Mothers and Babies Virtual Group (MBVG) for perinatal Latina women: study protocol for a hybrid type-1 effectiveness-implementation randomized controlled trial.

BACKGROUND: Immigrant Latinas (who are foreign-born but now reside in the USA) are at greater risk for developing postpartum depression than the general perinatal population, but many face barriers to treatment. To address these barriers, we adapted the Mothers and Babies Course-an evidence-based intervention for postpartum depression prevention-to a virtual group format. Additional adaptations are inclusion of tailored supplemental child health content and nutrition benefit assistance. We are partnering with Early Learning Centers (ELC) across the state of Maryland to deliver and test the adapted intervention. METHODS: The design is a Hybrid Type I Effectiveness-Implementation Trial. A total of 300 participants will be individually randomized to immediate (N = 150) versus delayed (N = 150) receipt of the intervention, Mothers and Babies Virtual Group (MB-VG). The intervention will be delivered by trained Early Learning Center staff. The primary outcomes are depressive symptoms (measured via the Center for Epidemiologic Studies-Depression Scale), parenting self-efficacy (measured via the Parental Cognition and Conduct Towards the Infant Scale (PACOTIS) Parenting Self-Efficacy subscale), and parenting responsiveness (measured via the Maternal Infant Responsiveness Instrument) at 1-week, 3-month, and 6-month post-intervention. Depressive episodes (Structured Clinical Interview for DSM-V- Disorders Research Version) at 3-month and 6-month post-intervention will also be assessed. Secondary outcomes include social support, mood management, anxiety symptoms, perceived stress, food insecurity, and mental health stigma at 1-week, 3-month, and 6-month post-intervention. Exploratory child outcomes are dysregulation and school readiness at 6-month post-intervention. Intervention fidelity, feasibility, acceptability, and appropriateness will also be assessed guided by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. DISCUSSION: This study will be one of the first to test the efficacy of a group-based virtual perinatal depression intervention with Latina immigrants, for whom stark disparities exist in access to health services. The hybrid effectiveness-implementation design will allow rigorous examination of barriers and facilitators to delivery of the intervention package (including supplemental components) which will provide important information on factors influencing intervention effectiveness and the scalability of intervention components in Early Learning Centers and other child-serving settings. REGISTRATION: ClinicalTrials.gov NCT05873569.

Sharing health care wishes among older adults with cognitive impairment in primary care: Results from a randomized controlled trial.

INTRODUCTION: Best practices for conducting advance care planning (ACP) among persons with cognitive impairment exist, but evidence-based models are lacking for the primary care setting. METHODS: We tested a remote multicomponent ACP model (SHARE) versus minimally enhanced usual care in 273 person-family dyads from eight primary care practices. RESULTS: Mean patient age was 88.0 years, 85 (31.1%) were Black/Latino; 189 (69.2%) had moderate-to-severe cognitive impairment. Most (101/145; 69.6%) intervention dyads engaged in ACP. At follow-up, no treatment effect was observed for care partner-reported quality of communication about end-of-life care at 6 or 12 months, but intervention patients reported better quality of communication about end-of-life care at 12 months. Intervention care partners and patients reported greater readiness to engage in ACP at 6 and 12 months, respectively, and increased completion of key aspects of ACP. DISCUSSION: SHARE supported key aspects of ACP processes and communication about end-of-life care. HIGHLIGHTS: Primary care-based models of ACP for persons with dementia are lacking. Involving persons with cognitive impairment in remote ACP is feasible with care partner involvement. Results indicate benefit for aspects of ACP processes and communication about end-of-life care.

Assessing Advance Care Planning Fidelity within the Context of Cognitive Impairment: The SHARE Trial.

CONTEXT: Advance care planning (ACP) is critical among primary care patients with cognitive impairment, but few interventions have tested ACP with this population. OBJECTIVE: Describe the development and evaluation of a tool for assessing ACP fidelity within the context of cognitive impairment, including inter-rater reliability, convergent validity, and overall fidelity using clinical trial data. DESIGN: SHARE is a multicomponent intervention inclusive of facilitated ACP conversations. From a two group, single blind, randomized controlled trial, recorded ACP conversations were rated for fidelity. 145 primary care patients and their care partners were randomized to receive the intervention. Participating patients were 80+ years, had a care partner, and indications of cognitive impairment. An ACP Fidelity Checklist was developed with three subscales: Meeting Set-Up; ACP Meeting Topics; and Communication Skills. Scores were converted to percentages (100% = perfect fidelity) with a target of ≥80% fidelity. A post-ACP meeting report completed by ACP facilitators was used to assess convergent validity of the checklist. Intra-class correlation (ICC) was to evaluate inter-rater reliability. RESULTS: ACP conversations averaged 33.6 minutes (SD = 14.1). The mean fidelity score across N = 91 rated meetings was 82.9%, with a range of 77.3%-90.6% for subscales. 63.7% of meetings achieved a rating of ≥80%. Cognitive function was positively associated with patient participation (rho = .59, P < 0.001). For checklist items, ICC scores ranged from 0.43-0.96. Post-ACP meeting form scores were correlated with the checklist Meeting Topics subscale (r = 0.36, P = 0.001). CONCLUSIONS: Assessing the fidelity of ACP conversations involving primary care patients living with cognitive impairment and their care partners is feasible.

SHARING Choices: Lessons Learned from a Primary-Care Focused Advance Care Planning Intervention.

BACKGROUND: Few advance care planning (ACP) interventions have been scaled in primary care. PROBLEM: Best practices for delivering ACP at scale in primary care do not exist and prior efforts have excluded older adults with Alzheimer's Disease and Related Dementias (ADRD). INTERVENTION: SHARING Choices (NCT#04819191) is a multicomponent cluster-randomized pragmatic trial conducted at 55 primary care practices from two care delivery systems in the Mid-Atlantic region of the U.S. We describe the process of implementing SHARING Choices within 19 practices randomized to the intervention, summarize fidelity to planned implementation, and discuss lessons learned. OUTCOMES: Embedding SHARING Choices involved engagement with organizational and clinic-level partners. Of 23,220 candidate patients, 17,931 outreach attempts by phone (77.9%) and the patient portal (22.1%) were made by ACP facilitators and 1215 conversations occurred. Most conversations (94.8%) were less than 45 minutes duration. Just 13.1% of ACP conversations included family. Patients with ADRD comprised a small proportion of patients who engaged in ACP. Implementation adaptations included transitioning to remote modalities, aligning ACP outreach with the Medicare Annual Wellness Visit, accommodating primary care practice flexibility. LESSONS LEARNED: Study findings reinforce the value of adaptable study design; co-designing workflow adaptations with practice staff; adapting implementation processes to fit the unique needs of two health systems; and modifying efforts to meet health system goals and priorities.

Sharing Health Care Wishes in Primary Care (SHARE) among older adults with possible cognitive impairment in primary care: Study protocol for a randomized controlled trial.

OBJECTIVE: Little is known about effective strategies to improve advance care planning (ACP) for persons with cognitive impairment in primary care, the most common setting of care. We describe a randomized controlled trial to test the efficacy of a multicomponent communication intervention, "Sharing Healthcare Wishes in Primary Care" (SHARE). PARTICIPANTS: Planned enrollment of 248 dyads of adults 80 years and older with possible cognitive impairment and their care partner, from primary care clinics at 2 Mid-Atlantic health systems. METHODS: The treatment protocol encompasses an introductory letter from the clinic; access to a designated facilitator trained in ACP; person-family agenda-setting to align perspectives about the family's role; and print education. The control protocol encompasses minimally enhanced usual care, which includes print education and a blank advance directive. Randomization occurs at the individual dyad-level. Patient and care partner surveys are fielded at baseline, 6-, 12-, and 24- months. Fidelity of interventionist delivery of the protocol is measured through audio-recordings of ACP conversations and post-meeting reports, and by ongoing monitoring and support of interventionists. OUTCOMES: The primary outcome is quality of end-of-life care communication at 6 months; secondary outcomes include ACP process measures. An exploratory aim examines end-of-life care quality and bereaved care partner experiences for patients who die by 24 months. CONCLUSIONS: Caregiver burden, clinician barriers, and impaired decisional capacity amplify the difficulty and importance of ACP discussions in the context of cognitive impairment: this intervention will comprehensively examine communication processes for this special subpopulation in a key setting of primary care. REGISTRATION: ClinicalTrials.gov: NCT04593472.

A randomized intervention involving family to improve communication in breast cancer care.

We examined the effects of a communication intervention to engage family care partners on patient portal (MyChart) use, illness understanding, satisfaction with cancer care, and symptoms of anxiety in a single-blind randomized trial of patients in treatment for breast cancer. Patient-family dyads were recruited and randomly assigned a self-administered checklist to clarify the care partner role, establish a shared visit agenda, and facilitate MyChart access (n = 63) or usual care (n = 55). Interviews administered at baseline, 3, 9 (primary endpoint), and 12 months assessed anxiety (GAD-2), mean FAMCARE satisfaction, and complete illness understanding (4 of 4 items correct). Time-stamped electronic interactions measured MyChart use. By 9 months, more intervention than control care partners registered for MyChart (77.8 % vs 1.8%; p < 0.001) and logged into the patient's account (61.2% vs 0% of those registered; p < 0.001), but few sent messages to clinicians (6.1% vs 0%; p = 0.247). More intervention than control patients viewed clinical notes (60.3% vs 32.7%; p = 0.003). No pre-post group differences in patient or care partner symptoms of anxiety, satisfaction, or complete illness understanding were found. Intervention patients whose care partners logged into MyChart were more likely to have complete illness understanding at 9 months (changed 70.0% to 80.0% vs 69.7% to 54.6%; p = 0.03); symptoms of anxiety were numerically lower (16.7% to 6.7% vs 15.2% to 15.2%; p = 0.24) and satisfaction numerically higher (15.8-16.2 vs 18.0-17.4; p = 0.25). A brief, scalable communication intervention led to greater care partner MyChart use and increased illness understanding among patients with more engaged care partners (NCT03283553).

SHARING Choices: A Pilot Study to Engage Family in Advance Care Planning of Older Adults With and Without Cognitive Impairment in the Primary Care Context.

CONTEXT: Few advance care planning (ACP) interventions proactively engage family or address the needs of older adults with and without cognitive impairment in the primary care context. OBJECTIVES: To pilot a multicomponent intervention involving: an introductory letter describing a new clinic initiative and inviting patients to complete a patient-family pre-visit agenda-setting checklist, share their electronic health information with family, and talk about their wishes for future care with a trained ACP facilitator (SHARING Choices). METHODS: SHARING Choices was delivered to 40 patient-family dyads from 3 primary care clinics. Facilitators completed post-ACP reports. Patient and family participants completed baseline and 6-week surveys. RESULTS: Patients were on average 75 years (range 65-90). Family were spouses (85.0%) or adult children (15.0%). At 6 weeks, nearly half of dyads participated in ACP conversations (n = 19) or used the agenda-setting checklist (n = 17), one-third (n = 13) registered family to access the patient's portal account, and most (n = 28) provided the primary care team with a new or previously completed advance directive. Of 12 patients who screened positive for cognitive impairment, 9 completed ACP conversations and 10 provided the clinic with an advance directive. ACP engagement, measured on a 4-point scale, was comparatively lower at baseline and 6 weeks among family (3.05 and 3.19) than patients (3.56 and 3.54). Patients remarked that SHARING Choices clarified communication and preferences while family reported a better understanding of their role in ACP and communication. CONCLUSION: SHARING Choices was acceptable among older adults with and without cognitive impairment and may increase advance directive completion.

How Clinicians Discuss Medications During Primary Care Encounters Among Older Adults with Cognitive Impairment.

BACKGROUND: People with cognitive impairment experience high rates of polypharmacy and potentially inappropriate medication use. How clinicians communicate about medications may affect to what extent patients and family companions understand and participate in decisions about medication use. OBJECTIVE: To characterize how primary care clinicians discuss medications during encounters with older adults with cognitive impairment and their companions. DESIGN: Qualitative content analysis of audio-recorded clinical encounters from SAME Page, a randomized controlled trial to examine the effects of a patient-family agenda setting checklist on primary care visit communication among patients with cognitive impairment. Visits occurred between August 2016 and August 2017. PARTICIPANTS: Patients were 65 or older, had > 1 incorrect answer on a cognitive screener, and attended visits with a relative or unpaid companion. Clinicians were physicians, nurse practitioners, or physician assistants at participating practices. APPROACH: The encounters were transcribed verbatim. We used qualitative content analysis to identify major themes. KEY RESULTS: Patients were on average 79.9 years of age. The average MMSE score was 21.6. About half of clinicians reported practicing for 15 or more years (n = 8). We identified three major themes. First, we found numerous instances in which primary care clinicians introduced patients and companions to key principles of optimal prescribing and deprescribing. Second, clinicians used a variety of approaches to foster shared decision-making about medication use. Third, several challenges prevented clinicians from working together with patients and companions to optimize prescribing and deprescribing. CONCLUSIONS: This study offers insight into key language clinicians can use to initiate discussions about optimizing prescribing, as well as barriers they face in doing so. Examples identified in these transcripts should be tested with patients and caregivers to examine how such communications are received and interpreted. Future research should develop and test interventions that seek to overcome obstacles to optimizing prescribing for older adults with cognitive impairment.

Sharing in care: engaging care partners in the care and communication of breast cancer patients.

PURPOSE: Family is often overlooked in cancer care. We developed a patient-family agenda setting intervention to engage family in cancer care communication. METHODS: We conducted a pilot randomized controlled trial (NCT03283553) of patients on active treatment for breast cancer and their family "care partner." Intervention dyads (n = 69) completed a self-administered checklist to clarify care partner roles, establish a shared visit agenda, and facilitate MyChart patient portal access. Control dyads (n = 63) received usual care. We assessed intervention acceptability and initial effects from post-visit surveys and MyChart utilization at 6 weeks. RESULTS: At baseline, most patients (89.4%) but few care partners (1.5%) were registered for MyChart. Most patients (79.4%) wanted their care partner to have access to their records and 39.4% of care partners reported accessing MyChart. In completing the checklist, patients and care partners endorsed active communication roles for the care partner and identified a similar visit agenda: most (> 90%) reported the checklist was easy, useful, and recommended it to others. At 6 weeks, intervention (vs control) care partners were more likely to be registered for MyChart (75.4% vs 1.6%; p < 0.001), to have logged in (43.5% vs 0%; p < 0.001) and viewed clinical notes (30.4% vs 0%; p < 0.001), but were no more likely to exchange direct messages with clinicians (1.5% vs 0%; p = 0.175). No differences in patients' MyChart use were observed, but intervention patients more often viewed clinical notes (50.7% vs 9.5%; p < 0.001). CONCLUSIONS: A patient-family agenda setting intervention was acceptable and affected online practices of cancer patients and care partners.

Patient-Family Agenda Setting for Primary Care Patients with Cognitive Impairment: the SAME Page Trial.

BACKGROUND: Establishing priorities for discussion during time-limited primary care visits is challenging in the care of patients with cognitive impairment. These patients commonly attend primary care visits with a family companion. OBJECTIVE: To examine whether a patient-family agenda setting intervention improves primary care visit communication for patients with cognitive impairment DESIGN: Two-group pilot randomized controlled study PARTICIPANTS: Patients aged 65 + with cognitive impairment and family companions (n = 93 dyads) and clinicians (n = 14) from two general and one geriatrics primary care clinic INTERVENTION: A self-administered paper-pencil checklist to clarify the role of the companion and establish a shared visit agenda MEASUREMENTS: Patient-centered communication (primary); verbal activity, information disclosure including discussion of memory, and visit duration (secondary), from audio recordings of visit discussion RESULTS: Dyads were randomized to usual care (n = 44) or intervention (n = 49). Intervention participants endorsed an active communication role for companions to help patients understand what the clinician says or means (90% of dyads), remind patients to ask questions or ask clinicians questions directly (84% of dyads), or listen and take notes (82% of dyads). Intervention dyads identified 4.4 health issues for the agenda on average: patients more often identified memory (59.2 versus 38.8%; p = 0.012) and mood (42.9 versus 24.5%; p = 0.013) whereas companions more often identified safety (36.7 versus 18.4%; p = 0.039) and personality/behavior change (32.7 versus 16.3%; p = 0.011). Communication was significantly more patient-centered in intervention than in control visits at general clinics (p < 0.001) and in pooled analyses (ratio of 0.86 versus 0.68; p = 0.046). At general clinics, intervention (versus control) dyads contributed more lifestyle and psychosocial talk (p < 0.001) and less biomedical talk (p < 0.001) and companions were more verbally active (p < 0.005). No intervention effects were found at the geriatrics clinic. No effect on memory discussions or visit duration was observed. CONCLUSION: Patient-family agenda setting may improve primary care visit communication for patients with cognitive impairment. TRIAL REGISTRATION: ClinicalTrials.gov : NCT02986958.