How the Elderly Live With Pain in Heart Failure

Study Events Patients admitted to TJUH with a HF diagnosis will be identified by intensive
clinical research coordinator screening methods. The potential subjects will be approached
in the acute care area for interview and consent to participate. At that visit, the
variables of interest will be collected and the questionnaires completed. Following
discharge, the subjects will be re-interviewed at follow-up clinic visits or by telephone,
depending on whether the visit is to a Jefferson University Physician provider or to an
outside provider or as circumstances allow.

Subjects will sign an informed consent to participate in HELP-HF. A selection of assessment
questionnaires (listed below) and performance measures will be completed during the index
hospitalization and at a subsequent follow up clinic visits or by telephone call. Some of
these assessments involve data collection from standard of care encounters or tests and will
be abstracted from the medical record.

The Kansas City Cardiomyopathy Questionnaire (KCCQ) The KCCQ is a valid, reliable and
responsive health status measure for HF patients and serves as a clinically meaningful
outcome assessment tool that is widely used in cardiovascular research, patient management,
and quality of life self-assessment.12 The Brief Pain Inventory (BPI) The BPI is one of the
most widely used measurement tools for assessing clinical pain. It allows patients to rate
the severity of their pain and the degree to which their pain interferes with common
dimensions of feeling and function. Initially developed to assess pain related to cancer,
the BPI has validated as an appropriate measure for pain caused by a wide range of clinical
conditions. , The Charlson Co-Morbidity Index (CCI) Comorbidity describes the effect of all
other diseases an individual patient might have other than the primary disease of interest.
The CCI is used to characterize comorbid medical conditions and allows inferences about the
extent to which symptoms and other factors related to quality of life may be attributable to
conditions other than HF. The CCI designates comorbid conditions in 19 categories and each
category has an associated weight based on the adjusted risk of one-year mortality, and the
overall comorbidity score reflects the cumulative increased likelihood of one-year
mortality. Charlson scores can range between 0 and 35, with a higher score indicating
increase in burden of comorbid disease.

OTC Medication Inventory A comprehensive list of any over the counter (OTC) medications will
be collected and reconciled via review of the electronic medical records and by subject
interview.

Brief Interventions Measures (BIM) The BIM questionnaire is a novel tool developed for use
in the HELP-HF study. It is adapted from similar questionnaires used in palliative oncology
care and incorporates an inventory of comfort measure identified in the literature. These
include measures like application of heat or cold, massage, and other self-selected
therapies.

Case Report Form and Data Capture A paper case report form (data collection tool) will be
developed for each subject's study records. All data will be entered by study personnel into
a password-protected database using the REDCap (Research Electronic Data Capture) system.
REDCap is a secure, web-based application designed to support electronic data capture for
research studies. REDCap is used by selected areas within the University. It is a service
available via a free collaboration with the NIH CTSA structure and accessed at TJU with
permission and oversight via internal Information Systems at the University's Kimmel Cancer
Center. REDCap allows for monitored dual data entry via a web-based system that is
maintained on a protected server and will be used by the study investigators, coordinators
and statistician.

Statistical Analyses Plan Subject demographics and co-morbidities as well as characteristics
of the self-reported pain, treatment selections, and efficacy will be reported as medians
and interquartile ranges (IQRs) for continuous variables and as percentages of non-missing
values for categorical variables. Patients will be stratified by pain scores. Univariate
comparisons between patients with and without pain will be performed using the Pearson χ2
test for categorical variables and the Wilcoxon rank-sum test for continuous and ordinal
variables.

Inclusion Criteria:

- Men and women ≥ 60 years.

- Admission to hospital for worsening HF

Exclusion Criteria:

- History of uncontrolled hypertension.

- Severe valve disease.

- End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left
ventricular assist device support.

- Advanced malignancy or other medical condition with life expectancy less than 2 years
or undergoing active chemotherapy or radiation therapy.

- Advanced chronic kidney disease (CKD) defined as estimated glomerular filtration rate
(GFR) < 20 mL/min/1.73 m2 based upon the Modification of Diet in Renal Disease (MDRD)
study equation), or on chronic or intermittent dialysis or dialysis anticipated
within the next 6 months.

- Chronic anemia with hemoglobin < 9 gm/dl for males, < 8 gm/dl for females or acute
anemia requiring transfusion of 2 or more units of blood.