Cognitive Impairment
Conditions
Keywords
Cognitive Impairment, Primary Care
Brief summary
This study evaluates the efficacy of Sharing Healthcare Wishes in Primary Care (SHARE), a two-group randomized trial at up to 9 primary care practices in which 124 dyads receive a control protocol of minimally enhanced usual care and 124 dyads receive the SHARE protocol. This study tests the efficacy of SHARE on quality of communication (primary outcome) and advance care planning processes (secondary outcomes) at 6 months among primary care patients with cognitive impairment (mild-severe) and family caregiver dyads. For patients who die while enrolled in the study by 24 months, this study examines the quality of end-of-life care and bereaved family caregiver experiences with medical decision-making (secondary outcomes).
Detailed description
SHARE is guided by the patient-provider communication, family caregiving, health services, and health informatics literatures in acknowledging the multiple pathways by which interpersonal relationships influence treatment decisions and end-of-life care. Each component of SHARE has been found to improve a range of communication outcomes in other care contexts, but have not previously been applied in this combination or examined with regard to advance care planning in persons with cognitive impairment. SHARE is designed to be broadly scalable and widely relevant to diverse primary care patients and stakeholders. The study goal is to engage family members or friends ("family" and/or "caregiver") in longitudinal interactions with primary care clinicians and stimulate and support advance care planning discussions in primary care. SHARE seeks to improve communication for persons with cognitive impairment by establishing a structured protocol to proactively engage family caregivers in ongoing interactions with primary care clinicians and stimulate and support advance care planning in primary care throughout the disease trajectory. SHARE evaluates a multicomponent communication intervention to proactively engage family members or friends and support advance care planning in primary care. SHARE encompasses the following four therapeutic elements: 1) a letter from the practice introducing the initiative, 2) access to a designated person (medical assistant, social worker, nurse, or lay person) trained to lead advance care planning discussions, 3) person-family agenda-setting to align perspectives about the role of the caregiver and stimulate discussion about goals of care, and 4) education about communication and available resources, including a 44-page brochure developed by the National Institute on Aging entitled "A Guide for Older People: Talking with your Doctor", a blank easy to complete advance directive, and facilitated registration to the patient portal (for patient and caregiver) to extend electronic interactions and information access to family. The control group receives minimally enhanced usual care with print educational materials that include the 44-page brochure developed by the National Institute on Aging entitled "A Guide for Older People: Talking with your Doctor" and a blank easy-to-complete advance directive. Participants in both groups are followed over a 24-month period. Outcomes are assessed from patient and caregiver enrollment surveys conducted in-person or by telephone or video conference at enrollment and follow-up telephone or web surveys at 6, 12, and 24 months; Electronic health record portal activity; information about advance directive completion from the electronic medical record; burdensome care at the end of life from family survey and Chesapeake Regional Information System for our Patients (CRISP).
Interventions
BEHAVIORALSharing Healthcare Wishes in Primary Care (SHARE)
SHARE is a multicomponent communication intervention to proactively engage family members or friends to support advance care planning in primary care.
BEHAVIORALMinimally Enhanced Usual Care
Minimally enhanced usual care participants are provided with print educational materials that include a 44-page brochure developed by the National Institute on Aging entitled "A Guide for Older People: Talking with your Doctor" and a blank easy-to-complete advance directive.
Sponsors
Johns Hopkins University
MedStar Health
Johns Hopkins Community Physicians
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient: 80 years or older, English speaking, able to provide informed consent themselves or through their legally authorized representative, identify a family member or friend who plays an active role in care coordination or accompanies them to primary care visits, not planning to move out of state within the next year, and cognitive impairment (mild-severe) on the basis of one or more incorrect answers or not being able to respond to a validated 6-item telephone screening instrument. * Family/Friend: 18 years and older, English speaking, hear well enough to communicate by telephone, not planning to move out of the state within the next year, do not report having a life-threatening illness and are a family member or unpaid friend who attends at least some medical visits of an eligible person with cognitive impairment, do not screen positive as having cognitive impairment on the basis of fewer than two incorrect answers on the 6-item telephone screening instrument.
Exclusion criteria
* Patient: less than 80 years old, non-English speaking, do not help with care coordination or attend primary care visits with a family member/friend, no willing/able legal guardian or representative to provide written informed consent for those who do not have capacity, plan to move out of state within the next year, or do not have cognitive impairment on the basis of all correct answers on the 6-item telephone screening instrument. * Family/Friend: less than 18 years old, non-English speaking, do not help with care coordination or attend at least some medical visits of an eligible patient, do not hear well enough to communicate by telephone, report having a life-threatening illness, plan to move out of state within the next year, are a non-family member who is paid for their services, or has cognitive impairment on the basis of two or more incorrect answers on the 6-item telephone screening instrument.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Scores for Patient and Caregiver-Reported Quality of Communication at 6-Months | 6 months | The primary outcome assesses family-reported quality of communication with the primary care team using the 7-item end-of-life subscale of the validated Quality of Communication Scale. The scale for each item is from 0 ('Worst you can imagine') to 10 ('Best you can imagine'), with a range of 0-70 with higher scores indicating higher perceived quality of communication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Scores for Patient and Caregiver-Reported Readiness to Engage in Advance Care Planning at 6-months | 6 months | The Advance Care Planning Engagement Survey is a validated patient-reported questionnaire that assesses advance care planning process measures on a 5-point Likert scale. The outcome assesses a 6-item subscale of the Advance Care Planning Engagement Survey that includes parallel items for patient and family participants. The scale for each item is from 1 ("I have never thought about it") to 5 ("I have already done it"), with a range of 6-30 with higher scores indicating higher perceived readiness to engage in advance care planning. |
| Proportion of Patients With Documentation of Advance Directive Completion in the Electronic Health Record at 6-months | 6 months | Documentation of advance directive completion in the electronic health record is defined as having a durable power of attorney or a living will documented in the primary care electronic health record. The Medical Order for Life Sustaining Treatment (MOLST) will not be included for this outcome as the completion of a Maryland MOLST is mandatory in certain situations, such as on transfer between settings of care, and is not indicative of having had an advance care planning discussion or naming a durable power of attorney. |
| Average Scores for Bereaved Family-Reported Decisional Conflict | 24 months | Caregivers of patients who die are asked to assess their Decisional Conflict 2-3 months after patient's death. The Decisional Conflict Scale is a 16-item instrument scored on a 5-point Likert scale ranging from 0 ("strongly agree") to 4 ("strongly disagree").The 16 items are summed, divided by 16, then multiplied by 25 to yield scores that range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). Higher scores indicate higher decisional conflict. |
| Average Scores for Bereaved Family-Reported Decisional Regret | 24 months | Caregivers of patients who die are asked to assess their Decisional Regret 2-3 months after patient's death. This outcome assesses bereaved family-reported decisional regret using a 5-item instrument that assesses the extent to which decision-makers experience regret about care. Response options are assessed using a 5-item Likert scale in which scores of 1 indicate the least regret and 5 the most regret. Scores are then reduced by 1 point and multiplied by 25 for a scale that ranges in value from 0 to 100. Prior studies have categorized scores of 0 as no regret, 1 to 25 as mild regret, and more than 25 as heightened regret. Higher scores indicate stronger feelings of regret. |
| Average Scores for Bereaved Family Symptoms of Anxiety | 24 months | Caregivers of patients who die are asked to respond to questions about Symptoms of Anxiety 2-3 months after patient's death. This outcome assesses bereaved family symptoms of anxiety using the Generalized Anxiety Disorder 7-item questionnaire (GAD-7). The GAD-7 is a validated instrument that asks about symptoms of anxiety using a two-week recall period with response categories that vary from 0 ("not at all") to 3 ("nearly every day"). Item responses are summed to construct composite scores. Higher scores indicate more symptoms of anxiety. |
| Average Scores for Bereaved Family-Reported Satisfaction With Care at the End-of-Life in Dementia | 24 months | Caregivers of patients who die are asked to assess their Satisfaction with Care at the End-of-life in Dementia 2-3 months after patient's death using the Satisfaction with Care at the End-of-Life in Dementia (SWC-EOLD). This is a 10-item instrument measured on a 4-point Likert scale that ranges from 1 ("strongly disagree") to 4 ("strongly agree") with a summary score ranging from 10-40 in which higher values indicate higher satisfaction. Higher scores indicate better satisfaction with care at the end-of-life in dementia. |
| Proportion of Patients Who Received Burdensome Care | 24 months | For patients who die while enrolled in the study by 24 months, this outcome assesses the proportion of patients who received burdensome care near the end of life. Burdensome care is defined as any intensive care unit use or life prolonging care (cardiopulmonary resuscitation, mechanical ventilation, tracheostomy, dialysis, artificial nutrition, chemotherapy) within 30 days of death using dates and services abstracted from medical records and the Chesapeake Regional Information System (CRISP), Maryland's Health Information Exchange, which includes all hospital encounters. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJennifer Wolff, PhD
Johns Hopkins Bloomberg School of Public Health
Participant flow
Recruitment details
Participants were recruited from 8 primary care practices at two health systems from October 2020 to December 2022. Both patient and care partner must have been eligible to participate. Eligible patients were ≥80 years and screened positive for cognitive impairment (1+ incorrect answer or unable to respond to a 6-item screening survey). Eligible care partners were ≥18 years, English-speaking, no life-threatening illness, and did not screen positive for cognitive impairment.
Pre-assignment details
Of 4,441 patient-family dyads who were outreached, 606 opted out of the study via opt-out card, and 3,835 were screened. Of 3,835 screened, 3,557 were ineligible (369 unreachable, 2,458 did not meet eligibility criteria, 730 refused, 5 consented not randomized due to lost to follow up). Patient and caregivers were enrolled as dyads. A total of 273 patient-family dyads were enrolled and randomized. The total number of individual participants is 546 (Participants started in Protocol Section).
Participants by arm
| Arm | Count |
|---|---|
| SHARE Group Of 273 patient-family dyads enrolled, 145 patients and 145 caregivers were randomized to the SHARE intervention group and received a packet from the primary care practice including a person-family agenda setting checklist, blank advance directive, guide for communication with clinicians, instructions for completing proxy registration for the patient portal and an invitation to a facilitator led ACP conversation. A total of 290 participants were randomized to the SHARE intervention group. | 290 |
| Control Group Of 273 patient-family dyads enrolled, 128 patients and 128 caregivers were assigned to the control group and received minimally enhanced usual care encompassing an introductory letter, the guide for communicating with clinicians and blank advance directive. A total of 256 participants were randomized to the control group. | 256 |
| Total | 546 |
Baseline characteristics
| Characteristic | SHARE Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical Caregiver <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Caregiver >=65 years | 64 Participants | 61 Participants | 125 Participants |
| Age, Categorical Caregiver Between 18 and 65 years | 81 Participants | 67 Participants | 148 Participants |
| Age, Categorical Patient <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Patient >=65 years | 145 Participants | 128 Participants | 273 Participants |
| Age, Categorical Patient Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous Caregiver | 65.7 years STANDARD_DEVIATION 10.8 | 66.3 years STANDARD_DEVIATION 13.6 | 66.0 years STANDARD_DEVIATION 12.2 |
| Age, Continuous Patient | 88.0 years STANDARD_DEVIATION 5.9 | 87.9 years STANDARD_DEVIATION 5.8 | 88.0 years STANDARD_DEVIATION 5.8 |
| Caregiver Relationship to Patient Adult Child | 103 Participants | 82 Participants | 185 Participants |
| Caregiver Relationship to Patient Other (friend, other relative) | 9 Participants | 10 Participants | 19 Participants |
| Caregiver Relationship to Patient Spouse/Partner | 33 Participants | 36 Participants | 69 Participants |
| Caregiver Reported Fair or Poor Self-rated Health | 22 Participants | 17 Participants | 39 Participants |
| Caregiver Reported - Hours helping patient in a typical week | 25.7 hours/week STANDARD_DEVIATION 33.3 | 22.4 hours/week STANDARD_DEVIATION 32.7 | 24.1 hours/week STANDARD_DEVIATION 33 |
| Caregiver Reported - Years accompanying patients to visits | 8.3 years STANDARD_DEVIATION 9.4 | 8.9 years STANDARD_DEVIATION 9 | 8.6 years STANDARD_DEVIATION 9.2 |
| Caregiver - Shared decision-making | 84.8 score on a scale STANDARD_DEVIATION 23.2 | 82.9 score on a scale STANDARD_DEVIATION 23.1 | 83.9 score on a scale STANDARD_DEVIATION 23.1 |
| Caregiver - Symptoms of anxiety | 3.4 score on a scale STANDARD_DEVIATION 4 | 2.6 score on a scale STANDARD_DEVIATION 2.9 | 3.0 score on a scale STANDARD_DEVIATION 3.5 |
| Caregiver - Symptoms of caregiving burden | 15.1 score on a scale STANDARD_DEVIATION 10.2 | 14.6 score on a scale STANDARD_DEVIATION 8.4 | 14.9 score on a scale STANDARD_DEVIATION 9.4 |
| Caregiver - Therapeutic Alliance | 55.3 score on a scale STANDARD_DEVIATION 9.4 | 53.3 score on a scale STANDARD_DEVIATION 10.5 | 54.3 score on a scale STANDARD_DEVIATION 10 |
| Education >12th grade Caregiver | 121 Participants | 96 Participants | 217 Participants |
| Education >12th grade Patient | 72 Participants | 69 Participants | 141 Participants |
| Ethnicity (NIH/OMB) Caregiver Hispanic or Latino | 6 Participants | 4 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Caregiver Not Hispanic or Latino | 139 Participants | 122 Participants | 261 Participants |
| Ethnicity (NIH/OMB) Caregiver Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Patient Hispanic or Latino | 6 Participants | 3 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Patient Not Hispanic or Latino | 139 Participants | 125 Participants | 264 Participants |
| Ethnicity (NIH/OMB) Patient Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Patient Diagnosis of Cognitive Impairment | 71 Participants | 63 Participants | 134 Participants |
| Patient - Live Alone | 40 Participants | 41 Participants | 81 Participants |
| Patient - Moderate or Severe Cognitive Impairment (based on TICS-m score) | 108 Participants | 81 Participants | 189 Participants |
| Patient Reported Quality of Life | 34.5 score on a scale STANDARD_DEVIATION 7 | 35.4 score on a scale STANDARD_DEVIATION 6.5 | 34.9 score on a scale STANDARD_DEVIATION 6.8 |
| Race/Ethnicity, Customized Caregiver Asian | 5 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized Caregiver Black | 45 Participants | 31 Participants | 76 Participants |
| Race/Ethnicity, Customized Caregiver Other race/missing | 5 Participants | 8 Participants | 13 Participants |
| Race/Ethnicity, Customized Caregiver White | 90 Participants | 84 Participants | 174 Participants |
| Race/Ethnicity, Customized Patient Asian | 6 Participants | 7 Participants | 13 Participants |
| Race/Ethnicity, Customized Patient Black | 46 Participants | 30 Participants | 76 Participants |
| Race/Ethnicity, Customized Patient Other race/missing | 5 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized Patient White | 88 Participants | 86 Participants | 174 Participants |
| Region of Enrollment United States | 290 Participants | 256 Participants | 546 Participants |
| Sex: Female, Male Caregiver Female | 122 Participants | 101 Participants | 223 Participants |
| Sex: Female, Male Caregiver Male | 23 Participants | 27 Participants | 50 Participants |
| Sex: Female, Male Patient Female | 89 Participants | 82 Participants | 171 Participants |
| Sex: Female, Male Patient Male | 56 Participants | 46 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 34 / 145 | 29 / 128 | 0 / 145 | 2 / 128 |
| other Total, other adverse events | 0 / 145 | 0 / 128 | 0 / 145 | 0 / 128 |
| serious Total, serious adverse events | 8 / 145 | 3 / 128 | 1 / 145 | 0 / 128 |
Outcome results
Primary
Average Scores for Patient and Caregiver-Reported Quality of Communication at 6-Months
The primary outcome assesses family-reported quality of communication with the primary care team using the 7-item end-of-life subscale of the validated Quality of Communication Scale. The scale for each item is from 0 ('Worst you can imagine') to 10 ('Best you can imagine'), with a range of 0-70 with higher scores indicating higher perceived quality of communication.
Time frame: 6 months
Population: 216 represents the total number participants (patients, caregivers) assessed in the intervention group for this outcome at 6 months, and 194 represents the total number of participants (patients, caregivers) assessed in the control group for this outcome at 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SHARE | Average Scores for Patient and Caregiver-Reported Quality of Communication at 6-Months | Caregivers | 3.41 score on a scale | Standard Deviation 2.4 |
| SHARE | Average Scores for Patient and Caregiver-Reported Quality of Communication at 6-Months | Patients | 3.06 score on a scale | Standard Deviation 2.8 |
| Minimally Enhanced Usual Care | Average Scores for Patient and Caregiver-Reported Quality of Communication at 6-Months | Caregivers | 3.09 score on a scale | Standard Deviation 2.4 |
| Minimally Enhanced Usual Care | Average Scores for Patient and Caregiver-Reported Quality of Communication at 6-Months | Patients | 1.93 score on a scale | Standard Deviation 1.9 |
Secondary
Average Scores for Bereaved Family-Reported Decisional Conflict
Caregivers of patients who die are asked to assess their Decisional Conflict 2-3 months after patient's death. The Decisional Conflict Scale is a 16-item instrument scored on a 5-point Likert scale ranging from 0 (strongly agree) to 4 (strongly disagree).The 16 items are summed, divided by 16, then multiplied by 25 to yield scores that range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). Higher scores indicate higher decisional conflict.
Time frame: 24 months
Secondary
Average Scores for Bereaved Family-Reported Decisional Regret
Caregivers of patients who die are asked to assess their Decisional Regret 2-3 months after patient's death. This outcome assesses bereaved family-reported decisional regret using a 5-item instrument that assesses the extent to which decision-makers experience regret about care. Response options are assessed using a 5-item Likert scale in which scores of 1 indicate the least regret and 5 the most regret. Scores are then reduced by 1 point and multiplied by 25 for a scale that ranges in value from 0 to 100. Prior studies have categorized scores of 0 as no regret, 1 to 25 as mild regret, and more than 25 as heightened regret. Higher scores indicate stronger feelings of regret.
Time frame: 24 months
Secondary
Average Scores for Bereaved Family-Reported Satisfaction With Care at the End-of-Life in Dementia
Caregivers of patients who die are asked to assess their Satisfaction with Care at the End-of-life in Dementia 2-3 months after patient's death using the Satisfaction with Care at the End-of-Life in Dementia (SWC-EOLD). This is a 10-item instrument measured on a 4-point Likert scale that ranges from 1 (strongly disagree) to 4 (strongly agree) with a summary score ranging from 10-40 in which higher values indicate higher satisfaction. Higher scores indicate better satisfaction with care at the end-of-life in dementia.
Time frame: 24 months
Secondary
Average Scores for Bereaved Family Symptoms of Anxiety
Caregivers of patients who die are asked to respond to questions about Symptoms of Anxiety 2-3 months after patient's death. This outcome assesses bereaved family symptoms of anxiety using the Generalized Anxiety Disorder 7-item questionnaire (GAD-7). The GAD-7 is a validated instrument that asks about symptoms of anxiety using a two-week recall period with response categories that vary from 0 (not at all) to 3 (nearly every day). Item responses are summed to construct composite scores. Higher scores indicate more symptoms of anxiety.
Time frame: 24 months
Secondary
Average Scores for Patient and Caregiver-Reported Readiness to Engage in Advance Care Planning at 6-months
The Advance Care Planning Engagement Survey is a validated patient-reported questionnaire that assesses advance care planning process measures on a 5-point Likert scale. The outcome assesses a 6-item subscale of the Advance Care Planning Engagement Survey that includes parallel items for patient and family participants. The scale for each item is from 1 (I have never thought about it) to 5 (I have already done it), with a range of 6-30 with higher scores indicating higher perceived readiness to engage in advance care planning.
Time frame: 6 months
Population: 216 represents the total number participants (patients, caregivers) assessed in the intervention group for this outcome at 6 months, and 194 represents the total number of participants (patients, caregivers) assessed in the control group for this outcome at 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SHARE | Average Scores for Patient and Caregiver-Reported Readiness to Engage in Advance Care Planning at 6-months | Caregivers | 27.01 score on a scale | Standard Deviation 4.2 |
| SHARE | Average Scores for Patient and Caregiver-Reported Readiness to Engage in Advance Care Planning at 6-months | Patients | 17.25 score on a scale | Standard Deviation 3.5 |
| Minimally Enhanced Usual Care | Average Scores for Patient and Caregiver-Reported Readiness to Engage in Advance Care Planning at 6-months | Caregivers | 24.82 score on a scale | Standard Deviation 6.9 |
| Minimally Enhanced Usual Care | Average Scores for Patient and Caregiver-Reported Readiness to Engage in Advance Care Planning at 6-months | Patients | 16.21 score on a scale | Standard Deviation 4.6 |
Secondary
Proportion of Patients Who Received Burdensome Care
For patients who die while enrolled in the study by 24 months, this outcome assesses the proportion of patients who received burdensome care near the end of life. Burdensome care is defined as any intensive care unit use or life prolonging care (cardiopulmonary resuscitation, mechanical ventilation, tracheostomy, dialysis, artificial nutrition, chemotherapy) within 30 days of death using dates and services abstracted from medical records and the Chesapeake Regional Information System (CRISP), Maryland's Health Information Exchange, which includes all hospital encounters.
Time frame: 24 months
Secondary
Proportion of Patients With Documentation of Advance Directive Completion in the Electronic Health Record at 6-months
Documentation of advance directive completion in the electronic health record is defined as having a durable power of attorney or a living will documented in the primary care electronic health record. The Medical Order for Life Sustaining Treatment (MOLST) will not be included for this outcome as the completion of a Maryland MOLST is mandatory in certain situations, such as on transfer between settings of care, and is not indicative of having had an advance care planning discussion or naming a durable power of attorney.
Time frame: 6 months
Population: Data was not collected.