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Evaluation of an Advance Care Planning Activity: Feasibility Testing for a Randomized Controlled Trial

Primary Purpose

Chronic Disease, Caregivers

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Conversation card game

Active Control

About this trial

This is an interventional supportive care trial for Chronic Disease focused on measuring advance care planning, advance directive, caregiving

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Participants are eligible to participate if they fall into at least one of the following three groups:

Group 1) CAREGIVERS:
- are 18 years or older
- speak and read English
- have been an unpaid caregiver for an adult over the age of 18 in the last 12 months. Being an unpaid caregiver may include helping with personal needs or household chores, managing a person's finances, arranging for outside services, or visiting regularly to see how they are doing. This person need not live with participants in order for them to identify as caregivers;
- are able to sit for about 2.5-3 hours
- are able to focus on the game for about 1.5-2 hours
- can complete required survey
- care recipient is capable of discussing medical issues
- care recipient has not completed an AD in past 18 months
Group 2) PATIENTS WITH CHRONIC ILLNESS; criteria include:
- are 18 years or older
- speak and read English
- have at least one chronic illness (cancer, chronic pulmonary disease, coronary artery disease, congestive heart failure, peripheral vascular disease, severe chronic liver disease, diabetes with end organ damage, renal failure-defined using Iezonnis' ICD-9 criteria*)
- have not completed an advance directive within the past 18 months
- are able to sit for about 2.5-3 hours
- are able to focus on the game for about 1.5-2 hours
- can complete required surveys
Group 3) SURROGATE DECISION MAKERS FOR PATIENTS WITH CHRONIC ILLNESS criteria include:
- considers themselves a surrogate decision maker for an adult with a chronic illness (defined by Iezonni's ICD-9 chronic illness categories*)
- are 18 years or older
- speak and read English
- are able to sit for about 2.5-3 hours
- are able to focus on the game for about 1.5-2 hours
- can complete required surveys
Iezonni's ICD-9 'chronic illness' definition contains codes within any of the following categories:
1. malignant cancer/leukemia
2. chronic pulmonary disease
3. coronary artery disease
4. congestive heart failure
5. peripheral vascular disease
6. severe chronic liver disease
7. diabetes with end-organ damage
8. renal failure.

Exclusion Criteria:

Do not fall into one of the above 3 categories
Are <18 years of age
Non-English speaking
Cognitively impaired by self-report or score less than 21 on the MoCA screening tool
Do not have a chronic illness (lacking one of the diseases from Iezonni's ICD-9 codes in chronic illness categories, described above)
Have completed an advance directive within the last 18 months
Do not provide informed consent or unable to provide informed consent
Carry a diagnosis of dementia
Unable to complete a 3 hour study session in one sitting (by self-report)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Play 'My Gift of Grace,' a conversation card game for 4-6 players (the game consists of 20 question cards that prompt players to identify and articulate their values and beliefs related to dying and end-of-life issues); all game sessions will be audio recorded and transcribed.

Review and discuss a brochure on ACP called "Advance Care Planning: Tips from the National Institute of Aging". Discussion will be prompted by the researcher asking participants to discuss the information they've just read with the group. However, there will not be a formal structure to this discussion.

Outcomes

Primary Outcome Measures

Completion of an online advance directive

Secondary Outcome Measures

Advance Care Planning Engagement Survey

This survey includes information about stage of readiness to perform advance care planning, self-efficacy, and other measures of behavioral change

Advance Care Planning Behaviors

Open-ended interviews will ascertain additional advance care planning behaviors performed

Full Information

NCT ID

NCT02619370

First Posted

November 30, 2015

Last Updated

March 21, 2017

Sponsor

Lauren Van Scoy

Collaborators

University of Kentucky, Francis Family Foundation, Penn State University

1. Study Identification

Unique Protocol Identification Number

NCT02619370

Brief Title

Evaluation of an Advance Care Planning Activity: Feasibility Testing for a Randomized Controlled Trial

Official Title

Evaluation of an Advance Care Planning Activity: Feasibility Testing for a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lauren Van Scoy

Collaborators

University of Kentucky, Francis Family Foundation, Penn State University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The overarching goal of this project is to facilitate engagement of individuals in effective advance care planning (ACP). Our specific objective is to conduct a randomized, controlled trial to determine whether playing a structured conversation game will increase the likelihood that participants will complete advance directives and perform other ACP behaviors compared to those who are provided with only standard ACP educational materials.

Detailed Description

Our central hypothesis is that having ACP conversations in a non-threatening and enjoyable game format will stimulate participants to engage in additional ACP behaviors including completion of ADs. We will use the ACP Engagement Survey to measure readiness to perform ACP, which includes measures of the "stage of change" for performing ACP behaviors. The proposed study has two specific aims: Aim 1. To determine whether individuals who play a conversation game are more likely to subsequently complete an online AD (called 'Making Your Wishes Known'; MYWK) compared to individuals who receive standard information about ACP. Our hypothesis is that playing a conversation game will result in a higher AD completion rate (compared to control) in the three months following the intervention. Aim 2. To identify which participant and/or conversation-related factors influence movement along the stages of change continuum with respect to ACP behaviors (discussing end-of-life wishes with families or clinicians and then completing ADs). Our hypotheses are that: H1) the game intervention will lead to higher quality conversations than the control; and H2) participants whose conversations consist of high-quality ACP discussions will be more likely to progress toward enacting ACP behaviors (as measured by the ACP Engagement Survey score) than those participants whose conversations consist of low-quality discussions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Disease, Caregivers

Keywords

advance care planning, advance directive, caregiving

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Conversation card game

Intervention Type

Behavioral

Intervention Name(s)

Active Control

Primary Outcome Measure Information:

Title

Completion of an online advance directive

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Advance Care Planning Engagement Survey

Description

This survey includes information about stage of readiness to perform advance care planning, self-efficacy, and other measures of behavioral change

Time Frame

3 months

Title

Advance Care Planning Behaviors

Description

Open-ended interviews will ascertain additional advance care planning behaviors performed

Time Frame

3 months

Other Pre-specified Outcome Measures:

Title

Satisfaction with advance care planning questionnaire

Description

8-item questionnaire on a 7-point likert scale

Time Frame

30 minutes after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Participants are eligible to participate if they fall into at least one of the following three groups: Group 1) CAREGIVERS: are 18 years or older speak and read English have been an unpaid caregiver for an adult over the age of 18 in the last 12 months. Being an unpaid caregiver may include helping with personal needs or household chores, managing a person's finances, arranging for outside services, or visiting regularly to see how they are doing. This person need not live with participants in order for them to identify as caregivers; are able to sit for about 2.5-3 hours are able to focus on the game for about 1.5-2 hours can complete required survey care recipient is capable of discussing medical issues care recipient has not completed an AD in past 18 months Group 2) PATIENTS WITH CHRONIC ILLNESS; criteria include: are 18 years or older speak and read English have at least one chronic illness (cancer, chronic pulmonary disease, coronary artery disease, congestive heart failure, peripheral vascular disease, severe chronic liver disease, diabetes with end organ damage, renal failure-defined using Iezonnis' ICD-9 criteria*) have not completed an advance directive within the past 18 months are able to sit for about 2.5-3 hours are able to focus on the game for about 1.5-2 hours can complete required surveys Group 3) SURROGATE DECISION MAKERS FOR PATIENTS WITH CHRONIC ILLNESS criteria include: considers themselves a surrogate decision maker for an adult with a chronic illness (defined by Iezonni's ICD-9 chronic illness categories*) are 18 years or older speak and read English are able to sit for about 2.5-3 hours are able to focus on the game for about 1.5-2 hours can complete required surveys Iezonni's ICD-9 'chronic illness' definition contains codes within any of the following categories: malignant cancer/leukemia chronic pulmonary disease coronary artery disease congestive heart failure peripheral vascular disease severe chronic liver disease diabetes with end-organ damage renal failure. Exclusion Criteria: Do not fall into one of the above 3 categories Are <18 years of age Non-English speaking Cognitively impaired by self-report or score less than 21 on the MoCA screening tool Do not have a chronic illness (lacking one of the diseases from Iezonni's ICD-9 codes in chronic illness categories, described above) Have completed an advance directive within the last 18 months Do not provide informed consent or unable to provide informed consent Carry a diagnosis of dementia Unable to complete a 3 hour study session in one sitting (by self-report)

12. IPD Sharing Statement

Learn more about this trial

Evaluation of an Advance Care Planning Activity: Feasibility Testing for a Randomized Controlled Trial

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