Standardized Patient-Centered Medication Review in Home Hospice (NCT03972163) | Clinical Trial Compass
CompletedNot Applicable
Standardized Patient-Centered Medication Review in Home Hospice
United States23 participantsStarted 2020-01-15
Plain-language summary
This is a pilot cluster randomized trial that tests the effect of a novel intervention that trains hospice staff to 1. regularly review, simplify, and align patients' prescribed medications with their goals of care as their illness progresses, and 2. support family caregivers with education that empowers them to understand each medication's use, develop skills for safe administration, and 3. understand when stopping medications may be beneficial.
Who can participate
Age range
65 Years – 110 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patient - Newly admitted home hospice enrollees, aged ≥65 years old with:
* 1\. advanced life-limiting illness;
* 2\. an estimated life expectancy of \>1 month;
* 3\. recent functional status decline (defined as change in Karnofsky Performance Status \[KPS\] to \< 80% in prior 3 months);
* 4\. polypharmacy (defined as ≥ 5 regularly scheduled medications \[excluding antimicrobials\]);
* 5\. cognitive ability to provide informed consent based on a Short Portable Mental Status Questionnaire (SPMSQ) score ≥6 OR, with a legally authorized representative who is willing and able to provide proxy consent.
Family ("any relative, partner, friend or neighbor who has a significant personal relationship with, and provides a broad range of assistance) Caregiver -
* self-identification as "usually" or "always" providing care to the eligible patient;
* English-speaking;
* telephone access; and
* cognitive ability to participate.
Exclusion Criteria:
Patient:
* Imminent death;
* pain crisis;
* no family caregiver or health care proxy
Family Caregiver:
* no telephone access;
* cognitive impairment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.