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Keywords:

  • ethics;
  • informed consent;
  • dementia research

OBJECTIVES: To evaluate a research advance directive for persons with established dementia diagnoses and their family caregivers or proxies.

DESIGN: Prospective randomized, controlled trial.

SETTING: Three clinics, one each in Ohio, Kentucky, and Illinois.

PARTICIPANTS: At the end of separate interviews about enrollment choices in five types of hypothetical research projects, 149 persons with established dementia diagnoses and their family proxies were randomized to jointly complete the Planning Ahead Together (PAT) document, a research advance directive (n=69) or to remain in the control group (n=80).

INTERVENTION: The directive was assessed at two points: immediately after sample members received naturally occurring invitations to participate in other studies and again 2 years after initial enrollment.

MEASUREMENTS: Personal enrollment rates, reported ease of enrollment decision for patients and proxies, and proxy comfort were compared between the experimental and control groups.

RESULTS: Forty-one dyads were reinterviewed immediately after consent discussions for other trials. Forty-seven patients and 106 proxies were interviewed at 2-year follow-up. There was no evidence immediately after a trial enrollment opportunity or in the follow-up interview that the research advance directive (PAT) assisted patients or proxies. Enrollment rates, decision ease, and proxy comfort and certainty were similar in the PAT and control groups.

CONCLUSION: Patient and proxy experience making hypothetical decisions in the interview may have affected enrollment decisions by the PAT and control groups. Although the low number of recruitment attempts and the natural attrition of the geriatric population limit conclusions about effectiveness that may be drawn from this unique data set, the feasibility of a research advance directive is clearly demonstrated.