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

NCT05049291 | Completed

• 1 other identifier: STUDY00021951
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Care Planning; Dementia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Decision Self-efficacy Scale

  6 months

• Family Member Decision-Making Self-Efficacy Scale

  6 months

• Adaptation of Advance Care Planning Engagement Survey

  6 months

• Preparation for Decision-Making Scale

  6 months

• Adaptation of Advance Care Planning Engagement for Surrogates Survey

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

One time receipt and review of an information sheet

Behavioral: telehealth advance care planning

Non-Intervention

NO INTERVENTION

Usual care will be delivered per standards of care.

Interventions

telehealth advance care planning BEHAVIORAL

An education information sheet containing prognosis and outcomes of acute care and intensive treatments

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• University of Pennsylvania: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 20, 2021
• Study Start: November 10, 2022
• Primary Completion: July 18, 2023
• Study Completion: July 18, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)