Evaluating a complex intervention with a single outcome may not be a good idea: an example from a randomised trial of stroke case management.
OBJECTIVE
to estimate the extent to which a case-management intervention for persons newly discharged into the community following an acute stroke effected a change in stroke outcome in comparison with usual care.


METHODS
a re-analysis of stratified, balanced, randomised clinical trial.


METHODS
five university-affiliated acute-care hospitals in Montreal, Quebec, Canada.


METHODS
a total of 190 persons (mean age 70 years) returning home directly from the acute-care hospital following a first or recurrent stroke with a need for health-care supervision post-discharge because of low function, co-morbidity or isolation.


METHODS
for 6 weeks following discharge a nurse case manager delivered, depending on need, over 50 different nursing interventions (range 2-15 per person), which targeted physical, emotional and psychological impairments, role participation restrictions and health perception.


METHODS
seven of the SF-36 subscales were used to measure the targeted constructs, at the post-intervention and 6 month evaluations. Seven binary response variables were created with a change of 10 points the criterion for individual response. Generalised estimating equations, equivalent to a logistic regression for multiple outcomes, were used.


RESULTS
the odds of responding to one or more outcomes was 41% greater in the intervention group than in the control group [odds ratio (OR): 1.41; 95% confidence interval (CI): 1.11-1.79].


CONCLUSIONS
an analysis considering the complexity of the intervention and outcomes targeted indicated effectiveness of the nurse case-management post-stroke, whereas the traditional one outcome analysis did not.
Division of Clinical Epidemiology, McGill University Hospital Center, Montreal, Quebec, Canada. nancy.mayo@mcgill.ca
Nancy E
NE
Mayo
Susan
S
Scott
D000368:Aged; D000369:Aged, 80 and over; D002170:Canada; D019090:Case Management / Q000592:standards*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000592:standards*; D011788:Quality of Life; D020521:Stroke / Q000628:therapy; D000071939:Stroke Rehabilitation; D016896:Treatment Outcome