Chronic Disease
Conditions
Keywords
Advance care planning, Latino Health, Medical decision making, Health Literacy, Limited English proficiency, Aging
Brief summary
In partnership with patients, caregivers, advocacy groups and clinicians, the investigators plan to: Aim 1: Adapt and refine PREPARE in Spanish through cognitive interviews with Spanish-speaking Latinos and stakeholders. Aim 2: Conduct a randomized clinical trial (RCT) to compare the efficacy of PREPARE plus a previously-tested, easy-to-read- AD (intervention) versus the AD alone (control) to: 2a. Engage older Spanish-speaking Latinos in multiple ACP behaviors (i.e., identify and discuss wishes with surrogates and clinicians and complete ADs) measured by self-report, chart review, surrogate reports, and 2b. Direct observation. 2c. Improve self-efficacy and satisfaction with medical decision making. 2d. Determine whether PREPARE efficacy varies by literacy, decision control preferences, and clinician-patient language concordance. Aim 3: Disseminate PREPARE with input from patients, surrogates, and stakeholders.
Detailed description
PREPARE is a website (www.prepareforyourcare.org) that teaches patients how to identify what is most important in life, how to communicate their preferences to clinicians and loved ones, and how to make informed decisions. It is written at a 5th grade level and includes voice-overs of text and closed captioning of videos that model advance care planning behaviors. The goal of this proposal is to test the efficacy of PREPARE plus an easy-to-read advance directive, versus an advance directive alone, to improve patient engagement in multiple advance care planning behaviors including discussions with surrogate decision makers and clinicians in addition to advance directive completion. The investigators will also determine whether PREPARE can empower and activate patients within clinical encounters with their clinicians and help to decrease health disparities in advance care planning.
Interventions
BEHAVIORALPREPARE Intervention
At week 1, 3, 6, and 12 months, interviews (telephone or in person based on preference) by blinded staff will assess engagement in advance care planning (ACP), self-efficacy with ACP, and activation in and satisfaction with decision making. Blinded telephone interviews will also assess surrogate reports of patient engagement in ACP.
Sponsors
Patient-Centered Outcomes Research Institute
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Spanish-speaking adults ≥ 55 years of age * ≥ 2 chronic illnesses determined by ICD-9 codes * ≥ 2 visits with an outpatient primary care clinician at San Francisco General hospital in the past year * ≥ 2 additional outpatient/inpatient visits to San Francisco General Hospital in the past year
Exclusion criteria
* Deaf, blind, demented or psychotic as determined by ICD-9 codes * Too mentally or physically ill to participate as determined by their clinicians * Moderate or severe cognitive impairment as determined by the Short Portable Mental Status Questionnaire (SPMSQ), and mild cognitive impairment by the SPMSQ plus an abnormal Mini-Cog (scores minimally affected by education/ethnicity) * Self-reported poor vision and inability to see the words on a newspaper * Lack of a telephone (for follow-up) * Traveling or moving out of the area for ≥3 months during the study follow-up period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New Advance Care Planning Documentation in the Medical Record at 15 Months | 15 months after study enrollment | The primary outcome is documentation of advance care planning wishes in the medical record. ACP documentation for the purposes of this study includes the easy-to-read advance directive or other valid advance directives or living wills, a durable power of attorney for healthcare document (DPOAHC), a physicians orders for life sustaining treatment (POLST) form, or other documentation of patients wishes for medical care (ie, documentation of oral directives by a physician, or code status, such as full code or do not resuscitate or do not intubate orders or notes by a physician). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Engagement in Advance Care Planning Behaviors | 12 months | Secondary outcomes were chosen to measure the full process of Advance Care Planning (ACP) using validated questionnaires, such as the patient-reported ACP Engagement Survey. This questionnaire includes both Behavior Change Process and ACP Action measures. Behavior Change Process measures include knowledge, contemplation, self-efficacy, and readiness for several ACP actions. The Process measures are assessed on an average 5-point Likert scale with a low of 1 and a high of 5, with high scores indicating more ACP engagement. Action measures include ACP actions such as identifying a surrogate decision-maker, identifying values and goals for medical care, choosing the level of leeway in surrogate decision-making, discussing one's wishes with clinicians and surrogates, and documenting one's wishes in an advance directive. Action measures use yes or no response options and are measured on a 0- to 25-point scale, where 0 is no action and 25 means they have engaged in more ACP actions. |
Countries
United States
Participant flow
Recruitment details
Study participants were enrolled from four primary care clinics associated with the San Francisco Health Network from November 2014 - March 2017. They were included if they were ≥55 years old, had ≥2 chronic medical conditions, had ≥2 visits with a PCP in the past year, and had ≥2 additional outpatient/inpatient visits in the past year.
Participants by arm
| Arm | Count |
|---|---|
| PREPARE Intervention The PREPARE arm will review the PREPARE website plus the easy-to-read advance directive (AD). Participants will review PREPARE on their own for ≥20 minutes with staff present to answer questions. During PREPARE, participants answer preference questions and make an action plan (i.e., commitment to engage in advance care planning). To ensure home access to PREPARE content, participants will be given a website login and PREPARE content in digital video disc (DVD), booklet, and pamphlet format as well as the action plan and AD. One to three days before a primary care visit, the PREPARE arm will receive a reminder to come to their appointment and to bring their action plan. | 219 |
| Control The control arm will review an easy-to-read AD. Controls will review the AD for ≥15 minutes with study staff present to answer questions and will take the AD home to complete if desired. One to three days before a primary care visit, controls will receive a reminder to come to their appointment. | 226 |
| Total | 445 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 2 |
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Removed by Study Staff | 2 | 2 |
| Overall Study | Withdrawal by Subject | 29 | 21 |
Baseline characteristics
| Characteristic | PREPARE Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 92 Participants | 88 Participants | 180 Participants |
| Age, Categorical Between 18 and 65 years | 127 Participants | 138 Participants | 265 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 6.8 | 64 years STANDARD_DEVIATION 7.2 | 64 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 216 Participants | 224 Participants | 440 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Prior ACP Documentation | 44 Participants | 64 Participants | 108 Participants |
| Region of Enrollment United States | 219 participants | 226 participants | 445 participants |
| Sex: Female, Male Female | 157 Participants | 163 Participants | 320 Participants |
| Sex: Female, Male Male | 62 Participants | 63 Participants | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 219 | 2 / 226 |
| other Total, other adverse events | 0 / 219 | 0 / 226 |
| serious Total, serious adverse events | 0 / 219 | 0 / 226 |
Outcome results
Primary
New Advance Care Planning Documentation in the Medical Record at 15 Months
The primary outcome is documentation of advance care planning wishes in the medical record. ACP documentation for the purposes of this study includes the easy-to-read advance directive or other valid advance directives or living wills, a durable power of attorney for healthcare document (DPOAHC), a physicians orders for life sustaining treatment (POLST) form, or other documentation of patients wishes for medical care (ie, documentation of oral directives by a physician, or code status, such as full code or do not resuscitate or do not intubate orders or notes by a physician).
Time frame: 15 months after study enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PREPARE Intervention | New Advance Care Planning Documentation in the Medical Record at 15 Months | 83 Participants |
| Control | New Advance Care Planning Documentation in the Medical Record at 15 Months | 58 Participants |
Secondary
Self-reported Engagement in Advance Care Planning Behaviors
Secondary outcomes were chosen to measure the full process of Advance Care Planning (ACP) using validated questionnaires, such as the patient-reported ACP Engagement Survey. This questionnaire includes both Behavior Change Process and ACP Action measures. Behavior Change Process measures include knowledge, contemplation, self-efficacy, and readiness for several ACP actions. The Process measures are assessed on an average 5-point Likert scale with a low of 1 and a high of 5, with high scores indicating more ACP engagement. Action measures include ACP actions such as identifying a surrogate decision-maker, identifying values and goals for medical care, choosing the level of leeway in surrogate decision-making, discussing one's wishes with clinicians and surrogates, and documenting one's wishes in an advance directive. Action measures use yes or no response options and are measured on a 0- to 25-point scale, where 0 is no action and 25 means they have engaged in more ACP actions.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PREPARE Intervention | Self-reported Engagement in Advance Care Planning Behaviors | Self-reported ACP Behavior Change Process Measures | 3.2 score on a scale | Standard Deviation 0.07 |
| PREPARE Intervention | Self-reported Engagement in Advance Care Planning Behaviors | Self-reported ACP Action Measures | 12.4 score on a scale | Standard Deviation 0.53 |
| Control | Self-reported Engagement in Advance Care Planning Behaviors | Self-reported ACP Behavior Change Process Measures | 2.9 score on a scale | Standard Deviation 0.07 |
| Control | Self-reported Engagement in Advance Care Planning Behaviors | Self-reported ACP Action Measures | 10.1 score on a scale | Standard Deviation 0.49 |