Pilot Study of an Advance Care Planning Intervention Among Persons With Dementia

Pilot Study of an Advance Care Planning Intervention Among Persons With Dementia in Long-term Services and Support Facilities

Advance care planning allows people to have their wishes taken into account even in the advanced stages of the persons' condition and at the end of life when the person may be unable to communicate. However, a recent review found an absence of high-quality guidelines for advanced care planning in dementia care. Since few evidence-based resources exist, the investigators propose a study to generate, refine, and pilot test an education information sheet designed to promote advanced care planning among families of persons with dementia.

Study Overview

• Status: Completed
• Conditions: Dementia; Advanced Care Planning
• Intervention / Treatment: Behavioral: telehealth advance care planning

Detailed Description

To determine the feasibility, acceptability and preliminary efficacy of an education information sheet to promote advance care planning among family members of persons with advanced dementia in long-term services and support facilities.

Introducing an education information sheet containing prognosis and outcomes will be feasible, acceptable, and increase self-efficacy and do-not-hospitalize decision preferences among family members of persons with advanced dementia.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Family member of a person with a diagnosis of dementia (any type)
• English-speaking family member
• Family member of a person with dementia admitted to a nursing home

Exclusion Criteria:

• Inability to understand/read English
• Advance directive already in patient chart

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; One time receipt and review of an information sheet	Behavioral: telehealth advance care planning; An education information sheet containing prognosis and outcomes of acute care and intensive treatments
No Intervention: Non-Intervention; Usual care will be delivered per standards of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Information Sheet among Study Population	Feasibility of the information sheet is defined as the consent rate of family members who are offered enrollment. This will be calculatd as a percent of family members (number of enrolled participants/number of eligible participants offered enrollment)	6 months
Acceptibility of Decision Aid Tool	Acceptability using an adapted tool (https://decisionaid.ohri.ca/eval_accept.html) which measures the ratings of comprehensibility of the information sheet among participants in the intervention group. Responses are reported descriptively in terms of proportions responding positively or negatively on each criteria.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision Self-efficacy Scale	Measures self-confidence or belief in one's abilities in decision making, including shared decision making. Eleven responses are measured on a 0-4 likert scale and a final summed scale is converted to a 0-100 range (scores are summed, divided by 11, then multiplied by 25). A score of zero means low self efficacy and score of 100 means extremely high self efficacy.	6 months
Family Member Decision-Making Self-Efficacy Scale	Measures family member self-efficacy in medical decision-making on behalf of a loved one. This scale has two versions, one for conscious and one for unconscious loved ones, which we will use accordingly. Thirteen items are measured on a 0-5 Likert scale with 1 being "cannot do at all" and 5 being "certain I can do." Higher scores indicate higher decision making self-efficacy.	6 months
Adaptation of Advance Care Planning Engagement Survey	Questions adapted from an 82-item questionnaire that measures advance care planning engagement in terms of knowledge, contemplation, self-efficacy and readiness. We include 10 questions from the measure. We used a mean imputation approach. All available data were included to create an average 5-point Likert score.	6 months
Preparation for Decision-Making Scale	Measures perception of the usefulness of a decision support tool in preparing respondent for decision-making. Responses are on a Likert scale of 1-5 with one being "not at all" and five being " a great deal." Items are summed for scoring. A higher score indicates a higher level of perceived helpfulness in preparing for decision-making.	6 months
Adaptation of Advance Care Planning Engagement for Surrogates Survey	We adapted 9 items from the 17-item Advance Care Planning for Surrogates survey. Response options are on a 5-point Likert scale. We will calculate a summary score, with higher scores indicates a higher level of engagement.	6 months
Knowledge about Dementia	Six questions to assess family members' knowledge about dementia were developed for this pilot study. All questions are true/false. Each correct answer will be coded as 1, each incorrect answer will be scored as 0. Higher scores indicate more knowledge.	6 months

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Actual): July 18, 2023
• Study Completion (Actual): July 18, 2023

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: STUDY00021951

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No