Study Description: The Palliative Care- Heart Failure Education And Research Trials (PC-HEART) collaborative is conducting a pilot study in outpatient settings of patients with advanced heart failure to:
- Identify the prevalence of pain, its location and possible causes in persons living with advanced heart failure,
- Identify the severity of pain, its interference with activities and impact on quality of life.
- Understand the correlates of other symptoms and issues in patients’ lives on their perception of pain,
- Identify current treatments for pain and their effectiveness in relieving pain.
Up to 30 sites are invited to participate. The study will enroll 400 subjects with advanced heart failure.
Data collection will include a directed physical exam, medical history (from the patient and chart review) and surveys. Surveys will be administered at enrollment and 2 weeks later. The first visit should take 45-60 minutes to complete, which includes the patient completing surveys and provider reviewing chart and doing focused physical exam. Then there will be a brief follow up call to remind patient to send in mailed surveys and answer any questions they may have. Then 10 minutes or so to enter that data when received.
We have a training manual and a project manager available to answer questions.
Site Characteristics: A study site should:
- Be a health maintenance organization, community practice, Veterans Administration, hospice agency or academic medical center providing care to patients with advanced heart failure;
- Have staff experienced in research (staff must be able to meet current standards for conducting clinical research including data collection, data entry and maintenance of study regulatory documents).
- Identify a site Investigator and site coordinator (nurse or research assistant) with ready-computer access and computer skills (to include being able to access designated website, select data tools on website, enter data on website, review PowerPoint presentations, and communicate via email and email attachments)
- Enroll a minimum of 15 patients over 4 months
Site Investigator: The site Investigator will be responsible for the overall execution of the research study at his/her site, to include:
- Obtaining and maintaining Institutional Review Board (IRB), Human Subjects Committee (HSC) or Ethics Committee (EC) approval at their site. In the event no IRB, HSC or EC is available to the site, the Investigator will work with the Principal Investigator (Sarah Goodlin MD) to obtain site approval via an independent review organization.
- Obtaining or designating a staff member to obtain informed consent by each subject to participate in the study.
- Maintaining records to comply with research standards and with human subjects and HIPAA regulations from the start of the study until 2 years after study completion.
- Verifying or designating the study Coordinator to verify the completion of study data collection and data entry.