NCT02956694

Brief Summary

The increasing prevalence of Alzheimer's disease and other forms of dementia causes new challenges to ensure that healthcare decisions are informed by research evidence and reflect what is important for seniors and their caregivers. Primary care providers point to a need for more training on communication with families of seniors living with dementia, and on the non-pharmacological health options that are often recommended before use of medications.Therefore, the investigators will design and evaluate an intervention to train primary healthcare providers on how to empower seniors with dementia and their caregivers in making health-related decisions based on research evidence and on their preferences and priorities. A distance professional training program on shared decision making will initially be designed, comprising evidence summaries to be shared with patients living with dementia and their caregivers who face difficult decisions. Patients with dementia, their caregivers and healthcare providers, will then provide feedback on the training program, which will then be improved following their suggestions. In a last step, the investigators will study the processes required to implement this training program and measure its effects on provider knowledge and intention to adopt shared decision making.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2018

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

October 31, 2016

Last Update Submit

March 19, 2020

Conditions

Keywords

AgedCognitive impairmentNeurocognitive DisordersShared decision makingDistance learningPrimary careDecision support toolPatient decision aid

Outcome Measures

Primary Outcomes (3)

  • Change in healthcare providers' intention to adopt shared decision making

    Participants' intention to use shared decision making with their next patient facing a preference-sensitive decision, and the determinants of this intention (attitude, beliefs about capabilities, moral norm, and social influence), using a brief 5-item version of the CPD-REACTION (Légaré et al. Development of a Simple 12-Item Theory-Based Instrument to Assess the Impact of Continuing Professional Development on Clinical Behavioral Intentions. PLoS One. 2014; 9(3): e91013.

    Right before training, and then one week after the end of training

  • Change in healthcare providers' knowledge

    This outcome comprises: knowledge about shared decision making, knowledge about risk communication, perceived awareness of the options. It also comprises variables to assess clinical knowledge on deprescribing anti-psychotics, on the impacts of stopping driving, on the strategies to communicate about stopping driving, on the risk factors for caregiver burden, on the awareness of the information to provide patients to reflect upon the power of attorney, on the elements to check prior to recommending a treatment to a vulnerable senior. Two questions were inspired by the Ottawa Decision Support Framework to assess participants' knowledge about SDM (https://decisionaid.ohri.ca/docs/develop/ODSF.pdf); and 10 questions included case-based scenarios,to assess clinical knowledge relative to the care of older adults living with NCD, and reflected the basic principles to develop constructed-response items \[28\].

    Right before training, and then one week after the end of training

  • Change in Healthcare providers' role preference

    Healthcare professionals' preferred role in decision-making (Strull WM, Lo B, Charles G. Do patients want to participate in medical decision making? JAMA.

    Right before training, and then one week after the end of training

Study Arms (1)

Professional training

EXPERIMENTAL

Professional e-learning program on shared decision making including two components: (1) a self-directed e-learning activity on shared decision making, lasting about 1 hour, that participants could complete in several sittings; and (2) five evidence summaries named Decision Boxes (DBs).

Behavioral: Professional e-learning program on shared decision making

Interventions

Clinicians will have access to a, e-learning program on shared decision making (e-TUDE) during one month. They will also receive five Decision Boxes (DB) dealing with difficult decisions often faced by seniors with dementia and their caregivers in primary care. They will receive five DBs by email, at a rate of 1 per week for 5 weeks.

Professional training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthcare professionals from various professions (e.g., family physicians, nurses, and social workers) who practice in family medicine clinics and homecare services in the province of Quebec, Canada.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Réseau de Recherche Axée sur les Pratiques de Première Ligne Université Laval (RRAPPL-UL)

Québec, G1V 0A6, Canada

Location

Related Publications (1)

  • Giguere AMC, Lawani MA, Fortier-Brochu E, Carmichael PH, Legare F, Kroger E, Witteman HO, Voyer P, Caron D, Rodriguez C. Tailoring and evaluating an intervention to improve shared decision-making among seniors with dementia, their caregivers, and healthcare providers: study protocol for a randomized controlled trial. Trials. 2018 Jun 25;19(1):332. doi: 10.1186/s13063-018-2697-1.

MeSH Terms

Conditions

DementiaCognitive DysfunctionNeurocognitive Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesMental DisordersCognition Disorders

Study Officials

  • Anik MC Giguere, PhD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: We evaluated the effectiveness of the intervention, here a training program, using a pre-post design, and also assessed the barriers and facilitators to completing the training program.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assitant Professor

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 7, 2016

Study Start

October 1, 2016

Primary Completion

October 8, 2018

Study Completion

October 8, 2018

Last Updated

March 23, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The data will be available after the study is published.
Access Criteria
Contact the trial sponsor at anik.giguere@fmed.ulaval.ca

Locations