Testing an implementation strategy bundle on adoption and sustainability of evidence to optimize physical function in community-dwelling disabled and older adults in a Medicaid waiver: a multi-site pragmatic hybrid type III protocol

Background: In partnership with a state Medicaid home and community-based waiver program, this study tests implementation strategies for adoption and sustainability of an evidence-based intervention to support disabled and older adults who have difficulty with physical function and daily living tasks. A multi-level implementation strategy bundle will be directed at relationship, coalition, and team building; readiness to implement, leadership, and clinician attitude toward evidence assessments; intervention and facilitation training; interdisciplinary coordination; facilitation; and audit and feedback to support practice change. Methods: Knowledge-to-Action model underpins this 2-arm, 3-year pragmatic mixed method randomized hybrid type III trial in 18 waiver program sites in Michigan. Data will be collected on sites, 775 clinicians (registered nurses, occupational therapists, social workers), and 15,000 disabled and older adults. Consolidated Framework for Implementation Research guides examination of site, clinician, and beneficiary characteristics; clinician attitude and self-efficacy; leadership and readiness to implement; and intervention impact on beneficiary outcomes. Sites will be randomized to either usual waiver care with internal facilitation of the bundle of implementation strategies or usual waiver care with both internal and external facilitation of the bundle. Primary outcomes are site-level adoption and sustainability over 12 months, and intervention effects on these outcomes are hypothesized to be mediated by clinicians’ attitude and self-efficacy. At the beneficiary level, by addressing the individual’s capabilities and home environment, the intervention is hypothesized to improve secondary outcomes of activities of daily living, pain, depression, falls, emergency department visits, and hospitalizations. Baseline site readiness and leadership and stages of implementation at 6months will be explored as potential moderators. Linear mixed effects models will be used to test intervention effects on primary outcomes, with bias-correcting analytic strategy in mediation analyses. Generalized linear mixed effects modeling will be employed for the analysis of intervention effects on secondary outcomes. Discussion: Synthesizing findings within and across the sites, we will specify how leadership, readiness for change, and level of facilitation enhance capacity for adoption and sustainability of an evidence-based intervention in an underresourced Medicaid setting that cares for disabled and older adults

Results of a multi-site pragmatic hybrid type 3 cluster randomized trial comparing level of facilitation while implementing an intervention in community-dwelling disabled and older adults in a Medicaid waiver

Background: Evidence-based interventions that optimize physical function for disabled and older adults living in the community who have difficulty with daily living tasks are available. However, uptake has been limited, particularly in resource-constrained (Medicaid) settings. Facilitation may be an effective implementation strategy. This study’s aim was to compare internal facilitation (IF) versus IF and external facilitation (EF) on adoption and sustainability of an intervention in a Medicaid home and community-based waiver. Methods: In a hybrid type 3 trial, waiver sites (N = 18) were randomly assigned to implement the intervention using a bundle of strategies with either IF or IF and EF. Adoption and sustainability were assessed via Stages of Implementation Completion (SIC) for each site. Clinician attitudes toward evidence-based practice and self-efficacy were evaluated among 539 registered nurses, social workers, and occupational therapists. Medicaid beneficiary outcomes of activities of daily living, depression, pain, falls, emergency department visits, and hospitalizations were evaluated in a sample of N = 7030 as reflected by electronic health records data of the Medicaid waiver program. Linear mixed-effects models were used to compare outcomes between trial arms while accounting for cluster-randomized design. Results: The mean SIC scores were 72.22 (standard deviation [SD] = 16.98) in the IF arm (9 sites) and 61.33 (SD = 19.29) in the IF + EF arm (9 sites). The difference was not statistically significant but corresponded to the medium clinically important effect size Cohen’s d = 0.60. Clinician implementation outcomes of attitudes and self-efficacy did not differ by trial arm. Beneficiary depression was reduced significantly in the IF + EF arm compared to the IF arm (p = .04, 95% confidence interval for the difference [0.01, 0.24]). No differences between trial arms were found for other beneficiary outcomes. Conclusions: Level of facilitation did not enhance capacity for adoption and sustainability of an evidence-based intervention in a Medicaid setting that cares for disabled and older adults. Improved beneficiary depression favored use of IF and EF compared to IF alone, and no differences were found for other outcomes. These findings also suggest level of facilitation may not have impacted beneficiary outcomes

Interventions Combining Motivational Interviewing and Cognitive Behavior to Promote Medication Adherence: A Literature Review

Aims and objectives: The World Health Organization has indicated medication adherence is a global problem. Both motivational interviewing (MI) and cognitive behavioral therapy (CBT) interventions alone have been found to be effective at improving medication adherence. This article summarizes research that has combined motivational interviewing and cognitive behavioral therapy to improve medication adherence. Background: Projections indicate that by 2015, 33% of cancer treatment will be in pill form, shifting responsibility for managing medication adherence to patients. These regimens are often complex, with multiple doses, drugs, or cycling, and patients often experience side effects from symptoms, making adherence difficult. Patients taking cancer treatment in pill form must strictly adhere to their regimen to achieve a therapeutically effective level for cancer treatment. Design: Literature review. Methods: Data were obtained from six studies that combined MI and CBT in an intervention to promote medication adherence. Analysis was performed based on an integrative review process. Results: Five studies on medication adherence rates using combined MI and CBT reported improved medication adherence rates; and one was trending toward improved medication adherence rates. Conclusions: Combined MI/CBT interventions improved medication adherence in various conditions; and may be effective in challenging clinical conditions, such as when cancer treatment is prescribed in pill form. Relevance to clinical practice: This review focused on interventions that combined motivational interviewing and cognitive behavioral therapy to promote medication adherence. Findings provide nurses with an overview of interventions that may be used in developing programs to help patients manage adherence to cancer treatment in pill form; as well as in other challenging conditions where medication adherence is crucial. A detailed description of the interventions found to be effective is provided to assist nurses in translating evidence into practice

How Increasing Personal Care Service Might Delay or Prevent Nursing Home Placement

There is a pressing need to retain dually eligible elderly Medicare and Medicaid beneficiaries in the community. The objective of this study was to examine median personal care services (PCS) hours, and how increasing PCS to the median (for those below), might delay nursing home placement (NHP) and save cost. Methods: Retrospective study of PCS hours, costs, and NHP in a statewide home and community based waiver program in the Midwest serving 6525 dually eligible Medicare-Medicaid beneficiaries aged 65 and older. Two Minimum Data Set-Home Care assessments and Medicaid claim files were examined to identify PCS hours and cost. A model was developed to estimate costs of increasing PCS to the median to compare retaining at home compared to NHP. Results: Participants with PCS greater than the median hours had a NHP rate of 25%, compared to 36% for those with less than median PCS hours. To attain a 25% NHP rate of participants below the median, we estimated savings by subtracting the usual monthly cost of the waiver ($960) from the monthly NHP cost and adding the cost of the additional PCS ($15.67/hour). For this sample, a total of $155,088 per month could be saved by adding PCS hours to the median. Conclusion: The NHP rate could be reduced from 25–36$2 million a year could be realized by increasing PCS hours to the median and retaining participants in the waiver program. Evaluating waiver participants who are below the median number and increasing those who need it could help retain participants in the home setting, where they most want to be, and allow for tremendous cost savings

A Trial Examining an Advanced Practice Nurse Intervention to Promote Medication Adherence and Symptom Management in Adult Cancer Patients Prescribed Oral Anti-Cancer Agents: Study Protocol

Aim: To report a study protocol that refines then examines feasibility, preliminary efficacy, and satisfaction of ADHERE, an intervention using motivational interviewing and brief cognitive behavioral therapy as a mechanism for goal-oriented systematic patient education to promote symptom management and adherence among cancer patients prescribed oral anti-cancer agents. Background: Cancer treatment with oral anti-cancer agents shifts responsibility for managing treatment from clinicians in supervised cancer centers to patients and their caregivers. Thus, a need exists to standardize start-of-care for support patient self-management of care at home. Design: A two-phase quasi-experimental sequential design with repeated measures. Methods: Sixty five adult patients newly prescribed an oral anti-cancer agent will be recruited from three community cancer centers. Phase one will enroll 5 patients to refine the ADHERE intervention prior to testing, using an iterative process. After completion, Phase two will enroll 30 patients who receive usual care to examine symptoms and ahderence. Advanced practice nurses will then be trained. Then 30 patients will be enrolled in the intervention group and provided ADHERE, a 4-week intervention using semi-structured interactions (initial face-to-face session and once a week phone sessions over 3-weeks) and a Toolkit to promote self-management of care. Outcome measures include: oral anti-cancer agents adherence rate, symptom presence and severity, feasibility, and satisfaction with ADHERE. This protocol was approved January 2014 and is registered at ClinicalTrials.gov (Identifier NCT02337296). Discussion: This nurse-led intervention has the potential to standardize the start-of-care training for the patients to self-manage when prescribed oral anti-cancer agents for treatment

Engaging caregivers to use an evidence‑based intervention for medicaid benefciaries with Alzheimer’s disease: a pilot study

Background This pilot study aimed to adapt an intervention, engaging informal caregivers to help clinicians with providing care to improve (or maintain) physical function of individuals with Alzheimer’s Disease or other dementias. To the best of our knowledge, for the frst time, we report on use of the intervention in those with Alzheimer’s Disease or other dementias. Methods This was a 5-month mixed methods cohort study in a convenience sample of clinicians, caregivers, and benefciaries at 3-Medicaid Home and Community-based Service sites in Michigan. Two content experts and 5 caregivers modifed the intervention. We trained 116 clinicians to engage caregivers and 50 caregivers to help clinicians provide the modifed intervention to 52 benefciaries with Alzheimer’s Disease or other dementias. Thematic analyses, descriptive statistics, counts, proportion comparisons, t-tests, and McNemar’s tests were used to examine socio-demographics, clinician knowledge uptake and satisfaction with training and use of the intervention; caregiver self-efcacy, feasibility, acceptability, usability, and satisfaction with intervention and benefciary outcomes (pre-/post). Results Feasibility (enrolled/recruited=78.5–86.7%), acceptability (7.55–8.35 [SD 1.50–2.06]), and usability (7.85–8.81 [SD 1.50–2.6]) of the modifed intervention (1=low;10=high) were high. Pre-/post-intervention clinician knowledge (12.33–12.28, SD 1.80–2.84; -0.52, SD 1.95) was high. Caregiver self-efcacy increased (0.81 [SD 0.62] p\u3c0.01). Benefciary outcomes did not improve nor decline (\u3e0.05). Conclusions Engaging informal caregivers to assist clinicians with providing an intervention adapted to the needs of those with Alzheimer’s Disease or other dementias was feasible, acceptable, and usable. Further testing in a broader sample of those with dementia in various settings is needed

mHealth SMS Text Messaging Interventions and to Promote Medication Adherence: An Integrative Review

Aims and objectives: This article is an integrative review of the evidence for mobile health Short Message Service text messages as an innovative and emerging intervention to promote medication adherence. Authors completed this review to draw conclusions and implications towards establishing a scientific foundation for use of text messages to promote medication adherence, thus informing clinical practice. Background: The World Health Organization has identified medication adherence as a priority global problem. Text messages are emerging as an effective means of improving health behaviours and in some diseases to promote medication adherence. However, a gap in the literature indicates lack of evidence in guiding theories and content of text messages, which should be synthesised prior to use in clinical practice. Design: Integrative review. Methods: Cumulative Index to Nursing and Allied Health Literature, Excerpta Medica dataBASE, Scopus, the Cochrane Library and PubMed were searched for relevant studies between 2004–2014. Inclusion criteria were (1) implementation of a text-message intervention and (2) medication adherence to a prescribed oral medication as a primary outcome. Articles were assessed for quality of methodology and measures of adherence. An integrative review process was used to perform analysis. Results: Thirteen articles meeting the inclusion criteria are included in this review. Nine of 13 studies found adherence rates improved between 15·3—17·8% when using text messages to promote medication adherence. Text messages that were standardised, tailored, one- or two-way and timed either daily to medication regimen, weekly or monthly showed improvement in medication adherence. Conclusions: This review established a scientific basis for text messages as an intervention to improve medication adherence across multiple diseases. Future large rigorous randomised trials are needed to further test text messaging interventions. Relevance to clinical practice: This review provides clinicians with the state of the science with regard to text messaging interventions that promote medication adherence. A description of intervention components are provided to aid nurses in development of text messages and in translating evidence into practice

A Randomized Controlled Trial of the Feasibility and Preliminary Efficacy of a Texting Intervention on Medication Adherence in Adults Prescribed Oral Anti-Cancer Agents: Study Protocol

Aim: The aim of this study was to report a study protocol that examines feasibility, preliminary efficacy and satisfaction of a text message intervention on the outcome of medication adherence in adult patients prescribed oral anti-cancer agents. Background: Administration of oral anti-cancer agents occurs in the home setting, requiring patients to self-manage the regimen as prescribed. However, many barriers to medication adherence exist: regimens are often complex, with cycling of two or more medications; side effects of treatment; most cancer patients are older with comorbid conditions and competing demands; and cognitive decline and forgetfulness may occur. Research indicates patients miss nearly one-third of the prescribed oral anti-cancer agent dosages. Text message interventions have been shown to improve medication adherence in chronic conditions other than cancer. However, a majority of those patients were less than 50 years of age and most cancer patients are diagnosed later in life. Design: A two-group randomized controlled trial with repeated measures. Methods: Seventy-five adult patients newly prescribed an oral anti-cancer agent will be recruited (project funded in April 2013) from community cancer centres and a specialty pharmacy. Participants will be randomized to either a control group (n = 25; usual care) or an intervention group (n = 50; usual care plus text messages timed to medication regimen). Outcome measures include: medication adherence, feasibility and satisfaction with the intervention. Data will be collected over 8 weeks: baseline, weekly and exit. Discussion: Standardized text message intervention protocol and detailed study procedures have been developed in this study to improve medication adherence

Proof of Concept of a Mobile Health Short Message Service Text Message Intervention That Promotes Adherence to Oral Anticancer Agent Medications: A Randomized Controlled Trial

Introduction: This multisite, randomized controlled trial assigned 75 adult cancer patients prescribed an oral anticancer agent to either an experimental group that received daily text messages for adherence for 21 days plus usual care or a control group that received usual care. Materials and Methods: Measures were administered at baseline, weekly (Weeks 1–8), and at exit (Week 9). A satisfaction survey was conducted following the intervention. Acceptability, feasibility, and satisfaction were examined. Primary outcomes were adherence and symptoms. Secondary outcomes were depressive symptoms, self-efficacy, cognition, physical function, and social support. Mixed or general linear models were used for the analyses comparing trial groups. Effect sizes (ES) were estimated to gauge clinical significance. Results: Regarding acceptability, 57.2% (83 of 145) of eligible patients consented, 88% (n = 37 of 42) receiving text messages read them most or all of the time, and 90% (n  = 38) were satisfied. The differences between experimental and control groups\u27 ES were 0.29 for adherence, 0.21 for symptom severity, and 0.21 for symptom interference, and differences were not statistically significant. Furthermore, perceived social support was higher (p = 0.04; ES = 0.54) in the experimental group. Conclusions: Proof of concept and preliminary efficacy of a mobile health intervention using text messages to promote adherence for patients prescribed oral anticancer agents were demonstrated. Patients accepted and had high satisfaction with the intervention, and adherence improved after the intervention. Text messages show promise. Additional research is needed prior to use in practice

Would Cancer Survivors Accept a Text Messaging Intervention? A Mobile Health (mHealth) Innovation

PURPOSE: 68% of adults own cell phones. Text messaging (TM) may be a way to promote care for cancer patients, however, most trials were in younger populations. We report on TM acceptability in cancer patients over 50. SUBJECTS: 80-participants from cancer centers/specialty pharmacy who were ≥age 21, had a cell phone to TM, and prescribed an oral anti-cancer agent for treatment. METHODS: A secondary data analysis from a randomized controlled trial that examined a 21 to 28-day TM intervention to promote oral-agent adherence and management for treatment-related symptoms. ANALYSES: Descriptive statistics for approached, eligible, and consented are reported on acceptability of TM interventions among cancer survivors. RESULTS: Regarding acceptability, 56.3% patients approached who were eligible consented to participate in the study. Mean age of consented 58.5; eligible not consented 57.24. Of the 142 approached who consented, 60% of those 65+ consented; 53% of those 50-64 consented, and 58.1% of those found. Regarding gender, 59% (n=47) who consented were female, 39% (n=24) eligible but not consented were female. A significant difference in enrollment by sex was found between consented versus eligible but not enrolled (p=.02), with females more likely to enroll. CONCLUSIONS: Among those eligible, age was not related to willingness to TM, with females more likely. Results suggest TM to be an acceptable intervention mode among cancer survivors