Improving communication with older patients with cancer using geriatric assessment (GA): A University of Rochester NCI Community Oncology Research Program (NCORP) cluster randomized controlled trial (CRCT).

LBA10003 Background: GA includes validated measures that assess age-related health domains (e.g., function, cognition) known to increase adverse outcomes. In this PCORI and NCI funded CRCT, we evaluated if providing a GA summary and recommendations for GA-guided interventions improves communication about age-related concerns for older patients (pts) with cancer. Methods: Pts aged ≥ 70 with advanced solid tumors or lymphoma and at least 1 impaired GA domain were enrolled. Oncology practices were randomized to intervention (oncologists received GA summary) or usual care (no summary provided). The primary outcomes were: 1) number of discussions about age-related concerns (the clinic visit after GA was audio-recorded and transcribed; 2 blinded coders evaluated quality of communication and plan for follow-up interventions) and 2) telephone surveys of patient satisfaction (modified Health Care Climate Questionnaire [HCCQ-age] scored 7-35). Outcomes were analyzed using linear mixed models with arm as the fixed effect, controlling for practice. Results: From 2014-17, 544 pts (295 in GA) were enrolled from 31 practices. There were no differences in demographics by arm (mean age 77 yrs; 49% female). More patients in usual care had impaired physical performance (96% vs 92%, p = 0.03) and social support (33% vs 25%, p = 0.05). In 530 evaluable pts, the overall mean number of discussions was 6.3 (SD: 4.0). The GA arm had 3.5 more discussions about age-related concerns (95%CI: 2.28-4.72, p = 10-6; intraclass correlation coefficient [ICC] = 0.24) compared to usual care; of these, in the GA arm, 2.0 more discussions on average had higher quality communication (95%CI: 1.20-2.69; p = 6x10-6) and 1.9 more led to interventions (95% CI: 1.14-2.73; p = 1.6x10-5). The GA arm had significantly more discussions for almost all GA domains. In 511 pts with HCCQ-age, the mean score was 22.9 (SD 4.5); the score was 1.12 points higher in the GA arm (95%CI: 0.23-2.03; p = .027; ICC = 0.02). Conclusions: Providing a GA summary to oncologists increases the number and quality of discussions about age-related concerns and improves pt satisfaction. Clinical trial information: NCT02107443.

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Improving person-centered communication of goals, proxy, and advance directives in older patients with advanced cancer: Secondary analysis from a University of Rochester NCI Community Oncology Research Program (NCORP) cluster randomized controlled trial (CRCT).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.11523 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 11523-11523

Author(s):

Marie Anne Flannery ◽

Eva Culakova ◽

Kah Poh Loh ◽

Ronald M. Epstein ◽

Charles Stewart Kamen ◽

...

Keyword(s):

Advanced Cancer ◽

Advance Directives ◽

Advance Directive ◽

Older Patients ◽

Controlled Trial ◽

Secondary Analysis ◽

Community Based ◽

Oncology Research ◽

Patient Goals ◽

Age Related

11523 Background: Quality person-centered care relies on effective communication between the clinical team and the patient/caregiver eliciting goals and discussing wishes. In a PCORI- and NCI-funded CRCT, we found that providing community-based oncologists with geriatric assessment-guided recommendations led to more and higher quality discussions of age-related issues for older patients with advanced cancer. In this secondary analysis, we assessed whether specific recommendations to oncologists to discuss patient goals, proxy and advance directives resulted in increased communication about these topics. Methods: Patients aged 70+ with advanced solid tumors or lymphoma and at least one impaired geriatric domain (e.g., function, cognition) were enrolled (URCC 13070; PI: Mohile). Oncology practices were randomized to the intervention (oncologists received recommendations to elicit goals and discuss wishes) or usual care. The clinic visit after the oncologist received recommendations was recorded and transcribed; two blinded coders evaluated the transcripts for discussion of the specific topic areas recommended in the intervention. Between arm differences were compared using generalized linear models controlling for practice cluster. Results: From 2014-17, 528 patients (284 intervention) provided transcripts from 31 practices (mean age = 77, range 70-96 years; 49% female; mixed cancer diagnoses). Topics related to patient goals, proxy and advance directive wishes were more often discussed in the intervention arm (goals of care preferences: 9 vs 2%, p = .02, treatment goals: 35 vs 20%. p = .04, elicit caregiver input: 28 vs 3%. p < .01, assess values and goals: 25 vs 7%, p = .07, health care proxy: 40 vs 1%, p = .004, advance directive: 25 vs 1%, p = .002). Conclusions: In this community-based study of older adults providing recommendations to oncologists to discuss specific topics resulted in increased person-centered discussions with patients and caregivers about goals, proxy and advance directive wishes. However, the content areas were discussed in less than half of all visits. Clinical trial information: NCT02107443.

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Communication about comorbidities among 527 older patients with advanced cancer and their oncologists and caregivers: A multisite cluster-randomized controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.12040 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 12040-12040

Author(s):

Amber Kleckner ◽

Nikesha Gilmore ◽

Elizabeth Belcher ◽

Allison Magnuson ◽

Richard Francis Dunne ◽

...

Keyword(s):

Cancer Treatment ◽

Advanced Cancer ◽

Older Patients ◽

Controlled Trial ◽

Random Effect ◽

Clinic Visit ◽

Care Physician ◽

Older Americans ◽

Cluster Randomized ◽

Management Recommendations

12040 Background: Older patients with advanced cancer often have comorbidities that increase the risk of toxicity from neoplastic therapy but are not always considered in treatment planning. We assessed the utility of a geriatric assessment (GA) intervention to increase the number and quality of discussions about comorbidities among oncologists, older patients, and caregivers. Methods: This multi-site trial enrolled patients who were ≥70 years, had advanced solid tumors or lymphoma, had ≥1 GA impairment, and who were considering or receiving cancer treatment. All patients received the GA and completed an Older Americans Resources and Services Comorbidity survey, which evaluated 15 conditions and interference with activities (clinical impairment = ≥3 comorbidities or ≥1 highly interfering). Oncology practices were randomized to intervention (GA with a summary with management recommendations provided to oncologists) or usual care (GA only). The clinic visit after GA was audio-recorded, transcribed, and coded for GA topics including comorbidity. Generalized linear mixed models adjusting for site (random effect) were used to assess the effect of the intervention. Results: Patients (n=527 evaluable, 76.6±5.2 years, 49% female) and oncologists (n=131, 63 in intervention) were enrolled from 31 sites. In total, 94.5% of patients had ≥1 comorbidity with an average of 3.2±1.9; 64% were clinically impaired by comorbidity (p=0.76 between arms). The intervention arm had twice the number of conversations about comorbidities (1.02 vs. 0.52 conversations per patient, difference 0.50, 95% CI 0.18-0.81, p=0.004) and conversations were more likely to be initiated by the oncologist (p<0.001, Table). Moreover, among patients who had conversations about comorbidities, more patients in the intervention arm had discussions specifically addressing comorbidities (e.g., cancer treatment modification, communication with the primary care physician; 24.3% vs. 7.5%, p=0.003). Conclusions: Providing oncologists with a GA summary and recommendations encouraged them to engage in more discussions about their patients’ comorbidities with the goal of addressing interactions between comorbidities, cancer, and its treatments. Funds: PCORI CD4634, NCI UG1CA189961 Clinical trial information: NCT02107443 . [Table: see text]

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Study Protocol: Partners at Meals Telehealth Intervention for Caregivers of Persons With Dementia

Innovation in Aging ◽

10.1093/geroni/igaa057.889 ◽

2020 ◽

Vol 4 (Supplement_1) ◽

pp. 278-278

Author(s):

Suparna Qanungo ◽

Elaine Amella Krug ◽

Kelly Martin ◽

Martina Mueller ◽

Mohan Madisetti ◽

...

Keyword(s):

Quality Of Life ◽

Usual Care ◽

Study Protocol ◽

Controlled Trial ◽

Intervention Group ◽

Train The Trainer ◽

Telehealth Intervention ◽

Alzheimer's Caregiving ◽

Cluster Randomized

Abstract Background: As the aging population continues to increase, it is estimated that persons with dementias (PWDs) will reach 13 million by 2050. Lack of caregiver skills related to mealtime planning and the ability to cope with dysfunctional behaviors are well-documented factors that influence nutritional outcomes for PWDs, leading to social isolation, and negatively impacting their home stay. The aim of this study protocol is to test the effectiveness of a train-the-trainer program in which non-paid volunteers in respite care centers deliver a telehealth mealtime intervention for caregivers of PWDs, Partners at Meals. The program is based on the C3P Model of Changing the Place, People and Person. Methods: A cluster-randomized controlled trial with parallel mixed methods evaluation processes is being conducted. Caregivers and PWD dyads, receiving respite services are randomized to receive Partners at Meals or enhanced-usual-care for six months. Within the intervention group, dyads are partnered with a C3P-trained volunteer who works with caregivers to devise monthly mealtime plans. Under enhanced-usual-care, dyads receive standardized educational materials modified from The Savvy Caregiver Program for Alzheimer’s caregiving. Primary outcomes include weight, calorie, protein and fluid intake of the PWDs and quality of life of the caregiver. Respite center administrators, program directors, volunteers and caregivers are evaluated for intervention fidelity, acceptability and sustainability. Implications: In this trial, we lay the groundwork to examine effectiveness and sustainability of a train-the-trainer telehealth program that could be widely disseminated for managing mealtimes in-the-home, while promoting quality of life of both the caregiver and PWDs.

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Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

10.2196/preprints.13973 ◽

2019 ◽

Author(s):

Sarah Dineen-Griffin ◽

Victoria Garcia Cardenas ◽

Kylie Williams ◽

Shalom Isaac Benrimoj

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Self Care ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Community Pharmacies ◽

Randomized Controlled ◽

Minor Ailments ◽

Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

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A tablet-based intervention for activating nursing home residents with dementia: results from a cluster-randomized controlled trial

International Psychogeriatrics ◽

10.1017/s1041610221000818 ◽

2021 ◽

pp. 1-13

Author(s):

Julie L. O’Sullivan ◽

Sonia Lech ◽

Paul Gellert ◽

Ulrike Grittner ◽

Jan-Niklas Voigt-Antons ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Nursing Home ◽

Nursing Homes ◽

Psychotropic Medication ◽

Controlled Trial ◽

Nursing Home Residents ◽

Randomized Controlled ◽

Cluster Randomized

Abstract Objectives: To investigate global and momentary effects of a tablet-based non-pharmacological intervention for nursing home residents living with dementia. Design: Cluster-randomized controlled trial. Setting: Ten nursing homes in Germany were randomly allocated to the tablet-based intervention (TBI, 5 units) or conventional activity sessions (CAS, 5 units). Participants: N = 162 residents with dementia. Intervention: Participants received regular TBI (n = 80) with stimulating activities developed to engage people with dementia or CAS (n = 82) for 8 weeks. Measurements: Apathy Evaluation Scale (AES-I, primary outcome), Quality of Life in Alzheimer’s Disease scale, QUALIDEM scale, Neuropsychiatric Inventory, Geriatric Depression Scale, and psychotropic medication (secondary outcomes). Momentary quality of life was assessed before and after each activity session. Participants and staff were blinded until the collection of baseline data was completed. Data were analyzed with linear mixed-effects models. Results: Levels of apathy decreased slightly in both groups (mean decrease in AES-I of .61 points, 95% CI −3.54, 2.33 for TBI and .36 points, 95% CI −3.27, 2.55 for CAS). Group difference in change of apathy was not statistically significant (β = .25; 95% CI 3.89, 4.38, p = .91). This corresponds to a standardized effect size (Cohen’s d) of .02. A reduction of psychotropic medication was found for TBI compared to CAS. Further analyses revealed a post-intervention improvement in QUALIDEM scores across both groups and short-term improvements of momentary quality of life in the CAS group. Conclusions: Our findings suggest that interventions involving tailored activities have a beneficial impact on global and momentary quality of life in nursing home residents with dementia. Although we found no clear advantage of TBI compared to CAS, tablet computers can support delivery of non-pharmacological interventions in nursing homes and facilitate regular assessments of fluctuating momentary states.

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Evaluating the provision of Further Enabling Care at Home (FECH+) for informal caregivers of older adults discharged home from hospital: protocol for a multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-046600 ◽

2021 ◽

Vol 11 (6) ◽

pp. e046600

Author(s):

Anne-Marie Hill ◽

Rachael Moorin ◽

Susan Slatyer ◽

Christina Bryant ◽

Keith Hill ◽

...

Keyword(s):

Quality Of Life ◽

Older Adults ◽

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Informal Caregivers ◽

Care Recipient ◽

Care At Home ◽

Randomised Controlled

IntroductionThere are personal and societal benefits from caregiving; however, caregiving can jeopardise caregivers’ health. The Further Enabling Care at Home (FECH+) programme provides structured nurse support, through telephone outreach, to informal caregivers of older adults following discharge from acute hospital care to home. The trial aims to evaluate the efficacy of the FECH+ programme on caregivers’ health-related quality of life (HRQOL) after care recipients’ hospital discharge.Methods and analysisA multisite, parallel-group, randomised controlled trial with blinded baseline and outcome assessment and intention-to-treat analysis, adhering to Consolidated Standards of Reporting Trials guidelines will be conducted. Participants (N=925 dyads) comprising informal home caregiver (18 years or older) and care recipient (70 years or older) will be recruited when the care recipient is discharged from hospital. Caregivers of patients discharged from wards in three hospitals in Australia (one in Western Australia and two in Queensland) are eligible for inclusion. Participants will be randomly assigned to one of the two groups. The intervention group receive the FECH+ programme, which provides structured support and problem-solving for the caregiver after the care recipient’s discharge, in addition to usual care. The control group receives usual care. The programme is delivered by a registered nurse and comprises six 30–45 min telephone support sessions over 6 months. The primary outcome is caregivers’ HRQOL measured using the Assessment of Quality of Life—eight dimensions. Secondary outcomes include caregiver preparedness, strain and distress and use of healthcare services. Changes in HRQOL between groups will be compared using a mixed regression model that accounts for the correlation between repeated measurements.Ethics and disseminationParticipants will provide written informed consent. Ethics approvals have been obtained from Sir Charles Gairdner and Osborne Park Health Care Group, Curtin University, Griffith University, Gold Coast Health Service and government health data linkage services. Findings will be disseminated through presentations, peer-reviewed journals and conferences.Trial registration numberACTRN12620000060943.

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Sustained impact of a sleep intervention and moderators of treatment outcome for children with ADHD: a randomised controlled trial

Psychological Medicine ◽

10.1017/s0033291718004063 ◽

2019 ◽

Vol 50 (2) ◽

pp. 210-219 ◽

Cited By ~ 7

Author(s):

E. Sciberras ◽

M. Mulraney ◽

F. Mensah ◽

F. Oberklaid ◽

D. Efron ◽

...

Keyword(s):

Usual Care ◽

Sleep Problem ◽

Controlled Trial ◽

Parent Report ◽

Daily Functioning ◽

Adhd Medication ◽

Randomised Controlled ◽

Severe Sleep Problem ◽

Over Time

AbstractBackgroundWe aim to (1) determine whether a behavioural sleep intervention for children with attention-deficit/hyperactivity disorder (ADHD) leads to sustained benefits; and (2) examine the factors associated with treatment response.MethodsThis study was a randomised controlled trial of 244 children (5–13 years) with ADHD from Victoria, Australia. All participants had a moderate/severe sleep problem that met American Academy of Sleep Medicine criteria for an eligible sleep disorder by parent report. The two-session intervention covered sleep hygiene and standardised behavioural strategies. The control group received usual care. Parent- and teacher-reported outcomes at 12 months included sleep, ADHD severity, quality of life, daily functioning, behaviour, and parent mental health. Adjusted mixed effects regression analyses examined 12 month outcomes. Interaction analyses were used to determine moderators of intervention outcomes over time. The trial was registered with ISRCTN, http://www.controlled-trials.com (ISRCTN68819261).ResultsIntervention children were less likely to have a moderate/severe sleep problem by parent report at 12 months compared to usual care children (28.4% v. 46.5%, p = 0.03). Children in the intervention group fared better than the usual care group in terms of parent-reported ADHD symptoms (Cohen's d: −0.3, p < 0.001), quality of life (d: 0.4, p < 0.001), daily functioning (d: −0.5, p < 0.001), and behaviour (d: −0.3, p = 0.005) 12 months later. The benefits of the intervention over time in terms of sleep were less for children not taking ADHD medication and children with parents experiencing depression.ConclusionsA behavioural sleep intervention for ADHD is associated with small sustained improvements in child wellbeing. Children who are not taking ADHD medication or have parents with depression may require follow-up booster sleep sessions.

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