Intervention to Improve Shared Decision Making Among Seniors With Dementia, Their Caregivers and Healthcare Providers

NCT ID: NCT02956694

Last Updated: 2020-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2018-10-08

Brief Summary

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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.

Detailed Description

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Background: The increasing prevalence of Alzheimer's disease and other forms of dementia causes new challenges in primary care. Indeed, primary care providers point to a need for more training to care for this population, especially seniors presenting behavioural and psychological symptoms of dementia. They also find the inter-professional nature of care, and the need to communicate with community services and families, very challenging. Moreover, patients living with dementia and their caregivers consistently report their need for more information about dementia. Therefore, in a recent survey, the investigators sought five difficult decisions that patients living with dementia and their informal caregivers often face in primary care settings. In the current study, they propose to tailor and evaluate an e-learning professional training program on shared decision making, comprising evidence summaries on the health options to consider before making these five difficult decisions. This tailored training program is expected to improve shared decision making between clinicians and patients with dementia and their caregivers, and in turn improve patient and caregiver empowerment in relation to their own health care.

Methods: In two phases, the aims of this study are to (1) design and tailor the intervention, and (2) implement and evaluate it. In the first phase, theory and user-centred design will be used to tailor a multifaceted intervention comprising a distance professional training program on shared decision making, and five shared decision-making tools dealing with difficult decisions often faced by seniors with dementia and their caregivers. Each tool will be designed in two versions, one for clinicians, and one for patients/caregivers. Forty-nine clinicians and 27 patients/caregivers will be invited to participate to three cycles of design-evaluation-feedback of each intervention components. Besides think-aloud and interview approaches, they will also complete questionnaires to identify the factors most likely to influence their adoption of shared decision making after exposure to the intervention. Thereafter, the intervention will be modified by adding/enhancing behaviour-change techniques targeting these factors. In the second phase, the effectiveness of this tailored intervention will be evaluated before/after implementation, in a two-armed, clustered randomized trial with a three-month follow-up. A convenience sample of primary care clinics and home care services will be enrolled in the province of Quebec (Canada), and health care providers who practice there will be recruited (mostly family physicians, nurses, and social workers). We will record participants' access to training component, and conduct telephone interviews with a purposeful sample of participants, half of whom completed training and the other half whom did not. The participants will also complete a survey before and after training, to assess their knowledge, and intention to adopt shared decision making. Three researchers will conduct a thematic qualitative analysis of the interviews, as per the theory of planned behaviour. We performed bivariate analyses with the survey data.

Discussion: The results of this study will allow modifying the training program to improve participation rates and, ultimately, uptake of meaningful sjared decision making with patients living with dementia.

Conditions

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Dementia Professional-Patient Relations Professional-Family Relations Aging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Professional training

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).

Group Type EXPERIMENTAL

Professional e-learning program on shared decision making

Intervention Type BEHAVIORAL

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.

Interventions

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Professional e-learning program on shared decision making

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

None.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministère de l'Économie, de l'Innovation et de l'Exportation du Québec

UNKNOWN

Sponsor Role collaborator

SOVAR

UNKNOWN

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role collaborator

Anik Giguère

OTHER

Sponsor Role lead

Responsible Party

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Anik Giguère

Assitant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anik MC Giguere, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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

Québec, , Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 29941020 (View on PubMed)

Other Identifiers

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2014-2015-PSVT2-31404

Identifier Type: -

Identifier Source: org_study_id

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