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IAD 07-162 – HSR Study

IAD 07-162
Outlook: An Intervention to Improve Quality of Life in Serious Illness
Karen E Steinhauser, PhD
Durham VA Medical Center, Durham, NC
Durham, NC
Funding Period: November 2008 - May 2009
The goal of palliative care is to reduce suffering and enhance quality of life. Quality of life at the end of life is a multifactorial construct encompassing physical symptoms as well as spiritual and psychosocial issues such as preparation and completion at life's end. The human development literature identifies these as key tasks at end of life. Efforts to improve care of dying persons often focus on pain and symptom control, but few, if any, effective interventions exist addressing preparation and completion. We designed the Outlook intervention, based on the human development literature and the robust evidence in health communication and clinical psychology that addresses the value of expressing emotions and stress on health outcomes. Original pilot data, collected from hospice patients, showed differential attrition by arm. Reviewers requested additional pilot data among non-hospice patients demonstrating comparable participation.

1) Conduct a three-arm feasibility study of the modified Outlook study design; 2) enroll 12 patients per arm with life-limiting illness, not yet hospice eligible; 3) use a total study participation fixed time frame of 8 weeks, for enrollment and baseline measure to the last post measure for all three study arms, 4) demonstrate equal retention among study arms, 5) generate appropriate effect sizes for sample size evaluation for a full intervention test.

A pilot randomized control trial to evaluate the intervention. 36 veterans with life limiting illness including cancer, CHF, or COPD will be randomly assigned into one of three intervention groups and complete a brief battery of pre-test measures. Subjects in the first group ("treatment") met with a facilitator three times for a period of forty-five minutes each. In the first session, subjects were asked to discuss issues related to life review. A week later, participants spoke in more depth about issues such as regret, forgiveness and things left undone. In the final session, a week hence, subjects focused on heritage and legacy. The subjects in the second group ("attention control") met with a facilitator three times for a period of forty-five minutes each and listened to a non-guided relaxation CD. The third group of participants ("true control") was exposed to no intervention or attention control. One week and two weeks later, participants in all groups received post-test measures administered by a blinded interviewer.

Outcomes were measured using the QUAL-E measure of quality of life at the end of life, the Rosow-Breslau ADL Scale, the Profile of Mood States, anxiety sub-scale, the CESD short version.

36 patients enrolled in the study (12 per arm) and 34 patients completed all data points. The majority were male (97%); 39% were African American, and 47% Caucasian; 50% had a high school education or less, 31% some college and 19% with graduate degrees; 56% were married or living with a partner. Average age was 67. 28% of the sample had congestive heart failure (CHF), 39% chronic obstructive pulmonary disease (COPD), 25% cancer, and 8% other (HIV or end stage renal disease). Relative to attention control and true control, intervention participants showed improved trends in anxiety, depression, completion and preparation. Model estimated effect sizes were generated. Sample sizes from the proposed IIR are sufficient and confirmed with these pilot data.

All study objectives were met. The pilot demonstrated feasibility in recruitment, enrollment, and completion. The study was acceptable to patients with a broad range of demographic characteristics. Additionally, improvement trends in key outcomes suggest a full trial is warranted.

This pilot study examined the feasibility of an end-of-life preparation and completion intervention conducted among non-hospice eligible patients with life-limiting illness. Trends in anxiety, depression, functional status, and quality of life were examined. The intervention (Outlook) offers a brief and transportable, non-physician treatment method for improving the experience of veterans at the end of life.

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Journal Articles

  1. Sautter JM, Tulsky JA, Johnson KS, Olsen MK, Burton-Chase AM, Lindquist JH, Zimmerman S, Steinhauser KE. Caregiver experience during advanced chronic illness and last year of life. Journal of the American Geriatrics Society. 2014 Jun 1; 62(6):1082-90. [view]
  2. Olsen MK, Stechuchak KM, Steinhauser KE. Comparing internal and external validation in the discovery of qualitative treatment-subgroup effects using two small clinical trials. Contemporary clinical trials communications. 2019 Sep 1; 15:100372. [view]

DRA: Aging, Older Veterans' Health and Care, Health Systems
DRE: Treatment - Observational
Keywords: End-of-life, Quality of life
MeSH Terms: none

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