what are the major research variables for this article: A…

Question Answered step-by-step what are the major research variables for this article: A… what are the major research variables for this article: A Longitudinal Fall Prevention Study for Older AdultsKaren H. Frith, PhD, RN, Amy N. Hunter, DNP, FNP-BC, Sharon S. Coffey, DNP, FNP-C, Zaheer Khan, MDa b s t r a c t Falls among the older adult population are a health concern that can be addressed by nurse practitioners in primary care settings. The purpose of the study was to improve gait and balance through exercise, reduction of polypharmacy and potentially inappropriate medication, education about medications, and removal of potential hazards in the home environment. Over 12 months, participants had a significant improvement in the fourth position of the 4-Stage Balance test and the 30-Second Chair Stand. They also had a reduced number of falls. Nurse practitioners can replicate the study using the STEADI Kit from the Centers for Disease Control and Prevention.© 2018 Elsevier Inc. All rights reserved. Falls and complications resulting from falls are an important concern for nurse practitioners in acute and primary care settings. Falls in older adults are the principal cause for injuries that lead to loss of independence or even death. These falls cost Medicare an estimated $50 billion each year.1,2 Because the older adult population in the United States will double to 98.2 million by 2060,3 falls present a significant public health concern. Fall prevention can be a critical intervention to enable older adults to maintain their health and independent lifestyle.Older adults fall for many reasons, including poor muscle strength, weakness, balance problems, sensory disorders (i.e., poor vision), hearing and peripheral neuropathy, postural hypotension, inappropriate footwear, household clutter, too many or inappropriate medications, and urinary incontinence.4 Falls are not an inevitable part of aging; rather, they result from a complex interplay of the cognitive, motor, and sensory dysfunction that can be mitigated with evidence-based fall prevention strategies.Many primary care settings use nurse practitioners to care for the health needs of the aging population.5 If primary care nurse practitioners routinely screen for fall risk at each visit, then, theoretically, a current risk reduction plan will continually be in place for each older client. This fall-risk assessment and corresponding fall-risk reduction plan should be a part of both the initial wellness visit and subsequent visits.Background and SignificanceOlder adults take many medications, often as a result of chronic illnesses or failure of providers to reevaluate the appropriateness of medications as adults become older. The reevaluation of medications is essential as older adults’ organ function declines, body fat increases, muscle mass decreases, and total body water shrinks.6 Any medication can have side effects, and some medications are particularly risky for older adults due to the medications’ effects on gait and balance.7 Medication review to reduce the number and the type of potentially inappropriate medications (PIMs) should be included in a comprehensive fall prevention program for older adults.Two definitions about medication prescribing are important for this evidence-based study. First, although a consensus definition of polypharmacy does not exist, it is commonly defined as the use of 4 or more medications.8 It is well established that polypharmacy is related to an increased risk for falls and negative health outcomes.9 Second, a potentially inappropriate medication is a drug for which “the risk of an adverse event outweighs its clinical benefit, particularly when there is evidence of a safer or more effective alternative therapy for the same condition”10 (p. 21). The Beers Criteria, first created in 2012 and updated in 2015, contains a list of potentially inappropriate medications developed by the American Geriatrics Society.7 This extensive list shows certain medication classifications are more problematic than others for older adults. It is the responsibility of health care providers to determine the appropriateness for the individual older adult, weighing the benefits versus the risks.Older adults can suffer from mental health conditions that put them at risk for falls with injuries including cognitive impairment and depression.11,12 Cognitive impairment and depression interfere with the executive function of the brain, which is associated with gait and balance problems. When treated with psychotropic drugs including antidepressants, benzodiazepines, hypnotics, narcotics, neuroleptics, and tranquilizers, older adults have a 2e6 times increased fall risk.13 Because of the well-documented risk of falls with psychotropic drugs, special assessment of need versus weaning of this drug class should be considered as described inclinical practice guidelines.9,14Other risk factors for falls among the older adult population are poor muscle strength, particularly in the lower extremities, and balance problems that can be made worse by poor eyesight or faulty footwear.11 The loss of muscle mass is gradual, and, combined with joint stiffness or joint deformity, these factors may lead older adults to believe that reduced mobility is a natural process. However, studies have shown that older adults can maintain mobility through strength training, balance and gait exercises, and coordination training; tai chi and Otago exercise programs have been researched extensively and found to be effective in the older adult population.8,15 The Centers for Disease Control and Prevention’s (CDC’s) Compendium of Effective Fall Interventions15 provides guidance about different exercise programs that can be done in group or home settings.Poor bone health puts older adults at risk for sustaining serious injuries after a fall. Low levels of serum calcium and vitamin D are precursors to weakened bones and osteoporosis.16 In the presence of poor mobility and of lack weight-bearing exercise, older adults are set up for bone fractures, even with falls that would not causesuch injuries in younger individuals.16Appropriate attention to fall prevention program planning and contact with older adults at regular intervals for education can reduce the fall risk for patients.17 Clinical practice guidelines from the U.S. federal agencies and from professional medical societies recommend fall prevention beginning with recognition, assessment, treatment, and monitoring.6,8,18,19 The literature demonstrates improved fall reduction with prevention programs that are multifactorial, beyond the isolated prevention strategy of reducing polypharmacy and PIMs.20 Prevention strategies can be developed to minimize the individual risks and maximize the quality of life of the older adult, based on the assessment of the older adult.15PurposeBecause of the importance of reducing falls, a nurse practitionereled research team developed a comprehensive fall prevention program for older adults living in community settings. The fall prevention program, called “Stay Standing,” included exercise, medication review with suggested reductions in polypharmacy and PIMs, patient education on medications, home modifications to improve safety, and referrals for vision and foot problems. The purpose of this study was to implement and evaluate the effectiveness of a comprehensive, evidence-based fall prevention program designed to improve gait/balance and to reduce falls among communitydwelling older adults.Research Questions1.  Will participation in the fall prevention program result in animprovement in gait and balance test scores and reduce the number of falls among older adults in a 12-month period compared with falls among older adults who receive usual care in a geriatric practice?2.  Will education about polypharmacy and PIMs improve olderadults’ knowledge about medications and side effects from baseline to 12 months?MethodsDesignThis study was conducted by nurse practitioners with experience in the primary care of older adults, a gerontologist, and a nurse scientist. The research team used a quantitative, repeatedmeasures design for the study. The intervention group was enrolled in a fall prevention program, while the control group received usual care. The study had 3 main outcomes: (1) improved gait and balance scores, (2) reduced number of falls, and (3) increased knowledge about polypharmacy and PIMs. Measurements of outcome variables were made at baseline and compared at 3, 6, 9, and 12 months for the intervention group; a comparison of falls between the intervention and control group was made at 12 months.SampleA power analysis for the study was conducted to ensure enough participants were enrolled in the study to find statistical differences if the interventions worked. Based on preliminary data, 30 participants were needed in each group. The inclusion criteria for each group included being an older adult with at least 1 fall during the preceding 12 months, having a Saint Louis University Mental Status (SLUMS) score of 24 or higher, and the ability to walk with or without assistive devices. A fall was defined as “an unplanned descent to the floor with or without injury.”21 The research team used convenience sampling to obtain community-dwelling participants from a local church and a local geriatric medical practice. The control group was obtained by matching patients on age, history of falls, co-morbidities, and polypharmacy in a local geriatric medical practice to participants in the intervention group. Individuals in the control group had a SLUMS score that met the inclusion criteria of 24 or higher and had a recorded TUG score in the medical record. The study received Institutional Review Board approval for human subjects from the university.InterventionThe intervention in this study followed the recommendations of the CDC’s Stopping Elderly Accidents, Deaths, and Injuries (STEADI) Tool Kit.18 The STEADI Tool Kit is publically available at https:// www.cdc.gov/steadi/index.html. Education brochures from the tool kit were also used in the intervention too.The nurse practitioners on the research team conducted the comprehensive fall prevention program by meeting with participants individually at baseline and every 3 months for 1 year to measure gait and balance, reconcile medications, reinforce teaching, assess for exercise adherence, and assess for falls. A home visit was conducted 1 time unless a participant requested additional visits. The nurse practitioners referred participants to a local church that offered Balance for Life classes twice per week in a group setting or the Otago exercise program for those who lived too distant from the church or who preferred home exercise. The Balance for Life classes were divided into 3 levels (beginning, intermediate, and advanced); all participants were to begin at the lowest level for safety reasons.InstrumentsGait and balance were evaluated using the Timed-Up-and-Go Test (TUG), the 30-Second Chair Stand Test and the 4-Stage Balance Test. The gait and balance tests used in the study were recommended by the CDC as valid and reliable tests for fall risk assessments.18 The TUG test was conducted at baseline for the intervention and control group. All tests were performed for the intervention group every 3 months for a year. Table 1 (available online) shows brief instructions for performing each gait and balance tests. A link to instructional videos in provided at the bottom of description.Knowledge about polypharmacy, PIMs, and reducing medications were tested using an investigator-developed instrument as a medication pretest and posttest (see Box 1). The items were assessed for face validity by 3 expert geriatric care providers and 1 researcher with knowledge of polypharmacy and PIMS.Procedure The research study was planned with a strict protocol (see Figure 1, available online). The baseline visit was extensive requiring 1 hour to complete. Any abnormities found in the297baseline assessment were used to make referrals or to educate participants on how to reduce their risk of falls. The follow-up visits were less time-consuming consisting of only the 3 gait and balance tests, assessment of falls, medication review, and scheduling for the next visit. The blanks in Figure 1 (available online) in months 3, 6, 9, and 12 indicate the absence of an assessment or intervention after the baseline visit.Participants were screened for meeting inclusion criteria, and after qualifying for the study, consent was obtained. Next the medication pretest was administered to the intervention group followed by education about medications. Education was individualized for each older adult by discussing the PIMs in their initial medication review and by identifying common over-the-counter medications or supplements to avoid. Education was reinforced at each appointment to improve adherence to the medication plan. The medication posttest was administered to evaluate the effectiveness of the educational component at 3 months and at 12 months. Participants received an individualized medication plan from the nurse practitioner at the initial appointment. Medication reconciliation was conducted at each follow-up appointment by the nurse practitioner to see if the recommended changes were made. If alterations in the medication plan were needed to improve adherence or mitigate problems, the nurse practitioner asked the participant to discuss medications with his or her provider. For example, 1 participant was taking multiple medications for depression and pain and had been on them for years. The medications needed to be tapered slowly under the direction of a health care provider.Measurements of gait and balance (TUG, 30-Second Chair Stand, and 4-Stage Balance) were assessed at the beginning of the study and at quarterly intervals during the project to ascertain the progress toward the specified outcomes in the intervention group. Results of testing were discussed with participants at each follow up appointment. This approach provided feedback about changes in gait and balance, even small ones, to encourage older adults to continue in the program and adhere to the medication plan. Measurement of orthostatic blood pressure was made at the baseline visit and after changes to medications that affected blood pressure.All participants were offered a home visit to assess for safety in the home. More than half of the participants agreed to have home visit. The home safety indicators that were evaluated were also recommended by the CDC, such as assessing for throw rugs and cords, pets that could cause a fall, grab bars in bathroom areas, and any type of clutter that could cause a fall.The final outcome, falls, was assessed at each visit by asking participants about the occurrence of a fall during the past 3 months for the intervention group. Figure 1 (available online) shows the research procedure across the 12-month study for the intervention group.Individuals in the control group received no contact from the research team. All of their care was directed by the geriatrician in a medical office setting. A nurse practitioner on the research team reviewed the medical record of the control group at the start of the study and after 1 year’s time to determine the number of medication changes that were made and the number of falls reported to the health care provider at the medical office. The routine practices at the medical office included medication reconciliation, reduction of the number of medications, and tapering of inappropriate medications; therefore, no changes with regard to the research study were requested of the health care providers in this medical office.Data Analysis PlanThe dependent variables were scores on gait and balance tests, falls, and medication knowledge. The research team used descriptive statistics, t-test, and repeated-measures analysis of variance to analyze the data.ResultsDemographics of the SampleThirty participants initially enrolled in the study. Of those participants, 18 (60%) completed the 12-month comprehensive fall prevention program. The attrition was due to deaths (2), withdrawals (4), and loss to follow-up because of difficultly in contacting or scheduling participants (7). The mean age of participants in the intervention group was 75.45 years; the vast majority of participants were white females. The mean number of medications at intake in the study was 10.65, and the SLUMS score (measure of cognitive functioning was 25.85; 24 is considered intact). The 18 participants were matched to patients at a local geriatric medical practice. There were no statistical differences between age, number of medications, TUG test, and SLUMS scores between the 2 groups at the beginning of the study.Gait and Balance ScoresThe intervention group participated in exercise to improve gait and balance as measured by 3 tests: the TUG test, the 30-Second Chair Stand, and the 4-Stage Balance Test. The TUG was performed at baseline for the intervention group (M ¼ 13.78, SD ¼ 5.75) and at each 3-month period. The final TUG for the interven-very small improvement that was not statistically signition group was (M ¼ 13.19, SD ¼ 4.811) This finding demonstrates aficant.Likewise, the 30-Second Chair Stand was measured at baseline, every 3 months, and at the end of the study. At baseline the intervention group could stand, on average, 8.10 times (SD ¼ 4.771), and at the end of 12 months the average number of stands was 9.70(eSD2.667¼ ,3.433)df ¼ 9, p. This difference was statistically signi< .05). The 4-Stage Balance Test was conducted atficant (t ¼baseline and at every 3 months for a year. Only the fourth position, standing on 1 foot with arms crossed, was statistically significant3.736)from baseline (Mt ¼ -2.449, df¼ 5.40¼ 9, SD, P <¼.05.3.864) to 12 months (M ¼ 6.20, SD ¼FallsThe number of falls was recorded at baseline and at each visit with participants. There were several participants who had multiple falls at baseline, but no participant had more than 1 fall at the end of 12 months; the analysis included all falls. The intervention group exhibited a reduction in the number of falls from baseline.875)(M ¼. However, the difference was not statistically signi2.20, SD ¼ 4.35) to the end of the study (mean ¼ 0.35ficant (, SDt ¼¼1.863, df ¼ 19, P ¼ .078). When comparing the falls for the inter-vention group (MeSD4.419¼ .607), df ¼ 37there was a statistically signi, P <¼.000)0.35, demonstrating the effectiveness of the fall, SD ¼ .875) to the control group (Mficant difference (¼ 1.42t ¼,prevention program.Knowledge About Polypharmacy and PIMsThe medication education provided to participants in the intervention group was effective but took time for the participants to learn about medications, particularly over-the-counter medications they should avoid. There was no significant difference between the test scores from baseline to 3 months; however, the paired