Intervention to Improve Shared Decision Making Among Seniors With Dementia, Their Caregivers and Healthcare Providers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02956694|
Recruitment Status : Completed
First Posted : November 6, 2016
Last Update Posted : March 23, 2020
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Dementia Professional-Patient Relations Professional-Family Relations Aging||Behavioral: Professional e-learning program on shared decision making||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 1, 2016|
|Actual Primary Completion Date :||October 8, 2018|
|Actual Study Completion Date :||October 8, 2018|
Experimental: 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).
Behavioral: 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.
- Change in healthcare providers' intention to adopt shared decision making [ Time Frame: Right before training, and then one week after the end of training ]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.
- Change in healthcare providers' knowledge [ Time Frame: Right before training, and then one week after the end of training ]
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 .
- Change in Healthcare providers' role preference [ Time Frame: Right before training, and then one week after the end of training ]Healthcare professionals' preferred role in decision-making (Strull WM, Lo B, Charles G. Do patients want to participate in medical decision making? JAMA.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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
|Réseau de Recherche Axée sur les Pratiques de Première Ligne Université Laval (RRAPPL-UL)|
|Quebec, Canada, G1V 0A6|
|Principal Investigator:||Anik MC Giguere, PhD||Laval University|
|Responsible Party:||Anik Giguère, Assitant Professor, Laval University|
|Other Study ID Numbers:||
|First Posted:||November 6, 2016 Key Record Dates|
|Last Update Posted:||March 23, 2020|
|Last Verified:||March 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
|Time Frame:||The data will be available after the study is published.|
|Access Criteria:||Contact the trial sponsor at email@example.com|
Shared decision making
Decision support tool
Patient decision aid
Central Nervous System Diseases
Nervous System Diseases