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Randomized Controlled Trial
. 2016 Aug 11;14(1):116.
doi: 10.1186/s12916-016-0663-x.

Improving comfort in people with dementia and pneumonia: a cluster randomized trial

Tessa van der Maaden  1   2 , Henrica C W de Vet  3   4 , Wilco P Achterberg  5 , Froukje Boersma  6 , Jos M G A Schols  7 , David R Mehr  8 , Francisca Galindo-Garre  3   4 , Cees M P M Hertogh  3   9 , Raymond T C M Koopmans  10   11   12 , Jenny T van der Steen  13   14   15
Affiliations
Randomized Controlled Trial

Improving comfort in people with dementia and pneumonia: a cluster randomized trial

Tessa van der Maaden et al. BMC Med. .

Abstract

Background: Pneumonia in people with dementia has been associated with severe discomfort. We sought to assess the effectiveness of a practice guideline for optimal symptom relief for nursing home residents with dementia and pneumonia.

Methods: A single-blind, multicenter, cluster randomized controlled trial was conducted in 32 Dutch nursing homes. Outcomes were assessed on the patient level. The main outcome measures were discomfort and symptoms: discomfort (DS-DAT: Discomfort Scale-Dementia of Alzheimer Type), (lack of) comfort (EOLD-CAD: End Of Life in Dementia-Comfort Assessment in Dying), pain (PAINAD: Pain Assessment in Advanced Dementia), and respiratory distress (RDOS: Respiratory Distress Observation Scale). Outcomes were scheduled daily from diagnosis until 10 days later and a final time between 13-15 days from diagnosis by trained observers who were blinded to the intervention and the residents' condition and treatment. In a pre-intervention phase, usual care was provided to all homes. In the intervention phase, matched clusters of homes were randomized to either the control (n = 16) or intervention condition (n = 16).

Results: Between 1 January 2012 and 1 May 2015, 464 episodes of pneumonia were included. Outcomes were obtained for 399 episodes in 367 residents. Longitudinal multilevel linear regression analyses were performed on log-transformed outcomes, so coefficients should be interpreted as a ratio, and a coefficient of 1 means no difference. The practice guideline in the intervention phase did not reduce the level of discomfort and symptoms: DS-DAT: 1.11 (95 % CI 0.93-1.31), EOLD-CAD: 1.01 (95 % CI 0.98-1.05), PAINAD: 1.04 (95 % CI 0.93-1.15), RDOS: 1.11 (95 % CI 0.90-1.24). However, in both the intervention and control groups, lack of comfort and respiratory distress gradually decreased during the entire 3.5 years of data collection, and were lower in the intervention phase compared to the pre-intervention phase: DS-DAT: 0.93 (95 % CI 0.85-1.01), EOLD-CAD: 0.98 (95 % CI 0.97-1.00), PAINAD: 0.96 (95 % CI 0.91-1.01), RDOS: 0.92 (95 % CI 0.87-0.98).

Conclusions: When compared to usual care, the practice guideline for optimal symptom relief did not relieve discomfort and symptoms in nursing home residents with dementia and pneumonia. However, discomfort and symptoms decreased gradually throughout the data collection in both the intervention homes and the control homes. An intervention that focuses on creating awareness may be more effective than a physician practice guideline.

Trial registration: The Netherlands National Trial Register (ID number NTR5071 . Registered 10 March 2015).

Keywords: Dementia; Discomfort; Nursing homes; Pneumonia; Practice guideline; Trial.

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Figures

Fig. 1
Fig. 1
Timeline of data collection. Q1 questionnaire 1, Q2 questionnaire 2, Q3 questionnaire 3, X day of death. Observers were scheduled to assess outcomes on day 0 and day 1 (2 times a day), daily for days 2–10 and once on day 13, 14, or 15. Attending physicians included residents at the time of diagnosis of pneumonia, completed Q1 within 2 days from diagnosis, Q2 between 7 days and 21 days from diagnosis, and Q3 when a resident died during the data collection within 14 days from (registration of) death. Data analyzed for the purpose of this article only consider observational data, inclusion of Q1 and Q2, and survival
Fig. 2
Fig. 2
Trial profile
Fig. 3
Fig. 3
Mean discomfort (Discomfort Scale-Dementia of Alzheimer Type, DS-DAT range 0–27) per observation day in control homes (a) and intervention homes (b); pre-intervention phase compared to intervention phase. Range among groups (pre-intervention phase, intervention phase, intervention homes, control homes) in the number of observations per day from pneumonia diagnosis: Day 0 (first observation): 28–43; day 0 (second observation): 14–28; day 1 (first observation): 54–86; day 1 (second observation): 40–66; day 2: 55–94; day 3: 54–90; day 4: 52–79; day 5: 50–80; day 6: 50–84; day 7: 53–87; day 8: 49–79; day 9: 53–72; day 10: 12–24; day 13: 25–56; day 14: 12–21
Fig. 4
Fig. 4
Mean DS-DAT score (a) and mean PAINAD score (b) (95 % confidence interval) on observation day 2 by year of data collection before and after the start of the intervention phase in both control and intervention homes. Range of the number of observations per period: −2 years: 14–16, –1 year: 136–140, 1 year: 105–109, 2 years: 35–36. DS-DAT Discomfort Scale-Dementia of Alzheimer Type; range 0–27, PAINAD Pain Assessment in Advanced Dementia; range 0–10
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References

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