DementiaNCT02956694
Intervention to Improve Shared Decision Making Among Seniors With Dementia, Their Caregivers and Healthcare Providers
A study testing Professional e-learning program on shared decision making in people with Dementia and Professional-Patient Relations, run by Anik Giguère at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Professional-Patient Relations, Professional-Family Relations
- What is being tested?
- Professional e-learning program on shared decision making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2016to 8 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Réseau de Recherche Axée sur les Pratiques de Première Ligne Université Laval (RRAPPL-UL)
Québec, G1V 0A6
About this study
Official title: Design, Implementation and Evaluation of a Tailored Intervention to Improve Shared Decision Making Among Seniors With Dementia, Their Caregivers and Healthcare Providers
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.
Read the 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 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.
- Being tested
- Professional e-learning program on shared decision making
- Keywords
- Aged, Cognitive impairment, Neurocognitive Disorders, Shared decision making, Distance learning, Primary care, Decision support tool, Patient decision aid
- Medical subject headings
- Dementia, Cognitive Dysfunction, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Professional e-learning program on shared decision makingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Professional e-learning program on shared decision making |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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].
Measured: 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.
Measured: Right before training, and then one week after the end of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start1 Oct 2016
- Primary completion8 Oct 2018
- Study completion8 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anik Giguère
- Sponsor type
- University, hospital or other
- Collaborators
- Ministère de l'Économie, de l'Innovation et de l'Exportation du Québec, SOVAR, Laval University
- Responsible party
- Sponsor-investigator, Anik Giguère, Laval University
- Investigators
- Anik MC Giguere, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956694
- Sponsor's protocol ID
- 2014-2015-PSVT2-31404
- Status last verified
- Mar 2020
- First submitted
- 31 Oct 2016
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Publications
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.
PubMed 29941020
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design, Implementation and Evaluation of a Tailored Intervention to Improve Shared Decision Making Among Seniors With Dementia, Their Caregivers and Healthcare Providers
- ClinicalTrials.gov ID
- NCT02956694
- Acronym / sponsor ID
- 2014-2015-PSVT2-31404
- Keywords
- Aged, Cognitive impairment, Neurocognitive Disorders, Shared decision making, Distance learning, Primary care, Decision support tool, Patient decision aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Anik GiguèreUniversity, hospital or other
- Collaborators
- Ministère de l'Économie, de l'Innovation et de l'Exportation du Québec, SOVAR, Laval University
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Professional training | Experimental | Behavioral: Professional e-learning program on shared decision makingProfessional 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Professional e-learning program on shared decision makingClinicians 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. | Behavioural | Professional training |
Primary outcome
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 [28].
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Derived from this study: PubMed 29941020Giguere 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.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anik MC Giguere, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Professional e-learning program on shared decision making in people with Dementia and Professional-Patient Relations, run by Anik Giguère at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in healthcare providers' intention to adopt shared decision making (time frame: Right before training, and then one week after the end of training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02956694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.