Care Planning for a Loved One With Dementia: Knowledge, Preparing for Decisions, and Emotions

Massachusetts General Hospital150 enrolled

Overview

The overall objective of this study is to compare knowledge, decisional conflict, preferences, and caregiver burden over time caregivers of Alzheimer's Disease and Related Dementias (ADRD) patients by comparing the effectiveness of a video decision aid intervention and enhanced usual care.

The investigators will conduct a randomized controlled trial in 150 caregivers of patients with ADRD, who will be randomized to either the video (intervention) or enhanced usual care (informational sheet, control). The intervention group will use the suite of video decision aids. Caregivers in the control group will review the informational sheet, which covers the same information. Data collection is estimated to take no longer than an hour and will be conducted after the scheduled visit at the Massachusetts General Hospital Memory Disorders Unit (MGH MDU) clinic. The relatively brief interviewing time (30 minutes) in which the survey is conducted should assure completion of the interview without burdening participants. The investigators do not foresee the additional time to complete the survey to be a barrier to successful recruitment and completion of the protocol. Participants will be provided written copies of the questions in order to follow along during the face-to-face interviews. The research assistant (RA) will collect baseline data, randomize caregivers to either the video or control arm via concealed envelopes, and administer the intervention. After this baseline interview and randomization, the RA will collect the remaining outcomes data regarding knowledge, preferences, decisional uncertainty, and caregiver burden from the caregiver. For those participants randomized to the video intervention, they will also be asked questions regarding the usefulness of the video and their comfort with the video. All caregivers will be given a website link to access the videos shown from their home. As the investigators have done in prior studies, the investigators will contact by telephone caregivers at 3 and 6 months to assess their caregiver burden at that time. Fidelity of the video intervention during the in-person survey and remotely at home will be tracked via a video website link that documents show-rates (date and time video accessed) as well as play-through rates (was the video watched to completion).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * All participants must be age 18 or older. * Participants must be able to speak and understand English. * Participants must be a caregiver of someone with Alzheimer's Disease, frontotemporal dementia, or a related dementia * Participants should be able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local participant privacy regulations. Exclusion Criteria: \* Participants who are not able to tolerate or perform the procedures or assessments.

Outcomes

Primary Outcomes

Change from Baseline in percent correct and in response confidence on Knowledge of Advanced Dementia Questionnaire.

The Knowledge of Advanced Dementia Questionnaire is a verbally administered self-reported instrument assessing knowledge with six true/false questions with a total possible score of 6 (1 point for each correct T/F), with high scores indicating better knowledge. A confidence rating scale with possible scores from 1 (not at all confident) to 5 (extremely confident). Change = (post Knowledge score - pre Knowledge score) Change = (post Confidence score - pre Confidence score)

Time frame: Baseline and immediately post-intervention

Change from Baseline in percent correct and in response confidence on Knowledge of Goals of Care Questionnaire.

The Knowledge of Goals of Care is a verbally administered self-reported instrument assessing knowledge with six true/false questions with a total possible score of 6 (1 point for each correct T/F), with high scores indicating better knowledge. A confidence rating scale with possible scores from 1 (not at all confident) to 5 (extremely confident). Change = (post Knowledge score - pre Knowledge score) Change = (post Confidence score - pre Confidence score)

Time frame: Baseline and immediately post-intervention

Change and Retention of Change in Advanced Care Planning (ACP) Engagement Survey

The ACP Engagement Survey is a self-reported instrument assessing confidence and readiness for ACP activities. Possible scores range from 1 (Not at all) to 5 (Extremely). Change = (Post intervention score - baseline score) Retention = (3 Month Follow Up - Post Intervention) Retention = (6 Month Follow Up - Post Intervention)

Time frame: Baseline and immediately post-intervention Post-intervention and 3 Month Follow Up Post Intervention and 6 Month Follow Up

Secondary Outcomes

Change and Retention of Change in Decisional Conflict Scale

The Decisional Conflict Scale is a validated, self-reported instrument assessing 5 dimensions of decision-making feelings (uncertain, uninformed, unclear about values, unsupported; ineffective decision making). Possible scores range from 1 (strongly disagree) to 5 (strongly agree). Change = (Post intervention score - baseline score) Retention = (3 Month Follow Up - Post Intervention) Retention = (6 Month Follow Up - Post Intervention)

Time frame: Baseline and immediately post-intervention Post-intervention and 3 Month Follow Up Post Intervention and 6 Month Follow Up

Response Rate and Retention of Response Rate for Limited Medical Care and Comfort Care

The ACP Preferences Survey is a self-reported instrument asking a one multiple choice question with 3 options; Life Prolonging Care, Limited Medical Care and Comfort Care. Change = (Post intervention response rate - baseline response rate) Retention = (3 Month Follow Up response rate - Post Intervention response rate) Retention = (6 Month Follow Up response rate - Post Intervention response rate)

Time frame: Baseline and immediately post-intervention Post-intervention and 3 Month Follow Up Post Intervention and 6 Month Follow Up

Response Rate for Advanced Care Planning (ACP) Documents Survey

The ACP Documents Survey is a self-reported instrument asking 3 yes/no/unsure questions assessing the completion of ACP documents with a total possible score of 3 (1 point for each yes answer). A higher score indicates a higher amount of documents completed. Change = (3 month follow up score - baseline score) Change = (6 month follow up score - baseline score)

Time frame: Baseline and Month 3 Follow Up Baseline and Month 6 Follow Up

Response Rate of Satisfaction Survey on Video Rating Survey post-intervention

Responses from the Video Rating Survey, a self-reported instrument asking 5 questions assessing perception of ACP Video: Goals of Care: Advanced Dementia. Possible scores range from 1 (strongly disagree) to 5 (strongly agree) for knowledge, comfort, desire to learn more and recommend to others with a higher summary score indicating a positive response except for comfort, where a higher response indicating more discomfort. Importance to learn about this topic was measured on a 5-point scale; 1 (Not at all important) to 5 (Very Important) with a higher summary score indicating higher importance.

Time frame: Immediately post-intervention

Care Planning for a Loved One With Dementia: Knowledge, Preparing for Decisions, and Emotions

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts