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NCT02917603

Shared Decision Making to Improve Palliative Care in the Nursing Home

Completed NA Results posted Last updated 20 January 2021
What this trial tests

NA trial testing Web Conferencing in Pain in 40 participants. Completed in 31 March 2018.

Timeline
1 September 2016
Primary endpoint
31 March 2018
31 March 2018

Quick facts

Lead sponsorWashington University School of Medicine
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment40
Start date1 September 2016
Primary completion31 March 2018
Estimated completion31 March 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

65 and older, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Difference in Mean Patient Health Questionaire 9 Score From Baseline Primary · 30 days

9 questions that indicate depression- taken at 30 days-Scale is 0-27 with higher values representing more depression. Measure collected every 30 days. Analysis is a comparison of means between the last measure taken and the baseline scores- with an overall average then computed.

GroupValue95% CI
Intervention.74± 1.19
Control3.38± 3.5
Zarit Burden Interview Secondary · 30 days

Family members will report which of their responsibilities are perceived as burdensome. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. Total score computed with an average score response.

GroupValue95% CI
Intervention3.16± 2.63
Control4.25± 4.93
Generalized Anxiety- 7 Secondary · 30 days

7 questions that measure family member anxiety. It has 7 items and is scored 0-21 with a higher number representing greater anxiety. A total score is computed.

GroupValue95% CI
Intervention.63± .96
Control2.06± 2.72
Caregiver Quality of Life Secondary · 30 days

4 questions pertaining to family quality of life. There are 4 items each scored 0-9 with a total score of 0 to 36 and higher scores representing poorer quality of life.

GroupValue95% CI
Intervention33.79± 4.21
Control32.06± 7.89

Sponsor's own description

Twenty-eight percent of Americans over the age of 65 die in a nursing home. Research has found the quality of care of end-of-life care in nursing homes to have many challenges. It has also been documented that family members, especially those living at a distance, want to be involved in the care of their resident and family support can be beneficial to residents. Family members' involvement in decision-making in the nursing home setting improves outcomes for residents with life-limiting illnesses. Shared decision-making (SDM) is a process wherein a healthcare choice is jointly made by a healthcare provider and a resident or resident's proxy, often a family member. This proposal seeks to facilitate SDM among family members, residents with life-limiting illnesses (who are not enrolled in hospice), and the nursing home care team. The overall research question (RQ) asks: To what extent are outcomes for family member and residents with life limiting illnesses associated with SDM via web-conferencing in the nursing home? The overall hypothesis (H) is that SDM among family members, residents (when possible), and skilled nursing home staff via web-conferencing will improve outcomes for family members and residents with life-limiting illnesses. This is an exploratory mixed methods randomized clinical trial pilot to test the effect of shared decision making using web-based conferencing on the depression and burden of family members and the pain of nursing home residents.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Interventions for increasing the use of shared decision making by healthcare professionals.
    Légaré F, Adekpedjou R, Stacey D, Turcotte S, et al · · 2018 · cited 365× · PMID 30025154 · DOI 10.1002/14651858.cd006732.pub4
  2. Interventions for interpersonal communication about end of life care between health practitioners and affected people.
    Ryan RE, Connolly M, Bradford NK, Henderson S, et al · · 2022 · cited 33× · PMID 35802350 · DOI 10.1002/14651858.cd013116.pub2
  3. A Pilot Study of An Intervention to Increase Family Member Involvement in Nursing Home Care Plan Meetings.
    Oliver DP, Rolbiecki AJ, Washington K, Kruse RL, et al · · 2021 · cited 2× · PMID 32787506 · DOI 10.1177/0733464820946927

Verify or expand the search:

Other recruiting trials for Pain

Currently open trials in the same condition.

Other Washington University School of Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02917603.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing