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

• ClinicalTrials.gov Identifier: NCT02956694
• Recruitment Status: Completed
• First Posted: November 6, 2016
• Last Update Posted: March 23, 2020
• Sponsor: Anik Giguère
• 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

Tracking Information

• First Submitted Date: October 31, 2016
• First Posted Date: November 6, 2016
• Last Update Posted Date: March 23, 2020
• Actual Study Start Date: October 1, 2016
• Actual Primary Completion Date: October 8, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 19, 2020)

• 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.

Original Primary Outcome Measures (submitted: November 3, 2016)

• 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)
• 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)

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: November 3, 2016)

• Patient decisional comfort (able patient) [ Time Frame: Within one hour after clinical consultation (T2) ]
  Self-reported, measured using the Decisional Conflict Scale
• Caregiver decisional comfort [ Time Frame: Within one hour after clinical consultation (T2) ]
  Self-reported, measured using the Decisional Conflict Scale
• 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
• 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
• 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
• Caregiver decisional regret [ Time Frame: 3 months after clinical consultation (T3) ]
  Self-reported, Measured using the Decisional Regret Scale
• Patient decisional regret (able patient) [ Time Frame: 3 months after clinical consultation (T3) ]
  Self-reported, Measured using the Decisional Regret Scale

• Current Other Pre-specified Outcome Measures: Not Provided

Original Other Pre-specified Outcome Measures (submitted: November 3, 2016)

• 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
• 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
• 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

Descriptive Information

• Brief Title: Intervention to Improve Shared Decision Making Among Seniors With Dementia, Their Caregivers and Healthcare Providers
• Official Title: Design, Implementation and Evaluation of a Tailored Intervention to Improve Shared Decision Making Among Seniors With Dementia, Their Caregivers and Healthcare Providers
• 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 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
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

Condition

• Dementia
• Professional-Patient Relations
• Professional-Family Relations
• Aging

Intervention

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.

Study Arms

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).

Intervention: Behavioral: Professional e-learning program on shared decision making

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 19, 2020): 47
• Original Estimated Enrollment (submitted: November 3, 2016): 162
• Actual Study Completion Date: October 8, 2018
• Actual Primary Completion Date: October 8, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02956694
• Other Study ID Numbers: 2014-2015-PSVT2-31404
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: The data will be available after the study is published.
• Access Criteria: Contact the trial sponsor at anik.giguere@fmed.ulaval.ca

• Current Responsible Party: Anik Giguère, Laval University
• Original Responsible Party: Same as current
• Current Study Sponsor: Anik Giguère
• Original Study Sponsor: Same as current

Collaborators

• 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

• PRS Account: Laval University
• Verification Date: March 2020