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

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ClinicalTrials.gov Identifier: NCT02956694
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Collaborators:
Ministère de l’Économie, de l’Innovation et de l’Exportation du Québec
SOVAR
Laval University
Information provided by (Responsible Party):
Anik Giguère, Laval University

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 evaluate whether this training program truly increases the participation of patients and their caregivers in decision making, their comfort with the decision that they have made, and their motivation and ability to control their life by taking care of their own health.

Condition or disease Intervention/treatment Phase
Dementia Professional-Patient Relations Professional-Family Relations Aging Behavioral: Training of clinicians + tools Other: Usual care Not Applicable

Detailed Description:

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 6 primary care clinics will be enrolled in the province of Quebec (Canada), and clinicians who practice there will be recruited (mostly family physicians, nurses, and social workers). These clinics will then be randomized to immediate exposure to the intervention, or usual care with delayed exposure to the intervention. Overall, 180 seniors with dementia, their caregivers, and their healthcare providers will be recruited. The investigators will evaluate impact of the intervention on patient involvement in the decision making process, decisional comfort, patient and caregiver personal empowerment in relation to their own health care, patient quality of life, caregiver burden, and decisional regret.

Discussion: The intervention will empower patients and their caregivers in their health care, by fostering their participation as partners during the decision-making process, and by ensuring they make informed decisions congruent with their values and priorities.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Design, Implementation and Evaluation of a Tailored Intervention to Improve Shared Decision Making Among Seniors With Dementia, Their Caregivers and Healthcare Providers
Study Start Date : October 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Training of clinicians + tools
Distance training program on shared decision making for clinicians (e-TUDE) + 5 Decision Boxes (DB) dealing with difficult decisions often faced by seniors with dementia and their caregivers in primary care, each designed in 2 versions, one adapted to clinicians (C-DB), and a simplified version adapted to patients/caregivers (P-DB).
Behavioral: Training of clinicians + tools
The clinicians will have access to a distance training 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. Each DB will be designed in two versions, one adapted to clinicians (C-DB), and a simplified version adapted to patients/caregivers (P-DB). They will receive the five C-DBs by email, at a rate of 1 per week for 5 weeks. Furthermore, they will also be invited to use the 5 P-DBs with their patients. To this end, they will receive a stack of printed copies of the P-DBs for use in home care consultations, and we will also leave some copies in a wall file in each consultation room of the clinic.
Usual care
Clinical practice as usual and access to the training program after the end of the study data collection.
Other: Usual care
Healthcare providers from the clinics allocated to the control group will practice as usual and have access to the same training program after the end of the study data collection (delayed intervention).



Primary Outcome Measures :
  1. Change in healthcare empowerment of patients (able patient) [ Time Frame: Baseline (T0: within one hour before çlinical consultation), 3 months after clinical consultation (T3) ]
    Structured interview, measured using the Healthcare Empowerment Questionnaire (HCEQ)

  2. Change in healthcare empowerment of caregivers [ Time Frame: Baseline (T0: within one hour before clinical consultation), 3 months after clinical consultation (T3) ]
    Structured interview, measured using the Healthcare Empowerment Questionnaire (HCEQ)


Secondary Outcome Measures :
  1. Patient decisional comfort (able patient) [ Time Frame: Within one hour after clinical consultation (T2) ]
    Self-reported, measured using the Decisional Conflict Scale

  2. Caregiver decisional comfort [ Time Frame: Within one hour after clinical consultation (T2) ]
    Self-reported, measured using the Decisional Conflict Scale

  3. Change in patient quality of life (able patient) [ Time Frame: Baseline (T0, within one hour before clinial consultation), 3 months after clinical consultation (T3) ]
    Self-reported by the patient, measured using the QoL-AD

  4. Change in patient quality of life (proxy rating by caregiver) [ Time Frame: (T0: within one hour before clinical consultation), 3 months after clinical consultation (T3) ]
    Self-reported by the caregiver, measured using the QoL-AD

  5. Change in caregiver burden [ Time Frame: (T0: within one hour before clinical consultation), 3 months after clinical consultation (T3) ]
    Self-reported, measured using the Zarit Burden Interview

  6. Caregiver decisional regret [ Time Frame: 3 months after clinical consultation (T3) ]
    Self-reported, Measured using the Decisional Regret Scale

  7. Patient decisional regret (able patient) [ Time Frame: 3 months after clinical consultation (T3) ]
    Self-reported, Measured using the Decisional Regret Scale


Other Outcome Measures:
  1. Patient and caregiver engagement in the decision-making process [ Time Frame: At time of patient exposure to the intervention, during clinical consultation (T1) ]
    Third-observer instrument, measured using the OPTION-5 scale

  2. Patient perceptions of the decision making processes (able patient) [ Time Frame: Within one hour after clinical consultation (T2) ]
    Self-reported, measured using the 3-item Collaborate instrument

  3. Caregiver perceptions of the decision making processes [ Time Frame: Within one hour after clinical consultation (T2) ]
    Self-reported, measured using the 3-item Collaborate instrument



Information from the National Library of Medicine

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Ages Eligible for Study:   66 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of dementia
  • Community-based

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956694


Contacts
Contact: Anik MC Giguere, PhD 418-656-2131 ext 8026 anik.giguere@fmed.ulaval.ca
Contact: Danielle Caron, PhD 418-656-2131 ext 7187 Danielle.Caron@fmed.ulaval.ca

Locations
Canada
Réseau de Recherche Axée sur les Pratiques de Première Ligne Université Laval (RRAPPL-UL) Recruiting
Quebec, Canada, G1V 0A6
Contact: Sabrina Guay-Bélanger, PhD    418-656-2131 ext 7515    Sabrina.G-Bélanger@crchudequebec.ulaval.ca   
Sponsors and Collaborators
Anik Giguère
Ministère de l’Économie, de l’Innovation et de l’Exportation du Québec
SOVAR
Laval University
Investigators
Principal Investigator: Anik MC Giguere, PhD Laval University

Responsible Party: Anik Giguère, Assitant Professor, Laval University
ClinicalTrials.gov Identifier: NCT02956694     History of Changes
Other Study ID Numbers: 2014-2015-PSVT2-31404
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Anik Giguère, Laval University:
Aged
Cognitive impairment
Neurocognitive Disorders
Shared decision making
Distance learning
Primary care
Decision support tool
Patient decision aid

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders