Measurement Reactivity in a Randomized Clinical Trial Using Self-Reported Data.

PURPOSE: The objective of this article is to describe how self-monitoring contributed to measurement reactivity in a randomized clinical trial (RCT). The implications of measurement reactivity on self-monitoring and suggestions for minimizing its effect will be discussed. DESIGN: The study involved a secondary data analysis of responses from 145 participants who completed a 12-month long RCT. The original sample consisted of 202 community-living adults with long-term indwelling urinary catheters. METHODS: The data analyzed were from the participants' brief responses to the final study question concerning their perceived study participation value. The data were discussed and coded iteratively until three researchers reached consensus. At the end, each item was recoded into eight categories and minor codes. FINDINGS: Our belief that the calendar was the probable cause of reactivity was not fully supported as the control group also learned about paying attention to urinary catheter problems by the questions asked through the seven bimonthly interviews. CONCLUSIONS: The calendar and interview questions were reactive by increasing participants' self-monitoring of catheter problems. Specifically, the frequent interviews exposed participants to catheter-related concerns and provided them with ideas as to how to better manage them. CLINICAL RELEVANCE: This article provides insight related to the internal validity threat of measurement reactivity in RCTs and gives suggestions to reduce its effects.

Exploring relationships of catheter-associated urinary tract infection and blockage in people with long-term indwelling urinary catheters.

AIMS AND OBJECTIVES: To describe and explore relationships among catheter problems in long-term indwelling urinary catheter users, including excess healthcare use for treating catheter problems. BACKGROUND: Long-term urinary catheter users experience repeated problems with catheter-related urinary tract infection and blockage of the device, yet little has been reported of the patterns and relationships among relevant catheter variables. DESIGN: Secondary data analysis was conducted from a sample in a randomised clinical trial, using data from the entire sample of 202 persons over 12 months' participation. METHODS: Descriptive statistics were used to characterise the sample over time. Zero-inflated negative binomial models were employed for logistic regressions to evaluate predictor variables of the presence/absence and frequencies of catheter-related urinary tract infection and blockage. RESULTS: Catheter-related urinary tract infection was marginally associated with catheter blockage. Problems reported at least once per person in the 12 months were as follows: catheter-related urinary tract infection 57%, blockage 34%, accidental dislodgment 28%, sediment 87%, leakage (bypassing) 67%, bladder spasms 59%, kinks/twists 42% and catheter pain 49%. Regression analysis demonstrated that bladder spasms were significantly related to catheter-related urinary tract infection and sediment amount, and catheter leakages were marginally significantly and positively related to catheter-related urinary tract infection. Frequencies of higher levels of sediment and catheter leakage were significantly associated with higher levels of blockage, and being female was associated with fewer blockages. Persons who need help with eating (more disabled) were also more likely to have blockages. CONCLUSIONS: Catheter-related urinary tract infection and blockage appear to be related and both are associated with additional healthcare expenditures. More research is needed to better understand how to prevent adverse catheter outcomes and patterns of problems in subgroups. RELEVANCE TO CLINICAL PRACTICE: Nurses can develop care management strategies to identify catheter blockage prior to its occurrence by tracking the amount of sediment and frequency of leakage. Bladder spasms could be an early warning of catheter-related urinary tract infection.

Self-care management questionnaire for long-term indwelling urinary catheter users.

AIMS: Self-management is believed to be an important behavioral capacity in people with chronic illness, and self-efficacy is an important component contributing to self-management. Two new and related measures for urinary catheter self-efficacy (C-SE) and self-management (C-SMG) were developed based on existing tools and tested for psychometrics for use in a randomized clinical trial (RCT) teaching urinary catheter self-management. METHODS: The instruments were evaluated at baseline (intake face to face interview) with 202 persons and with 158 of the same individuals 6 months later by telephone interviews. Exploratory factor analysis was conducted in an iterative process related to items' theoretical and statistical appropriateness. To assess construct validity and goodness of fit for model testing, confirmatory factor analysis was conducted with the samples at intake and 6 months. Also, bivariate analyses were conducted of the measures in relation to each other. RESULTS: Both scales were modified reducing the items to 13 in each, with four factors in C-SE and three factors in C-SMG. Reliability testing (Cronbach's alpha) was viewed as satisfactory for both scales, though some of the subscale (factors) reliabilities were lower in the self-management measure. Confirmatory factor analysis was adequate. Correlation of the two instruments (r = 0.25, P < 001) suggests that they are related scales. CONCLUSION: With a change in the C-SMG scale from 3- to 5-level responses and subsequent testing, both new scales are appropriate for use separately or together as a questionnaire related to catheter self-care management in intervention research with long-term indwelling urinary catheter users. Neurourol. Urodynam. 35:492-496, 2016. © 2015 Wiley Periodicals, Inc.

Testing a Model of Self-Management of Fluid Intake in Community-Residing Long-term Indwelling Urinary Catheter Users.

BACKGROUND: Urinary tract infection and blockage are serious and recurrent challenges for people with long-term indwelling catheters, and these catheter problems cause worry and anxiety when they disrupt normal daily activities. OBJECTIVE: The goal was to determine whether urinary catheter-related self-management behaviors focusing on fluid intake would mediate fluid intake-related self-efficacy toward decreasing catheter-associated urinary tract infection (CAUTI) and/or catheter blockage. METHODS: The sample involved data collected from 180 adult community-living, long-term indwelling urinary catheter users. The authors tested a model of fluid intake self-management related to fluid intake self-efficacy for key outcomes of CAUTI and blockage. To account for the large number of zeros in both outcomes, a zero-inflated negative binomial (ZINB) structural equation model was tested. RESULTS: Structurally, fluid intake self-efficacy was positively associated with fluid intake self-management, suggesting that higher fluid intake self-efficacy predicts more (higher) fluid intake self-management; however, fluid intake self-management was not associated with either the frequency of CAUTIs or the presence or absence of CAUTI. Fluid intake self-efficacy was positively related to fluid intake self-management, and fluid intake self-management predicted less frequency of catheter blockage, but neither fluid intake self-efficacy nor fluid intake self-management predicted the presence or absence of blockage. DISCUSSION: Further research is needed to better understand determinants of CAUTI in long-term catheter users and factors which might influence or prevent its occurrence. Increased confidence (self-efficacy) and self-management behaviors to promote fluid intake could be of value to long-term urinary catheter users to decrease catheter blockage.

Feasibility of a Web-Based Self-management Intervention for Intermittent Urinary Catheter Users With Spinal Cord Injury.

PURPOSE: The purpose of this study was to evaluate the feasibility of a new Web-based intermittent catheter self-management intervention. DESIGN: We tested the acceptability and usability of intervention components, which included multiple Web-based materials (an online urinary diary adapted for mobile phone use and an educational booklet), 3 phone calls with a nurse, and a peer-led discussion forum. SUBJECTS AND SETTING: Thirty adults with spinal cord injury using intermittent catheterization for bladder drainage were enrolled; 26 participants received the nurses' phone-based consultations. METHODS: Preliminary effectiveness of new self-efficacy and self-management scales were evaluated using baseline and 3-month online surveys. Participants' perceived value of the intervention components, self-management changes, and suggestions were assessed with data from the 3-month surveys, followed by brief tape-recorded interviews. RESULTS: Several catheter practices improved somewhat over 3 months. The frequency of catheterizations every 4 to 6 hours increased from 71% to 77%. Self-management of neurogenic bladder dysfunction increased significantly (P = .032); participant comments indicated that fluid intake was the biggest change. Catheter-related self-efficacy and quality-of-life scores increased but not significantly. The frequency of urinary tract infection and pain did not change significantly. For feasibility, intervention components, with the exception of the forum, were rated highly by the majority of participants for usefulness, satisfaction (desired information), and Web-based usability. CONCLUSION: Further testing of this intervention is recommended in a multisite randomized clinical trial.

Self-management intervention for long-term indwelling urinary catheter users: randomized clinical trial.

BACKGROUND: People using long-term indwelling urinary catheters experience multiple recurrent catheter problems. Self-management approaches are needed to avoid catheter-related problems. OBJECTIVES: The aim was to determine effectiveness of a self-management intervention in prevention of adverse outcomes (catheter-related urinary tract infection, blockage, and accidental dislodgement). Healthcare treatment associated with the adverse outcomes and catheter-related quality of life was also studied. METHODS: A randomized clinical trial was conducted. The intervention involved learning catheter-related self-monitoring and self-management skills during home visits by a study nurse (twice during the first month and at 4 months-with a phone call at 2 months). The control group received usual care. Data were collected during an initial face-to-face home interview followed by bimonthly phone interviews. A total of 202 adult long-term urinary catheter users participated. Participants were randomized to treatment or control groups following collection of baseline data. Generalized estimating equations were used for the analysis of treatment effect. RESULTS: In the intervention group, there was a significant decrease in reported blockage in the first 6 months (p = .02), but the effect did not persist. There were no significant effects for catheter-related urinary tract infection or dislodgment. Comparison of baseline rates of adverse outcomes with subsequent periods suggested that both groups improved over 12 months. DISCUSSION: A simple-to-use catheter problems calendar and the bimonthly interviews might have functioned as a modest self-monitoring intervention for persons in both groups. A simplified intervention using a self-monitoring calendar is suggested-with optimal and consistent fluid intake likely to add value.

A hybrid process fidelity assessment in a home-based randomized clinical trial.

A process fidelity assessment was conducted as a nested study within a home-based randomized clinical trial teaching self-management to 101 long-term indwelling urinary catheter users in the treatment group. Our hybrid model combined external assessments (outside observations and tape recordings) with internal evaluation methods (through study nurse forms and notes) for a comprehensive process fidelity assessment. Barriers, patient-related issues, and nurse perspectives were identified demonstrating the complexity in home care intervention research. The complementary and synergistic approaches provided in-depth information about the context of the delivery and the impact of the intervention on study outcomes.

Development of a Web-Based Self-management Intervention for Intermittent Urinary Catheter Users With Spinal Cord Injury.

While Web-based interventions have proliferated recently, information in the literature is often lacking about how the intervention was developed. In response to that gap, this is a report of the development of a Web-based self-management intervention for intermittent urinary catheter users and pretesting with four adults with spinal cord injury living in the community. Two Web sites were created, one for recruitment and the other for the intervention itself. The intervention involved developing new Web-based technology, including an interactive urinary diary (with fluid intake/urine output and a journal), extensive catheter products information, three intervention nurse phone call consultations, and user-community discussion forums. Study participants completed an online survey and were interviewed twice about the enrollment process and their perceptions of their involvement in the intervention. Suggestions from the pretesting participants were used to revise the Web site applications prior to the next stage of research (a feasibility study). Numerous recommendations and comments were received related to content, interactivity of components, and usability. This article provides a description of how the Web sites were developed (including the technology and software programs used), issues encountered and what was done to address them, and how the Web-based intervention was modified for improvements.

A Web-Based Self-Management Intervention for Intermittent Catheter Users.

A new Web-based self-management intervention was developed for persons with spinal cord injury who use intermittent urinary catheters. Included are a description of the components, examples from the educational book, and multiple screen shots of the online urinary diary.

Successful recruitment methods in the community for a two-site clinical trial.

Effective screening and recruitment are essential to the success of randomized clinical trials. This report is to describe key screening and recruitment strategies in a two site randomized clinical trial (RCT) conducted in community settings with a vulnerable chronically ill population and to suggest valuable approaches when planning trials. Differences between sites in a complex study with two considerably different environments (academic versus home care) and their participant pools presented challenges which required different screening and recruitment methods. A high level of communication between sites, creative problem solving and the ability to be flexible when problems were encountered were needed for successful screening and recruitment.

Long-term urinary catheter users self-care practices and problems.

AIMS AND OBJECTIVES: To characterise a sample of 202 adult community-living long-term indwelling urinary catheter users, to describe self-care practices and catheter problems, and to explore relationships among demographics, catheter practices and problems. BACKGROUND: Long-term urinary catheter users have not been well studied, and persons using the device indefinitely for persistent urinary retention are likely to have different patterns of catheter practices and problems. DESIGN: The study was a cross-sectional descriptive and exploratory analysis. METHODS: Home interviews were conducted with catheter users who provided information by self-reported recall over the previous two months. Data were analysed by descriptive statistics and tests of association between demographics, catheter practices and catheter problems. RESULTS: The sample was widely diverse in age (19-96 years), race and medical diagnosis. Urethral catheters were used slightly more often (56%) than suprapubic (44%), for a mean of six years (SD 7 years). Many persons were highly disabled, with 60% having difficulty in bathing, dressing, toileting and getting out of the bed; 19% also required assistance in eating. A high percentage of catheter problems were reported with: 43% experiencing leakage (bypassing of urine), 31% having had a urinary tract infection, 24% blockage of the catheter, 23% catheter-associated pain and 12% accidental dislodgment of the catheter. Treatments of catheter-related problems contributed to additional health care utilisation, including extra nurse or clinic visits, trips to the emergency department or hospitalisation. Symptoms of catheter-associated urinary tract infections were most often related to changes in the colour or character of urine or generalised symptoms. CONCLUSIONS: Catheter-related problems contribute to excess morbidity and health care utilisation and costs. RELEVANCE TO CLINICAL PRACTICE: More research is needed in how to minimise catheter-associated problems in long-term catheter users. Information from this study could help inform the development of interventions in this population.

Urinary bag decontamination for long-term use: a systematic review.

A systematic review of research on urinary drainage bag decontamination methods was conducted to evaluate existing evidence for practice related to long-term urinary catheter users. Six trials were found that met inclusion criteria. In addition, 9 clinical practice guidelines about urinary catheter care from 3 English-speaking countries were examined. Two studies were of modest quality; they included a randomized trial of 54 persons in a rehabilitation hospital and a laboratory comparison of 5 decontamination products. Three other articles included in the review were case series. All were published between 1985 and 1994. Bleach (NaClO) solutions of varying concentrations (0.06%-1%) were most often tested, and results were similar in controlling microbial contamination in the drainage bags. However, the studies often lacked definitions or standardization of key outcome measures such as safety and ease of the procedure and integrity of the drainage bag. The clinical practice guidelines differed in advice on bag decontamination, and some did not address it. Further research is recommended to evaluate the efficacy of decontamination procedures in patients with long-term indwelling catheters and drainage bags.

Internet recruitment and retention for a 6 months' longitudinal study.

PURPOSE: To examine factors influencing recruitment and retention of study participants in a longitudinal study. METHODS: After completion of a longitudinal (6 months) study of long-term indwelling urinary catheter users, three types of data were analyzed: number of problems with data entry into an online survey, number of reminders sent by study staff to participants, and number and nature of e-mail contacts between participants and study staff and among study staff regarding the study. CONCLUSIONS: The Internet can be used effectively for research, especially involving small, specialized populations. In order to retain study subjects and obtain complete and accurate data, study staff must be closely involved and responsive to participants' issues, and technical support staff must be readily available and invested in the research project. CLINICAL RELEVANCE: Using the Internet to reach small, special, marginalized, or geographically dispersed populations for research is becoming common. Researchers need to know how best to recruit, support, and retain participants in Internet-based studies.

Preventing catheter-associated urinary tract infections in acute care: the bundle approach.

Catheter-associated urinary tract infections account for 40% of all nosocomial infections. A multidisciplinary team implemented evidence-based guidelines and a urinary catheter bundle, focusing on optimizing the use of urinary catheters through continual assessment and prompt catheter removal. Data were obtained on catheter device days, compliance with urinary catheter orders, and computer documentation of continued catheter indications. Results included an overall reduction of 71% in catheter device days and a 56% reduction in catheter use.

A qualitative descriptive study of self-management issues in people with long-term intermittent urinary catheters.

AIM: The study was to identify and describe issues of intermittent urinary catheter users for future self-management research and/or training programmes. BACKGROUND: Limited studies were found of how people using clean intermittent catheterization manage their daily routines or troubleshoot problems. Self-management research related to intermittent catheterization could lead to improved compliance with the method and better quality of life. METHOD: This qualitative descriptive study involved in-depth tape-recorded telephone interviews in 2008-2009 with 34 people in the United States of America using permanent intermittent catheterization, mostly individuals with spinal cord injury or multiple sclerosis. Recruitment was through Internet sites where individuals could link to the study website and then contact the researchers. The sample included 13 men and 21 women aged 21-72 years (mean 42 years). Content analysis for qualitative data involved iterative comparisons of transcripts, summaries and memos. Coding, key quotes and tables were developed to determine themes. FINDINGS: Six major themes were identified: Knowing the Body, Practising Intermittent Catheterization, Limited Options in Catheters and Equipment, Inaccessible Bathrooms, Hassles, and Adjustment in Making Intermittent Catheterization a Part of Life. While some persons had choices in catheters, many did not because of insurance constraints. Some individuals developed knowledge of how to balance the procedure with fluid intake and activities. CONCLUSION: The lack of acceptable bathrooms can interfere with being able to go to work, travel or be with friends and family. All using intermittent catheterization should have adequate insurance coverage when this is needed. Research into training programmes could incorporate knowledge of experienced users.

A new urinary catheter-related quality of life instrument for adults.

AIMS: To develop and assess the measurement properties of a catheter-related quality of life (C-IQoL) instrument designed to support research with persons using long-term urinary catheter users who use indwelling urethral or suprapubic catheters permanently. METHODS: Testing was conducted in two small studies for psychometric qualities of reliability (internal consistency and test-retest) and factor analysis. The initial instrument, which was modified after each study, was based on an International Continence Society (ICS) validated generic incontinence quality of life tool. ICS guidelines were used to develop content, including using descriptive and qualitative literature as well as and subjective/objective measures. Literature included content areas related to sexuality, embarrassment, and everyday catheter management. RESULTS: A three-factor solution of subscales (management, interpersonal, and psychosocial) was created. The final instrument contains 22 items. Reliabilities were all satisfactory. CONCLUSIONS: Quality of life continence instruments need to be device-specific to address appropriate and critical issues in randomized trials. For further development of a valid and reliable measure, continued collaboration is needed among researchers working with this population.

Study on the use of long-term urinary catheters in community-dwelling individuals.

PURPOSE: The purpose of this study was to determine the incidence and distribution of catheter-related problems in long-term indwelling urinary catheter users. We also sought to assess appropriateness of catheter use and examine relationships among catheter complications and catheter care practices. DESIGN: This repeated-measures study involved self-reported data collection by recall at intake and by prospective data collection at 2, 4, and 6 months in long-term urinary catheter users. SUBJECTS AND SETTING: Two sampling arms were used: a home care (HC) agency with 10 individuals and the Internet with 33 people having spinal cord injury. METHODS: Home visit and follow-up telephone call interviews were used with the participants from the HC agency. Data were self-administered through SurveyMonkey in the Internet sample, and communication was through e-mail, telephone, and postal mail. Analysis included descriptive statistics and generalized estimating equation techniques to adjust for within-subject variation over time. RESULTS: All study participants had at least 1 catheter-related problem during 8 months, and many had multiple, recurring problems. Catheter-associated urinary tract infection (CAUTI) was reported by 70%, blockage by 74%, leakage by 79%, and accidental dislodgement by 33%. Key tests of associations (generalized estimating equation) predicted that catheter size contributed to CAUTI, with significant covariates of female gender and younger age. The presence of sediment in the urine on the day of the survey predicted catheter blockage. CONCLUSION: The incidence of all complications was higher than expected. Problems associated with long-term indwelling catheter use may contribute to excess healthcare utilization adversely affecting both users and their families.

A pilot study of self-monitoring urine flow in people with long-term urinary catheters.

Self-monitoring of urine flow may be beneficial in preventing catheter-related problems. An intervention was pilot tested using a single group design with 11 individuals over 6 months. Feasibility of the intervention, performance of new measures (awareness, self-monitoring, and self- management of urine flow), and health outcomes were assessed. The intervention was well received by participants, none of whom withdrew voluntarily from the study. All data were collected at intake, and bimonthly at 2, 4, and 6 months. Nine of 11 participants reported that the intervention had helped them to pay attention to fluid intake. Episodes of UTI decreased over the course of the intervention, with the greatest drop between 2 and 4 months.

Somali Older Adults' and Their Families' Perceptions of Adult Home Health Services.

Many studies have identified the vulnerability of ethnic elders, and there is promising evidence indicating home health care (HHC) services can improve the health outcomes of Somali older adults. This study used a community-engaged qualitative descriptive approach with the participation of non-profit organization Refugees Helping Refugees. The purpose of this study was to explore and describe Somali older adults' and their families' perceptions of and experiences with HHC services in order to improve its use and access. Data collection included home visits (n = 15), semi-structured interviews (n = 17) and debriefing sessions (n = 16) with 19 individuals from 14 Somali families. Somali families recognized HHC services were needed and believed having services in the home facilitated learning but HHC agencies should work more with the Somali community. HHC agencies need to work with community organizations to facilitate cultural and health understanding, and better health care for Somali older adults.

Using a Clinical Outreach Project to Foster a Community-Engaged Research Partnership With Somali Families.

BACKGROUND: Community-engaged research partnerships build the capacity of community and educational organizations to work together toward addressing important health issues and disparities for vulnerable populations, such as refugees or immigrants. A critical step for building a community-engaged research partnership is the Thrst contact or entrée into the community. PURPOSE: The purpose of this paper is to describe how a successful home health community-engaged partnership became the entrée and foundation for a community-engaged research partnership to explore the home health needs of Somali older adults and their families. METHODS: A number of strategies were used to engage the Somali community, initially in a clinical home health project and subsequently in an academic research study. LESSONS LEARNED: Valuable lessons were learned on delivering home health care (HHC) services to Somali older adults and their families as well as conducting research with this population. The most important lesson was that none of the work could be done without the involvement of the Somali community. The partnership described is one of the Thrst to address the home health needs and experiences of Somali older adults and their families. The project illustrates a mutually beneThcial relationship that can occur when a community-engaged clinical project expanded to address an issue of importance to the community through research. CONCLUSIONS: This foundation served to create an opportunity for more comprehensive community-academic partnerships with the potential to improve the delivery of HHC to Somali older adults, as well as open avenues for research in other areas that are relevant to the Somali, medical, and academic communities.