Frequency score measures burden of agitation in patients with dementia. CMAI-frequency score ranges between 29 to 203, higher scores indicate worsening of symptoms.
The proportion of participants on polypharmacy [Data collected at baseline, 3 weeks, 8 weeks, and 12 weeks]
The percentage and the total number of participants on 2 or more psychotropics

Secondary Outcome Measures

The impact of the ICP on falls [Every 2 weeks]
Recording the number of falls

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

A clinical diagnosis of Dementia of Alzheimer's or Mixed type using the Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5) criteria
AD-AA as defined by Agitation in cognitive disorders; International Psychogeriatric Association provisional consensus clinical and research definition
Participant or substitute decision maker (SDM) able and willing to provide consent for enrollment in the study
50 years or older
Medical stability to participate in the trial.

Exclusion Criteria:

Having dementia other than Alzheimer's or Mixed type.
DSM-5 diagnoses other than dementia that is thought to be significantly impacting the presentation of AD-AA such as delirium, bipolar disorder, or major depressive disorder.
Any other reason which in the opinion of study investigator will make the study participation intolerable for the participant.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Calgary	Calgary	Alberta	Canada	T2N 1N4
2	Providence Care	Kingston	Ontario	Canada	K7L 4X3
3	LAWSON Health Research Institute	London	Ontario	Canada	N6C 2R5
4	Centre for Addiction and Mental Health	Toronto	Ontario	Canada	M6J 1H4
5	Ontario Shores Centre for Mental Health Sciences	Whitby	Ontario	Canada	L1N 5S9
6	Douglas Hospital Research Centre	Montréal	Quebec	Canada	H4H 1R3