Adapting Strategies for Optimal Intervention Implementation in Nursing Homes: A Formative Evaluation.

BACKGROUND AND OBJECTIVES: Nursing homes pose unique challenges for implementation of research and quality improvement (QI). We previously demonstrated successful implementation of a nursing home-led intervention to improve relationships between frontline staff and residents in 6 U.S. Department of Veterans Affairs (VA) Community Living Centers (CLCs). This article discusses early adaptations made to the intervention and its implementation to enhance frontline staff participation. RESEARCH DESIGN AND METHODS: This is a formative evaluation of intervention implementation at the first 2 participating CLCs. Formative evidence-including site visitors' field notes, implementation facilitation records, and semistructured frontline staff interviews-were collected throughout the study period. Data analysis was informed by the Capability, Opportunity, Motivation, and Behavior model of behavior change. RESULTS: Adaptations were made to 5 a priori intervention implementation strategies: (a) training leaders, (b) training frontline staff, (c) adapting the intervention to meet local needs, (d) auditing and providing feedback, and (e) implementation facilitation. On the basis of a 6-month implementation period at the first CLC, we identified elements of the intervention and aspects of the implementation strategies that could be adapted to facilitate frontline staff participation at the second CLC. DISCUSSION AND IMPLICATIONS: Incremental implementation, paired with ongoing formative evaluation, proved critical to enhancing capability, opportunity, and motivation among frontline staff. In elucidating what was required to initiate and sustain the nursing home-led intervention, we provide a blueprint for responding to emergent challenges when performing research and QI in the nursing home setting.

Blended Facilitation as an Effective Implementation Strategy for Quality Improvement and Research in Nursing Homes.

BACKGROUND: Blended facilitation, which leverages the complementary skills and expertise of external and internal facilitators, is a powerful strategy that nursing stakeholders and researchers may use to improve implementation of quality improvement (QI) innovations and research performed in nursing homes. PROBLEM: Nursing homes present myriad challenges (eg, time constraints, top-down flow of communication, high staff turnover) to QI implementation and research. APPROACH: This methods article describes the theory and practical application of blended facilitation and its components (external facilitation, internal facilitation, relationship building, and skill building), using examples from a mixed QI and research intervention in Veterans Health Administration nursing homes. CONCLUSIONS: Blended facilitation invites nursing home stakeholders to be equal partners in QI and research processes. Its intentional use may overcome many existing barriers to QI and research performed in nursing homes and, by strengthening relationships between researchers and stakeholders, may accelerate implementation of innovative care practices.

Impact of Intervention to Improve Nursing Home Resident-Staff Interactions and Engagement.

Background and Objectives: For nursing home residents, positive interactions with staff and engagement in daily life contribute meaningfully to quality of life. We sought to improve these aspects of person-centered care in an opportunistic snowball sample of six Veterans Health Administration nursing homes (e.g., Community Living Centers-CLCs) using an intervention that targeted staff behavior change, focusing on improving interactions between residents and staff and thereby ultimately aiming to improve resident engagement. Research Design and Methods: We grounded this mixed-methods study in the Capability, Opportunity, Motivation, Behavior (COM-B) model of behavior change. We implemented the intervention by (a) using a set of evidence-based practices for implementing quality improvement and (b) combining primarily CLC-based staff facilitation with some researcher-led facilitation. Validated resident and staff surveys and structured observations collected pre and post intervention, as well as semi-structured staff interviews conducted post intervention, helped assess intervention success. Results: Sixty-two CLC residents and 308 staff members responded to the surveys. Researchers conducted 1,490 discrete observations. Intervention implementation was associated with increased staff communication with residents during the provision of direct care and decreased negative staff interactions with residents. In the 66 interviews, staff consistently credited the intervention with helping them (a) develop awareness of the importance of identifying opportunities for engagement and (b) act to improve the quality of interactions between residents and staff. Discussion and Implications: The intervention proved feasible and influenced staff to make simple enhancements to their behaviors that improved resident-staff interactions and staff-assessed resident engagement.

Post-traumatic stress disorder and prediction of aggression in persons with dementia.

OBJECTIVE: This prospective cohort study evaluated the potential of increased aggression in patients with dementia who had a preexisting diagnosis of post-traumatic stress disorder (PTSD) compared with those without a diagnosis of PTSD. METHODS: Patients more than 60 years of age with newly diagnosed dementia between 2001 and 2004 were identified from the Michael E. DeBakey Veterans Affairs (VA) Medical Center in Houston, TX. Among these patients, we identified patients with a preexisting diagnosis of PTSD. The proportions of patients who became aggressive within 2 years of enrollment were compared in patients with and without PTSD. Fisher's exact tests were used to compare differences in the number of PTSD patients with and without aggression. RESULTS: A total of 215 patients were identified with newly diagnosed dementia. Ten were found to have a diagnosis of PTSD, and 205 did not. Eighty-four (41%) of the 205 were found to be aggressive. Among the 10 patients with a diagnosis of PTSD, 4 (40%) were aggressive. CONCLUSION: There was no evidence to support an increased risk of aggression in patients with a coexisting diagnosis of dementia and PTSD.

Aggression in individuals newly diagnosed with dementia.

Aggression is often associated with dementia. In this study, aggression in veterans newly diagnosed with dementia was examined and characterized. Participants were >or=60 years diagnosed with dementia at the Michael E. DeBakey Veterans Affairs Medical Center in Houston, Texas, from 2001 to 2004. Aggression was defined as a positive caregiver response to 1 or more of 3 probes from the Ryden Aggression Scale, administered during a telephone screen. Of 1276 contacts, 385 (30%) were eligible and agreed to participate; at initial screening, 75 (19.5%) were aggressive (23 [31%] verbally, 9 [12%] physically, 24 [32%] verbally and physically, and 19 [25%] with unspecified aggression). The surprisingly high prevalence of aggression in individuals newly diagnosed with dementia suggests the potential usefulness of early screening for aggression in this population.

Mobilization-Observation-Behavior-Intensity-Dementia Pain Scale (MOBID): development and validation of a nurse-administered pain assessment tool for use in dementia.

Pain assessment in older persons with severe cognitive impairment (SCI) is a challenge due to reduced self-report capacity and lack of movement-related pain assessment instruments. The purpose of this article was to describe the development of the Mobilization-Observation-Behaviour-Intensity-Dementia Pain Scale (MOBID) and to investigate aspects of reliability and validity. MOBID is a nurse-administered instrument developed for use in patients with SCI, where presence of pain behavior indicators (pain noises, facial expression, and defense) may be observed during standardized active, guided movements, and then inferred to represent pain intensity. Initially, the MOBID contained seven items (observing at rest, mobilization of the hands, arms, legs, turn over in bed, sitting on bedside, and teeth/mouth care). This was tested in 26 nursing home patients with SCI. Their primary caregivers, five registered nurses and six licensed practical nurses (LPNs), rated the patients' pain intensity during regular morning care, and by MOBID, both at bedside and from video uptakes. Three external raters (LPNs), not knowing the patients, also completed the MOBID by rating the videos. Internal consistency of the MOBID indicated high Cronbach's alpha (alpha=0.90) after deleting the items for observation at rest and observation of teeth/mouth care. MOBID disclosed significantly more pain than did pain scorings during regular morning care, and video observation demonstrated higher pain intensity than bedside scoring. Intertester reliability for inferred pain intensity was high to excellent (intraclass correlation coefficient=0.70-0.96), but varied between poor and excellent for pain behavior indicators (kappa=0.05-0.84). These results suggest that registration of pain behavior indicators during active, guided movements, as performed by the MOBID procedure, is useful to disclose reliable and valid pain intensity scores in patients with SCI.

Randomized, double-blind study of emtricitabine (FTC) plus clevudine versus FTC alone in treatment of chronic hepatitis B.

Emtricitabine (FTC) is approved for the treatment of human immunodeficiency virus. FTC and clevudine (CLV) have activity against hepatitis B virus (HBV). This report summarizes the results of a double-blind, multicenter study of patients with chronic hepatitis B who had completed a phase 3 study of FTC and were randomized 1:1 to 200 mg FTC once daily (QD) plus 10 mg CLV QD or 200 mg FTC QD plus placebo for 24 weeks with 24 weeks of follow-up. One hundred sixty-three patients were treated (82 with FTC plus CLV [FTC+CLV] and 81 with FTC); 72% were men, 53% were Asian, 47% were Caucasian, and 52% were hepatitis B e antigen positive, and the median baseline HBV DNA level was 6 log(10) copies/ml. After 24 weeks of treatment, 74% (FTC+CLV) versus 65% (FTC alone) had serum HBV DNA levels of <4,700 copies/ml (P = 0.114) (Digene HBV Hybrid Capture II assay). Twenty-four weeks posttreatment, the mean change in serum HBV DNA levels from baseline was -1.25 log(10) copies/ml (FTC+CLV), 40% had undetectable viremia (versus 23% for FTC alone), and 63% had normal alanine aminotransferase levels (versus 42% for FTC alone) (P < or = 0.025 for all endpoints). The safety profile was similar between arms during treatment, with less posttreatment exacerbation of hepatitis B in the combination arm. In summary, after 24 weeks of treatment, no significant difference between arms was observed, but there was a significantly greater virologic and biochemical response 24 weeks posttreatment in the FTC+CLV arm.

A double-blind placebo-controlled study of emtricitabine in chronic hepatitis B.

BACKGROUND: Emtricitabine is a nucleoside analogue approved for treatment of human immunodeficiency virus 1 with clinical activity against hepatitis B virus (HBV). METHODS: To compare the safety and efficacy of emtricitabine with placebo in patients with HBV, we conducted a randomized (2:1), double-blind study at 34 sites in North America, Asia, and Europe that enrolled adults between November 2000 and July 2002 who had chronic HBV infection but had never been exposed to nucleoside or nucleotide treatment. Each patient received either 200 mg of emtricitabine (n=167) or placebo (n=81) once daily for 48 weeks and underwent a pretreatment and end-of-treatment liver biopsy. Histologic improvement was defined as a 2-point reduction in Knodell necroinflammatory score with no worsening in fibrosis. RESULTS: At the end of treatment, 103 (62%) of 167 patients receiving active treatment had improved liver histologic findings vs 20 (25%) of 81 receiving placebo (P<.001), with significance demonstrated in subgroups positive (P<.001) and negative (P=.002) for hepatitis Be (HBe) antigen. Serum HBV DNA readings showed less than 400 copies/mL in 91 (54%) of 167 patients in the emtricitabine group vs 2 (2%) of 81 in the placebo group (P<.001); alanine aminotransferase levels were normal in 65% (109/167) vs 25% (20/81), respectively (P<.001). At week 48, 20 (13%) of 159 patients in the emtricitabine group with HBV DNA measured at the end of treatment had detectable virus with resistance mutations (95% confidence interval, 8%-18%). The rate of seroconversion to anti-HBe (12%) and HBe antigen loss were not different between arms. The safety profile of emtricitabine during treatment was similar to that of placebo. Posttreatment exacerbation of HBV infection developed in 23% of emtricitabine-treated patients. CONCLUSION: In patients with chronic HBV, both positive and negative for HBe antigen, 48 weeks of emtricitabine treatment resulted in significant histologic, virologic, and biochemical improvement.

Safety and antiviral activity of emtricitabine (FTC) for the treatment of chronic hepatitis B infection: a two-year study.

BACKGROUND/AIMS: The aim of this study was to evaluate long term safety and antiviral activity of different doses of emtricitabine given once daily to patients chronically infected with hepatitis B. METHODS: Eligible patients were randomized in a double-blind, parallel study to evaluate 25, 100 or 200 mg once daily doses of emtricitabine for 48 weeks. Patients were then followed for an additional 48 weeks on open-label 200 mg emtricitabine. Serum HBV DNA, ALT, and hepatitis B serology were measured at regular intervals over the 2 years. Resistance surveillance was performed after 1 and 2 years on viremic samples, i.e. > 4700 copies/mL. RESULTS: Emtricitabine was well tolerated and produced a dose proportional antiviral response. After 2 years, 53% of the patients had serum HBV DNA < or = 4700 copies/mL, 33% seroconverted to anti-HBe and 85% had normal ALT. Eighteen percent of the patients who had received 200 mg emtricitabine for 2 years developed resistance mutations. CONCLUSIONS: Emtricitabine was well tolerated and demonstrated a potent antiviral response for up to 2 years in patients with chronic hepatitis B infection. Based on these data, 200 mg emtricitabine once daily was chosen as the optimal dose for future hepatitis B studies.

A phase II dose-escalating trial of clevudine in patients with chronic hepatitis B.

Current therapies available for the treatment of chronic hepatitis B are limited in their ability to result in a cure. Clevudine is a new pyrimidine analog with potent anti-hepatitis B virus (HBV) activity in vitro. A multicenter dose-escalation study evaluated clevudine at 10, 50, 100, and 200 mg once daily for 28 days. Eligible patients had HBV DNA levels of 3 x 10(6) copies/mL or more, had not undergone nucleoside treatment, and were without human immunodeficiency or hepatitis C virus coinfection. Thirty-two patients were enrolled (5, 10, 10, and 7 patients in the 10-, 50-, 100-, and 200-mg dose groups, respectively), 81% were male, 81% Asian, and 88% were hepatitis Be antigen (HBeAg) positive at baseline. Median pretreatment serum HBV DNA levels ranged from 7.3 to 8.8 log(10) copies/mL. After 28 days, the median HBV DNA log(10) change from baseline was -2.5, -2.7, -3.0, and -2.6 log(10). Six months after dosing, median changes from baseline were -1.2, -1.4, -2.7 and -1.7 log(10) in the 10-, 50-, 100-, and 200-mg cohorts, respectively. Six of 27 patients lost HBeAg, and 3 of 27 patients seroconverted to HBe antibody. Clevudine was well tolerated, with no dose-limiting toxicities. A transient increase in alanine aminotransferase of up to 7.8 times the upper limit of normal (increase ranged from 20 to 186 IU/L) was observed in six patients in the 100-mg cohort, without signs of liver failure. These increases were associated with improved viral suppression. The pharmacokinetic profile of clevudine was proportional to the dose. In conclusion, these results demonstrate the tolerability and potent activity of clevudine in HBV-infected patients and support further clinical study.