Why do older adults decline participation in research? Results from two deprescribing clinical trials.

BACKGROUND: Heterogenous older adult populations are underrepresented in clinical trials, and their participation is necessary for interventions that directly target them. The purpose of this study was to evaluate reasons why hospitalized older adults declined participation in two deprescribing clinical trials. METHODS: We report enrollment data from two deprescribing trials, Shed-MEDS (non-Veterans) and VA DROP (Veterans). For both trials, inclusion criteria required participants to be hospitalized, age 50 or older, English-speaking, and taking five or more home medications. Eligible patients were approached for enrollment while hospitalized. When an eligible patient or surrogate declined participation, the reason(s) were recorded and subsequently analyzed inductively to develop themes, and a chi-square test was used for comparison (of themes between Veterans and non-Veterans). RESULTS: Across both trials, 1226 patients (545 non-Veterans and 681 Veterans) declined enrollment and provided reasons, which were condensed into three themes: (1) feeling overwhelmed by their current health status, (2) lack of interest or mistrust of research, and (3) hesitancy to participate in a deprescribing study. A greater proportion of Veterans expressed a lack of interest or mistrust in research (42% vs 26%, chi-square value = 36.72, p < .001), whereas a greater proportion of non-Veterans expressed feeling overwhelmed by their current health status (54% vs 35%, chi-square value = 42.8 p < 0.001). Across both trials, similar proportion of patients expressed hesitancy to participate in a deprescribing study, with no significant difference between Veterans and non-Veterans (23% and 21%). CONCLUSIONS: Understanding the reasons older adults decline participation can inform future strategies to engage this multimorbid population.

Patient-Reported Barriers and Enablers to Deprescribing Recommendations During a Clinical Trial (Shed-MEDS).

BACKGROUND AND OBJECTIVES: Effective deprescribing requires shared decision making between a patient and their clinician, and should be used when implementing evidence-based deprescribing conversations. As part of the Shed-MEDS clinical trial, this study assessed barriers and enablers that influence patient decision making in deprescribing to inform future implementation efforts and adaptations. RESEARCH DESIGN AND METHODS: Shed-MEDS, a randomized controlled deprescribing trial, included hospitalized older adults discharging to post-acute care facilities. A trained clinician reviewed each participant's medical history and medication list to identify medications with potential for deprescribing. The study clinician then conducted a semistructured patient-centered deprescribing interview to determine patient (or surrogate) concerns about medications and willingness to deprescribe. Reeve et al.'s (2013) framework was used to categorize barriers and enablers to deprescribing from the patient's perspective, including "appropriateness of cessation," "fear," "dislike of a medication," "influences," and "process of cessation." RESULTS: Overall, participants/surrogates (N = 177) agreed with 63% (883 total medications) of the study clinician's deprescribing recommendations. Thematic analysis revealed that "appropriateness" of a medication was the most common barrier (88.2%) and enabler (67.3%) to deprescribing. Other deprescribing enablers were in the following domains: "influences" (22.7%), "process" (22.5%), "pragmatic" (19.4%), and "dislike" (5.3%). DISCUSSION AND IMPLICATIONS: Use of a semistructured deprescribing interview conversation tool allowed study clinicians to elicit individual barriers and enablers to deprescribing from the patient's perspective. Participants in this study expressed more agreement than disagreement with study clinicians' deprescribing recommendations. These results should inform future implementation efforts that incorporate a patient-centered framework during deprescribing conversations. CLINICAL TRIALS REGISTRATION NUMBER: NCT02979353.

A patient-centered deprescribing intervention for hospitalized older patients with polypharmacy: rationale and design of the Shed-MEDS randomized controlled trial.

BACKGROUND: Polypharmacy is prevalent among hospitalized older adults, particularly those being discharged to a post-care care facility (PAC). The aim of this randomized controlled trial is to determine if a patient-centered deprescribing intervention initiated in the hospital and continued in the PAC setting reduces the total number of medications among older patients. METHODS: The Shed-MEDS study is a 5-year, randomized controlled clinical intervention trial comparing a patient-centered describing intervention with usual care among older (≥50 years) hospitalized patients discharged to PAC, either a skilled nursing facility (SNF) or an inpatient rehabilitation facility (IPR). Patient measurements occur at hospital enrollment, hospital discharge, within 7 days of PAC discharge, and at 60 and 90 days following PAC discharge. Patients are randomized in a permuted block fashion, with block sizes of two to four. The overall effectiveness of the intervention will be evaluated using total medication count as the primary outcome measure. We estimate that 576 patients will enroll in the study. Following attrition due to death or loss to follow-up, 420 patients will contribute measurements at 90 days, which provides 90% power to detect a 30% versus 25% reduction in total medications with an alpha error of 0.05. Secondary outcomes include the number of medications associated with geriatric syndromes, drug burden index, medication adherence, the prevalence and severity of geriatric syndromes and functional health status. DISCUSSION: The Shed-MEDS trial aims to test the hypothesis that a patient-centered deprescribing intervention initiated in the hospital and continuing through the PAC stay will reduce the total number of medications 90 days following PAC discharge and result in improvements in geriatric syndromes and functional health status. The results of this trial will quantify the health outcomes associated with reducing medications for hospitalized older adults with polypharmacy who are discharged to post-acute care facilities. TRIAL REGISTRATION: This trial was prospectively registered at clinicaltrials.gov ( NCT02979353 ). The trial was first registered on 12/1/2016, with an update on 09/28/17 and 10/12/2018.

Comparison Between Quality of Care Provided by Trained Feeding Assistants and Certified Nursing Assistants During Between-Meal Supplementation in Long-Term Care Settings.

The purpose of this study was to compare the quality of feeding assistance provided by trained non-nursing staff with care provided by certified nursing assistants (CNAs). Research staff provided an 8-hr training course that met federal and state requirements to non-nursing staff in five community long-term care facilities. Trained staff were assigned to between-meal supplement and/or snack delivery for 24 weeks. Using standardized observations, research staff measured feeding assistance care processes between meals across all study weeks. Trained staff, nurse aides, and upper level staff were interviewed at 24 weeks to assess staff perceptions of program impact. Trained staff performed significantly better than CNAs for 12 of 13 care process measures. Residents also consumed significantly more calories per snack offer from trained staff ( M = 130 ± 126 [ SD] kcal) compared with CNAs ( M = 77 ± 94 [ SD] kcal). The majority of staff reported a positive impact of the training program.

Training Nonnursing Staff to Assist with Nutritional Care Delivery in Nursing Homes: A Cost-Effectiveness Analysis.

OBJECTIVES: To determine the effect and cost-effectiveness of training nonnursing staff to provide feeding assistance for nutritionally at-risk nursing home (NH) residents. DESIGN: Randomized, controlled trial. SETTING: Five community NHs. PARTICIPANTS: Long-stay NH residents with an order for caloric supplementation (N = 122). INTERVENTION: Research staff provided an 8-hour training curriculum to nonnursing staff. Trained staff were assigned to between-meal supplement or snack delivery for the intervention group; the control group received usual care. MEASUREMENTS: Research staff used standardized observations and weighed-intake methods to measure frequency of between-meal delivery, staff assistance time, and resident caloric intake. RESULTS: Fifty staff (mean 10 per site) completed training. The intervention had a significant effect on between-meal caloric intake (F = 56.29, P < .001), with the intervention group consuming, on average, 163.33 (95% CI = 120.19-206.47) calories per person per day more than the usual care control group. The intervention costs were $1.27 per person per day higher than usual care (P < .001). The incremental cost-effectiveness ratio for the intervention was 134 kcal per dollar. The increase in cost was due to the higher frequency and number of snack items given per person per day and the associated staff time to provide assistance. CONCLUSION: It is cost effective to train nonnursing staff to provide caloric supplementation, and this practice has a positive effect on residents' between-meal intake.

Elevated Serum Osmolality and Total Water Deficit Indicate Impaired Hydration Status in Residents of Long-Term Care Facilities Regardless of Low or High Body Mass Index.

BACKGROUND: Dehydration is typically associated with underweight and malnutrition in long-term care (LTC) settings. Evidence is lacking regarding the influence of the rising prevalence of overweight and obesity on risk factors, prevalence, and presentation of dehydration. OBJECTIVE: The aim of this study was to objectively assess hydration status and the adequacy of total water intake, and determine relationships between hydration status, total water intake, and body mass index (BMI) in LTC residents. DESIGN: A cross-sectional analysis of baseline data was performed. PARTICIPANTS AND SETTING: Baseline data from 247 subjects recruited from eight community-based LTC facilities participating in two randomized trials comparing nutrient and cost-efficacy of between-meal snacks vs oral nutrition supplements (ONS). MAIN OUTCOMES: Hydration status was assessed by serum osmolality concentration and total water intakes were quantified by weighed food, beverage, water, and ONS intake. STATISTICAL ANALYSES: Simple and multiple linear regression methods were applied. RESULTS: Forty-nine (38.3%) subjects were dehydrated (>300 mOsm/kg) and another 39 (30.5%) had impending dehydration (295 to 300 mOsm/kg). The variance in serum osmolality was significantly accounted for by blood urea nitrogen level, mental status score, and having diabetes (R(2)=0.46; P<0.001). Total water intake averaged 1,147.2±433.1 mL/day. Thus, 96% to 100% of subjects did not meet estimated requirements, with a deficit range of 700 to 1,800 mL/day. The variance in total water intake was significantly accounted for by type of liquid beverages (thin vs thick), type of ONS, total energy intake, total activities of daily living dependence, sex, and BMI (R(2)=0.56; P<0.001). CONCLUSIONS: Dehydration and inadequate total water intake is prevalent in LTC residents across all BMI categories. Type of liquid beverages, type of ONS, and type of between-meal snacks are factors that could be targeted for nutrition interventions designed to prevent or reverse dehydration.