The process of clinical trials: a model for successful clinical trial participation.

PURPOSE/OBJECTIVES: To present barriers and strategies related to successful clinical trial participation and integrate them into a model for successful trial participation. DATA SOURCES: The proposed model was developed based on a literature review related to clinical trial participation, review of empirical studies related to clinical trials, and experiences with subject participation. DATA SYNTHESIS: Successful clinical trial participation depends on study design, participant factors, issues related to ethnic diversity, the informed consent process, and physician factors. CONCLUSIONS: Clinical trial participation is critical for all disciplines. However, nurses either are researchers or co-investigators with physicians on clinical trials, and it is critical for them to understand specific barriers and success strategies for patient participation. Future studies need to be conducted related to participation in nursing clinical trial research. These study results will facilitate successful nursing clinical trials. IMPLICATIONS FOR NURSING PRACTICE: This model can be used in implementation of clinical trials across disciplines prior to and during enrollment of patients into studies.

Health-promoting educational practices related to osteoporosis.

This descriptive study was conducted to determine what routine osteoporosis-related education was provided to women aged 49 years and younger and women aged 50 years and older. Forty-seven primary care providers (PCPs) including physicians/osteopaths (74%), nurse practitioners (19%), and physician assistants (7%) participated in the study. Significant differences were found in the frequency of performing osteoporosis risk assessments (t = 7.697, p = 0.0), performance of diet histories (t = 6.212, p = 0.0), exercise assessments (t = 2.483, p = 0.0), and provision of osteoporosis-related information (t = 8.700, p = 0.0) with women aged 50 or older receiving more attention than women aged 49 years or younger. Taken together, the findings of this study suggest that primary care providers generally assess the risk factors associated with osteoporosis and provide education more frequently to women 50 years of age and older. Despite the small sample size, there was a clear age-related difference in the assessment of osteoporosis risk factors and provision of risk-modifying education.

Assessing abuse among the elderly living in public housing.

Abuse and victimization among the elderly have received increased attention in the last few years from practitioners, researchers, and policymakers but remain growing problems, especially for elders who live in public housing. This study assessed the psychometric properties of an existing instrument, the Hwalek-Sengstock Elder Abuse Screening Test (HSEAST), which has been tested in only two studies. The instrument was administered to 100 African American, Hispanic, and White elders living in public housing. Study results were compared to findings from a previous study of elderly groups. A principal components factor analysis of the 15-item instrument supported the 3-factor structure for a total of 10 items (factor loadings = 0.4 or >), explaining 38% of the variance. A discriminant function analysis showed that 6 items were as effective as the 9-item model in classifying cases (71.4%) as abused.

Baccalaureate nursing education and home health: a collaborative alliance.

Nursing educators are challenged to prepare practitioners to move out of acute care and perform competently in nontraditional settings. Faculty from a university college of nursing and registered nurse preceptors from 13 home health agencies formed an alliance to serve as co-educators for junior-level baccalaureate nursing students in a 35-hour, two-semester home health clinical rotation. The outcomes of this alliance were evaluated with a qualitative descriptive study that evaluated the effectiveness of the model. Content analysis of students' journal reflections revealed that the collaborative alliance in home health enabled students to integrate practice with theory and to view the new practice environment as a meaningful learning experience. Nurse preceptors serving as co-educators in the home setting were viewed as valuable role models who provided opportunities for active participation of students. In addition, this collaborative alliance enhanced students' assimilation of the principles of nontraditional practice and facilitated the personal and professional growth they needed to prepare them for nursing practice in the future.

Self-efficacy: an essential component of advanced-practice nursing.

The concept of self-efficacy has been used widely as a model for examining health-promoting education in such areas as cardiac rehabilitation, smoking cessation, dietary modifications, pulmonary rehabilitation, and compliance with prescribed regimens. Consequently, self-efficacy has emerged as an essential concept in developing and implementing health promotion programs in advanced practice. Self-efficacy refers to an individual's perceived ability to perform a specific behavior. It is the mediator between knowledge and action, and it influences the selection of behavior, the environment in which the behavior occurs, and the amount of effort and perseverance expended on performing the behavior. This paper analyzes the concept of self-efficacy and suggests applications of self-efficacy in advanced-practice nursing.

Redesigning emergency care: financial and cost analysis of services provided.

Developing an interdiscliplinary team to monitor and implement redesign is critical to successful, quality outcomes. Analysis of the current status of the organization and national trends is essential prior to redesign. Key assessment data gathered were: profiling users, payer distribution, inpatient admissions, data on types of chronic conditions, DRGs, readmits, short-stay admissions, non-admits, and outpatient services and charges. Organizational realignment requires time and analysis of financial, clinical, and demographic data. The team-building framework used in this emergency room redesign was based on a collaborative model. A crucial initial step was to get support from the organization's executive level of leadership for the new redesign vision. Another factor considered essential for a successful outcome was commitment from each member of the interdisciplinary team. Communication between the team and staff was a top priority.

Collaboration in research: testing the PIPC model on clinical and nonclinical outcomes.

This outcomes research used a collaborative framework between a college of nursing and a medical center to test the effects of the Partners in Patient Care delivery model (PIPC) on clinical and nonclinical outcomes. An experimental pretest-postest design was used to compare selected nonclinical outcomes and clinical outcomes of care in two patient units. Results showed that there were significant differences between units in the nonclinical outcomes of nurse satisfaction, salary costs, supply costs, and productivity as measured by documentation time. In addition, there were significant differences in the clinical outcomes of care in terms of patient satisfaction. No significant differences were found in number of falls, medication errors, and intravenous infections; however, when ratios of these indicators were examined in relation to patient days, significant differences in the medication error ratio and the fall ratio were revealed. The results indicate that the PIPC delivery model did have positive effects on patient satisfaction and nurse satisfaction but that there were increased costs and increased time spent in documentation on the pilot unit.

The use of focus groups to assist in the design and implementation of a new nursing practice model.

Focus groups facilitate change in healthcare institutions by providing comparative perceptions of all levels of healthcare staff in the environment, obtaining impressions of new options for healthcare delivery for which no information is available, and stimulating new ideas to improve cost-effective quality care. The authors discuss their experience using this data gathering and evaluation approach during the planning and implementation of a new nursing practice model. Factors to consider when using focus groups are offered, and lessons learned from the experience are presented.

A reliability and validity study of the Women's Role Strain Inventory.

The purpose of this study was to theoretically conceptualize, develop and test the Women's Role Strain Inventory (WRSI) which assesses role strain in women who have multiple roles. There is limited research published related to role strain of women, although role strain, role conflict and role stress have been documented to have negative and positive effects (Hall 1975, Hall 1992). The theoretical basis for this study is based upon Goode's Theory of Role Strain (1960) and Sieber's Theory of Role Accumulation (1974). The pilot consisted of 62 female nurses, and the sample used for construct validity consisted of 445 female nurses. Content validity resulted in a content validity index of (.91). Exploratory factor analysis with varimax rotation resulted in a three-factor solution supporting Goode's (1960) theory of role strain, and Sieber's (1974) theory of role accumulation. Alpha coefficients for the three subscales were .89 (role distress), .86 (role enhancement), and .81 (role support). Internal consistency of .93 was achieved for the overall WRSI. Test-retest coefficients ranged from .61 to .91. The high reliability and validity of the WRSI make it a reliable and valid instrument to measure role strain of women.

Partners in patient care: measuring the effects on patient satisfaction and other quality indicators.

An experimental pretest/posttest design compared pilot and control nursing units in a medical center in Southwest Florida to assess the effects of a Partners in Patient Care (PIPC) nursing care delivery model on selected quality of care outcomes-patient satisfaction, patient medication errors, falls, and IV infections. There were no significant differences between units in the number of falls, medication errors, and IV infections. When the ratios of these events to patient days were examined, there was a significant difference between the pilot and control units in the medication error ratio and the fall ratio. The results indicate that the PIPC nursing model had a positive effect on patient satisfaction.

Effects of the PIPC model on outcome measures of productivity and costs.

The purpose of this experimental research was to determine the effects of the Partners in Care Practice Model (PIPC) on the outcomes of productivity and costs. Over an 18-month study period, no significant differences were found in costs per patient day between the pilot and control units; however, significant differences were found in actual salaries, amount of time spent in documentation, and supply costs. Differences in costs and productivity reflected increased training costs and costs for additional supplies on the pilot unit.

Design, implementation, and evaluation of an educational program for a new practice model.

Redesigning patient care delivery is vital to the quality of care delivered and has resulted in the development of new nursing practice models that use some form of "nurse extender." In this article, the authors describe the design, implementation, and evaluation of an educational program for a new nursing practice model at a medical center in the Southeast. The major focus of the educational program is the use of modules to train a new nontraditional nurse extender who works in partnership with an RN. The role of the partner in patient care was developed to expedite the provision of a variety of services at the bedside and to help the nurse deliver quality patient care. The training program consisted of five modules: fundamentals of nursing, selected respiratory therapy skills, selected physical therapy skills, electrocardiogram (EKG)/arrhythmia interpretation, and phlebotomy. A major factor in the success of the program was that it was carefully developed and evaluated to meet the needs of students and staff members. This program can serve as a model for other hospitals that plan to use nurse extenders.

Team-building process in launching a practice model.

With the growing use of multiple types of nurse extenders in new patient care-delivery models, there is a need not only for outcome research on their design and use but for identification and discussion of effective team-building processes necessary to implementing these models. This article presents an analysis of the interdisciplinary team process and the levels of team building and processes needed at each level to test a new nursing practice model. The team processes included not only those within the medical center but included the collaborative process established between the college of nursing and medical center. Both of these were crucial to a successful change in nursing practice.

Effects of the partners in care practice model on nursing outcomes.

The purpose of this study was to identify the effects of an empirically-designed nursing practice model on the outcome variables of job satisfaction, autonomy, and retention/turnover of nursing staff. After 6 months significant differences were found on the experimental unit in overall job satisfaction, and on the subscales of job satisfaction in task requirements and perception of pay. Significant differences were found between the control and experimental unit on the Job Satisfaction Index subscales of interaction, task requirements, and autonomy. No significant differences were found in retention/turnover of staff between the experimental and control unit.

Effects of professional development seminars on role conception, role deprivation, and self-esteem of generic baccalaureate students.

This study compared differences in role conception (professional, bureaucratic, and service), role deprivation, and self-esteem among baccalaureate students enrolled in specially designed professional development seminars. More than 100 students participated in the pretests, given on entry to the program, of which 63 completed both the pretest and the posttest given on program exit. The Corwin Role Conception Scale assessed role conceptions and role deprivation and the Coopersmith Adult Form Self-Esteem Inventory assessed self-esteem. Statistically significant differences were found within groups in bureaucratic role conceptions (P = .0009) and self-esteem (P = .0019) and between groups in professional role conception (P = .0057). No differences were found between or within groups for service role conception or role deprivation.

Redesigning nursing practice. The partners in patient care model.

Several nursing practice models use nurse extenders/partners to extend nurses' time. The authors discuss the development, implementation, and evaluation of the "partner in patient care" (PIPC) model. Unique aspects of the model are emphasized, including use of a collaborative process to generate the design and guide the implementation; staff participation throughout the design and implementation of the project; and use of evaluation at each phase of the implementation process to improve on the outcomes.

Development of a predictive model for role strain in registered nurses returning to school.

This study identified the individual characteristics that are expected to predict and explain role strain in registered nurses (RNs) returning to school. A model was developed and tested to predict and explain role strain. The characteristics expected to predict role strain were personality, stage of career development, and marital status. Personality was assessed by the Comrey Personality Scales, stage of career development was assessed by the Career Concerns Inventory, and the criterion variable role strain was assessed by the Lengacher Role Strain Inventory. A convenience sample of 123 RN students were asked to participate in the study and 86 RNs volunteered. The data were analyzed using multiple stepwise regression analysis. Results of the stepwise regression analysis identified 13 variables as significant predictors of role strain. A double cross-validation regression procedure was completed to validate the results of the multiple regression analysis. In subsample A of the cross-validation analysis, six variables were found to be significant predictors of role strain, while in subsample B, 12 variables were significant predictors.

Development and study of an instrument to measure role strain.

The purpose of the Lengacher Role Strain Inventory (LRSI) is to assess the characteristic of role strain in female nursing students who have multiple roles (being in school, having a family, and being employed). The LRSI consists of a 100-item Likert-type scale instrument. It was administered to 327 students (a pilot and five groups) in three different colleges. Reliability and internal consistency were determined with alpha coefficients. Coefficients of .93, .94, and .95 were obtained for female nursing students and .95 and .87 were obtained for the nonnursing community college student groups. Evidence of construct validity of the LRSI may be seen in comparing the mean scores of female nursing students and male and female nonnursing students using a contrasted-groups approach. Tests of significance between the nursing student groups and the nonnursing students resulted in significant differences of p < .05, p < .01, p < .0001, and p < .0000.

Comparative analysis of role strain and self-esteem across academic programs.

The purpose of this analysis was to compare differences across programs in role strain and self-esteem between and among licensed practical nursing (LPN) students and basic traditional associate degree nursing (ADN) students enrolled in an ADN program and to compare differences between and within bachelor of science in nursing (BSN) students. Faculty were particularly concerned about differences in role strain and self-esteem between and within these groups from entry into to exit from their programs. Though 113 students participated in the analysis, the 88 who completed both the pretest and the posttest comprised 47 traditional ADN students, 17 LPN transition students, and 24 BSN students. The LPN students and the experimental group of BSN students attended stress-reducing seminars, with the goals of increasing self-esteem and decreasing role strain. The Lengacher Role Strain Inventory was utilized to assess role strain; Coopersmith's Self-Esteem Inventory assessed self-esteem. Analysis of the data by use of a t-test for independent samples and a 2 x 2 ANOVA resulted in statistically significant differences, at entry and exit, between LPN transition students and traditional ADN students in self-esteem. A paired t-test and a 2 x 2 ANOVA's demonstrated statistically significant differences in self-esteem among the ADN students and the BSN students from entry to exit and significant differences in role strain between and among LPN and ADN students from entry to exit. No significant differences in role strain were observed between or within the baccalaureate students at entry and exit.