CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 121 enrolled
Drug / intervention
AIDS EPC Package plus MI +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01848483
NCT01848483N/ACompleted

The Living Well Project: Early Palliative Care and Motivational Interviewing (MI) for Persons With AIDS

Emory University·interventional·Posted May 7, 2013·Updated Dec 30, 2019

In Brief

A clinical study evaluating AIDS EPC Package plus MI and Standard of Care (SOC) for Acquired Immunodeficiency Syndrome (AIDS). Completed, enrolled 121 participants across 1 site.

Detailed Summary

The overall goal of this project is to implement and test the efficacy of an enhanced comprehensive multidisciplinary early palliative care (EPC) package that includes four motivational interviewing sessions (MI) for persons diagnosed with AIDS. We posit that the innovative EPC will improve quality of life, clinical and psychosocial outcomes and advance care planning in a cost effective manner and could promote engagement and retention in HIV care. If successful, it could serve as a model of early palliative care for persons with AIDS in the US.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGrady Health System

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 7, 2013
Enrollment StartJun 1, 2014
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 13.2 years ago

Interventions

AIDS EPC Package plus MIbehavioral

1. Motivational Interviewing: In MI session #1, the nurse will set the agenda \& ask the participant to discuss any adjustments to the AIDS diagnosis. In sessions #2 - 4, the participant will be asked to set the agenda related to current concerns. In sessions #3 \& 4, the nurse will also introduce advance care planning. 2. EPC Package: Participants will be seen by palliative care providers, for approximately 30 minutes each, in the following order: 1) Chaplain: introduces the concept of EPC clinic \& conducts a spiritual evaluation/intervention as needed. 2) Social worker: conducts an evaluation/intervention as needed. 3) Psychologist: conducts an evaluation/intervention as needed. 4) Palliative Care Physician: conducts symptom management, medication reconciliation \& coordination of care.

Standard of Care (SOC)other

The routine standard of care provider visit occurs in the following order. The vital signs are taken and the participant sees the nurse to review medications. The provider visits are scheduled for approximately 30 minutes, except for a new patient or patient with complex medical needs. The provider conducts a history to elicit symptoms, health problems, concerns, and a physical exam, then orders labs or immunizations; and referrals to subspecialty clinics. Medications are prescribed or renewed. The patient then receives a follow-up appointment, typically every 3 months for a stable patient. If the patient starts Antiretroviral therapy (ART), an appointment to the nurse educator is required. Typically, the patient will have 1- 2 visits to the nurse educator to begin medications and follow-up for side-effects.