Background
Methods/Design
Theoretical foundation
Aims and primary hypotheses
Setting
Overview of study procedures
Participants
Veteran patient | |
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Inclusion criteria | 60 years of age or older |
Obtains care in the primary care clinics (General Medicine, Geriatrics, and Women’s Clinic) at the San Francisco VA Medical Center | |
Has been seen at least twice in the last year by a primary care provider (a measure of established primary care) and had at least two additional visits to the VA in the past year (a measure of frequent the medical center) | |
Exclusion criteria | Dementia by ICD-9 codes, clinician assessment, chart review or self-report |
Blindness or poor vision by ICD-9 codes, clinician assessment, chart review, self-report of blindness or the inability to read print on a newspaper, or research staff assessment of less than 20/200 vision on the Snellen eye chart with corrective lenses [42]. | |
Deafness by ICD-9 codes, clinician assessment, self-report, chart review or research staff assessment | |
Delirium or psychosis as assessed by a clinician or research staff | |
Does not report fluency in English | |
No phone for additional study contacts and follow-up interviews | |
Active drug or alcohol abuse within the past 3 months determined by clinician assessment, self-report, chart review or research staff assessment | |
Patients who report they will be out of town during their scheduled follow-up interview dates outside of a window of 2 months | |
Patients who cannot answer consent teach-back questions after three attempts | |
Surrogate participant | |
Inclusion criteria | 18 years of age or older |
An enrolled patient must identify the surrogate as someone who could make medical decisions for him or her if needed | |
An enrolled patient must give the surrogate’s contact information and give permission to contact their potential surrogate | |
Exclusion criteria | Self-reported dementia, blindness, or deafness |
Delirium or psychosis as assessed by research staff | |
Does not report fluency in English | |
No phone for follow-up interviews | |
Surrogates who report they will be out of town during their scheduled follow-up interview dates outside of a window of 2 months | |
Surrogate for whom we cannot schedule an interview greater than 6 months from the Veteran’s final 6-month follow-up interview date | |
Surrogates for whom we have attempted to contact 5 times or more without a response | |
Surrogates who cannot answer consent teach-back questions after three attempts |
Recruitment
Health Insurance Portability and Accountability Act (HIPAA) waiver
Data extraction
Clinician involvement
Targeted patient recruitment by letter
Targeted patient recruitment by phone
Recruitment fliers
Surrogate recruitment
Screening for eligibility of Veterans and surrogates
Consent procedures
Written consent for patients
Electronic or written consent for clinicians to be audio-recorded
Verbal and written consent for surrogates
Intervention and control conditions
Randomization procedures
Blinding
Intervention fidelity
Ethics
Measures and data collection
Construct | Measure | # items | Reliability/validity | Screener | Baseline | 1 week | 3 month | 6 month |
---|---|---|---|---|---|---|---|---|
Eligibility screening variables | ||||||||
Cognitive impairment | Short Portable Mental Status Questionnaire (SPMSQ) | 7 | Sensitivity 86.2 %, specificity 99.0 % [43] | X | ||||
0 to 2 = eligible | ||||||||
3 to 7 moderate impairment (go on to the Mini Cog three-item recall) | ||||||||
≥8 severe impairment = ineligible | ||||||||
Cognitive impairment (participants scoring 3 to 7 errors on the SPMSQ) | Mini Cog (three-item recall as needed, if SPMSQ screen + for cognitive impairment) | 3 | Sensitivity 76 %, specificity 89 % [44] | X | ||||
If recall ≥ two words = eligible | ||||||||
Vision | Ability to see words on a newspaper [42] | 1 | ||||||
Moderator variables | ||||||||
Demographic information | Age, gender, race/ethnicity [45], income, marital status, and education | X | X | |||||
Health literacy screen | “How comfortable are you filling out medical forms by yourself?” | 1 | AUROC 0.80 (95 % CI = 0.67.0.93) for inadequate health literacy [46] | X | ||||
“Qué tan seguro (a) se siente al llenar formas usted solo (a)” | ||||||||
Health literacy assessment | Short form Test of Functional Health Literacy in Adults s-TOFHLA, scores 0 to 36) [47] Continuous & dichotomized to limited = 0 to 22 and adequate = 23 to 36 | 36 | Cronbach’s α = .97 | X | ||||
Correlation coefficient w/ other literacy tests > 0.80 [47] | ||||||||
United States acculturation | Based on Acculturation scale (USAS) “How many years have you lived in the U.S.?” | 1 | Cronbach’s α = .98 | X | ||||
Associated w/ desire to know prognosis [48] | ||||||||
Finances | “In general, how do your finances usually work out at the end of the month?” | 1 | Associated with functional impairment and comorbidity [49] | X | ||||
Socioeconomic status and social standing | Social standing ladder (that is, place an “x” where you think you stand relative to other people in society) | 1 | Associated with functional decline [50] | X | ||||
Functional status | Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) | 15 | X | |||||
Self-rated health status | In general how would you rate your health? (5-pt Likert) | 1 | Correlation with global health, spearman’s rho = -63, and mortality [53] | X | ||||
Self-rated quality of life | In general, how would you rate your overall quality of life in the past week (5-pt Likert) | 1 | Test-retest coefficient = 0.81 [54] | X | ||||
Comorbid illness | Determined by ICD-9 codes (chart) | 0 | Mortality c-stat: [23] | X | ||||
Charlson comorbidity score [24] | Charlson = 0.704 | |||||||
Elixhauser comorbidity score [55] | Elixhauser = 0.793 | |||||||
Social support | Modified Medical Outcomes Study Social Support (mMOS-SS) | 11 | Cronbach’s α = 0.88-.93 [56] | X | ||||
Religion/spirituality | Self-reported extent of how spiritual/religious (5-pt Likert) and role play in decision-making. | 4 | Spirituality associated with quality of life. Religiosity associated with wanting all measures to extend life [57] | X | ||||
Prior ACP experience | Prior ACP experiences (for example, Ever had to make life threatening medical decisions?”) [12] | 5 | X | |||||
Major life changes | For example, “In the past 6 months, have you or someone close to you been faced with a serious medical problem or diagnosis?” | 4 | X | |||||
Mediator variablesa (also measured as Outcome Variables) | ||||||||
Baseline knowledge | Knowledge subscales of the ACP Engagement Survey. | 6 | Cronbach’s α = 0.84 (0.76-0.90), ICC = 0.70 (0.50-0.82) [15] | X | ||||
Baseline self-efficacy | Self-efficacy subscales of the ACP Engagement Survey. | 6 | Cronbach’s α = 0.83 (0.75-0.89), ICC = 0.60 (0.41-0.76) [15] | X | ||||
Baseline readiness | Readiness subscales of the ACP Engagement Survey. | 10 | Cronbach’s α = 0.92 (0.88-0.95), ICC = 0.60 (0.53-0.81) [15] | X | ||||
Baseline barriers | Checkbox of 13 common barriers | 13 | Associated with ACP [25] | X | ||||
Baseline attitudes | Processes of Change for ACP [16] | 34 | Responsive to an ACP intervention [15] | X | ||||
Desired role in decision-making | Control Preference Scale (CPS) [58] | 2 | X | X | ||||
Primary Outcome Variables | ||||||||
Full process of ACP | ACP Engagement Survey: Process Measures of knowledge, contemplation, self-efficacy, readiness | 116 | Process Measures: Cronbach’s α = 0.94 (0.91-0.96), ICC = 0.70 (0.54-0.82) [15] | X | X | X | X | |
Action Measures: completion of advance directives, discussions | Action Measures: ICC = 0.87 (0.79-0.92) [15] | |||||||
Secondary outcome variables | ||||||||
Communication quality | Modified CAHPS (that is, did this provider explain things in a way that was easy to understand?) | 14 | Comparative Fit Index = 0.98, Tucker Lewis Index = 0.98 | X | X | |||
Internal consistency: 0.58 to 0.92. ≥ 0.70 for four of eight constructs [62] | ||||||||
Satisfaction with communication | For example, “How satisfied are you that you could share your most important concerns with X/that X understood what was most important to you?) | 8 | X | X | X | X | ||
Satisfaction with care | Care Consistent with Goals: Comparison of 10-point ratings about aggressiveness of care desired and care currently receiving. | 4 | X | X | ||||
Barriers to ACP | Checkbox of 13 common barriers (for example, thinking about the topic makes me nervous or sad; I am too healthy; I am too busy; my family or doctor is too busy; I prefer to leave my health in God’s hands; I don’t want to burden my family and friends; I want to leave the choice to my friends and family; I want to leave the choice to my doctors; and an open-category response for “other.”) | 13 | Associated with ACP [25] | X | X | |||
Attitudes about ACP | Processes of change for ACP [16] | 34 | Responsive to ACP intervention [15] | X | ||||
Desired role in decision-making | Control Preference Scale (CPS) [58] | 2 | X | X | ||||
Satisfaction with decision making | Decisional Conflict Scale | 20 | test-retest coefficient = 0.81 | X | X | X | ||
α coefficient: 0.78-0.92 for total scale. 0.58-0.92 for subscales [31] | ||||||||
Depression and anxiety | Patient Health Questionnaire (PHQ-4) | 4 | Cronbach’s α = 0.78 [63] | X | X | X | X | |
Surrogate reports of patient engagement in ACP and other surrogate items | Modified from the ACP Engagement Survey [22], (for example, “Did [Veteran] ask you to be their surrogate decision maker, talk to you about leeway, talk to you about their values, tell other family or friends about their wishes, ask clinicians questions or have you ask clinicians questions?” | 45 | X | |||||
Prior ACP | 6 | |||||||
Care consistent with goals | 4 | |||||||
Decisional Conflict | 19 | |||||||
Implementation | 13 | |||||||
Implementation: acceptability | Acceptability and Usability | 1 factor explained 81-85 % of variance/scale. Kuder-Richardson >0.75 [12] | X | |||||
(a) Ease of use and understanding | 8 | |||||||
(b) Usefulness in decisions & discussions | 6 | |||||||
(c) Attitudes about norms or expectations | 6 | |||||||
for example, “Did you try to fill out the advance directive we gave you?” “Did you give it to a medical provider, social worker, or case manager?” If they respond no, “Why do you think you did not turn it in?” “What can we do to get other people to look over these materials?” “What would motivate them?” “What suggestions do you have to make these materials better?” | ||||||||
Implementation: feasibility | Feasibility (Control) (for example, when and where to review ACP materials) | 7 | X | |||||
Feasibility (PREPARE only) (for example, when and where to review ACP materials, and which PREPARE materials did you use and would recommend) | 34 | |||||||
“Do you remember what your action plan was?” | ||||||||
“Did you complete your action plan?” | ||||||||
If no to completing an action plan, “Why do you think you have not completed your action plan?” | ||||||||
“After the first study visit, did you look at the (action plan, summary of your wishes, the PREPARE website, pamphlet, Booklet/or DVD) again? | ||||||||
If no, “Why do you think you didn’t you look at it?” | ||||||||
Satisfaction questions include “Which of the PREPARE materials was the most helpful?”; “Which would you use again?” “Which did you share with your decision maker, friends, or family?” “When is the best time to see the PREPARE materials?” “Where do you think most people would prefer to review the PREPARE materials (home, clinic, or public space)? |