Interventions to improve hemodialysis adherence - Wiley Online Library

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Abstract. Over 485,000 people in the United States have chronic kidney disease, a progressive kidney disease that may lead to hemodialysis. Hemodialysis ...
Hemodialysis International 2010; 14:370–382

Interventions to improve hemodialysis adherence: A systematic review of randomized-controlled trials Michelle L. MATTESON, Cynthia RUSSELL Sinclair School of Nursing, University of Missouri, Columbia, Missouri, USA

Abstract Over 485,000 people in the United States have chronic kidney disease, a progressive kidney disease that may lead to hemodialysis. Hemodialysis involves a complex regimen of treatment, medication, fluid, and diet management. In 2005, over 312,000 patients were undergoing hemodialysis in the United States. Dialysis nonadherence rates range from 8.5% to 86%. Dialysis therapy treatment nonadherence, including treatment, medication, fluid, and diet nonadherence, significantly increases the risk of morbidity and mortality. The purpose of this paper is to systematically review randomized-controlled trial intervention studies designed to increase treatment, medication, fluid, and diet adherence in adult hemodialysis patients. A search of Cumulative Index of Nursing and Allied Health Literature (CINAHL) (1982 to May 2008), MEDLINE (1950 to May 2008), PsycINFO (1806 to May 2008), and all Evidence-Based Medicine (EBM) Reviews (Cochran DSR, ACP Journal Club, DARE, and CCTR) was conducted to identify randomized-controlled studies that tested the efficacy of interventions to improve adherence in adult hemodialysis patients. Eight randomized-controlled trials met criteria for inclusion. Six of the 8 studies found statistically significant improvement in adherence with the intervention. Of these 6 intervention studies, all studies had a cognitive component, with 3 studies utilizing cognitive/behavioral intervention strategies. Based on this systematic review, interventions utilizing a cognitive or cognitive/behavioral component appear to show the most promise for future study. Key words: Dialysis, hemodialysis, adherence

INTRODUCTION Over 485,000 people in the United States have chronic kidney disease, a progressive disease resulting from hypertension and diabetes, which leads to a need for hemodialysis. In 2005, over 312,000 patients were undergoing hemodialysis in the United States and this number is projected to rise to over 650,000 by 2010.1,2 The 1-year survival rate for hemodialysis patients is 78.3% and decreases to 32.1% at 5 years.2 Correspondence to: M. Matteson, Division of Gastroenterology and Hepatology, University of Missouri, 101 Fairview, Columbia, MO 65203, USA. E-mail: [email protected]

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The World Health Organization defines adherence as ‘‘the extent to which a person’s behavior (taking medications, following a recommended diet, and/or executing lifestyle changes) corresponds with the agreed recommendations of a health care provider’’ (p. 13).3 According to the National Kidney Foundation Dialysis Outcome and Quality Initiative (KDOQI) guidelines, the measures for nonadherence include missed treatments, shortened treatments, interdialytic weight gain (IDWG), serum phosphorus, treatment adequacy (Kt/V), and serum albumin.4–6 Hemodialysis involves a complex regiment of treatment, medication, fluid, and diet management. McDonald et al. found that as complexity and duration of the medical treatment regimen increase, adherence decreases.7 World-wide, dialysis nonadherence rates range from 8.5% to 22.1%8

r 2010 The Authors Hemodialysis International r 2010 International Society for Hemodialysis DOI:10.1111/j.1542-4758.2010.00462.x

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and have been reported as high as 86%.9 Specifically, US treatment nonadherence in hemodialysis ranges from 7.9% to 8.5% for skipped treatments and 19.6% to 20.3% for shortened treatments (410 minutes), which is higher than Japan and Europe combined.4,8 Medication nonadherence in hemodialysis ranges from 15.4% to 50.2%,4,9 while fluid nonadherence in hemodialysis ranges from 9.7% to 49.5%.4,8,9 Diet nonadherence in hemodialysis patients ranges from 9% to 22.1%.4,8,9 Nonadherence to dialysis therapy can result in poor outcomes such as bone demineralization, pulmonary edema, and metabolic disturbance, leading to cardiovascular damage, which can result in death.2,9 The Dialysis Outcomes and Practice Patterns Study (DOPPS) revealed that nonadherence to dialysis treatments, including treatment, medication fluid, and diet nonadherence significantly increases the risk of hospitalization and mortality.4,8 Predictors of hemodialysis nonadherence have been studied at length. Russell et al.10 performed a literature review finding that patient demographic predictors do not consistently correlate with nonadherence. The authors examined the demographic predictors of age, gender, employment status, smoking history, time on dialysis, and ethnicity. Young age and smoking were the only factors that consistently predicted nonadherence.10 No report has systematically reviewed the hemodialysis intervention literature to glean direction for clinical practice and research. The purpose of this paper is to review the randomized-control trial (RCT) intervention studies designed to increase treatment, medication, fluid, and diet adherence in the adult hemodialysis population. By identifying the strengths and limitations of the current hemodialysis intervention literature, hemodialysis adherence interventions in clinical practice could be strengthened. By improving the quality of future research, clinical outcomes may be enhanced further decreasing the risk of complications, costs, and overall morbidity and mortality for adult hemodialysis patients.

METHOD A search of Cumulative Index of Nursing and Allied Health Literature (CINAHL) (1982 to May 2008), MEDLINE (1950 to May 2008), PsycINFO (1806 to May 2008), and all Evidence-Based Medicine (EBM) Reviews (Cochran DSR, ACP Journal Club, DARE, and CCTR) was conducted to identify studies that tested the efficacy of interventions to improve adherence to fluid, diet, medications, and treatments in adult hemodialysis patients. Combinations of the terms ‘‘dialysis,’’ ‘‘hemodialysis,’’ ‘‘haemodialysis,’’ ‘‘kidney failure,’’ ‘‘kidney,’’ ‘‘artificial,’’ ‘‘intervention,’’

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Table 1 KDOQI guidelines—nonadherence measures Missed treatment

Attendance at less than the prescribed number of weekly dialysis treatments Shortened Shortening a single prescribed dialysis treatments treatment by 10 min or more Interdialytic weight o1.0 kg/day gain Serum phosphorous o3.5 or 45.5 mg/dL Kt/V o1.2 Serum albumin o4.0 g/dL

‘‘complian,’’ ‘‘noncomplian,’’ ‘‘non-complian,’’ ‘‘adheren,’’ ‘‘nonadheren,’’ ‘‘non-adheren,’’ ‘‘concordance,’’ ‘‘non-concordance,’’ ‘‘medication,’’ ‘‘drugs,’’ and ‘‘diet or ‘‘fluid’’ or ‘‘nutrition’’ or ‘‘phosphate’’ or ‘‘drinking’’ were used. Study inclusion criteria were RCT design testing an intervention aimed at enhancing adherence to fluid, diet, medications, and treatment in adult hemodialysis patients. Using peer-reviewed articles, data extraction was performed by 2 reviewers. Data extraction included author and year, sample/setting, study design, intervention description (dose, duration), theory, measures, results, strengths, and weaknesses and is noted in Table 1.

Measures The well-established KDOQI guidelines were used to operationally define outcomes, allowing for enhanced comparison across studies: missed treatments, shortened treatments, IDWG, serum phosphorus, Kt/V, and serum albumin.4–6 Table 1 delineates the nonadherence measures. Treatment nonadherence was defined as a combination of missed treatments, shortened treatments, and Kt/V (o1.2).4,5,8 Kt/V is a marker of treatment adequacy, and measures how much urea (waste product) is removed in dialysis, reflecting the time on dialysis (t), the patient’s body water volume (V), and the dialyzer (K).5 Therefore, patients with combined fluid nonadherence and missed/ shortened treatments result in the Kt/Vo1.2, increasing the risk of complications, morbidity, and mortality. Interdialytic weight gain is a measure of fluid and treatment adherence and is expressed as the weight change in kilograms between dialysis treatments. Diet (phosphorus) adherence is defined as phosphorus of o5.5 mg/dL and is a reflection of the dietary protein and phosphorus, as well as phosphorus-binder medication adherence.5

RESULTS Eight studies were located meeting the inclusion criteria, and are presented in Table 2. The study publication years

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Ford et al.15

Determine the effect of dietetic educational intervention on phosphorus and calcium of hemodialysis patients with hyperphosphatemia

Ashurst and Dobbie14

Sample

Intervention

N = 56 Interventionist: renal Age: x= 54.2 dietitian (22–77) years Content: educational Male: 66% intervention and 1:1 Tobacco: NR teaching session Employment: NR (approximately 40 min), Ethnicity: 48% attempted to improve Caucasians patients’ knowledge of TOD: NR phosphorus management Setting: teaching and their compliance hospital HD unit with diet and in London, UK medications. Utilized ‘‘A Patient’s Guide to Keeping Healthy: Managing your Phosphate’’ comprised of a booklet, medication record and chart, refrigerator magnet. Daily medication chart was also to be completed by the patients. Theory: None Duration: 1-time intervention Evaluate the effectiveN = 63 Interventionist: ness of diet education Age: 74% 4age Registered Dietitian on improving serum 50 years Content: 20–30 min/ phosphorus and other Male: 38% month diet education laboratory values in Employment: NR focusing on phosphorus dialysis patients with TOD: 60.3% 1 to control. Educational hyperphosphatemia 5 years tools included posters, Ethnicity: NR handouts, puzzles, and Setting: 3 outpatient individualized dialysis centers in phosphorus-tracking a southern US tool. Monthly, the state dietitian stressed the importance of all aspects of phosphorus control, prevention of renal bone disease, foods high in phosphorus, medications, and the importance of diet, dialysis, and drug therapy.

Purpose

References

Table 2 Randomized-control trial (RCT) studies: interventions in hemodialysis Strengths/limitations

Strengths: Study included only nonadherent participants Same person administered pre/ post testing Included 3 centers Limitations: Small sample size No theoretical basis Low dose of intervention (monthly for 6 months) Knowledge test created by authors; no established validity noted

Statistically significant Strengths: decrease in serum Study included phosphorus after the only nonadherent education session; results participants sustained over a period Limitations: of 3 months (Po0.02). Small sample size No statistically significant No theoretical basis change in serum calcium 1-time intervention or in calcium/phosphorus product. Improvement noted in the calcium and calcium/phosphorus products. Secondary: daily medication charts: 16/29 returned at the end of the study and 12/16 returned 3 wk after study.

Results

Knowledge test Statistically significant Phosphorus increase in knowledge Diet adherence: weights (Po0.05); decrease in and serum phosphorus, serum phosphorus calcium, calcium/ (Po0.05); decrease in phosphorus product, and the calcium/phosphorus albumin levels obtained product (Po0.01). for 6 consecutive months. Secondary: Within the PTH levels assessed intervention group, during the first and last statistically significant months of the study. Selfincrease in knowledge reported appetite levels (59.7% to 68.7%) and compliance with (Po0.005); serum prescribed phosphorus phosphorus decreased binders reassessed during from 6.8 to 5.2 monthly nutrition rounds (Po0.0001), and Timing: baseline, immediate decreased calcium/ postintervention (4 wk), phosphorus product and 10-wk (Po0.0001). postintervention

Phosphorus Calcium Calcium/phosphorus product Timing: 3 months after intervention compared with preintervention

Measures

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Sehgal et al.13

Determine the effect of N= 169 a tailored intervention Age: 55 years

Evaluate Karamanidou, psychoeducational Weinman, and Horne (2008)12 intervention aimed to improve phosphate control understanding and provide a rational for phosphate binding medications

Interventionist: registered dietitian

Theory: None Duration: 6 months N = 39 Interventionist: Age: x= 57.7 investigator-clinical Male: 52.6% psychologist Employment: 10% Content: 2-step in the intervention intervention included group, 5% in the psychoeducational control group intervention with leaflet TOD: 79.2 months and demonstration of Ethnicity: NR binders. Baseline Setting: satellite questionnaire and clinics in the UK discussion regarding phosphate management and medication; investigator discussed leaflet followed by questions. Leaflet based on an earlier performed qualitative study, which identified problems and treatments. A demonstration of the binder was performed (visually) and the patients were asked to articulate the process of binding. Questionnaire given postintervention Theory: Kanfer’s self-regulatory theory Duration: 1-time intervention

Kt/V Secondary outcomes:

Phosphorus knowledge: 12 item true/false test Medication Adherence Self-Report: phosphorus medication adherence self-report Beliefs about Medicines Questionnaire: subscales include: phosphorus binding (PB) necessity, PB coherence, understanding problems of high phosphate levels, medication outcome efficacy belief, general understanding, and risk perception Phosphorus level: (indirect measure) Timing: baseline, immediately before intervention, 1-month post, then 4-month postintervention No statistical difference in mean scores of phosphorus knowledge, medication adherence self report, or Beliefs about medicines questionnaire or demographics between groups at baseline. Statistically significant group effect: phosphorus knowledge (Po0.05 at 1 month, and Po0.01 at 4 months; no statistically significant change in Medication adherence to Binders (self-report); no statistically significant change in serum phosphorus levels Immediate effects (within intervention group): Statistical improvement in knowledge Po0.01; Medical necessity Po0.05; Treatment coherence Po0.05; Risk perception Po0.05; Understanding increased phosphorus levels Po0.05; General understanding Po0.05; Medication outcomes efficacy Po0.05. Between Groups 1 and 4 month post: Statistically significant increase in knowledge at 4 months Po0.01; understanding increased phosphorus levels at 4 months only Po0.05; medication outcome efficacy at 4 months Po0.05. Statistically significant improvement in Kt/v Strengths: Multicenter

Strengths: Theoretical basis Detailed description of intervention Limitations: Self-report of adherence Small sample size Low dose and duration of the intervention Nonvalidated phosphorus knowledge test Study did not focus on nonadherent participants

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Tsay16

Sharp et al.17

References

Purpose

Sample

Measures

Results

Strengths/limitations

IDWG Statistically significant Strengths: Timing: baseline, 1, 3, 6 difference in IDWG Theoretical basis months following training (Po0.01) between groups Power analysis Baseline body weight had a performed significant differences Limitations: (P= 0.01). Limited Between group (main group generalizability effect) Po0.006, ESRD Low dose and

IDWG weekly mean At week 4 no statistically Strengths: Secondary: significant results: IDWG Power analysis Hospital Anxiety and Short-term analysis performed Depression Scale (HADS) between treatment and Randomization SF-36 control P40.05. procedures used Health Belief Questionnaire Longitudinally (week 14): Study included Timing: baseline, 0 to statistically significant only 4-wk posttreatment decrease in mean IDWG nonadherent and week 14 f/u (Po0.001); and participants significant decrease Low rate of attrition between baseline and Limitations: follow-up IDWG Low dose and (Po0.001). duration of IDWG 100% non-adherence intervention at beginning of study, Nonblinded decreased to 80% nonSmall sample size adherence at the end of No theoretical basis the study, with 37.5% achieving IDWG o2.5 kg.

Content: optimizing changes in prescription, completion (Po0.001); Large sample size dialysis prescriptions, catheter use, and achievement of the facility Study included expedited conversion of treatment time barriers at Kt/V goal (Po0.01); only nonadherent catheters to grafts/ baseline; and changes in improvement in dialysis participants fistulas; patient education quality of life among all prescription (Po0.001). Limitations: regarding treatment time patients Secondary: Limited compliance (Kt/V) Timing: baseline and Four times more likely to generalizability due tailored to patient6 months change from catheter to to highly African specific barriers fistulas/grafts (P = 0.04) American male Theory: none sample Duration: 6 months No theoretical basis

Intervention

Interventionist: trainee clinical psychologist Content: group-based cognitive behavioral intervention using education and cognitive/ behavioral strategies to enhance effective selfmanagement of fluid consumption (Groups 3 to 8 participants and 1 h weekly for 4 wk). Intervention given in 2 intervals—immediate treatment group and the delayed treatment group Theory: none Duration: 4 wk, baseline randomization, 4-wk treatment phase, postintervention assessment, 10-wk f/u after intervention Examine the effectiveness N = 62 Interventionist: 2 of self-efficacy training Age: 57.7 years nephrology nurse on fluid intake Male: 41.9% specialists compliance Employment: 12.9% Content: 12 1-h sessions Ethnicity: 100% 3 times per week Taiwanese focusing on TOD: 40.79 months pathophysiology of endSetting: community stage renal disease,

Male: 74% Employment: NR Ethnicity: 71% African American TOD: 3.8 years Setting: communitybased hemodialysis clinics in northeast Ohio in adults receiving inadequate hemodialysis Report the effect N = 56 of cognitive behavioral Age: 56.05 mean group intervention Male: 62.1% (Glasgow University Employment: Liquid Intake Program 13.8% full time [GULP]) aimed TOD: 42.52 months to improve fluid Ethnicity: NR restriction selfSetting: 4 outpatient management in hemodialysis units nonadherent patients in West and Central Scotland

on adequacy of hemodialysis, consisting of barrier assessment, recommendations about dialysis prescriptions, and education

Table 2 (Continued).

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Tobin11

hemodialysis, medications, complications, nutrition, fluid restriction, control of thirst/urge to drink, and stress management Theory: Bandura’s self-efficacy theory Duration: 4 wk Investigate the N = 68 Interventionist: effectiveness of 2 Age: 47.89 years investigator (PhD treatments Male: 45.6% student) and dietician (hypnotherapy and Tobacco: NR Content: 4 groups of ‘‘coaching’’) in TOD: 14.22 months patient (no treatment improving medical Employment: NR group; hypnotherapy compliance in Ethnicity: 91% group; coaching by hemodialysis patients African Americans investigator; and Setting: Chicago coaching by dietician Kidney Center, received the following: free standing or Coaching: investigator satellite dialysis and dietician gave center information regarding the participant’s diet and the relationship between compliance and their health. Encouraged to keep trying to adhere to their medical regimen (education, lab reports, discussion, and encouragement) Hypnotherapy: entered hypnotic trance and given suggestions designed to help participant to relax and experience greater control over their medical regimen (performed by investigator) Theory: none Duration: 10 weekly sessions of hypnotherapy during a dialysis treatment (30–40 min in duration). Investigator blinded to adherence measures in

dialysis center in Taiwan

Kaplan–DeNour Czaczkes No statistically significant 1972 scale (o3 difference in adherence in compliant; 44 hypnotherapy group or noncompliant) based on coaching groups compliance measures BUN decreased in both of IDWG, potassium, and groups-those receiving BUN dietician coaching Rotter’s 1966 Internalizingperformed better-subjects externalizing scale maintained fluid Bendig’s 1956 Short Form— adherence in 4/10 wk and Manifest Anxiety Scale subjects retained weight Timing: BUN/potassium: gains throughout the 3 months before entire study. (calculating means and 3 Secondary: fluid adherence months after intervention; and overall compliance of IDWG 10 wk prior and the compliant subjects 10 wk during the became significantly treatments phase worse (Po0.05). Compliant group entirely female (P =0.009). Older patients more compliant (P =0.013)

patients who received the SE training have better fluid compliance.

Strengths: Study performed during summer months (more difficult to be fluid adherent) Described group assignments Study included only nonadherent participants (89% of patients noncompliant at beginning of study Limitations: Difficult to generalize due to 91% African American, very low socioeconomic status, and volunteer sample Small sample size Self-report of anxiety and locus of control Limited validity and reliability of the instruments for anxiety and locus of control No theoretical basis

duration of intervention Study did not focus on nonadherent participants

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Shaw-Stuart and Stuart18

References

Purpose

Sample

Intervention

Measures

Results

Strengths/limitations

hypnotherapy group. Coaching received 10 weekly sessions, but group divided between investigator and dietician Determine the N = 81 Interventionist: Serum phosphorus level No statistically significant Strengths: effectiveness of an Age: x= 57.9 years (implied) dietician (46.0 mg/dL considered difference in phosphorus Detailed educational patient Male: 38% Content: educational elevated) between groups, however description compliance program Tobacco: NR program used interactive Timing: 3 months a significant decrease in of intervention (A Taste For Life) on Employment: NR educational modules, preintervention, 3 months phosphorus across time Limitations: improving serum Ethnicity: 92% motivational posters, during, and 6months within groups was noted Seasonal variability phosphate levels in African Americans creative games/puzzles, postintervention (Po0.05). (performed over hemodialysis patients TOD: NR videos, and an in-center Secondary: Mean serum thanksgiving and Setting: private achievement contest. The phosphorus levels Christmas) freestanding educational, between the pretreatment Limited clinics in North informational, and period and the treatment generalizability Carolina motivational program and posttreatment periods Small sample size included a flip chart were significantly different No power analysis overview of the basics of (Po0.0001). performed bone disease, ‘‘bone Low dose and disease demonstrator,’’ duration of which dramatized intervention progression of renal No theoretical basis osteodystrophy without Study did not focus intervention, interactive on nonadherent educational modules; patients educational booklets, videos; and an in-center achievement contest. In addition, ‘‘in-house’’ educational materials depicting alternatives for high phosphorus foods were used. The experimental group was divided into 2 teams for the competitive contest ‘‘Bone Voyage,’’ movement of a team from start to finish depended on respective teams achieving goals set for the phosphorus control. At the end of the third

Table 2 (Continued).

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NR = not reported; TOD = time on dialysis; x = mean; yrs= years.

months, team with the most points won. Winning teams and most improved patients were awarded monthly and at the end of 3 months Theory: none Duration: 3 months

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ranged from 198611 to 2008,12 with 7 of the 8 studies performed since the year 2000.12–18 The sample size of the studies ranged from 3912 to 16913 adult hemodialysis patients. Employment status of the participants was noted only in 3 studies.12,16,17 Time on dialysis of the subjects ranged from 1411 to 79 months.12 Nonadherent patients were the subjects of study in 5 of the 8 RCTs.11,13–15,17 The RCT studies were performed in the United States,11,13,15,18 United Kingdom,12,14 Scotland,17 and Taiwan.16 The interventionist most often was a registered dietician,11,14,15,18 but also included a trainee clinical psychologist,17 a psychologist,12 nephrology nurse specialists,16 and a team of a hypnotherapist and a dietitian.11 One study did not identify the interventionist.13 The dose of the interventions spanned from a few minutes12,14,15 to hours11,15–17 and the duration of the intervention from 1 time12,14 to 6 months.13,15 Follow-up time ranged from 10 weeks11,15 to 6 months.13,16,18 Theory-driven interventions were tested in only 2 of the 8 RCTs. Karamanidou et al.12 used Leventhal’s self-regulation model to guide a phosphorus/medication adherence intervention to optimize ‘‘illness-related behaviours’’ (p. 206). Tsay16 applied Bandura’s self-efficacy theory to increase selfefficacy thereby increasing fluid adherence. Leventhal’s self-regulation model proposes that health behaviors are determined through a combination of past and current experiences, beliefs, and expectations, called illness representations.19 How the illness is experienced and interpreted (the person’s belief about the illness and potential duration, severity, and treatment) impacts the appraisal of the symptom experienced and thus the coping mechanism chosen in response to the symptom/ illness representation. Evaluation of the coping mechanism determines how the illness is experienced and interpreted when a future symptom/illness arises resulting in a feedback loop. Appraisal of the experience then impacts the choice of coping mechanism with future symptoms/illnesses, affecting behavior change. Bandura’s self-efficacy theory is based on the relationship between individual beliefs, attitudes, intentions, behavior, and perceived control over that behavior. Self-efficacy is the perception that one can master or perform a task adequately in a given situation. It provides guidance, exerting influence over how people choose coping mechanisms, intensity of effort expended, and the level of persistence required to lead their lives.20 Self-efficacy is enhanced by mastery experiences, vicarious experiences, verbal persuasion, and physiological states.21 With increased self-efficacy, healthy behavior changes may be enhanced. The hemodialysis adherence enhancing interventions focused in 3 areas: cognitive, cognitive/behavioral, and

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hypnotherapy/coaching interventions. The 3 cognitive interventions targeted either phosphorus management (dietary sources of phosphorus, binder adherence)12,14 or treatment time adherence.13 Each cognitive intervention was delivered differently. Ashurst and Hamish14 utilized an educational guide ‘‘A Patient’s Guide to Keeping Healthy: Managing Your Phosphate.’’ Karamanidou et al.12 utilized a 2-step intervention targeting education of phosphorus management as well as a visual demonstration of the phosphorus binder. Sehgal et al.13 combined education specific to individual barriers with treatment time adherence. Four studies utilized a combination of cognitive/ behavioral interventions to enhance hemodialysis adherence targeting diet/medication (phosphorus)15,18 or fluid adherence.16,17 Of these, 2 targeted diet/medication adherence. Ford et al.15 targeted patient education on phosphate control and diet using posters, handouts, and puzzles, while participants behaviorally tracked phosphorus on visual tracking tools. Shaw-Stuart and Stuart18 utilized ‘‘a Taste for Life,’’ which involved a combination of an educational program and a patient competition of phosphorus management called ‘‘Bone Voyage.’’ Two of the 4 cognitive/behavioral intervention studies targeted fluid adherence.16,17 Of these 2, Sharp et al.17 used a group-based cognitive/behavioral intervention, the Glasgow University Liquid Intake Program (GULP), for nonadherent patients through education, self-monitoring skills, and stress reduction exercises. Tsay16 utilized stress management techniques, self-efficacy training, and a cognitive intervention that targeted the pathophysiology of ESRD, hemodialysis, medications, complications, nutrition, fluid restriction, and control of thirst/urge to drink through performance mastery and experience sharing. Lastly, hypnotherapy and coaching were used by Tobin11 to improve adherence to fluid and dialysis treatment adherence. Hypnotherapy, as defined by Tobin was the induction of ‘‘a hypnotic trance in which suggestions were given to relax and experience greater control over the medical regimen’’ (p. 7). Coaching was a combination of education with regard to diet and the relationship between compliance and health, and encouragement to keep trying to adhere to the medical regimen. Statistically significant results in the main outcome were noted in 6 of the 8 studies and were equally divided between medication and diet adherence outcomes (operationally defined as phosphorus o3.5 or 45.5) (Table 3) and fluid and dialysis treatment outcomes (operationally defined as Kt/Vo1.2 or IDWG41.0 kg/day) (Table 4). Of these 6 intervention studies, all studies had a cognitive component, with 3 studies utilizing cognitive/

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Table 3 Diet and medication (phosphorus) adherence results References

Intervention 14

Ashurst and Hamish

Cognitive

Ford et al.15

Cognitivebehavioral

Karamanidou et al.12

Cognitive

Shaw-Stewart and Stuart18

Cognitivebehavioral

1= statistically significant;

Results Phosphorus1 Calcium Ratio Phosphorus1 Knowledge1 Ratio1 Phosphorus1 Knowledge1 Self-report medication Adherence Phosphorus

= not statistically significant.

behavioral interventions to increase diet/medication (phosphorus) or fluid adherence.15–17

DISCUSSION The purpose of this paper was to systematically review RCT intervention studies designed to increase treatment, medication, fluid, and diet adherence in adult hemodialysis patients. Six of 8 RCTs (75%) resulted in statistically significant improvement in adherence outcomes with the intervention, which is remarkable given that the chronic disease adherence intervention literature documents much lower success rates.7,22–28 Systematic reviews performed across chronic illness adherence intervention literature have found that statistically significant improvements from baseline adherence ranges from 33%7 to 54.1%.26 Meta-analyses across adherence intervention literature in chronic disease have effect sizes ranging from 0.0423 to 0.74.22 Table 5 illustrates the results of 3 meta-analyses and the 5 systematic reviews.

Table 4 Fluid and dialysis treatment (Kt/V or IDWG) adherence results Author 13

Sehgal et al. Sharp et al.17 Tobin11 Tsay16

Intervention

Results

Cognitive Cognitive-behavioral Hypnotherapy-boaching Cognitive-behavioral

Kt/V1 IDWG1 IDWG IDWG1

1= statistically significant;

= not statistically significant.

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Table 5 Meta-analysis and systematic reviews of chronic disease adherence literature Methods

References

Number of studies evaluated

Effect size

% adherence change

Meta-analysis

Peterson et al.22

N =61

ES 0.74

NA

Systematic review

Roter et al.23 Conn et al.24 McDonald et al.7

N =153 N =33 N =3 (short-term adherence) N =36 (long-term adherence) N =9 (short-term adherence) N =58 (long-term adherence) N =15 N =37 N =63

ES 0.04–0.46 ES 0.33 NA

NA NA 33 50 44.4 44.8 46.6 54.1 80.9

Haynes et al.28

Systematic review of correlational studies

Haynes et al.25 Kripalani et al.26 DiMatteo et al.27

NA NA NA NA

NA = not available.

Methodological differences Methodologically, the 75% success rates of these studies (6/8 studies) may be related to the small number of studies and the homogeneity of the subjects in this review. One study could dramatically alter the results; one statistically less significant study would result in 65% success rate, while one more study would result in 88% success rate. The homogenous hemodialysis population may also have contributed to the high success rates of the interventions. The characteristics of the sample can affect the significance of the desired outcomes. In this review, nonadherent patients were the subjects of study in 5 of the 8 RCTs.11,13–15,17 Utilizing a nonadherent population to test an adherence enhancing intervention increases the likelihood that a measurable effect will be found, increasing the significance of the outcome.29 Also, smaller, more homogenous samples were studied in the cognitive/ behavioral hemodialysis intervention studies than cognitive alone. Statistical power tends to be low with small samples30; however, if a sample is homogenous, a small sample may be adequate (p. 301), and permits a more focused inquiry (p. 306). Homogenous samples enhance internal validity of the study, and also decrease the external validity of the study30 (p. 219). Overall, the studies examined for this review had low variability in the sample with the majority of the sample age being over 50 years, male, and more often African American.

Intervention differences The type of interventions utilized may have contributed to the statistical significance of the studies. Across previ-

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ous meta-analyses and systematic reviews of the chronic disease adherence intervention literature, cognitive/ behavioral interventions are more effective than cognitive alone. McDonald et al.7 found the combination of cognitive/behavioral interventions to be more effective than single interventions. Kripalani et al.26 found that of the 20 statistically significant studies, 6 were behavioral alone (ES 0.27–1.20), 6 were cognitive alone (ES 0.35–1.13), and 8 combined cognitive/behavioral/affective (ES 0.43–1.20). Haynes et al.,25 Peterson et al.,22 and Roter et al.23 also reported that a combination of cognitive/behavioral was more effective than any single type of intervention. In transplantation and dialysis, Dew and colleagues found that a combination of interventions may be successful in transplantation,7,24,25,31 while Denhaerynck et al. suggested that the behavioral dimension of hemodialysis can be targeted by nursing to assess adherence and implement interventions.32 As such, changing knowledge is necessary, but alone is not sufficient to change adherence behavior.24

Theory The absence of theoretical basis of the adherence enhancing intervention was apparent. The 2 theories utilized in the reviewed studies (Self-Regulation Theory and Social Cognitive Theory) address individual adherence behaviors, with minor emphasis on the influence of the environment. Environmental factors such as a health care provider, organization, and system factors were ignored in the reviewed studies. Absence of interventions directed toward the environment potentially may miss an important factor in adherence. Currently, adherence outcomes are assumed to be patient factors and not of the environment in which

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the patient functions.33 Tailoring of the adherence intervention may assist patients to identify areas to enhance behavior change, possibly focusing on the environment in which they function.33 A theory that holds promise in the area of adherence is the ecological model of McLeroy.34,35 McLeroy’s health promotion model targets the individual and the environmental (interpersonal, organizational, community, and public policy) factors maintaining healthy behaviors.35 There are 4 levels within the model: patient, micro, meso, and macro. Interventions that target the patient through behavioral, cognitive, or affective interventions are patient-level interventions. Interventions targeting the micro level are focused on the patient-provider interactions. Interventions targeting the meso level are focused on the treatment center or hospital interactions with the patient. Interventions targeting the macro level focus on the health care system or society. In our systematic review, only one study addressed the meso level23 with the remainder of the studies focusing on the patient level. Other reviews have suggested that addressing environmental factors in addition to patient factors may be successful. In an integrated review of RCTs of medication adherence in the elderly, Russell recommends theorybased interventions by diverse providers and promoting self-management programs to enhance medication adherence in the elderly.36 Krammerer recommends focusing interventions on the individual, the patient-provider relationship, and the system in which the providers function for success in dialysis patient adherence.37

Strengths Strengths of the intervention studies were the standardized outcome measures of hemodialysis adherence utilizing the KDOQI guidelines. The KDOQI guidelines have been established since 1997, leading to standardization of adherence outcome measures. Standardization allows future research to be easily compared across the hemodialysis body of literature. A second strength is that of the 8 studies, 5 studied adherence enhancing interventions in nonadherent patients.11,13–15,17 Utilizing a nonadherent population to test an adherence enhancing intervention increases the likelihood that a measurable effect can be seen, increasing the significance of the outcome.29 Focusing the intervention on nonadherent patients directs the researcher to help those most in need. Focusing clinical care and limited clinic time on nonadherent individuals may have a greater impact on adherence outcomes.

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A third strength is that the interventions did achieve statistically significant improvements in adherence measures, even though the dose and duration of the intervention were limited. The intervention dose was higher (4–12 hours over 4 weeks to 6 months) and follow-up was longer (10 weeks to 6 months f/u) in the cognitive/ behavioral studies than in cognitive alone studies. Short intervention dose and duration may be less expensive, quicker to administer, and may lessen patient burden, leading to improvement in short-term adherence outcomes. The longest follow-up in the reviewed studies was 6 months; therefore, the long-term adherence outcomes are unknown.

Limitations The limitations of the reviewed studies include short intervention dose and duration,11–18 no long-term outcome data,11–18 small sample sizes with a lack of adequately powered studies,11,12,14,15,18 no pediatric interventional studies, lack of theoretical basis for the intervention,11,13–15,17,18 and varied instruments to measure adherence outcomes. Each of these limitations will be briefly detailed. The dose of the intervention and the duration of the follow-up was very short, and therefore the effect on long-term outcomes is not known. Increasing the intensity of the intervention combined with a 1-year or 2-year follow-up is necessary to determine if behavior is changed. Secondly, sample sizes were small and lacked power. Of the 8 studies, all were single center, sample sizes were small, and only 2 studies performed a power analyses.17 Therefore, the remaining studies are underpowered, increasing the risk for a Type II error.38 Third, no pediatric intervention studies were identified. The pediatric population is grossly underrepresented and understudied in the interventional hemodialysis research. No RCTs have been performed in pediatric hemodialysis patients, and only 2 pediatric/adolescent hemodialysis quasiexperimental studies have been performed.39,40 Therefore, generalizability to pediatric populations is limited. Generalizability is limited by other factors. Three studies were performed in the United States with a high representation of African American male samples.11,13,18 International representation with diverse populations would increase the generalizability of the results. In addition, the interventionist in the reviewed studies was most often a dietitian.11,13–15,18 A multidisciplinary team of interventionists may have a greater impact on the adherence outcome. Finally, 7 of the 8 studies included participants who were 450 years of age,12–18 therefore generalizing results to younger adults is limited.

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Fourth, lack of a theoretical basis for the interventions was apparent. Only 2 of the 8 RCTs were theory based, with these studies resulting in statistically significant results.12,16 Adherence research needs to be theory driven, testing constructs to gain insight, and understanding of treatment adherence.29 Fifth, the intervention studies reviewed varied in the measurement of the adherence outcome measures. Sehgal was the only study that utilized treatment adherence (Kt/V) as the outcome measure.13 Additionally, IDWG was measured in multiple ways in the reviewed studies. Sharp measured a weekly IDWG mean, Tsay measured IDWG between dialysis sessions, and Tobin utilized the Kaplan-DeNour-Czaczkes 1972 scale (based on means of IDWG, potassium, and BUN).11,16,17 Diet/medication nonadherence measurement varied across the studies. Diet nonadherence was measured most often by serum phosphorus levels11,12,18 with Ford and Ashurst adding the serum calcium, calcium/phosphorus product, and albumin levels to further assess diet nonadherence.14,15 Self-report of phosphorus binder adherence was utilized by Karamanidou and Ford; self-report can overestimate medication adherence and have decreased validity.12,15,30 According to Denhaerynck, further research is necessary to establish operational definitions of nonadherence and their measures in hemodialysis.32

CONCLUSION In summary, 8 RCTs attempted to improve hemodialysis adherence. This systematic review of treatment, diet, fluid, and medication adherence interventions in hemodialysis patients has shown the strengths and the limitations of the current research to date. The KDOQI parameters were used to make comparison across studies; however, slight adherence measurement variation was noted. Future hemodialysis research must address the lack of diversity in the samples and the use of multidisciplinary teams of interventionists. Future samples must be larger, younger, female, and more ethnically diverse. Physicians, nurses, and social workers in addition to dieticians as the interventionists are also recommended. To change hemodialysis practice, stronger evidence is needed. Integrating findings of this review along with previous meta-analyses, systematic reviews, and integrative reviews, hemodialysis intervention studies must address the environment in which the patient functions, have a theoretical basis, and a behavioral component to enhance medication adherence.41 McLeroy’s theory shows promise in addressing the environmental system and the patient as a whole.34 Theoretical interventions with a behavioral component include motivational interviewing or

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continuous self improvement. These 2 interventions have shown promise in enhancing adherence in other chronic diseases. However, this conclusion is based on few studies with many limitations.

Manuscript received October 2009; revised May 2010.

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