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2009

Supplemental Digital Content Item 3: Table of Evidence 2009 Studies

2009

Randomized Controlled Trials (N=51)

Citation

Study Aim

Population / Setting

Study Design

Methods

Outcome Measures

1=care processes

2=patient experience

3=patient health indices

4=quality of life

5=cost

1. Bakas T, Farran CJ, Austin JK, et al. Stroke caregiver outcomes from the Telephone Assessment and Skill-Building Kit (TASK). Top. 2009;16(2):105-121.1

To explore the efficacy of The Telephone Assessment and Skill-Building Kit (TASK) in improving stroke caregiver outcomes and addressing stroke caregiver needs.

The sample was comprised of caregivers (N=293) who were recruited from a local rehabilitation hospital and three local acute care hospitals. The final analysis included 40 caregivers.

Quantitative

Longitudinal

Subjects were randomized into the TASK intervention or the attention control group. The TASK intervention was designed to reduce caregiver task difficulty by addressing caregivers' needs in four areas and to increase caregiver optimism and reduce threat appraisal. Six outcomes were measured at baseline, 4 weeks, 8 weeks, and 12 weeks. Caregiver and stroke survivor characteristics were also measured at baseline. Caregivers in the TASK intervention group received eight weekly calls by a nurse who facilitated caregivers weekly assessment of skill needs using the CNCC, followed by individualized interventions that addressed priority skill needs identified by the caregiver. The final TASK notebook contained 38 written tip sheets, a stress management workbook, and a brochure on family caregiving from the American Stroke Association (ASA). After baseline, the notebook was mailed to caregivers randomized to the TASK intervention. The individualized interventions based on each caregivers priority skill needs enabled the caregivers to build their skills in the areas most pertinent to them during the early discharge period.

2, 3, 4

Results

Conclusion

The TASK intervention exhibited evidence of efficacy in increasing caregiver optimism and in reducing task difficulty and threat appraisal. TASK effects on outcomes of depressive symptoms, life changes, and general health perceptions were not significant.

In this small pilot study, the TASK program showed improvements in caregiver optimism, task difficulty, and threat appraisal consistent with the conceptual model derived from Lazaruss theory. Delivered completely by telephone, the TASK program offers an inexpensive way to provide stroke caregivers with information about stroke, assistance with stroke-related care, and follow-up after discharge. However, the authors suggest that the TASK program be revised and retested in a larger and ethnically diverse randomized controlled clinical trial using separate nurse interveners.

2009

Randomized Controlled Trials (N=51)

Citation

Study Aim

Population/ Setting

Study Design

Methods

Outcome Measures

1=care processes

2=patient experience

3=patient health indices

4=quality of life

5=cost

2. Bakitas M, Lyons KD, Hegel MT, et al. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: The Project ENABLE II randomized controlled trial. JAMA: Journal of the American Medical Association. 2009;302(7):741-749.2

To determine the effect of a nursing-led intervention on quality of life, symptom intensity, mood, and resource use in patients with advanced cancer.

The sample was comprised of patients (N=279) from a National Cancer Institutedesignated comprehensive cancer center in New Hampshire and affiliated outreach clinics and a VA medical center in Vermont.

Quantitative

Longitudinal

Subjects were randomized into 2 groups. Those in the usual care for persons newly diagnosed with advanced cancer were compared to those within a palliative care intervention group. The intervention used a case management, educational approach to encourage patient activation, self-management, and empowerment. The team refined and converted the in-person and group strategies used in prior studies and demonstration project to a manualized, telephone-based format to improve access to palliative care in a rural population. One of 2 advanced practice nurses with palliative care specialty training conducted 4 initial structured educational and problem-solving sessions and at least monthly telephone follow-up sessions until the participant died or the study ended. Advanced practice nurses caseloads were balanced by diagnosis and sex. Participants completed baseline questionnaires upon enrollment. Follow-up questionnaires were mailed 1 month after baseline and every 3 months until the participant died or study completion.

2, 3

Results

Conclusion

The intervention group had improved quality of life without symptom improvement. The estimated treatment effects for all participants were a mean (SE) of 4.6 (2) for quality of life (p=0.02), 27.8 (15) for symptom intensity (p=0.06), and 1.8 (0.81) for depressed mood (p=0.02). The estimated treatment effects in participants who died during the study were a mean (SE) of 8.6 (3.6) for quality of life (p=0.02), 24.2 (20.5) for symptom intensity (p=0.24), and 2.7 (1.2) for depressed mood (p=0.03). Intensity of service did not differ between the 2 groups.

This study shows that integration of a nurse-led palliative care intervention concurrent with anticancer treatments demonstrated higher quality of life, lower depressed mood, but limited effect on symptom intensity scores and use of resources in intervention participants relative to those receiving usual cancer care. The intervention had no effect on the number of days in the hospital and ICU, the number of emergency department visits, or anticancer treatment because the proportions of participants in each group receiving these therapies were similar.

2009

Randomized Controlled Trials (N=51)

Citation

Study Aim

Population/ Setting

Study Design

Methods

Outcome Measures

1=care processes

2=patient experience

3=patient health indices

4=quality of life

5=cost

3. Bauer MS, Biswas K, Kilbourne AM. Enhancing multiyear guideline concordance for bipolar disorder through collaborative care. Am J Psychiatry. 2009;166(11):1244-1250.3

To investigate the hypothesis that treatment with a collaborative care model improved multiyear concordance with guideline recommendations for anti-manic treatment.

The sample was comprised of patients (N=306) in 11 VA hospitals who were hospitalized for bipolar disorder.

Quantitative

Longitudinal

Participants were randomly assigned at hospital discharge to receive 3 years of treatment in the collaborative care model or continued usual care. Concordance with guideline-recommended anti-manic pharmacotherapy was assessed at baseline and prospectively over six 6-month epochs. Group differences were assessed with generalized estimating equations that controlled for relevant covariates. The collaborative care model consisted of three manual-based components, which correspond to the core elements of chronic care models for medical illnesses.

Treatment of bipolar disorder was transferred to collaborative care clinics staffed by a part-time psychiatrist and a half-time nurse, with a nurse-to-patient ratio of approximately 1:50. All other mental and medical health care was provided as clinically indicated. Usual care reflected the situation that is encountered in many clinical settings in a variety of health care systems.

3

Results

Conclusion

A primary analysis revealed that anti-manic treatment guideline concordance was significantly higher in the collaborative care arm compared to the usual-care arm (odds ratio=1.74, 95% CI=1.052.88, p=0.047) after controlling for covariates. A secondary analysis among a subgroup of participants who received any anti-manic medication demonstrated concordance rates (e.g., therapeutic lithium level among those receiving lithium, therapeutic risperidone dosage among those receiving risperidone) were still significantly higher in the collaborative care group (odds ratio=1.83, 95% CI=1.103.05, p=0.033) and were substantially higher in both treatment arms in this subgroup than in the overall sample.

The findings of this study indicate that multicomponent collaborative care models, which include not only provider support for guideline implementation but also patient self-management skill enhancement and facilitated treatment access and continuity, can improve guideline concordance over the long term, even in severely impaired patients. Furthermore, this study provides the first prospectively collected data of more than 1 years duration on clinical practice guideline concordance in the treatment of bipolar disorder. Additionally, it provides the first prospective bipolar clinical trials data comparing guideline concordance in an intervention group and a comparison group. Treatment in the multicomponent collaborative care model significantly improved and sustained long-term guideline concordance rates compared to usual care. These benefits were demonstrated despite enrolling a severely ill population with high rates of medical comorbidity, psychiatric comorbidity, suicidality, and psychosis. The lack of effect of age and bipolar type indicates that these benefits are relatively broad-based.

2009

Randomized Controlled Trials (N=51)

Citation

Study Aim

Population/ Setting