- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01160367
Trial of Ascertaining Individual Preferences for Loved One's Role in End-of-Life
Specific Aims and Hypotheses:
Aim 1: To test the effect of the "Trial of Ascertaining Individual preferences for Loved Ones' Role in End-of-life Decisions" (TAILORED) Intervention on family decision-making self-efficacy at 8 weeks both with respect to the patient's present situation and in a hypothetical situation in which the patient lacks decision-making capacity.
Hypotheses 1a: Family decision-making self-efficacy will be greater at 8 weeks in pairs that have undergone the TAILORED Intervention than in pairs receiving the standard information on advance directives in the patient's present situation.
Hypotheses 1b: Family decision-making self-efficacy will be greater at 8 weeks in pairs that have undergone the TAILORED Intervention than in pairs receiving the standard information on advance directives in the hypothetical situation in which the patient lacks decision making capacity.
Aim 2: To test the effect of the TAILORED Intervention on family psychological outcomes (depression, caregiver burden, decision making distress).
Hypotheses 2a: Depression will be less at 8 weeks in family members who have undergone the TAILORED Intervention than in family members who have received the standard information on advance directives.
Hypotheses 2b: Caregiver burden will be less at 8 weeks in family members who have undergone the TAILORED Intervention than in family members who have received the standard information on advance directives.
Hypotheses 2c: Decision-making distress will be less at 8 weeks in family members who have undergone the TAILORED Intervention than in family members who have received the standard information on advance directives.
Aim 3: To test the effect of the TAILORED Intervention on patient and family satisfaction with family decision-making involvement.
Hypothesis 3a: Patient satisfaction with family decision involvement will be greater at 8 weeks in patients who have undergone the TAILORED Intervention than in patients receiving the standard information on advance directives.
Hypothesis 3b: Family member satisfaction with decision involvement will be greater at 8 weeks in family members who have undergone the TAILORED Intervention than in family members receiving the standard information on advance directives.
Aim 4: To explore family decision-making self-efficacy and perceptions of the TAILORED Intervention.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Maryland
-
Baltimore, Maryland, Förenta staterna, 21205
- Johns Hopkins University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
Patient Inclusion Criteria
- Age 18 or older
- Speaks and reads English
- Diagnosed by a specialist at either Johns Hopkins Medical Institutions or University of Chicago Medical Center as having ALS or stage III or IV GI or pancreatic cancer.
- Accompanied to clinic by a family member who may participate in the patient's health care decisions and who patient gives permission to approach for participation in study.
- Lives within a 2-hour drive of The Johns Hopkins Medical Institutions or The University of Chicago Medical Center
5.G.2. Family Inclusion Criteria
- Age 18 or older
- Speaks and reads English
- Identified by the patient-subject as a family member whom the patient may involve in health care decision making in the present and/or should the patient become too ill to make health care decisions.
- Person who the patient-subject has granted investigators permission to approach for participation in this study.
Exclusion Criteria:
Patient Exclusion Criteria
- Severe visual impairment that would limit ability to visualize instrument illustrations
- Cognitive impairment indicated by a Short Portable Mental Status Questionnaire adjusted error score of >5
- Has no family member who might assist in decision making or family member declines to participate.
- Is not accompanied to the clinic by family member.
- G.4. Family Exclusion Criteria
- Declines to participate.
- Severe visual impairment that would limit ability to visualize instrument illustrations.
- Cognitive impairment indicated by a Short Portable Mental Status Questionnaire adjusted error score of >5
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: standard of care health decision making
Patient-family dyads will receive the standard of care for support of patient and family members health care decision making during a clinic appointment.
|
Patient-family dyads will receive standard of care in health decision-making
|
Experimentell: TAILORED intervention
Patients and family members who receive the TAILORED Decision Making Intervention
|
Patient-family dyads will receive TAILORED intervention on health decision making
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
family decision-making self-efficacy
Tidsram: at 8 weeks after the intervention
|
at 8 weeks after the intervention
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
family psychological outcomes (depression, caregiver burden, decision making distress)
Tidsram: 8 weeks after the intervention
|
8 weeks after the intervention
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NA_00010044
- 5R01NR010733-02 (U.S.S. NIH-anslag/kontrakt)
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