Phillips 1999.
Methods | DETAILS OF STUDY AIM OF INTERVENTION: telehealth interventions offer a potentially promising way to improve care and continue patient education once patients have returned to the community/ AIM OF STUDY: to determine which of 3 approaches to care produces the lowest incidence or pressure ulcers, promotes the most effective care of sores that develop and leads to the fewest hospitalizations in newly injured patients with spinal cord injury after discharge. STUDY DESIGN: CCT. METHODS OF RECRUITMENT OF PARTICIPANTS: During a 6 month period, patients with newly injured spinal cords were recruited. Patients for the video group were first recruited; those qualifying were informed about the study and asked to volunteer; following recruitment of the video group, matched controls (age, race, severity of injury) were recruited for the telephone group and the standard care group. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: scheduled for discharge to the community/ have telephone at home and for the video group living in Georgia. EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: not specified. INFORMED CONSENT OBTAINED? yes ETHICAL APPROVAL? unclear. FUNDING: unclear. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT: inadequate. EPOC‐ QUALITY CRITERIA 2002: C.high risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE:not done. METHOD OF CONCEALMENT OF ALLOCATION: not specified. BLINDING: ·PARTICIPANTS: no. ·PROVIDER/S: no. ·OUTCOME ASSESSORS: not clear. INTENTION TO TREAT ANALYSIS: not stated. BASELINE COMPARABILITY OF INTERVENTION AND CONTROL GROUPS: yes. STATISTICAL METHODS AND THEIR APPROPRIATENESS: kruskall‐wallis test/ chi‐square. CONSUMER INVOLVEMENT: not stated. |
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Participants | DESCRIPTION: neurological patients. GEOGRAPHIC LOCATION: USA. SETTING: discharged home from an acute care setting. NUMBER OF PARTICIPANTS: ELIGIBLE: 37. RANDOMISED TO INTERVENTION: 14. RANDOMISED TO CONTROL: 12 ‐ 11. INCLUDED IN ANALYSIS INTERVENTION GROUP: 13. INCLUDED IN ANALYSIS CONTROL GROUP: 12 ‐ 10. AGE: RANGE OR MEAN (SD): 33 (12). GENDER (% MALE): 74. ETHNICITY: 31% African American. PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: new spinal cord injury. OTHER HEALTH PROBLEM/S: unclear. TREATMENT RECEIVED/RECEIVING: unclear. OTHER SOCIAL/DEMOGRAPHIC DETAILS: 46% married; 91% employed; 48% post high school education; slight differences in video group. |
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Interventions | DETAILS OF INTERVENTION: both the video and the telephone group received weekly interventions for 10‐12 weeks. The telephone group participated in telephone only counseling sessions for approximately 10 weeks after discharge. During the telephone sessions patients were guided through skin check‐ups and were also assisted in problem solving related to bowel, diet or any matter of concern. DETAILS OF CONTROL: The videogroup received weekly interventions for approximately. 10‐12 weeks. In the video group, patients participated in weekly counseling sessions using the video‐unit for the first 6‐8 weeks following discharge; through the images generated the nurse was able to check visually the condition of the patients skin and to monitor him for ulcers; through visual contact the nurse could also help resolve problems related to wheelchairs, mattresses and mobility about the house. Following the video‐sessions, patients then received weekly telephone counseling for approximately. 4‐6 weeks. The standard care group was given instruction on using the centers' help line; this line provides information and counseling free of charge to patients who call the center on their own initiative. CO‐INTERVENTION? no. DETAILS OF CO‐INTERVENTIONS: DELIVERY OF INTERVENTION Frequency: 12. First time at day 7 after discharge. Period: 12 weeks. PROVIDERS: nurse. INTERVENTION QUALITY: unclear. FIDELITY/INTEGRITY: unclear. |
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Outcomes | NUMBER OF OUTCOMES: 2 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, ..): Tracking/diagnosing pressure ulcer / self‐developed / no / unclear / every 8‐12 weeks but only reported for a 1 year period (therefore not included in the analysis for this review). C.Other consumer oriented outcomes (eg. treatment adherence, knowledge, adverse events, ..): D. Health service delivery oriented outcomes (eg. hospital readmission, health services utilization, ..): Readmission / unclear / unclear / unclear / at 1 year (not included therefore in review data‐analysis) |
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Notes | ·CHANGES IN TRIAL PROTOCOL ·CONTACT WITH AUTHOR ·POWER CALCULATION? yes. ·RECORD IF THE STUDY WAS TRANSLATED FROM A LANGUAGE OTHER THAN ENGLISH. ·RECORD IF THE STUDY WAS A DUPLICATE PUBLICATION. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | High risk | C ‐ Inadequate |