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Trials. 2018 Jun 25;19(1):332. doi: 10.1186/s13063-018-2697-1.

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.

Author information

1
Department of Family Medicine and Emergency Medicine, Laval University, Pavillon Ferdinand-Vandry, room 2881-C, 1050 avenue de la Médecine, Quebec, QC, G1V 0A6, Canada. anik.giguere@fmed.ulaval.ca.
2
Quebec Centre for Excellence on Aging, St-Sacrement Hospital, Room L2-21, 1050, chemin Sainte-Foy, Quebec City, Quebec, Canada. anik.giguere@fmed.ulaval.ca.
3
Laval University Research Centre on Primary Care and Services, Quebec City, Quebec, Canada. anik.giguere@fmed.ulaval.ca.
4
Research Axis of Population Health and Practice-Changing Research Group, CHU de Quebec Research Centre, Quebec city, QC, Canada. anik.giguere@fmed.ulaval.ca.
5
Department of Family Medicine and Emergency Medicine, Laval University, Pavillon Ferdinand-Vandry, room 2881-C, 1050 avenue de la Médecine, Quebec, QC, G1V 0A6, Canada.
6
Quebec Centre for Excellence on Aging, St-Sacrement Hospital, Room L2-21, 1050, chemin Sainte-Foy, Quebec City, Quebec, Canada.
7
Laval University Research Centre on Primary Care and Services, Quebec City, Quebec, Canada.
8
Faculty of Nursing Sciences, Laval University, Pavillon Ferdinand-Vandry, room 2881-C, 1050, avenue de la Médecine, Quebec, QC, G1V 0A6, Canada.
9
Research Axis of Population Health and Practice-Changing Research Group, CHU de Quebec Research Centre, Quebec city, QC, Canada.
10
Faculty of Pharmacy, Laval University, St-Sacrement Hospital, Room L2-30, 1050, Chemin Sainte-Foy, Québec, QC, G1S 4L8, Canada.
11
Department of Family Medicine, Faculty of Medicine, McGill University, 5858 chemin de la Cote-des-Neiges, 3rd floor, Suite 300, Room 328, Montreal, Quebec, Canada.

Abstract

BACKGROUND:

The increasing prevalence of Alzheimer's disease and other forms of dementia raises new challenges to ensure that healthcare decisions are informed by research evidence and reflect what is important for seniors and their caregivers. Therefore, we aim to evaluate a tailored intervention to help healthcare providers empower seniors and their caregivers in making health-related decisions.

METHODS:

In two phases, we will: (1) design and tailor the intervention; and (2) implement and evaluate it. We will use theory and user-centered design to tailor an 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. We will recruit 49 clinicians and 27 senior/caregiver to participate in three cycles of design-evaluation-feedback of each intervention components. Besides think-aloud and interview approaches, users will also complete questionnaires based on the Theory of Planned Behavior to identify the factors most likely to influence their adoption of shared decision-making after exposure to the intervention. We will then modify the intervention by adding/enhancing behavior-change techniques targeting these factors. We will evaluate the effectiveness of this tailored intervention before/after implementation, in a two-armed, clustered randomized trial. We will enroll a convenience sample of six primary care clinics (unit of randomization) in the province of Quebec and recruit the clinicians who practice there (mostly family physicians, nurses, and social workers). These clinics will then be randomized to immediate exposure to the intervention or delayed exposure. Overall, we will recruit 180 seniors with dementia, their caregivers, and their healthcare providers. We will evaluate the impact of the intervention on patient involvement in the decision-making process, decisional comfort, patient and caregiver personal empowerment in relation to their own healthcare, patient quality of life, caregiver burden, and decisional regret.

DISCUSSION:

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

TRIAL REGISTRATION:

ClinicalTrials.org, NCT02956694 . Registered on 31 October 2016.

KEYWORDS:

Aging; Alzheimer; Caregiver; Clinical tool; E-learning; Evidence summary; Knowledge translation; Patient partnership; Primary care

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