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. 2006 Oct 18;2006(4):CD004510. doi: 10.1002/14651858.CD004510.pub3

Jones 1988.

Methods DETAILS OF STUDY
AIM OF INTERVENTION: To enhance compliance (based on health belief model)/
AIM OF STUDY: the purpose of the study was to test the effect of clinical and telephone intervention on compliance for ED‐patients.
STUDY DESIGN: RCT.
METHODS OF RECRUITMENT OF PARTICIPANTS: consecutive patients who met the sampling criteria were randomly assigned to one of 4 groups.
INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: Patients presenting at the ED with one of following problems (chest pain, hypertension, asthma, otitis media, diabetes, urinary tract infection, headache, urethritis, vaginitis, low back pain, rash)/ signed release of information/ able to respond to HBM intervention/ did not require hospital admission/ had a referral follow‐up recommendation/ telephone at home.
EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: not specified.
INFORMED CONSENT OBTAINED? yes.
ETHICAL APPROVAL? yes.
FUNDING: yes.
ASSESSMENT OF STUDY QUALITY
ALLOCATION CONCEALMENT: unclear.
EPOC‐ QUALITY CRITERIA 2002: C.high risk of bias.
METHOD OF GENERATING RANDOMISATION SCHEDULE: 2X2X11 factorial design/ blocked randomization within each presenting problem.
METHOD OF CONCEALMENT OF ALLOCATION: not specified.
BLINDING: 
 ·PARTICIPANTS: no. 
 ·PROVIDER/S: no. 
 ·OUTCOME ASSESSOR/S: no.
INTENTION TO TREAT ANALYSIS: not stated.
BASELINE COMPARABILITY OF INTERVENTION AND CONTROL GROUPS: not stated.
STATISTICAL METHODS AND THEIR APPROPRIATENESS: chi‐square/logistic regression.
CONSUMER INVOLVEMENT: not stated.
Participants DESCRIPTION: ED patients.
GEOGRAPHIC LOCATION: USA.
SETTING: discharged home from an acute care setting.
NUMBER OF PARTICIPANTS: 
 ELIGIBLE: 842. 
 RANDOMISED TO INTERVENTION: 166. 
 RANDOMISED TO CONTROL: 264 ‐ 251 ‐ 161. 
 INCLUDED IN ANALYSIS INTERVENTION GROUP: 166. 
 INCLUDED IN ANALYSIS CONTROL GROUP: 264 ‐ 251 ‐ 161.
AGE: RANGE OR MEAN (SD): 0 to 60+
GENDER (% MALE): unclear.
ETHNICITY: unclear.
PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: mixed (largest groups: chest pain, urinary tract infection and low back pain).
OTHER HEALTH PROBLEM/S: unclear.
TREATMENT RECEIVED/RECEIVING: unclear.
OTHER SOCIAL/DEMOGRAPHIC DETAILS: 61% single.
Interventions DETAILS OF INTERVENTION: Telephone call, which was a modified and shortened application of the Health Belief Model (HBM) clinical intervention, by a nurse 1 or 2 days after the ED‐visit/
DETAILS OF CONTROL: There are 3 control groups: group 1 received usual care, group 2 received a HBM clinical intervention during their ED‐visit, and group 3 received a HBM clinical intervention during their ED‐visit and a telephone HBM follow‐up.
CO‐INTERVENTION? no.
DETAILS OF CO‐INTERVENTIONS:
DELIVERY OF INTERVENTION 
 Frequency: 1. 
 First time at day 1 after discharge. 
 Period:
PROVIDERS: nurse.
INTERVENTION QUALITY: unclear.
FIDELITY/INTEGRITY: unclear.
Outcomes NUMBER OF OUTCOMES: 1
OUTCOME / TOOL / TOOL VALIDATED / METHOD OF ASSESSMENT / TIME OF ASSESSMENT 
 A.Psycho‐social health of patients (uncertainty, anxiety, informational needs, mood, coping, quality of life, social activity, ..):
B.Physical health of patients (eg. functional status, self‐care, self‐efficacy, independence, ..):
C.Other consumer oriented outcomes (eg. treatment adherence, knowledge, adverse events, ..): Compliance / self‐developed / unclear / telephone interview to health agency where patient had referral / different across patients.
D. Health service delivery oriented outcomes (eg. hospital readmission, health services utilization, ..):
Notes ·CHANGES IN TRIAL PROTOCOL
·CONTACT WITH AUTHOR
·POWER CALCULATION?
·RECORD IF THE STUDY WAS TRANSLATED FROM A LANGUAGE OTHER THAN ENGLISH.
·RECORD IF THE STUDY WAS A DUPLICATE PUBLICATION. yes, Jones et al. published 5 manuscripts, in which they present results for several subgroups (eg. hypertension, low back pain, otitis media, urinary tract infection).
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear