Clinical trial NCT02619370: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Caregivers
Keywords: advance care planning
advance directive
caregiving
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: University of Kentucky
name: Francis Family Foundation
name: Penn State University
First posted: 2015-12-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

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:

  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)

Primary outcomes:
measure: Completion of an online advance directive
timeFrame: 3 months
Secondary outcomes:
measure: Advance Care Planning Engagement Survey
timeFrame: 3 months
measure: Advance Care Planning Behaviors
timeFrame: 3 months
Other outcomes:
measure: Satisfaction with advance care planning questionnaire
timeFrame: 30 minutes after intervention
Locations:
Study officials:
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