Description

Research question: Are the methods used in a pilot study that is designed to implement a nurse-led daily weight monitoring intervention, appropriate for a larger study to be conducted later, which will test the intervention's effect on self-care and quality of life among older adults with heart failure, compared to those who receive routine care? It may be unrealistic to expect patients to have the agency to perform adequate self-care when they are living with activity-limiting symptoms, and perceive that heart failure (HF) self-care instructions are complicated. Given that HF symptoms interfere with the ability to perform self-care, it is vital to concurrently address symptoms and self-care, while also attempting to reduce information overload. Therefore, the purpose of this pilot study is to implement a simple weight tracking tool to affect HF self-care and HF quality of life (using a measure that focuses on symptoms and quality of life) in a population of adults age 55 years and older who have HF, and test the methods to be used in a larger study.

1. The primary (exploratory) aims of this pilot study are to test methods to be used in a future randomized controlled trial:
2. Determine intervention fidelity by 1) examining unintended variations in intervention implementation by nurse investigators, and 2) evaluating use (versus no use) of the Wake and Weigh tool by participants.
3. Determine the feasibility of recruitment by assessing how long it takes to recruit 10% of the anticipated larger study sample size.
4. Determine the feasibility of randomization and retention for each group.
5. Test the use and appropriateness of the SCHFI and KCCQ in a population of recently discharged adults aged 55 years and older who have HF who had been admitted to a small regional hospital.
6. Test the appropriateness of the chosen measures by i. Determining percentage of completed SCHFI and KCCQ
7. The secondary aim for this study is to test participants' HF self-care and quality of life i. Reporting test scores for the SCHFI and KCCQ (descriptive) ii. Reporting results of additional questions on confidence, belief, and likelihood of use for Wake and Weigh tool (see variable list) iii. Reporting change in test scores if sample size allows. The setting for this study is a 126-bed regional hospital (Cleveland Clinic, Avon Hospital) in Northeast, Ohio. The hospital inpatient areas include adult medical-surgical units and a 12-bed medical intensive care unit. All inpatient areas in the hospital care for patients with HF. Participants for this study will be selected from a population of adult inpatients at the study site who have a new or existing diagnosis of HF.

The intervention for this study will be the introduction and implementation of the Wake and Weigh tool, which will be provided on hospital admission to patients with HF who are randomized to the intervention group. Currently, usual care education for weight and fluid management is delivered utilizing a HF handbook. Although the handbook is available, patient use of the weight record in the handbook is inconsistent. The handbook is given only on initial HF admission, whereas the Wake and Weigh tool is designed as an additional visual management tool, to remind patients to weigh upon waking and to monitor for weight changes. It is designed for any and all admissions for patients with HF. Further, the Wake and Weigh tool is designed to help patients learn to recognize weight changes through daily weighing, using nurse-led role modeling while they are hospitalized and for easy use at home after discharge.

The nurse investigators will introduce the Wake and Weigh tool to admitted patients and will educate them on the importance of weighing daily (See Wake and Weight script). They will be encouraged to use it daily while in the hospital, and at home after discharge. Because it is a short, paper tool, it can be easily taken to provider follow-up appointments. The Wake and Weigh tool includes the patient's dry weight and instructions for daily weight monitoring. Patients and/or family members can log the date, time, and weight value beginning in the hospital and maintain the same routine after discharge. It will also include the cardiologist or PCP contact information depending on which provider is managing the patient's HF and follow up care upon discharge. Participants in the intervention group will be instructed to 1) use the same scale each day and record their weight on the form, 2) weigh themselves first thing each morning after using the bathroom, and before eating breakfast, and 3) report to their provider if there is an increase or decrease in four pounds or more when compared to dry weight (discharge weight). While in the hospital, weight is being managed by the healthcare team, so the goal during hospitalization is to educate the patient on what to do once discharged, and to recognize changes in weight.

Pilot feasibility

1. Intervention fidelity will be determined by 1) nurse investigators' consistent patient education of the Wake and Weigh intervention, and 2) the participant use of the tool.

First, fidelity will be determined by the number of times it takes for all nurse investigators (n=5) to provide the Wake and Weigh intervention education consistently through role-playing prior to recruiting participants. An intervention checklist will be used and all areas must be complete to be counted. If this can be accomplished in 5 or fewer attempts, the fidelity of the intervention will be considered feasible.

Post-intervention, the investigators will determine whether the participant used the Wake and Weigh form or not. They will also be asked whether they went to their follow-up visit, whether they took it to their provider and whether they were hospitalized since starting the study; however, this will not be included as an intervention outcome. During the post-intervention phone call, the nurse investigator will ask the participant about Wake and Weigh use (see follow-up calls document). Greater than 70% of participants using the Wake and Weigh form (determined by self-report of weighing and recording weight at least half the time since hospital discharge) will be required to determine that the intervention is feasible for the larger study.

2. Recruitment feasibility will be determined by the length of time (weeks, months) it takes to recruit a minimum sample size (n=42), which 9% of the minimum for a larger study.

3. Randomization and retention feasibility will be determined by the percentage of participants who stay in the assigned group and in the study until completion of exit surveys. Study dropouts will be reported by group. If 70% or more of the control group and 70% or more of the intervention group remain in the study for two weeks or until study follow-up call, randomization will be considered feasible. If 70% or more of all participants remain in the study for two weeks or until study follow-up call, retention will be considered feasible.

4. The appropriateness of the instruments and instrument scores will be determined with internal consistency, percentage of completed surveys (80% of participants complete both surveys=appropriate for a larger study), and survey inter-correlations (surveys correlated at < 0.3). Test scores will be reported descriptively and change in test scores will be reported if minimum sample size or greater is obtained.

Measures

1. Self-care in Heart Failure Index (SCHFI). The SCHFI v7.2-C will be used to measure HF self-care behaviors. It includes 3 scales: Self-Care Maintenance (5-point Likert scale from 1 to 5), Symptom Perception (first 9 items were rated on a 5-point Likert scale, and the last 2 items were responded to as "have not had symptoms," 0 (I did not recognize the symptoms), 1 (not quickly) to 5 (very quickly), and Self-Care Management (5-point Likert scale from 1 to 5 for the first 7 items and a 6-point rating scale for the last item). Symptom perception was found to include monitoring ("listening" to their bodies) and recognition (engage in active behaviors based on interpretation of symptoms) of HF symptoms. Cronbach's alpha for all scales was ≥ 0.70. Participants who were healthier had higher self-care maintenance score (r = -0.19, P = .08) and higher symptom perception scores (r = -0.31, P = .003). A standardized score from 0 to 100 was calculated for each scale, with higher scores indicating better self-care behavior.
2. KCCQ-12. Heart failure quality of life will be measured by the KCCQ-12. The KCCQ-12, a shortened and more feasible version of the KCCQ-23, is a HF specific health related quality of life questionnaire that describes physical limitations and symptoms, quality of life, social interference, and self-efficacy. This 12-item questionnaire uses a Likert scale from 1-5 (1 = every morning, all of the time, every night, or it has extremely limited my enjoyment of life, 5 = never over the past 2 weeks, it has not limited my enjoyment of life at all), and 2 items on a 1-6 scale (1 = extremely limited/severely limited, 6 = limited for other reasons or did not do the activity/does not apply or did not do for other reasons). Higher scores indicate the following: fewer physical limitations, fewer symptoms, better social functioning, and better sense of self-efficacy and higher quality of life, referred to here as HF quality of life. The KCCQ-12 has high correlations with the original scale (>0.93) and high test-retest reliability (>0.76). 16 Items are scored from 0 to 100 with 0 representing the worst and 100 the best possible functional status.
3. Charlson Comorbidity Index. The Charlson Comorbidity Index (CCI) measures the burden of chronic conditions by applying a weight to a list of specific diseases. The original CCI was reduced to 12 diseases, each of which is specified by using ICD-10 codes. The C-statistic for the Quan 12-item CCI was 0.825, indicating very good discrimination for in-hospital mortality prediction. Stepwise increases in the CCI score were associated with increases in mortality for a wide variety of conditions and in multiple versions (p<0.001) of the CCI.

Middle Range Theory. The Wake and Weigh tool is a simple weight monitoring intervention, derived from aspects of Riegel's middle range theory of self-care in chronic illness, including that self-care is a learned process, effective management requires ongoing monitoring, patients need to identify changes in order to act on them appropriately, and maintenance leads to illness stability and optimal quality of life. Consistent with the theory of self-care, the Wake and Weigh tool is designed to help patients 1) learn from nurses' role modeling of the importance of self-care behaviors related to fluid retention (learn), 2) track weight in the hospital and following discharge, (track), 3) recognize changes in weight before complications arise (identify), and 4) establish a sustainable routine for daily weight monitoring (maintain).

Data Collection The unit RNs will be introduced to the study during huddles and a study sign will be hung in break rooms. Only the research team will introduce the Wake and Weigh form using a script and do education surrounding the form (beyond usual care). Patients will be recruited by the study team members. After determining patients with HF have been admitted to the hospital (HF dashboard will be accessed by one of the team members [BM]), potential participants' names and MRNs who fit inclusion, will be added to a password protected EXCEL spreadsheet, accessible only to the research team. A subject ID will be given for each participant in REDCap, a secure data management system, and data will be recorded and stored in REDCap until analysis. The subject ID will be added to paper surveys (SCHFI and KCCQ) until the data has been entered into REDCap. Since admission for those diagnosed while in the hospital will precede HF diagnosis, the time of diagnosis will be used to determine hospital admission. Within 24 hours of admission, a team member will approach potential participants in the privacy of their patient room, explain the study, and obtain signed informed consent. This will then be documented in the data collection form. After consent, participant will be randomized to group (REDCap), and for those in the intervention group, the Wake and Weigh form will be introduced.

The SCHFI and KCCQ paper surveys will be given immediately before randomization (in person). If the patient verbalizes they are too tired to take the surveys, nurse investigator will approach the potential participant up to 2 additional times (no closer than 24 hours between each time to be sensitive to patient fatigue) until patient feels well enough to take the surveys or declines to participate. The participant will be asked to continue to use Wake and Weigh form as instructed throughout admission, and a nurse investigator will check in daily to reinforce the intervention briefly (ask if they are using it and if they have any questions).

Follow-up (post-intervention) will occur 2 weeks (intervention group only) and 4 weeks after discharge (both groups) via phone. For the 2-week follow-up calls, the nurse investigator will ask the intervention group participants if they have any questions about the Wake and Weigh tool.

For the 4-week follow-up call:

1. Did you attend a provider follow-up visit after discharge? yes/no; 1a. If "yes", which provider (specialty)? 2. Did you take your Wake and Weigh form with you to the follow-up visit (intervention group only)? yes/no); 3. Are you confident that you can recognize weight changes before symptoms appear? Yes/no; 4. Did you experience weight changes of 4 pounds or more since beginning this study and if so, when? Yes/no/don't know; Comments ______5. If yes, did you report the weight change to your provider? Yes/no; 5a. If "yes", which provider (specialty)? 6. Do you believe daily weighing is important for preventing hospitalization? Yes/no; 7. Have you had a hospitalization since beginning this study? Yes/no; 8. If "yes", were you admitted to a Cleveland Clinic hospital? Yes/no; 9. Are you likely to continue to use the Wake and Weigh tool on a regular basis? Yes/no (intervention group only). 10. Reason for continuing/not continuing to use Wake and Weigh (intervention group only).

**per patient report

If at any point during contact (in person or on the phone) participant complains to nurse investigator of new or worsening symptoms, the clinical nurse caring for the patient will be notified (while in hospital), and after discharge participant will be referred to provider.

Analysis Plan Primary analysis will be performed using the intent-to-treat population. Patient characteristics will be summarized by group using frequencies and percentages for categorical factors, and means and standard deviations for continuous measures, if normally distributed, and medians and quartiles, otherwise. Feasibility endpoints will be summarized descriptively as the frequencies with percentages or summaries of time measures, as appropriate. Groups will be compared on overall self-care (SCHFI) and quality of life (KCCQ) using analysis of covariance models that adjust for the baseline levels of each outcome measure. Mean differences in outcomes will be estimated and both 95% two-sided confidence intervals and one-sided 90% confidence intervals will be generated to evaluate plausible differences and the feasibility of an 8-point difference based on this study. To evaluate the association between SCHFI and KCCQ, Pearson correlations between tools will be estimated. McDonald's omega will be used to assess internal consistency of each tool. Secondary analyses may include adjustment for patient characteristics that show standardized differences between randomized groups in excess of 0.2. Additionally, if there are issues with adherence to the intervention, similar analyses among those who adhere to the intervention will also be performed. Analyses will be performed using SAS software (version 9.4) or R software (version 4.2). An overall significance level of 0.05 will be assumed for all tests.

Feasibility This pilot study is feasible as designed due to a large number of weekly HF admissions. Also, the research team consists of research-active nurses and members of the research council, and are being mentored by a nurse scientist from nursing research and innovation. This study has received the approval of the hospital's Chief Nursing Officer (CNO) and a letter of support(CNO Avon letter of support document) will be uploaded into Webkit. Additionally, the hospital's CNO has agreed to provide funds for the cost of the KCCQ.

Limitations and Anticipated Problems The main limitation of this pilot study is the possible inability to infer differences between groups. Analysis of group differences is not a primary aim and will only be conducted if greater than minimum sample size is met for both groups. Anticipated problems for this study include difficulties with recruitment and retention. As this is a common problem with randomized controlled trials, a pilot study will be conducted first to determine challenges and make changes in methods to prepare for a larger study.

Protection of Human Subjects This pilot study will be approved by the institutional review board prior to implementation. Further, informed written consent will be obtained from participants in both groups, and they will be assured that they can stop participation in the study at any time. Names and MRNs will be removed and replaced with a subject number prior to analysis. Any collected data on paper, including consents, will be kept in a locked office chosen by the PI, at Avon Hospital's campus, in a locked filing cabinet. All electronic data (REDCap) will be stored on the PI's computer which requires password entry and will be in a folder accessible only to the PI and the research team. Data will be stored for a period of six years after completion of the study.